Federal Agencies
Federal Executive Branch
Here's a look at documents from the U.S. Executive Branch
Featured Stories
State Dept. Fact Sheet: 2026 Quad Foreign Ministers' Meeting in New Delhi
WASHINGTON, May 27 -- The U.S. State Department issued the following fact sheet on May 26, 2026:* * *
2026 Quad Foreign Ministers' Meeting in New Delhi
The Foreign Ministers of Australia, India, Japan and the Secretary of State of the United States met in New Delhi, India, on 26 May 2026, for the 11th Quad Foreign Ministers' Meeting.
The Ministers/Secretary of State welcomed recent and upcoming activities conducted by their four countries and in cooperation with partners to advance a free and open Indo-Pacific. Ministers announced key new initiatives to strengthen maritime and transnational ... Show Full Article WASHINGTON, May 27 -- The U.S. State Department issued the following fact sheet on May 26, 2026: * * * 2026 Quad Foreign Ministers' Meeting in New Delhi The Foreign Ministers of Australia, India, Japan and the Secretary of State of the United States met in New Delhi, India, on 26 May 2026, for the 11th Quad Foreign Ministers' Meeting. The Ministers/Secretary of State welcomed recent and upcoming activities conducted by their four countries and in cooperation with partners to advance a free and open Indo-Pacific. Ministers announced key new initiatives to strengthen maritime and transnationalsecurity, economic prosperity and security, critical and emerging technology, and support humanitarian assistance and emergency response across the region.
Maritime and Transnational Security
i. The Quad partners launched the first ever Indo-Pacific Maritime Surveillance Collaboration (IPMSC) initiative to leverage Quad country maritime surveillance in the Indo-Pacific, enhancing information sharing and maritime domain awareness capacity with an initial focus on the Indian Ocean Region as well as through subject matter expert exchanges and tabletop exercises.
ii. The Quad partners expanded their work as part of the Indo-Pacific Partnership for Maritime Domain Awareness (IPMDA). Quad countries are developing a comprehensive Common Operating Picture (COP). The IPMDA initiative enhances maritime domain awareness in the Indo-Pacific, harnessing real-time information in Indo-Pacific maritime zones which will have benefits for the entire region.
iii. India will host the next edition of the Quad-at-Sea Ship Observer Mission to strengthen interoperability and knowledge-sharing to best address unlawful maritime activities across the region.
iv. India hosted two Quad Workshops on counterterrorism in September 2025 focused on Countering the Use of Unmanned Aerial Vehicles (UAVs)/Drones for Terrorist Purposes and Preventing Terrorist Exploitation of New and Emerging Technologies. Quad partners will hold the Quad Counterterrorism Tabletop Exercise focused on state-sponsored terrorism threats and uncrewed aerial vehicles in Australia in June 2026.
Economic Prosperity and Security
i. The Quad partners are pleased to announce the new Quad Critical Minerals Initiative Framework, which will guide Quad partners to leverage economic policy tools and coordinate investment to strengthen critical minerals supply chains, including in mining, processing, and recycling.
ii. Quad partners are pleased to announce the Quad Initiative on Indo-Pacific Energy Security to help strengthen regional energy resilience. Each country will leverage unique resources and capabilities from their respective energy sectors. Through this initiative, Quad partners will work to identify areas of cooperation in technology, management, policy, international market analysis, and emergency response exercises.
iii. Following the Quad Ports of the Future Partnership conference hosted in India in October 2025, the Quad committed to identifying critical port projects that it can support to increase trade and economic prosperity by increasing port infrastructure and capacity for key Indo-Pacific corridors. As such, we are proud to announce that the Quad countries will work with the Government of Fiji, to advance port infrastructure and associated activities in the country.
iv. The Quad has supported various fellowship programs over the years to bolster workforce skills development in the infrastructure, maritime, and STEM sectors. It will continue to explore opportunities that would advance prosperity and national security across the Indo-Pacific.
v. With undersea cable networks under increased risk, the Quad partners are delivering on a commitment to expand and secure resilient connectivity in the Indo-Pacific. In this regard, Quad partners have provided tangible support to ensure that all Pacific Island Forum countries are connected via undersea cables by 2026 to secure their digital futures.
vi. Quad partners are providing important funding and technological assistance across energy technology supply chains in the Indo-Pacific, with combined efforts in this regard exceeding $25 million.
Critical and Emerging Technology
i. We welcome the progress made under the Quad Open Radio Access Networks (Open RAN) cooperation with Palau, which saw the successful selection of trusted suppliers in February 2026. This will strengthen Palau's access to secure 4G and 5G connectivity and contribute to the country's digital supply chain resilience.
ii. The Quad partners intend to collaborate on Next-Gen Communication Standards. This project will focus on promoting Telecommunications and Open RAN technical standards collaboration, focusing primarily on 6G standards development.
iii. The Quad countries concurred on a Workshop on Digital Identity Standards to create a technical "translation guide" to enhance cross-border interoperability. The project aims to ensure that both Quad countries and their respective private sector companies can operate seamlessly with a common recognition for implementation of their respective digital identity standards.
iv. Under the Advancing Innovations for Empowering NextGen Agriculture (AI-ENGAGE) initiative, Quad partner countries have announced over $6 million in awards for six international research projects. These research projects will result in tools for farmers for better crop yields, pest management, and food security leveraging technology innovations. The Quad is committed to using artificial intelligence, robotics, and sensing to transform agriculture and empower farmers across the Indo-Pacific through the initiative.
Humanitarian Assistance and Emergency Response
i. Quad partners are providing training to health professionals in the Indo-Pacific to strengthen responses to public health emergencies such as disease outbreaks, as well as providing tools that benefit the people and the region. Collectively, these efforts are valued at over $50 million.
ii. The tabletop exercise (TTX) and Strategic Working Group meeting in Honolulu in 2025 significantly enhanced the Quad's disaster response capabilities and underscored the Quad's commitment to reliable and effective life-saving support for the people of the Indo-Pacific.
* * *
Original text here: https://www.state.gov/releases/office-of-the-spokesperson/2026/05/2026-quad-foreign-ministers-meeting-in-new-delhi/
STB Institutes Proceeding, Streamlines Permitting for New Rail Line in Nevada
WASHINGTON, May 27 -- The U.S. Department of Transportation's Surface Transportation Board issued the following news release on May 26, 2026:* * *
STB Institutes Proceeding, Streamlines Permitting for New Rail Line in Nevada
The Surface Transportation Board today instituted a proceeding to consider a proposal by Nevada Gold Rail LLC (NG Rail), an affiliate of Nevada Gold Mines LLC (NGM), to construct approximately 55.7 miles of rail line in Eureka and Lander Counties, Nevada. In today's decision, the Board waives certain requirements based on recent changes to the interpretation and application ... Show Full Article WASHINGTON, May 27 -- The U.S. Department of Transportation's Surface Transportation Board issued the following news release on May 26, 2026: * * * STB Institutes Proceeding, Streamlines Permitting for New Rail Line in Nevada The Surface Transportation Board today instituted a proceeding to consider a proposal by Nevada Gold Rail LLC (NG Rail), an affiliate of Nevada Gold Mines LLC (NGM), to construct approximately 55.7 miles of rail line in Eureka and Lander Counties, Nevada. In today's decision, the Board waives certain requirements based on recent changes to the interpretation and applicationof the National Environmental Policy Act (NEPA), thereby streamlining the permitting process while ensuring opportunities for robust public involvement.
NG Rail states that the line would connect NGM's mining facilities to an existing Union Pacific Railroad mainline to allow gold ore transportation by rail instead of truck, which would provide a safer, more cost-effective, and environmentally friendly means of transporting gold ore.
NEPA requires that the Board examine the potential environmental impacts of "major federal actions" that it undertakes. In today's decision, the Board determines that the preparation of an Environmental Impact Statement (EIS) is appropriate. The EIS process here will include meaningful public involvement early in the environmental review and will ensure that the Board considers the potential environmental effects of the line as required under NEPA. The agency has requested preliminary comments from appropriate federal, state, Tribal, and local agencies, and it will host public meetings and provide opportunities for substantive public comment, along with launching a public project webpage that will be updated throughout the EIS process.
Congress, Presidential Executive Orders, the Council on Environmental Quality, and the Supreme Court have changed NEPA's statutory and regulatory framework significantly since the Board last revised its environmental regulations in 1991. Based on these recent changes, and to promote a more efficient and streamlined process, the EIS process laid out in today's decision waives certain requirements in 49 C.F.R. 1105.10(a)(2)-(4) for publication of a Final Scope of Study and a Draft EIS in this proceeding. This process is consistent with the Board's proposed changes to its environmental regulations in Permitting Reform--Environmental Review Process, EP 779 (STB served Mar. 25, 2026).
The Board's Office of Environmental Analysis (OEA) will prepare and publish a Notice of Intent (NOI) to Prepare an EIS, which will include detailed information about the planned scope of analysis for the EIS. The NOI will be more fulsome than under prior Board EIS process and will serve as an opportunity for interested members of the public to substantively engage earlier in the environmental review process. The NOI will also include a request for public comments on potential environmental effects and on relevant information, studies, or analyses with respect to the line. Following the NOI and Scoping, OEA will then prepare and publish an EIS that will analyze in detail the potential environmental impacts of the line, respond to public comments on the NOI, and make any appropriate recommendations for environmental mitigation. OEA will also evaluate the potential impacts of the line on historic properties during the EIS process.
Public participation is an integral part of the Board's environmental review process, and the EIS process in this proceeding is intended to provide ample opportunities for timely public participation. In making its final decision on whether the line should be authorized, and if so, what environmental mitigation conditions to impose, the Board will consider the entire record, including the record on the transportation merits, the NOI, the EIS, and all public and agency comments received.
Today's decision in Nevada Gold Rail LLC--Construction Exemption--in Eureka and Lander Counties, Nevada, Docket No. FD 36889, may be viewed and downloaded here (https://dcms-external.s3.amazonaws.com/DCMS_External_PROD/1779461083183/53043.pdf).
* * *
Original text here: https://www.stb.gov/news-communications/latest-news/pr-26-11/
IRS Issues Notice on Credit for Carbon Oxide Sequestration 2026 Section 45Q Inflation Adjustment Factor
WASHINGTON, May 27 -- The Internal Revenue Service issued the following notice (No. 2026-29) on May 26, 2026, entitled "Credit for Carbon Oxide Sequestration 2026 Section 45Q Inflation Adjustment Factor".* * *
SECTION 1. PURPOSE
This notice publishes the inflation adjustment factor for the credit for carbon oxide sequestration under Sec. 45Q of the Internal Revenue Code (Sec. 45Q credit) for calendar year 2026./1 The inflation adjustment factor is used to determine the amount of the credit allowable under Sec. 45Q for taxpayers that make an election under Sec. 45Q(b)(3) to have the dollar amounts ... Show Full Article WASHINGTON, May 27 -- The Internal Revenue Service issued the following notice (No. 2026-29) on May 26, 2026, entitled "Credit for Carbon Oxide Sequestration 2026 Section 45Q Inflation Adjustment Factor". * * * SECTION 1. PURPOSE This notice publishes the inflation adjustment factor for the credit for carbon oxide sequestration under Sec. 45Q of the Internal Revenue Code (Sec. 45Q credit) for calendar year 2026./1 The inflation adjustment factor is used to determine the amount of the credit allowable under Sec. 45Q for taxpayers that make an election under Sec. 45Q(b)(3) to have the dollar amountsapplicable under Sec. 45Q(a)(1) or (2) apply.
SECTION 2. BACKGROUND
Section 45Q was added to the Code by Sec. 115 of the Energy Improvement and Extension Act of 2008, enacted as Division B of Pub. L. 110-343, 122 Stat. 3765, 3829 (October 3, 2008), to provide a credit for the sequestration of carbon dioxide. Section 45Q was amended by Sec. 1131 of the American Recovery and Reinvestment Tax Act of 2009, enacted as Division B of Pub. L. 111-5, 123 Stat 115 (February 17, 2009), Sec. 41119 of the Bipartisan Budget Act of 2018 (BBA), Pub. L. No. 115-123 (February 9, 2018), Sec. 121 of the Taxpayer Certainty and Disaster Tax Relief Act of 2020, enacted as Division EE of the Consolidated Appropriations Act, 2021, Pub. L. 116-260, 134 Stat. 3051 (December 27, 2020), Sec. 13104 of Pub. L. 117-169, 136 Stat. 1818 (August 16, 2022), commonly known as the Inflation Reduction Act (IRA), and Sec. 70522 of Pub. L. 119-21, 139 Stat. 72 (July 4, 2025), commonly known as the One, Big, Beautiful Bill Act (OBBBA).
Section 45Q(a)(1) allows a credit of $20 per metric ton of qualified carbon oxide (i) captured by the taxpayer using carbon capture equipment which is originally placed in service at a qualified facility before the date of the enactment of the BBA, (ii) disposed of by the taxpayer in secure geological storage, and (iii) not used by the taxpayer as a tertiary injectant in a qualified enhanced oil or natural gas recovery project.
Section 45Q(a)(2) allows a credit of $10 per metric ton of qualified carbon oxide (i) captured by the taxpayer using carbon capture equipment which is originally placed in service at a qualified facility before the date of the enactment of the BBA, and (ii) either (I) used by the taxpayer as a tertiary injectant in a qualified enhanced oil or natural gas recovery project and disposed of by the taxpayer in secure geological storage or (II) utilized by the taxpayer in a manner described in Sec. 45Q(f)(5).
Section 45Q(b)(3) provides that, for purposes of determining the carbon oxide sequestration credit under this section, a taxpayer may elect to have the dollar amounts applicable under Sec. 45Q(a)(1) or (2) apply in lieu of the dollar amounts applicable under Sec. 45Q(a)(3) or (4) for each metric ton of qualified carbon oxide which is captured by the taxpayer using carbon capture equipment which is originally placed in service at a qualified facility on or after the date of the enactment of the BBA.
Notice 2022-38 provided that 2022 was the final calendar year for which a taxpayer may claim a Sec. 45Q credit under Sec. 45Q(a)(1) and (2) for qualified carbon oxide that is captured by carbon capture equipment originally placed in service at a qualified facility before the date of enactment of the BBA. Therefore, the inflation adjustment amounts in section 3 of this notice only apply if a taxpayer elects under Sec. 45Q(b)(3) to apply the dollar amounts applicable under Sec. 45Q(a)(1) or (2) in lieu of the dollar amounts applicable under Sec. 45Q(a)(3) or (4).
Under Sec. 45Q(f)(7), for taxable years beginning in a calendar year after 2009, the dollar amounts contained in Sec. 45Q(a)(1) and (2) must be adjusted for inflation by multiplying such dollar amount by the inflation adjustment factor for such calendar year determined under Sec. 43(b)(3)(B), determined by substituting "2008" for "1990."
Section 43(b)(3)(B) defines the term "inflation adjustment factor" as, with respect to any calendar year, a fraction the numerator of which is the GNP implicit price deflator for the preceding calendar year and the denominator of which is the GNP implicit price deflator for 1990. For purposes of Sec. 45Q(f)(7), for the 2025 calendar year, the inflation adjustment factor is a fraction the numerator of which is the GNP implicit price deflator for 2025 (128.888) and the denominator of which is the GNP implicit price deflator for 2008 (88.046).
SECTION 3. INFLATION ADJUSTMENT FACTOR
The inflation adjustment factor for calendar year 2026 is 1.4639. The Sec. 45Q credit for calendar year 2026 is $29.28 per metric ton of qualified carbon oxide under Sec. 45Q(a)(1) and $14.64 per metric ton of qualified carbon oxide under Sec. 45Q(a)(2).
SECTION 4. DRAFTING INFORMATION
The principal author of this notice is the Office of Associate Chief Counsel (Energy, Credits, and Excise). For further information regarding this notice contact (202) 317-6853 (not a toll-free number).
* * *
Footnote:
1/ Unless otherwise specified, all "section" or "Sec." references are to sections of the Internal Revenue Code or the Temporary Regulations under Title II of the Omnibus Reconciliation Act of 1980 (26 CFR part 6a).
* * *
Original text here: https://www.irs.gov/irb/2026-22_IRB#NOT-2026-29
FDA Human Foods Program Issues Warning Letter to Shineluck Foods
WASHINGTON, May 27 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Shineluck Foods Inc. from its Human Foods Program:* * *
Recipient: Charles C. Li, Owner, Shineluck Foods, Inc., 1919 W. 43rd St., Chicago, IL 60609-3116, United States
Issuing Office: Human Foods Program, United States
WARNING LETTER
CMS # 720155
Dear Mr. Charles C. Li:
The U.S. Food and Drug Administration (FDA) inspected your firm located at 1919 W. 43rd St., Chicago, IL 60609-3116 on October 7, 2025, through October 14, 2025. Our current inspection ... Show Full Article WASHINGTON, May 27 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Shineluck Foods Inc. from its Human Foods Program: * * * Recipient: Charles C. Li, Owner, Shineluck Foods, Inc., 1919 W. 43rd St., Chicago, IL 60609-3116, United States Issuing Office: Human Foods Program, United States WARNING LETTER CMS # 720155 Dear Mr. Charles C. Li: The U.S. Food and Drug Administration (FDA) inspected your firm located at 1919 W. 43rd St., Chicago, IL 60609-3116 on October 7, 2025, through October 14, 2025. Our current inspectionrevealed serious violations of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption regulation (Produce Safety regulation), Title 21, Code of Federal Regulations, Part 112 (21 CFR Part 112). Based on FDA's inspectional findings, we have determined that your mung bean sprouts are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. Sec. 342(a)(4)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health. In addition, failure to comply with the Produce Safety regulation is a prohibited act under section 301(vv) of the Act [21 U.S.C. Sec. 331(vv)]. You can find the Act and FDA's regulations through links on FDA's home page at http://www.fda.gov.
This inspection resulted in FDA's issuance of a Form FDA 483, Inspectional Observations (FDA 483) listing the observations FDA made at your farm during our inspection. To date, we have not received a response to the FDA 483. Our previous inspection of your firm, conducted from August 28, 2023 through September 18, 2023, also resulted in the issuance of an FDA 483. Some observations made during our September 2023 inspections were repeated during our current inspection, as indicated below.
During the current inspection, our FDA investigator observed the following significant violations of the Produce Safety regulation, 21 CFR Part 112:
1. You did not implement a written environmental monitoring plan designed to identify L. monocytogenes if it is present in the growing, harvesting, packing or holding environment, as required by 21 CFR 112.145(a).
Specifically, your "Shineluck Foods Inc. Standard Operating Procedure: Operations ENVIRONMENTAL LISTERIA MONITORING" states in part, "(b)(4)". However, since September 2023, your firm collected environmental samples for Listeria spp. only (b)(4). You did not collect any samples for the 22 months in between September 2023 and July 2025, nor did you collect any samples for September 2025.
This is a repeat observation from the previous FDA inspection.
2. You did not test spent sprout irrigation water (SSIW) from each production batch of sprouts for E. coli O157:H7 and Salmonella species, as required by 21 CFR 112.144(b).
Specifically, you must either: test SSIW from each production batch of sprouts for at least E. coli O157:H7 and Salmonella species, or if testing SSIW is not practicable (for example, soil-grown sprouts harvested with roots or for hydroponically grown sprouts that use very little water), test each production batch of sprouts at the in-process stage (i.e., while sprouts are still growing) for such species.
You place mung beans intended for sprouting into (b)(4) growing bins, (b)(4) from (b)(4) through (b)(4). You typically have at least (b)(4) growing bins active per week. However, you stated that you typically collect (b)(4) samples per day, (b)(4) a week, which indicates that you test SSIW from only (b)(4) growing bins each week. Additionally, a review of your SSIW test results from April 1, 2025, through October 3, 2025, revealed that only (b)(4) growing bins were sampled from the weeks of June 29, 2025, and July 6, 2025, and no samples were collected the week of August 17, 2025.
3. You did not discontinue the use of all seeds from a lot for which you knew or had reason to believe were contaminated with a pathogen, as required by 21 CFR 112.142(b)(1) and you did not report the findings of microbial testing to the entity from whom you received your seeds, as required by 21 CFR 112.142(b)(2).
Specifically, on August 19, 2025, you collected SSIW from Bin (b)(4), (b)(4) growing bins of mung bean sprouts, that tested positive for E. coli O157:H7. In response, you stated (b)(4). You also did not report the information to your seed supplier. Additionally,
you did not perform actions that would have allowed you to continue use of the seeds or not report the information to your supplier. Specifically, you did not treat the seeds with a process reasonably certain to achieve destruction or elimination of the most resistant microorganisms of public health significance likely to occur in the seeds, as stated in 21 CFR 112.142(c)(1), nor did you demonstrate any reasonable determination through appropriate follow-up actions that the lot of seeds was not the source of contamination, as stated in 21 CFR 112.142(c)(2).
4. You did not use equipment and tools that are of adequate design, construction, and workmanship to enable them to be adequately cleaned and maintained, as required by 21 CFR 112.123(a).
Specifically, on October 7, 2025 and October 8, 2025, during (b)(4) of mung bean sprouts, we observed that several strips of silicone applied to the conveyor belt, the equipment used to transport mung bean sprouts from the growing bin to the rinse water basin, were peeling and falling off in some areas while the silicone strips in other areas had already previously peeled or fallen off the belt. We also observed rough welds on the metal panel that directly contacted mung bean sprouts as they fell off the conveyor belt into the rinse water basin.
These conditions make proper cleaning and sanitization of the conveyor belt difficult. This conveyor belt transports mung bean sprouts to a rinse basin before they are placed into final packaging.
5. Your required records were not reviewed, dated, and signed by a supervisor or responsible party within a reasonable time after the records are made, as required by 21 CFR 112.161(b).
Specifically, a review of your SSIW testing records, from April 1, 2025, through October 3, 2025, which are required under 21 CFR 112.150(b)(4)], revealed they were not reviewed, signed, and dated by a supervisor or responsible party.
This is a repeat observation from the previous FDA inspection.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
In addition, we offer the following comments:
* After you received a positive E. coli O157:H7 finding in an SSIW sample, you stated that you collected another sample from the same bin on August 22, 2025, which tested negative. However, this additional test does not indicate that the SSIW was not contaminated with E. coli O157:H7 because it was conducted using a second sample from the same production batch, rather than on the same enrichment sample that resulted in the presumptive positive from the screening test.
* A review of your SSIW testing records, from April 1, 2025, through October 3, 2025, which are required under 21 CFR 112.150(b)(4), revealed that your firm does not maintain records linking each mung bean sprout production batch identification with the seed lots used to produce that production batch. 21 CFR 112.161(a)(1)(iii) requires your records include an adequate description (such as the commodity name, or the specific variety or brand name of a commodity, and, when available, any lot number or other identifier) of covered produce applicable to the record. Seed lot documentation will allow you to effectively correlate positive test results with the seeds that might have been the contamination source.
* On October 8, 2025, employees were observed touching multiple non-food contact surfaces including a broom, black plastic pallet on the ground, scale, conveyor belt, garbage can handles, and electrical cords and then returned to harvesting, rinsing, and packaging mung beans without changing their gloves. 21 CFR 112.32 requires you to ensure that personnel who may contact produce or food contact surfaces use hygienic practices to protect against contamination of produce.
* On October 7, 2025, after cleaning and sanitizing operations were completed, mung bean sprouts and sprout pieces were found between the moving parts of the white conveyor belt, a direct food contact surface, used to transport sprouts from the rinse basin to the hand-packaging area. This equipment was not cleaned or sanitized again before being used to convey, mung bean sprouts on October 8, 2025. Please note that 21 CFR 112.123(d)(1) requires you to inspect, maintain and clean and, when necessary and appropriate, sanitize food contact surfaces as frequently as reasonably necessary to protect against contamination of produce. Further 21 CFR 112.140(b) requires you to establish and keep documentation of the date and method of cleaning and sanitizing of equipment
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps that you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your reply to the Food and Drug Administration, Attention: Rochelle R. Blair, Compliance Officer, Human Foods Program, Food and Drug Administration 5001 Campus Drive, College Park, MD 20740, or electronically to producefarminspection@fda.hhs.gov. If you have questions regarding any issues in this letter, please contact Rochelle R. Blair at (949) 608-4496 or at producefarminspection@fda.hhs.gov.
Sincerely,
/S/ Maria S. Knirk, JD, MBA, Director, Office of Enforcement, Office of Compliance and Enforcement, Human Foods Program, U.S. Food and Drug Administration
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shineluck-foods-inc-720155-04292026
FDA Center for Drug Evaluation & Research Issues Warning Letter to GC America
WASHINGTON, May 27 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to GC America Inc. from its Center for Drug Evaluation and Research:* * *
Recipient: Mr. Joseph T. Talanges, President & Chief Operating Officer, GC America, Inc., 3737 West 127th Street, Alsip, IL 60803, United States
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
Dear Mr. Talanges:
The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, GC America, Inc., FEI 1410097, ... Show Full Article WASHINGTON, May 27 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to GC America Inc. from its Center for Drug Evaluation and Research: * * * Recipient: Mr. Joseph T. Talanges, President & Chief Operating Officer, GC America, Inc., 3737 West 127th Street, Alsip, IL 60803, United States Issuing Office: Center for Drug Evaluation and Research (CDER), United States WARNING LETTER Dear Mr. Talanges: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, GC America, Inc., FEI 1410097,at 3737 West 127th Street, Alsip, Illinois, from November 3 to 7, 2025.
This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
We reviewed your November 21, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.
During our inspection, our investigator observed specific violations including, but not limited to, the following.
1. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2)).
Your firm manufactures OTC drug products, including those for (b)(4). Your firm failed to ensure components were suitable for use in manufacturing your drug products.
(b)(4) Used as a Component in Drug Products
You did not adequately demonstrate your (b)(4), at a minimum, meets specifications in the United States Pharmacopeia (USP) (b)(4) monograph. For example, your (b)(4) system records show that you only performed (b)(4) testing. However, the USP monograph requires additional testing for chemical purity and microbial quality. We also noted you failed to establish a procedure describing (b)(4) sampling requirements and acceptance criteria. According to your management, you manufactured approximately (b)(4) finished drug batches with inadequately tested (b)(4) from 2023 through 2025.
Products Containing Ingredients at Risk for (b)(4) Contamination
You also state in your correspondence to the agency that you do not conduct identity testing on each shipment of each lot of your incoming components at high risk of (b)(4) contamination before using them to manufacture your drug products. This includes, but is not limited to, testing (b)(4) to determine its appropriate identity prior to use in manufacturing your drug products.
Identity testing for (b)(4) and certain other high-risk drug components includes a USP limit test to ensure the component meets the relevant safety limits for (b)(4) levels. Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to assure the acceptability of these components for use in the manufacture of your drug products.
The use of ingredients contaminated with (b)(4) has resulted in various lethal poisoning incidents in humans worldwide. See FDA's guidance document (b)(4).
In your response, you acknowledge you do not perform all testing of (b)(4) per USP, and you commit to sending a sample of your (b)(4) to a third-party testing laboratory. You also commit to conducting a risk assessment of your deficient (b)(4) testing on drug products released from 2023 to 2025 and to establishing a (b)(4) testing SOP.
Your response is inadequate. You do not provide a detailed procedure explaining how you will assess your (b)(4) against compendial requirements. You also lack a comprehensive review of your material system, including supplier evaluations, to ensure the quality of all materials is consistently acceptable.
Without adequate testing, you do not have scientific evidence that components conform to appropriate specifications prior to use in the manufacture of your drug products. As a manufacturer, you have a responsibility to adequately sample, test, and examine drug components before use in production to assure quality.
In response to this letter, provide:
* A procedure for your (b)(4) system monitoring that specifies routine microbial testing of (b)(4) to ensure its acceptability for use in each batch of drug products produced by your firm.
* The current action/alert limits for total counts and objectionable organisms used for your (b)(4) system. Ensure that the total count limits for your (b)(4) are appropriately stringent in view of the intended use of each of the products produced by your firm.
* A procedure governing your program for ongoing control, maintenance, and monitoring that ensures the remediated system consistently produces (b)(4) that meets (b)(4) USP monograph specifications and appropriate microbial limits.
* A comprehensive, independent review of your material system, including but not limited to:
o evaluating all suppliers of materials (components, containers, and closures) to determine if they are reliable and appropriately qualified
o an assessment of all materials to determine whether they are consistently of acceptable quality
o a review to ensure assigned expiration or retest dates are appropriate (supported by data)
o adequacy of the supplier qualification program, and its selection, qualification, and disqualification provisions
* Based on a thorough review, provide a summary of your systems corrective actions and preventive actions (CAPA) to remediate the vendor qualification program and prevent use of unsuitable components, containers and closures.
* Your (b)(4) system qualification report.
* The chemical and microbiological quality control specifications you use to test and release each incoming lot of components for use in manufacturing, including high risk drug components.
* A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier's certificates of analysis instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier's results through initial validation as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of (b)(4), and certain additional high-risk components we note that this includes the performance of (b)(4) of the USP monograph.
* A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.
* A commitment to provide (b)(4) test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of (b)(4).
* A full risk assessment for drug products that are within expiry which contain any ingredient at risk for (b)(4) contamination (including, but not limited to, (b)(4)). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain (b)(4), including customer notifications and product recalls for any contaminated lots. Identify additional appropriate CAPA that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.
2. Your firm failed to establish and follow a written testing program designed to assess the stability characteristics of drug products and to test an adequate number of batches of each drug product to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a) and 211.166(b)).
Your firm failed to establish a stability program with adequate data from long-term or accelerated storage conditions, demonstrating that drug products remain acceptable throughout the labeled expiry period. For example, the only stability data provided for (b)(4) consisted of a single batch tested for (b)(4) at (b)(4) degrees Celsius with no controlled humidity condition. Furthermore, you have no ongoing stability studies for any drugs currently manufactured.
Without an appropriate stability program, you lack adequate scientific evidence to demonstrate your drug products meet established specifications and retain their quality attributes through your labeled expiry.
See FDA's guidance document Q1A(R2) Stability Testing of New Drug Substances and Products to help you meet the CGMP requirements for stability testing at https://www.fda.gov/media/71707/download.
In your response, you acknowledge you do not have an appropriate written testing program to assess the stability characteristics of your drugs. You also state you will test expired reserve samples and perform a risk assessment for distributing drugs without adequate stability data. You also commit to initiating ongoing stability testing and modifying your procedures to include updated stability instructions.
Your response is inadequate. You lack analytical data to show your drugs maintain their quality attributes throughout their shelf life. You also fail to provide updated procedures and training records indicating you have implemented an adequate stability program.
In response to this letter, provide:
* A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:
o Stability indicating methods
o Stability studies for each drug product in its marketed container-closure system before distribution is permitted
o an ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valid
o detailed definition of the specific attributes to be tested at each station (timepoint)
o all procedures that describe these and other elements of your remediated stability program
3. Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit (21 CFR 211.22(d)).
Your quality unit (QU) did not adequately oversee your drug manufacturing operations. For example, your QU failed to ensure adequate control of your analytical data. Our investigator documented an uncontrolled password for the (b)(4) meter affixed to a laptop by a sticker used for processing (b)(4) meter test results. In addition, the data from the (b)(4) meter is automatically deleted when the laptop is shutdown, so no records were available to show that your QU reviewed this data. Furthermore, you were unable to provide audit trails or an SOP describing oversight and retention requirements of electronic records. The lack of proper electronic record controls undermines the reliability and integrity of your laboratory data (21 CFR 211.68(b)).
Your QU also failed to perform annual product reviews of your drug products since our previous inspection in 2018. Furthermore, no written procedures for this requirement were available (21 CFR 211.180(e)).
In your response, you acknowledge you did not exercise appropriate controls to ensure authorized access to electronic records. Also, you commit to removing shared passwords, creating a data integrity policy, and implementing an annual product review procedure.
Your response is inadequate. You do not provide updated procedures and training records to demonstrate you have corrected your data control deficiencies. You also lack product quality assessments.
Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA's guidance document Data Integrity and Compliance with Drug CGMP: Questions and Answers for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.
We strongly recommend that you retain a qualified consultant to assist in your remediation. In response to this letter, provide:
* A comprehensive investigation into the extent of the inaccuracies in data records and reporting including results of the data review for drugs distributed in the United States. Include a detailed description of the scope and root causes of your data integrity lapses.
* A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations.
* A management strategy for your firm that includes the details of your global corrective action and preventive action plan. The detailed corrective action plan should describe how you intend to ensure the reliability and completeness of all data generated by your firm including microbiological and analytical data, manufacturing records, and all data submitted to FDA.
* A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:
o A determination of whether procedures used by your firm are robust and appropriate
o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices
o A complete and final review of each batch and its related information before the QU disposition decision
o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.
* A complete assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm's documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.
CGMP Consultant Recommended
Based upon the nature of the violations we identified at your firm, you should engage a qualified consultant as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements.
Your use of a consultant does not relieve your firm's obligation to comply with CGMP. Your firm's executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.
Conclusion
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.
Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.
Failure to address violations may also cause FDA to withhold issuance of export certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.
This letter notifies you of our findings and provides you with an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 1410097 and ATTN: Matthew Jensen.
Sincerely,
Kennerly K. Chapman -S, Francis Godwin, Director
Digitally signed by Kennerly K. Chapman -S
Date: 2026.05.14 15:58:58 -04'00'
Office of Manufacturing Quality Office of Compliance
Center for Drug Evaluation and Research
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gc-america-inc-727602-05142026
Census Bureau Releases New Educational Enrollment Data
WASHINGTON, May 27 (TNSrep) -- The U.S. Census Bureau issued the following tip sheet on May 26, 2026:* * *
Census Bureau Releases New Educational Enrollment Data
The U.S. Census Bureau today released data tables examining the educational characteristics of people age 3 and over. Data are based on statistics from the 2024 School Enrollment Supplement.
In 2024, 23.4% of people age 3 and over were enrolled in school. Of those age 3 and over enrolled in school:
* 11.3% were in nursery school or kindergarten.
* 42.7% were in elementary school.
* 22.8% were in high school.
* 23.2% were in college ... Show Full Article WASHINGTON, May 27 (TNSrep) -- The U.S. Census Bureau issued the following tip sheet on May 26, 2026: * * * Census Bureau Releases New Educational Enrollment Data The U.S. Census Bureau today released data tables examining the educational characteristics of people age 3 and over. Data are based on statistics from the 2024 School Enrollment Supplement. In 2024, 23.4% of people age 3 and over were enrolled in school. Of those age 3 and over enrolled in school: * 11.3% were in nursery school or kindergarten. * 42.7% were in elementary school. * 22.8% were in high school. * 23.2% were in college(undergraduate or graduate school).
Other Highlights
Nursery School and Kindergarten Enrollment
* In 2024, 58.8% of U.S. children ages 3 to 4 were enrolled in school, up 5.3 percentage points from 53.5% in 2023.
* 53.5% of children ages 5 to 6 were enrolled in nursery school or kindergarten.
Elementary and High School Enrollment
* In 2024, 38.9% of children ages 5 to 6 and 96.4% of children ages 7 to 13 were enrolled in elementary school (grades 1 through 8).
* 85.1% of children ages 14 to 17 were enrolled in high school (grades 9 through 12).
* 83.7% of male children and 86.6% of female children ages 14 to 17 were enrolled in high school.
College Enrollment
* In 2024, 57.9% of students age 18 and older enrolled in college (undergraduate or graduate school) were female and 42.1% were male.
* 79.1% of students age 18 and older enrolled in college were enrolled in undergraduate 2- or 4-year programs, and 20.9% were enrolled in graduate programs.
The Current Population Survey, sponsored by the Census Bureau and the U.S. Bureau of Labor Statistics, is the primary source of labor force statistics for the nation's population. The Census Bureau and the National Center for Education Statistics sponsored the October 2024 School Enrollment Supplement. Definitions and information on confidentiality protection, methodology, and sampling and nonsampling error are available in the technical documentation. All comparative statements in this release have undergone statistical testing and are statistically significant at the 10% confidence level.
* * *
View data tables here: https://www.census.gov/data/tables/2024/demo/school-enrollment/2024-cps.html
* * *
Original text here: https://www.census.gov/newsroom/press-releases/2026/educational-enrollment-data.html
BLS: Portland-Vancouver-Hillsboro Metro Area Employment Down 32,600 From March 2025 to March 2026
WASHINGTON, May 27 (TNSLrpt) -- The U.S. Department of Labor Bureau of Labor Statistics issued the following document on May 26, 2026, from Economics Daily:* * *
Portland-Vancouver-Hillsboro metro area employment down 32,600 from March 2025 to March 2026
From March 2025 to March 2026, nonfarm payroll employment increased in 8 metropolitan areas, decreased in 8 areas, and was essentially unchanged in 371 areas.
* * *
Chart: Over-the-year percent change in total nonfarm employment for metropolitan areas, not seasonally adjusted
* * *
The largest over-the-year employment increases occurred ... Show Full Article WASHINGTON, May 27 (TNSLrpt) -- The U.S. Department of Labor Bureau of Labor Statistics issued the following document on May 26, 2026, from Economics Daily: * * * Portland-Vancouver-Hillsboro metro area employment down 32,600 from March 2025 to March 2026 From March 2025 to March 2026, nonfarm payroll employment increased in 8 metropolitan areas, decreased in 8 areas, and was essentially unchanged in 371 areas. * * * Chart: Over-the-year percent change in total nonfarm employment for metropolitan areas, not seasonally adjusted * * * The largest over-the-year employment increases occurredin San Jose-Sunnyvale-Santa Clara, California (+17,900), Raleigh-Cary, North Carolina (+15,400), and Fresno, California (+9,300). The largest over-the-year percentage gains in employment occurred in Barnstable Town, Massachusetts (+5.1 percent), and Traverse City, Michigan (+4.7 percent), followed by Atlantic City-Hammonton, New Jersey, and Merced, California (+3.5 percent each).
The largest over-the-year employment decreases occurred in Washington-Arlington-Alexandria, DC VA MD WV (-107,900), Portland-Vancouver-Hillsboro, Oregon-Washington (-32,600), and Toledo, Ohio (-7,800). The largest over-the-year percentage decreases occurred in Sierra Vista-Douglas, Arizona (-5.1 percent), Yuma, Arizona (-4.1 percent), and Washington-Arlington-Alexandria, DC VA MD WV (-3.2 percent).
These data are from the Current Employment Statistics program and are not seasonally adjusted. Data for the most recent month are preliminary. To learn more, see "Metropolitan Area Employment and Unemployment (State and Metro Area) -- March 2026." We also have charts related to the latest "Metropolitan Area Employment and Unemployment" news release.
* * *
SUGGESTED CITATION
Bureau of Labor Statistics, U.S. Department of Labor, The Economics Daily, Portland-Vancouver-Hillsboro metro area employment down 32,600 from March 2025 to March 2026 at https://www.bls.gov/opub/ted/2026/portland-vancouver-hillsboro-metro-area-employment-down-32600-from-march-2025-to-march-2026.htm (visited May 27, 2026).
* * *
View original text plus charts and tables here: https://www.bls.gov/opub/ted/2026/portland-vancouver-hillsboro-metro-area-employment-down-32600-from-march-2025-to-march-2026.htm