Following the Supreme Court’s February 2026 decision invalidating the tariffs imposed under the International Emergency Economic Powers Act (IEEPA), the Trump Administration invoked Section 122 to impose a temporary 10% tariff on nearly all imports entering the United States. Section 122 authorizes the President to impose temporary import restriction when “fundamental international payments problems” exist, including serious deficits or imminent depreciation of the U.S. dollar. The Trump Administration justified the tariffs on the United States’ trade deficit and broader economic concerns. 

In a split decision, a CIT three-judge panel ruled that the Trump Administration’s use of Section 122 tariffs was invalid and unauthorized by law. The majority emphasized that Congress enacted Section 122 to address limited balance-of-payments emergencies during a very different and specific international monetary environment. Under the majority’s reading, that environment shaped the meaning of the term “balance of payments deficits” in the law. The majority found that the conditions invoked by the Trump Administration were not balance of payments under the law and therefore, could not support imposing duties under Section 122.

The CIT declined to issue a nationwide injunction, so the decision only applies to the three successful private parties and the State of Washington. Therefore, Section 122 collections will continue as to all other importers. This case, however, was immediately appealed, and the appeals court imposed a temporary stay of the lower court’s decision and scheduled briefing on whether to extend the stay until the end of the appeal. 

Dental Trade Alliance members should monitor this case as it winds its way through appeal. At this moment, little likelihood exists that any future Section 122 refund claims you may wish to raise will be lost in the event the appeals court(s) affirm the CIT’s decision.

If you have any questions about this alert, please contact Rick Van Arnam, DTA’s regulatory affairs counsel, at rvanarnam@barnesrichardson.com.

• CAPE system deployment and purpose: CAPE automates the removal of IEEPA-related duty lines, recalculates duties as if IEEPA duties were never owed, and consolidates refunds into lump sums rather than issuing entry-by-entry refunds.
• Refund request submission: Importers of Record (IORs) or brokers submit CAPE Declarations via the ACE Portal by uploading CSV files listing up to 9,999 entry numbers; multiple declarations can be filed for larger sets.
• Validation process: CAPE performs two-stage validation with file-level checks (format, authorization, file integrity) and entry-level checks that exclude entries flagged for reconciliation, drawback, protests, certain AD/CVD statuses, or those more than 80 days past liquidation. Entries failing entry-level validation are removed but others continue processing.
• Operational guidance: CBP advises submitting CAPE declarations before filing drawback claims and avoiding submissions for entries where surety paid IEEPA duties in whole or part.
• Liquidation and reliquidation timelines: Unliquidated entries are generally set to liquidate 45 days after CAPE acceptance unless in extended, suspended, or under-review status; warehouse entries follow standard procedures. Liquidated-but-not-final entries reliquidate the next business day.
• Refund consolidation and offsets: Refunds are consolidated by IOR or designated 4811 party and liquidation date, issued as lump sums via ACH, and offset for unpaid CBP debts. Consolidated refunds may combine entries from multiple declarations and vary in timing due to differing entry statuses.
• Expected refund timing: For standard unliquidated, non-warehouse entries not under extended or suspended status, refunds are expected to be generally issued within 60 to 90 days after CAPE acceptance, including CBP review and Treasury processing time, barring additional compliance review.
• Protests and Post Summary Corrections (PSCs): Importers may withdraw protests filed solely for IEEPA refunds within 80 days of liquidation to expedite processing and submit via CAPE. PSCs cannot be used to request IEEPA refunds and should be filed before CAPE submissions if needed to correct other information relating to the entry that does not involve the IEEPA refunds.
• Monitoring and ACH payments: Refund activities can be tracked through the ACE Portal’s REV-615 CAPE Refunds Trade Report. All refunds are issued electronically via ACH, requiring IORs or designated parties to be enrolled for ACH to avoid delays.

To utilize the CAPE, you must have an ACE account with CBP. Follow this link to set up an account if you don’t have one. And you need to activate the ACH Refund Authorization Tab, as explained in these directions.

Note that CAPE currently can only handle entries that have not liquidated, or which have not achieved finality of liquidation, which from CBP’s perspective is the liquidation date plus 80 days. CBP has stated that CAPE II will be able to handle entries where liquidation has become final, but it is unclear if and when CAPE II will be operational. Also, please be mindful that while the government is busy working to develop the CAPE, the very real possibility exists that the government will appeal the court’s order mandating that CBP establish it. If this happens, I assume that no refunds will be issued via the CAPE while the appeal proceeds. And if the government is successful with its appeal, then it is possible that the CAPE will not be authorized to process refunds, at which point claim would become time barred as the finality of liquidation will occur. For these reasons, we continue to recommend that you protest entries that have liquidated to keep them from achieving final liquidation and bring a court case to cover entries where liquidation became final before the date of the finality of the Supreme Court decision.

If you have any questions about the IEEPA Tariff Refund Process, please contact Rick Van Arnam, DTA’s regulatory affairs counsel, at rvanarnam@barnesrichardson.com.

• Micro and small enterprises may use an external Person Responsible for Regulatory Compliance (PRRC) who needs to be ‘available’ rather than ‘permanently and continuously’ present
• Small and medium sized enterprises (SMEs) benefit more broadly from eased regulatory obligations, i.e., audits and fees, reflecting their role in innovation and device availability
• Remove the 5-year re-certification cycle with the certificates of conformity being valid for more than 5 years
• Creation of specific categories with accelerated procedures
• Electronic submission of all documents and information including the EU Declaration of Conformity and labeling in digital format
• Simplified rules for repackaging and relabeling, including the removal of the requirement for a notified body certificate and prior notification obligations for these activities
• Targeted adaptations of classification rules, resulting in lower risk classifications for certain devices, such as reusable surgical instruments, accessories to active implantable devices and certain software
• Reduced frequency of a Periodic Safety Update Report (PSUR): every two years for class IIb/III devices, and “as necessary” for class IIa devices, lessening administrative burden
• A definition of “well-established technology”
• Greater flexibility in the use of clinical and non-clinical data, including increased reliance on non-clinical evidence and new approach methodologies

Additionally, the DTA and MedTech Europe, our European trade association counterpart, met to discuss the implications of the proposal. Overall, its simplification measures, i.e., removed 5-year recertification cycle, risk-based sampling during conformity assessment, recognition of well-established technologies (WET), acceptance of non-clinical evidence and digitalization are welcome revisions.

Please click on the button below to download MedTech Europe's Summary Position on the MDR/IVDR revision.

Click Here to View the Summary Position

Also included is the amended regulation dated March 20, 2026 of the class IIb implantable devices exempted from the obligation to perform an assessment of the technical documentation for every device and the expansion of the list of WET. Please click on the button below to download a copy of the delegated act.

Click Here to View the Expansion List of WET

This proposal will expand the list of WET referred to in the EU MDR, which includes several new dental devices, i.e., dental implants, orthodontic devices, dental barriers, bone fillers and substitutes. The expanded list of devices will be exempt from some legal requirements and reduce administrative burden. This act has been adopted and is now in the 3-month scrutiny phase. We are hopeful that there will be no objections and it will be published in the next few months.

Lastly, while the timeline for the EU MDR approval is a moving target, a best estimation for approval would be closer to mid-2027. The good news is some of the short-term measures are already being implemented, such as electronic Instructions for Use (eIFUs) for professional use for all medical devices as noted here.

The DTA will continue to monitor any new developments with the EU MDR and update our members as we learn of them. If you have any questions, please contact Colleen Boswell, DTA Regulatory and Compliance Specialist, at cboswell@dentaltradealliance.org or call directly at 714-585-3431.

Section 301 investigations look at the practices of foreign countries and if found to create an unreasonable or discriminatory burden on or otherwise restrict US trade, then the US can attempt to remediate those unjustified practices via the imposition of tariffs. In the case of the countries listed above, the US will be eyeing structural excess capacity and overproduction in various manufacturing sectors to see if such acts or practices are damaging U.S. production.

The U.S. has requested consultation with those countries as a first step in these investigations. The next step will be the public comment period. Ambassador Greer stated that the window will open on March 17th, and close on April 15th. During this period, stakeholders may submit written comments in favor or against the proposed actions and can request an opportunity to be heard at a public hearing scheduled for May 5th. Those interested in appearing not only need to request that opportunity before April 15th but must also submit a summary of their anticipated testimony by then as well.

As mentioned above, it is anticipated that the duty rates assigned to these countries will mirror the rates that those countries previously negotiated with the U.S. (for those countries that had done so), or the IEEPA rates implemented when the initial 90-day pause was lifted. If the current China Section 301 duties serve as an example, these new Section 301s will stack on top of other duties.

DTA will continue to keep members informed on evolving US trade policy.

If you have any questions about this alert, please contact Rick Van Arnam, DTA’s regulatory affairs counsel, at rvanarnam@barnesrichardson.com.

First, Customs makes it clear that it cannot comply with the current court order to liquidate entries now without respect to IEEPA. In other words, do not expect refunds of today’s liquidations. This is true for a variety of technical reasons. Therefore, Customs is proposing to create a new functionality in it automated commercial environment (“ACE”) for this purpose. The elements would be:

• Each importer (i.e. IOR) files a declaration in ACE that includes a complete list of entries on which IEEPA duties were paid
• ACE validates that each entry has IEEPA duties and recalculates the entry without IEEPA
• CBP verifies (as soon as practicable, which is legalese for “eventually”) the refund and interest for processing
• ACE then finalizes (liquidates or reliquidates, per the proposal) the entries
• CBP then certifies the refunds
• Treasury electronically transfers refunds and interest to the importer
• Customs believes it can create the infrastructure for this within 45 days

There are some important details that will still need to be worked out. Not the least of which is the treatment of entries that liquidated more than 90 days ago (and so are no longer open to Customs for its voluntary action but are still able to be captured in a court case), as well as how importers should deal with normal protest issues in the ordinary course.

However, there are several things you can do today. First, ensure you can receive electronic refunds from Treasury. Second, start reviewing your trade data to understand what your claim would look like in this system. Third, do not start counting your money, since “as soon as practicable” is not “soon.” Fourth, focus your energy on the steps above. Court cases, protests, and PSCs may no longer be needed in the immediate future if this proposal or one similar is accepted.

If you have any questions about this alert, please contact Rick Van Arnam, DTA’s regulatory affairs counsel, at rvanarnam@barnesrichardson.com.

Submitted via www.regulations.gov

The Honorable Lee Zeldin
Administrator
U.S. Environmental Protection Agency
1200 Pennsylvania Ave. NW
Washington, DC 20460

Attn: Megan Nelson
Chemical Information, Prioritization, and Toxics Release Inventory Division (7406M)
Office of Pollution Prevention and Toxics
U.S. Environmental Protection Agency

Re: Comments of Interest Party, The Dental Trade Alliance “Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) Data Reporting and Recordkeeping Under the Toxic Substance Control Act (TSCA); Revision to Regulation; Docket No. EPA-HQ-OPPT-2020-0549

Dear Administrator Zeldin:

On behalf of the Dental Trade Alliance (“DTA”) I respectfully submit the following written comments in response to Docket No. EPA-HQ-OPPT-2020-0549, “Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) Data Reporting and Recordkeeping Under the Toxic Substance Control Act (TSCA); Revision to Regulation.” The DTA is a member supported trade association, consisting of suppliers and service providers to the oral health profession.

Our main goal is to improve the state of oral health care in the United States, and toward that goal the organization provides resources, knowledge-sharing opportunities and advocacy that supports businesses throughout the United States, as well as the rest of the world. DTA members manufacture and distribute essential, and in some cases life-supporting, medical devices and dental products.

The DTA offers the following comments on the agency’s proposal to implement a de minimis level exception to the PFAS reporting requirement and to exclude from the reporting requirement imported articles containing PFAS. In addition, DTA believes that the existing schedule for reporting PFAS to the EPA, currently scheduled to commence on April 13, 2026, needs to be extended until after this rulemaking is completed.

1. The EPA Should Revise its Regulations to Remove the Reporting Requirements for Imported Articles and for Domestically Produced Articles that Contain PFAS

As originally promulgated, the EPA reporting regulations require importers of articles that contain the presence of PFAS in them to identify and report on that presence during the decade-long lookback period. Only recently has the EPA begun focusing on the presence of chemical substances (like PFAS) in articles, rather than limiting its concern to chemicals as discrete articles of commerce in bulk form. We respectfully submit this new approach is inconsistent with the governing statute and creates an unreasonable burden on importers and domestic companies that produce products containing PFAS.

As the EPA recognizes in these proposed revisions, the National Defense Authorization Act for Fiscal Year 2020 (“NDAA”), which amended the Toxic Substances Control Act (TSCA) to add the PFAS reporting requirement to section 8(a) of the TSCA, can be read as excluding PFAS in articles from the reporting requirement. We agree with that reading. The operative language of the amended statute requires PFAS reporting from “each person who has manufactured a chemical substance that is a [PFAS] in any year since January 1, 2011.” Clearly, an article (imported or produced domestically) is not a “chemical substance that is a [PFAS];” it is a different article of commerce entirely. Had the drafters intended to include PFAS in articles they would have used different statutory language, such as “chemical substance that is a [PFAS] or an article containing PFAS.” Having failed to do so, the EPA should not expand the statute by its regulations to include an additional class of merchandise that is not a chemical substance.

For this reason, DTA supports the EPA’s proposal to exempt imported articles that contain PFAS from the reporting requirement. By doing so, the EPA will be lessening the burden on private actors, a goal consistent with its reason for the proposed revisions. DTA believes that its members are representative of companies that import foreign made articles and then distribute them in the U.S. As such, requiring information on imports of articles (rather than bulk chemicals) during a lookback period starting in 2011 creates an unreasonable burden by requiring companies to provide data they never had in the first place. Those articles have long since been out of the control of the companies that imported them (or manufactured them domestically), and many of them, having reached their end-of-use, are no longer in existence. Furthermore, articles imported more than a decade ago may no longer even be in commercial circulation today, which raises questions about the value of collecting historical data in evaluating today’s exposure levels and risks caused by PFAS.

For this same reason, DTA believes that the proposed exception for imported articles should be expanded to include all articles, imported or produced domestically. The NDAA does not distinguish between imported and domestically produced articles, as it makes no mention of either. Therefore, excepting all articles from the reporting requirements is the appropriate construction of the NDAA.

2. DTA Supports the De Minimis Concentration Exemption

The DTA supports the EPA’s proposal to create a 0.1 percent de minimis exception for PFAS in mixtures and articles. As the EPA recognizes, during the lookback period for reporting, reporters are unlikely to have records of PFAS amounts below 0.1 percent due to U.S. and international requirements at the time, such as labeling and recordkeeping requirements. In addition, PFAS that remain in products at de minimis levels may be present unintentionally as impurities or byproducts, meaning their unintended presence in a mixture or article could be undocumented and nearly impossible for the manufacturer to report to the EPA. Incorporating a de minimis limit so that reporting is excused where PFAS levels are below that limit is consistent with the EPA’s goal of reducing reporting requirements by excluding data of lesser value for calculating PFAS exposures during the lookback period.

While DTA supports incorporating a de minimis threshold, the EPA should consider limiting reporting where certain production volume thresholds are not met. The EPA already utilizes this approach in administration of the TSCA, so it has experience administering manufacturing minimums which, if not met, would excuse PFAS reporting of those products. See generally 40 CFR § 711.9. This approach would also decrease the amount of information affected companies would need to gather, analyze, and submit to the EPA and would only impact PFAS reporting for products produced in low volumes.

3. The April 13, 2026 Submission Window Start Date Should be Postponed Until After EPA Concludes this Rulemaking and Promulgates any Revisions to the Current Regulation

DTA requests that the reporting submission period, currently scheduled to open on April 13, 2026, be postponed until several months have passed after completion of this rulemaking. As currently drafted, the proposed revisions contemplate several changes that will greatly impact the companies that need to report their PFAS usage during the lookback period.

Six to nine months would be an appropriate extension, giving affected parties the opportunity to complete their review of the lookback period pursuant to the revised regulations. The EPA will also need to complete beta testing on its reporting application before the reporting window opens. This will give the agency time to resolve programming issues and allow the user community to train personnel to use the system. DTA understands that the original reporting window was already extended, but under the current circumstances we believe another extension is appropriate.

In sum, the DTA thanks you for the opportunity to comment on this important issue. Please contact us via email should you have questions regarding this submission.

Sincerely,

Greg Chavez
CEO, Dental Trade Alliance
GregChavez@dentaltradealliance.org

¹ If the EPA were to expand the proposed exemption currently contemplated for imported articles to include all articles, then the need for a de minimis exception for articles would be moot.

The Honorable Howard W. Lutnick
Secretary of Commerce
U.S. Department of Commerce
1401 Constitution Ave., N.W.
Washington, DC 20230

Attn: Stephen Astle
Director, Defense Industrial Base Division
Office of Strategic Industries and Economic Security
Bureau of Industry and Security
U.S. Department of Commerce

Re: Request for Comments: "Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Personal Protective Equipment, Medical Consumables, and Medical Equipment, Including Devices;" Docket No. BIS-2025-0258, XRIN 0694-XC134

Comments of the National Association of Dental Laboratories, American Dental Association, Association of Dental Support Organizations and the Dental Trade Alliance

Dear Mr. Secretary:

We respectfully submit on behalf of the National Association of Dental Laboratories (NADL), American Dental Association (ADA), Association of Dental Support Organizations (ADSO) and the Dental Trade Alliance ("DTA") as a concerned dental related coalition the following written comments in response to Docket No. BIS-2025-0258, "Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Personal Protective Equipment, Medical Consumables, and Medical Equipment, Including Devices" we submit these comments opposing the proposed Section 232 action, in particular as it relates to medical devices and equipment used in the dental and related professions.

As a diverse group of associations representing dental professionals, dental support companies, dental manufacturers and dental distribution companies all working in unison to provide oral health care and device solutions to patients in the United States we have come together to provide our comments on the proposed 232 action.

We share the administration's desire to protect the national and economic interests of the United States but respectfully submit that our country's national security interests are not threatened by the current dental medical device supply chain, as required under Section 232. To the extent that national security vulnerabilities exist within the larger scope of the "medical devices" supply chain, then the Department of Commerce should be judicious in its use of tariffs to address only those foreign sourced medical devices that threaten national security. We do not believe, however, that dental medical devices, consumables, equipment or PPE fall into this category.

Dental medical devices play a vital role in domestic oral healthcare, and while much of it is manufactured offshore by FDA-registered manufacturers, those devices are already subject to the existing tariff regimes imposed under Section 301 of the Trade Act of 1974 ("Section 301") and/or the International Emergency Economic Powers Act ("IEEPA"). These companies that import and distribute dental medical devices, consumables, equipment and PPE are U.S. companies that service U.S. professional practices. Adding an additional tier of Section 232 duties to imported dental medical devices will only add to an increase to the overall cost of healthcare.

In turn, these increased costs will be passed down through the supply chain to dental practices and laboratories and then ultimately to patients. In this scenario, the ripple effect of added tariffs runs contrary to the Administration's stated goal to "Make America Healthy Again." Higher dental costs, brought on by the cost of tariffs passed on by the importers through the supply chain, will result in fewer patients seeking dental care. Thus, U.S. citizen-patients, already confronted with increasing healthcare costs for non-tariff reasons such as inflation, will experience greater out-of-pocket costs if Section 232 duties are imposed on dental medical devices. These higher dental healthcare related costs will have an immediate negative impact on patients accessing dental care.

Furthermore, by delaying routine oral health exams because of rising costs, patients increase the risk that other, more serious oral conditions and diseases will go undetected. A significant amount of scholarly research has shown a direct link in periodontal disease to several chronic diseases including diabetes, cardiovascular disease, and stroke. The economic burden imposed by a sectoral section 232 duty on medical devices, consumables, equipment and PPE, in addition to the existing Section 301 and IEEPA tariffs, will have a negative impact on oral healthcare in the U.S. as those costs are passed through the supply chain to dental patients. Clearly, MAHA goals are not met when people skip visits to their dentists because of the expense or cannot purchase dental products because of cost.

We do not believe that the national security of the United States is compromised by the existing device supply chain for dental-related medical devices, consumables, equipment and PPE. Dental medical devices, consumables, equipment and PPE are not sensitive, defense-related goods. Unlike other products that are subject to existing Section 232 duties, such as steel and aluminum, the U.S. dental device market is healthy and globally competitive.

While approximately 2/3rd of dental medical devices is foreign sourced, no significant overreliance on countries adverse to the U.S.'s interest exists. In fact, it is reported that U.S. origin medical devices, taken as a whole, constitute seventy percent of the medical devices used in hospitals. Dental medical devices, consumables, equipment and PPE benefit practitioners and patients as tools to promote and effectuate good oral health. They are not the types of products that provide any strategic or national security benefit to the United States, and as such do not create the possible adverse scenarios that a Section 232 remedy is designed to address.

The Notice seeks response to certain questions. Below are our responses to some of those questions.

Questions (i) – (iv), and (viii):

• Current and projected demand in US for the subject merchandise.
• Can US domestic production meet US domestic demand.
• The role of foreign supply chains in meeting US domestic demand.
• The concentration of US imports from a small number of suppliers or foreign nations.
• The feasibility of increasing domestic capacity for the subject merchandise.

It is estimated that the current market size for dental medical devices is between $5.5 billion to $6.0 billion and is projected to grow to between $7.5 to $8.0 billion annually by 2030. The aging population in the U.S., chronic oral health conditions, and cosmetic dentistry are principal drivers of this growth.

U.S. domestic production, while strong, cannot currently meet overall market demands, thus necessitating foreign-based supply chains. Expanding capacity or building new manufacturing facilities in the United States will require time and capital. Thus, reshoring foreign production will require new or retrofitted facilities, which will be more difficult to finance if working capital is now required for tariffs while these new facilities are produced. Also, organizations are facing challenges of staffing because of low unemployment and the availability of fewer skilled workers, factors which will further complicate reshoring initiatives.

As mentioned above, approximately 2/3rd of dental medical devices in the U.S. market are of foreign origin. Approximately 30 percent is of Chinese origin, with the rest coming from the following countries Mexico, Germany and Japan all of which combine for approximately 35 percent of the overseas products. Thus, most of the foreign-source dental medical devices are from countries historically allied with the United States. Because the bulk of imported dental medical devices come from reliable foreign sources that currently do not threaten to impair U.S. national security, but rather are allied with the U.S. in security objectives, it is respectfully submitted that no overreliance exists on markets that could pose threats to the U.S. U.S. citizens benefit from the current supply chain for devices that are readily available and to a large part affordable.

Questions (v) – (vii), and (x) – (xi):

• Impact of foreign government subsidies or predatory trade practices impacting manufacturers in the US of like products.
• Impact of foreign state-sponsored overproduction on US manufacturers of like products.
• The ability of foreign governments to weaponize the supply of the subject merchandise.
• The potential for foreign control or exploitation of supply chains for the subject merchandise.
• The ability of foreign entities to weaponize the capabilities or attributes of foreign-built PPE, medical consumables, and medical equipment, including devices.

Over the years the dental device industry has encountered examples of foreign governments subsidizing certain products or markets, but these were extremely limited. Foreign overcapacity in certain product areas, such as low-cost rotary burs and generic handpieces does exist however, we do not believe the scope of this would be considered an example of predatory pricing sponsored by a foreign government.

Nor do we believe that the existing supply chain for dental medical devices, equipment, consumables and PPE could be subject to foreign-government or person weaponization or exploitation. Foreign-based manufacturing facilities and foreign-based exporters looking to sell into the U.S. market must comply with stringent FDA oversight. This includes agency authorization for certain classes of dental medical devices prior to entering the United States market, and compliance with current good manufacturing practices and quality systems, which are subject to FDA audit.

For these reasons, the market for dental medical devices is low risk for weaponization by foreign governments, and we have seen no direct evidence of weaponization existing currently. We believe that dental medical devices still are not of a class of merchandise that should trigger national security concerns and thus do not need a Section 232 remedy to safeguard against such concerns.

Questions (ix) and (xii):

• Impact of current trade policy on domestic production of the subject merchandise and whether duties or quotas are necessary to protect national security.
• Any other relevant factors.

We feel that duties or quotas on dental medical devices, consumables, equipment and PPE are not necessary to protect the national security of the United States for the reasons stated above. We do not believe that increasing tariffs on these products will result in stabler economic conditions, better access to resources or protection from global market disruptions for these products.

Instead, the U.S. dental companies and practices involved in importing, distributing and prescribing these products will experience greater economic hardship if the existing tariff regime is augmented by a new Section 232 tariff, likely at a rate exceeding most reciprocal tariff rates. We believe that such products should not be subject to duties under Section 232, as their importance to healthcare has not changed.

In sum, we appreciate the opportunity to comment on this important issue. Please contact us via email should you have questions regarding this submission.

Sincerely,

Betsy A. Shapiro, D.D.S., J.D.
Interim Executive Director, American Dental Association
shapiroe@ada.org

Bennett Napier
Executive Director, National Association of Dental Laboratories
bennett@executiveoffice.org

Andrew Smith
Chief Executive Officer, Association of Dental Support Organizations
asmith@theadso.org

Greg Chavez
Chief Executive Officer, Dental Trade Alliance
GregChavez@dentaltradealliance.org

Submitted via www.regulations.gov

The Honorable Lee Zeldin
Administrator
U.S. Environmental Protection Agency
1200 Pennsylvania Ave. NW
Washington, DC 20460

Attn: Susan Euling
Drinking Water Science and Engineering Division
Office of Ground Water and Drinking Water
U.S. Environmental Protection Agency

Re: Comments of Interest Party, The Dental Trade Alliance
"Review of Science on Fluoride in Drinking Water: Preliminary Assessment Plan and Literature Survey"
Docket No. EPA-HQ-OW-2025-3823FRL 131-01-OW

Dear Administrator Zeldin:

On behalf of the Dental Trade Alliance ("DTA") we respectfully submit the following written comments in response to Docket No. EPA-HQ-OW-2025-3823FRL 131-01-OW, "Review of Science on Fluoride in Drinking Water: Preliminary Assessment Plan and Literature Survey."

The DTA is a member supported trade association, consisting of suppliers and service providers to the oral health profession. Our main goal is to improve the state of oral health care in the United States, and toward that goal the organization provides resources, knowledge-sharing opportunities and advocacy that supports businesses throughout the United States, as well as the rest of the world. DTA members manufacture and distribute essential, and in some cases life-supporting, medical devices and dental products.

The DTA supports efforts to determine safe and effective usage levels for fluoride, and we recognize the well-established science showing that fluoride at levels at or below the U.S. recommended level of 0.7 mg/L is safe for use preventing cavities and tooth decay in children. The DTA, however, respectfully submits that the EPA's current examination of fluoride toxicity values must utilize peer-reviewed studies and reject those studies that are not peer-reviewed or are recognized as flawed by the scientific community.

The DTA has heard from several oral health professionals and professional organizations regarding this matter. Below please find a number of studies that the profession recommends the EPA utilizes:

1) Jayanth V. Kumar, Mark E. Moss, Honghu Liu, Susan Fisher-Owens, Association Between Low Fluoride Exposure and Children's Intelligence: a Meta-Analysis Relevant to Community Water Fluoridation, Public Health, vol. 219, pp. 73-84 (water fluoridated for caries presentation (~0.9 ppm) has no effect on cognitive development (8 studies); 2) John Robert Warren, Gina Rumore, Soobin Kim, Eric Grodsky, Chandra Muller, Jennifer J. Manly, Adam M. Brickman, Childhood Fluoride Exposure and Cognition Across the Life Course, Science Advances, vol 11, no. 47, (In a study across a wide swath of the US starting in 1980 and concluding in 2021, water fluoridated for caries prevention (~0.9 ppm) may have had positive effects and did not have any negative effects on cognitive development (57,960 high schoolers and 13,260 when they were 60 years old). Additionally, we believe the EPA should update its literature survey to include all relevant reports that may have been issued in 2025 and 2026. This will create a well-rounded selection of reports and viewpoints.

In sum, the DTA thanks you for the opportunity to comment on this important issue. Please contact us via email should you have questions regarding this submission.

Sincerely,

Greg Chavez
Chief Executive Officer
GregChavez@dentaltradealliance.org

Scot Andersen
Chair, DTA Board of Directors
scot.andersen@ultradent.com

The Honorable Donald J. Trump
President of the United States
White House
1600 Pennsylvania Avenue
Washington, DC 20500

Re: Allied Position of the Dental Trade Alliance, the American Dental Association and the National Association of Dental Laboratories Regarding the Economic Impact of Increased Duties on the Dental Industries and the Oral Health Community

Dear President Trump:

The Dental Trade Alliance (“DTA”), the American Dental Association (“ADA”) and the National Association of Dental Laboratories (“NADL”) support President Trump’s goal of boosting the U.S. economy. The widespread use of tariffs, however, jeopardizes the availability of key dental and other medical devices, and other supplies, that are essential to the provision of dental care in the U.S. For this reason, the DTA, ADA and NADL respectfully request that the administration exclude medical devices and other key supplies used by the American dental industry from any additional duties, and roll back those additional duties already being assessed on medical devices used by the U.S. dental industry.

Currently, many dental products and accessories, including raw materials, tools, instruments and equipment used in dental practices and laboratories (“Dental Equipment”), are subject to the existing China Section 301 duties and the recently imposed additional ten percent duties on Chinese origin merchandise. Furthermore, Dental Equipment produced in the United States from foreign origin steel or aluminum will now become more expensive as the tariffs assessed on those raw materials filter down through the supply chain.

Lastly, the contemplated twenty-five percent duties on Mexican and Canadian origin Dental Equipment, and any possible reciprocal tariffs on foreign origin Dental Equipment, will cause economic consequences felt first by DTA members, as the initial importers or producers of the Dental Equipment, then by dentists, oral surgeons, emergency room physicians, commercial dental laboratories and other oral health professionals as those costs are passed on, and eventually to consumers, who will see the cost for oral healthcare increase to offset the duties being assessed on these FDA regulated medical devices.

The DTA members who are importing the Dental Equipment, as well as the dental professionals in the ADA and NADL who purchase and use them, are U.S. companies and U.S. professional practices, often small businesses. They employ U.S. citizens in good paying jobs with benefits. These associations, however, believe that lost business, reduced staff, delayed business expansion and possible discontinuation of some product lines of medical devices will result from wide use of tariffs. This will result in increased cost of care, which will ultimately be passed on to the patient.

In turn, these increased costs will negatively impact oral health in the U.S. Higher dental costs result in fewer patients seeking care. Thus, patients, already confronted with ever increasing health costs for non-tariff reasons, will ultimately experience greater out-of-pocket costs because these additional duties are now being assessed on dental medical devices and other imported dental materials, tools and equipment, which costs then get absorbed into the patient’s bill.

Furthermore, by delaying routine oral health exams because of rising costs, patients increase the risk that other, more serious oral conditions and diseases will go undetected. Thus, the economic burden imposed by extra duties on dental medical devices, as passed on to health care providers and then to their patients, ties to a negative public health impact in the U.S. when U.S. citizens skip trips to the dentist because of cost.

Thank you for the opportunity to raise this important issue to your attention. Please contact us via email should you have questions regarding this request.

Sincerely,

Betsy A. Shapiro, D.D.S., J.D.
Interim Executive Director
American Dental Association
shapiroe@ada.org

Bennett Napier
Executive Director
National Association of Dental Laboratories
Bennett@executiveoffice.org

Greg Chavez
CEO
Dental Trade Alliance
GregChavez@dentaltradealliance.org

¹ The DTA is a member supported trade association, consisting of suppliers and service providers to the oral health profession. DTA members manufacture and distribute essential, and in some cases life-supporting, medical devices and dental products, including personal protective equipment for fighting the COVID-19 pandemic. The ADA, with approximately 159,000+ members, is the leading advocate for dentistry in the U.S. Its mission is to help dentists succeed and to support the advancement of oral healthcare in the U.S. The leading trade association for the dental laboratory industry, the NADL represents commercial dental laboratories that serve the dental profession as they fulfill their integral role in the deliverance of oral healthcare.

Additionally, electronic or written comments are encouraged. These comments must be submitted by July 16, 2025, with the specifics detailed in the Federal Register Notice referenced below.

As background, prescription fluoride drops and tablets for ingestion were first marketed in the U.S. in the 1940s to prevent dental caries, particularly in children who lived in areas with low or no water fluoridation. Although these products are still prescribed today, none have been reviewed and approved by FDA for safety, effectiveness, or quality. FDA has previously not taken action to remove such unapproved drug products from the market. Over the years, numerous medical and dental organizations in the United States have recommended the use of ingestible fluoride products for individuals for whom regular topical treatment is difficult to achieve and those for whom topical fluoride only is insufficient to avoid dental decay.

Because the FDA continuously monitors the safety of drug products in the U.S., including marketed unapproved prescription drug products, they became aware of recent scientific research on the safety of ingestible fluoride. While the safety concerns presented in the scientific literature have generally focused on fluoride levels greater than those found in prescription drug products marketed in the U.S., given that these products are predominantly used in young children, FDA is undertaking a review of their safety.

Click Here to Read the Full Federal Register Notice.

If you have any questions about this alert, please contact Colleen Boswell, the DTA’s regulatory and compliance specialist, at colleenboswell@dentaltradealliance.org.

Click here to download the full document. 

If you have any questions about this alert or the topic, please contact Rick Van Arnam, DTA’s regulatory affairs counsel, at rvanarnam@barnesrichardson.com.

We are excited to kick off DTA’s Regulatory and Compliance Committee 2.0, but in order to do so, we need your help!

The purpose of our Regulatory and Compliance Committee is to engage with DTA members to address current and potential regulatory and compliance issues. As the DTA’s membership has grown, we would like to extend an invitation to our new regulatory professionals to join our committee and request that our current committee members confirm their continued participation.

Click here to confirm your participation as a committee member.

Once our Committee members are established, we will convene our Regulatory and Compliance Committee. It would be helpful if you could identify key issues that you would like the DTA Committee to address so we can begin tackling these important topics, such as CA Prop 65, PFAS compliance state/national/international, EUMDR, to name a few. Click the link below to enter the portal to submit your items. 

Click here to enter the portal. 

• The CIT decision was immediately and temporarily “stayed” by the US Court of Appeals for the Federal Circuit while the parties brief the court on whether the stay should be extended to cover the entire period of the appeal. A decision on the stay extension request is expected by the middle of June. Because a stay is now in place (perhaps only temporarily), the IEEPA-based duties remain in effect and are being assessed and collected on imports currently being entered.
• A second court, the US District Court for the District of Columbia, issued a preliminary injunction against the continued assessment and collection of IEEPA duties on goods imported by the two named plaintiffs in that case. The DC District Court preliminarily determined that the President likely exceeded his authority by using the IEEPA to impose customs duties, finding that the likelihood of the plaintiffs’ ultimate success in the lawsuit warranted a preliminary injunction to protect the two plaintiffs from irreparable harm that the court determined would befall them. Then the DC District court stayed its preliminary injunction for fourteen days to allow the government time to seek an immediate appeal at the US Court of Appeals for the DC Circuit.

Click here to download the full document.

If you have any questions about this alert or the topic, please contact Rick Van Arnam, DTA’s regulatory affairs counsel, at rvanarnam@barnesrichardson.com.

On May 28, 2025, the U.S. Court of International Trade (“CIT”) issued a decision that permanently enjoined all tariffs imposed by President Trump using the International Emergency Economic Powers Act (IEEPA). The CIT, established under Article III of the U.S. Constitution, has nationwide jurisdiction over civil actions arising out of the international trade laws of the United States. This decision extends to all importers of goods subject to the IEEPA duties.

The now-enjoined IEEPA tariffs are the following:

1. The 25 percent tariffs on goods from Mexico and Canada, which were imposed to address the fentanyl and illegal immigration issues.
2. The 20 percent tariff on goods from China, which was imposed to address the fentanyl issue.
3. The “reciprocal” tariffs, currently at 10 percent but scheduled to graduate to higher country-specific rates for approximately 60 countries and the EU, which were imposed to address the balance of trade issues.

The court, a three-judge panel with judges appointed by Reagan, Obama and Trump, found that President Trump’s use of the “reciprocal” duties went beyond the authority granted to him under the IEEPA to use tariffs as a means of regulating importations. Furthermore, the IEEPA duties assessed on Canada, Mexico and China goods based on the fentanyl problem and illegal immigration were found to be improper because they do not deal with those threats.

The court has given the government 10 days to implement a means to shut down the collection of the IEEPA duties. Neither the decision nor the order makes any mention of possible refunds for duties already paid.

Meanwhile, the government has already filed a notice of appeal with the U.S. Court of Appeals for the Federal Circuit. We expect the next step will be the government seeking an immediate stay of execution of the CIT’s decision. If granted, then the IEEPA duties will continue to be collected during the pendency of the appeal, which will eventually make its way to the U.S. Supreme Court.

This decision does not impact duties assessed and paid under the China section 301 tariffs, as section 301 is a different statutory delegation than the IEEPA. The court case contesting the section 301 duties is still on appeal before the Federal Circuit. Nor does it affect the existing 25 percent section 232 tariffs on steel and aluminum and on autos and auto parts.

1. The Upcoming PFAS Reporting Requirement has been Delayed.

In a previous counsel alert, DTA informed its members that the EPA had finalized regulations for reporting per- and polyfluoroalkyl substances (PFAS). Under this one time reporting requirement, manufacturers and importers of PFAS and articles containing PFAS in them need to report their use, disposal and hazards associated with these PFAS that occurred during the period January 1, 2011 through December 31, 2022. Now, the PFAS reporting period will open on April 13, 2026, and close on October 13, 2026.

2. The DOL Reverts to Previous Test for Determining Independent Contractor or Employee Status

As previously reported by the DTA, in January 2024, the DOL released a final rulemaking in which it announced a new test for determining whether one was an employee or an independent contractor. It is now taking steps to walk back from that test and to reinstate the test it used previously, known as the “economic reality” test. In doing so, the DOL will now look to see if the employee “follows the usual path of an employee and is dependent on the business which he or she serves.”

Click here to download the full document. 

If you have any questions about this alert or the topic, please contact Rick Van Arnam, DTA’s regulatory affairs counsel, at rvanarnam@barnesrichardson.com. 

On June 26, 2024, the U.S. Supreme Court issued Loper Bright Enterprises v. Raimondo, a 6-2 decision (Justice Jackson recused herself), overruling the Chevron deference doctrine established in Chevron U.S.A. Inc. v. National Resources Defense Council. In essence this decision emphasizes the judiciary’s role in interpreting laws and clarifies that agency interpretations of statutes receive no deference when those statutes are unclear. In doing so, Loper Bright has significant implications for administrative law and the balance of power between federal executive agencies and the courts.

This case centered around a challenge to a rule issued by the National Marine Fisheries Service interpreting a federal fishery law, the Magnuson-Stevens Act. Under the Chevron doctrine, a court reviewing an agency action had to give deference to a “permissible” interpretation of a statute by that agency even if the court read the statute differently. Thus, under Chevron, courts deferred to agency interpretations of statutes if the statute was ambiguous.

In Loper Bright, the Supreme Court overruled Chevron. In turn, it held that the Administrative Procedure Act requires courts to exercise independent judgment in deciding whether an agency has acted within its statutory authority. Courts may no longer simply defer to an agency’s interpretation of the law solely because a statute is ambiguous. The Court emphasized that Article III of the U.S. Constitution assigns the federal judiciary the responsibility to adjudicate statutory disputes. While respecting agency interpretations, courts must not blindly defer to them.

What impact will Loper Bright have? Most obvious is that the test used to challenge federal agency action has changed, as deference to the agency’s action is no longer the standard. A court will now gauge independently an agency’s action based on the court’s interpretation of the statutory language in question and its legislative history. A basic tenet of adminnistrative law had been that federal agencies were well positioned to interpret statutes impacting their jurisdictions because they have special understanding of the issues they regulate. In the post-Chevron world, however, courts may impose their interpretation of ambiguous statutory language that resulted in a particular agency action, notwithstanding the subjectmatter expertise possessed by the agency.

Loper Bright will invigorate litigators, as the elimination of the Chevron hurdle makes challenging administrative actions easier. Look for an increase in lawsuits contesting longsettled regulations, to be decided by a judiciary arguably ill prepared to address the technical questions typically resolved by knowledgeable agency personnel. For example, this could result in challenges to the way medical devices, including dental devices, are regulated by the Food and Drug Administration. And those agencies will need to be more cautious in their statutory interpretations and agency rulemaking, mindful that their actions are now open to broader judicial second-guessing. In sum, if challenged in the courts, much policymaking authority historically exercised by federal agencies now will be exercised by the judiciary.

New Salary Requirements to Qualify as Exempt from Minimum Wage and Overtime

1. To qualify as an executive, administrative, or professional employee (“EAP”) under the Fair Label Standards Act (FLSA), and thus exempt from the overtime and minimum wage pay requirement, an employee must generally be compensated on a predetermined and fixed salary basis at a weekly rate not less than:
   Beginning July 1, 2024, $844 per week ($43,888 per year); increased from the current rate of $684 per week ($35,568 per year).
   Beginning January 1, 2025, $1,128 per week ($58,656 per year).
2. To be exempted from overtime and minimum wage as a highly compensated employee (“HCP”), the final rule increases the amount of annual compensation an employee earns to:
   Beginning July 1, 2024, $132,965 or more per year; increased from the current amount of $107,432 (at least $684 per week).
   Beginning July 1, 2025, $151,164 or more per year.
   
   

Certain employees, including doctors, lawyers, teachers and outside sales employees are not subject to the salary tests. Also, qualifying as either an EAP or an HCP requires satisfaction of other regulatory requirements setting out certain duties associated with executives, administrative, professional employees.

Will These Changes Really Go into Effect?

Time will tell whether the changes will be implemented on July 1, 2024. In 2016, the Labor Department pushed forward a similar proposed rulemaking, only to have it struck down by a federal district court in Texas. As of now, no court case has been brought to enjoin the changes from going live on July 1st.

However, two Republican lawmakers, Rep. Tim Walberg (Mich) and Sen. Mike Braun (Ind), have introduced a resolution under the Congressional Review Act (“CRA”) to block the changes from being promulgated. Under the CRA, agencies must report the issuances of rules to Congress and provide Congress with special procedures in the form of a joint resolution of disapproval under which Congress may overturn the administrative rule. If a joint resolution is approved or disapproved by the Senate and the House and is signed by the President, or if Congress were to override a Presidential veto, then the rule cannot go into effect.

We will continue to monitor this matter and will advise the association of further developments on this topic. 

The new test adopts a totality of the circumstances approach, and looks to several economic factors to determine if, as a matter of economic reality, an individual is an employee or an independent contractor under the FLSA. No one factor is considered more important than the others; however, situational circumstances could result in one or more factors having differing importance. In determining whether a worker is an employee under the FLSA, the following factors will be considered:

1. The worker’s opportunity for profit or loss depending on their managerial skills – This criterion looks at a worker’s independence in making and exercising managerial decisions. For example, does the worker negotiate what they charge or what they are paid? Can the worker decide which jobs to perform or how to grow their business? Does the worker make hiring or other managerial decisions? “Yes” responses to these and similar questions weigh in favor of finding an independent contractor.
2. Investments made by the worker – this criterion analyzes whether any investments made by the worker are capital or entrepreneurial in nature. Investments of new capital or actions that are entrepreneurial in nature typically serve a business-like function by increasing a worker’s ability to do more or different work, or to do it more cost effectively. These types of investments are indicative of an independent contractor. They should not, however, be confused with work-related expenses imposed by an employer on a worker required to perform a specific job, such as the cost of tools and equipment necessary for performance.
3. Degree of permanence of the work relationship – Where the work relationship is indefinite in duration or continuation, or is exclusive of work for other employees, then this factor would weigh in favor of the worker being an employee.
4. The nature and degree of control – This factor looks at who can control the work and economic aspects of the workplace. For example, does the worker have control over factors such their work schedules or who supervises them? Is the worker free to work for others? Also important to this factor are things like who controls the economic aspects of the working relationship, such as who sets prices or rates for services, or markets the services or products of the worker. An employee relationship is supported where the worker does not control these and similar factors.
5. The extent to which the work performed is an integral part of the potential employer’s business – Is the function being performed by the worker an integral part of the business? If so, then the work being performed, being critical, necessary, or central to the potential employer’s business, weighs in favor of the worker being an employee.
6. Skill and initiative required for job – Whether the worker uses specialized skills to perform the work required of the position is considered under this factor. If the work is not specialized, or the employer must train the worker to perform the work, then this factor weighs in favor of finding that the worker is an employee. While both employees and independent contractors can bring specialized skills to a workplace, an independent contractor status arises where the use of those skills supports the worker’s, rather than the employer’s, business initiatives.
7. Additional factors – Factors in addition to the ones highlighted above may also be considered if those factors shed light on whether the worker is in business for themself, or economically dependent on someone else.

No single factor determines whether a worker is an employee or an independent contractor. Instead, these economic reality factors are assessed and weighted to answer the question. Also, a worker cannot voluntarily choose to be considered an independent contractor. If an employee is an employee under the economic reality factors, then the worker is an employee for purposes of the FLSA.

One last point. The economic reality factors are to be used for determining worker classification under the FLSA. Similar determinations under other laws, such as the Internal Revenue Code or various state laws, are controlled by definitions germane to those laws.

Any questions can be directed to Rick Van Arnam, the Dental Trade Alliance’s regulatory affairs counsel, at rvanarnam@barnesrichardson.com.

DTA is seeking more industry representative to participate in the ANSI and international ISO standards. For more information for participating in Dental Standards, please contact Fred Freedman fredfeedman@dentaltradealliance.org at DTA.

More than 40 U.S. volunteers, industry representatives along with FDA and ADA staff participated in ISO TC 106 Meetings over six days in Berlin, Germany. U.S. industry participation allows U.S. companies to shape and write the standards for all dental devices, equipment and ancillary products in the dental space. Without U.S. participation, other international manufacturers have an opportunity to write standards that in some cases supports their device specifications but may be at odds with U.S. manufacturing.

For more information about ISO Standards and ANSI sponsored TC 106 Working Groups, please reach out to Fred Freedman from the DTA at fredfeedman@dentaltradealliance.org.

• IAF Global Certificate Database
  • UDI Class I Compliance
  • EU MDR
  • China 301 Duties

• CA Prop 65
  • CA “Do No Flush”
  • Vaccine Mandate
  • EU Potential BpA Ban

• Salary Transparency Laws
  • Electronic Data Confidentially Issues
  • Electronic Health Record System Interoperability
  • S 4408 – would prohibit data brokers from selling and transferring certain sensitive data.
  • H.R.8152 - To provide consumers with foundational data privacy rights, create strong oversight mechanisms, and establish meaningful enforcement.

• 1st Week of Meetings September 19-23 (virtual for everyone)
• 2nd Week of Meetings September 26-30 (in-person in Berlin)

• Choose in-person for your registration even though the first week will be virtual.
• A U.S. delegation outing Sunday, September 25 with a U.S. delegation reception on Monday, September 26 evening.