Legislation Archives - The National Law Forum

Illinois Ruling on Civil Liability for Employers Confirms Risks to Companies

Since their inception, the Illinois Workers’ Compensation Act (820 ILCS 305/1 et seq.) and Workers’ Occupational Diseases Acts (820 ILCS 310/1 et seq.) (the “Acts” or “Act”) have offered some certainty and predictability with respect to injuries sustained in the course of employment. The Acts provide a clear framework within which injured employees may pursue claims against their employers and ensures they can receive payment of their medical expenses, lost wages associated with their injuries, and compensation for any permanent disabilities and/or disfigurement sustained, without having to prove fault on behalf of the employer. In exchange, the employer pays for these benefits and enjoys some predictability and limitations on the allowable damages under the Acts, assured that the Acts offer the exclusive remedy against the employer, such that no civil lawsuits, where awards may include pain and suffering and be much higher in value, may be brought against them for the same injury. Generally, an employer would be entitled to the exclusive remedies provided under the Acts, assuming that the injury or disease was accidental, arose during and in the course of employment, and is compensable under the Acts. 820 ILCS 310/5(a), 11 (West 2022); 820 ILCS 305/5(a), 11 (West 2022). So, understandably, when an employer is sued in a civil court for a work-related injury, they may look to the protection of the Acts, to defend the claim and argue for dismissal based on the Acts’ exclusivity provisions.

The Acts contain a repose period of 25 years for injury or disability caused by exposure to asbestos. See 820 ILCS 310/1(f) and 820 ILCS 305/1(f). Thus, prior to 2019, no claims could be brought under the Acts more than 25 years after the date of last exposure to asbestos. In the 2015 landmark case of Folta v. Ferro Engineering, 43 N.E. 108 (Ill. 2015), Mr. Folta claimed his mesothelioma was caused, at least in part, from exposure to asbestos while working for his employer, Ferro Engineering, for whom he last worked in 1970. Mr. Folta was diagnosed with mesothelioma over 40 years later in 2011, and filed a civil lawsuit against Ferro (and others) in state court. Ferro moved to dismiss the civil suit, arguing that Mr. Folta’s exclusive remedy was found in the Workers’ Occupational Disease Act, and could not be brought as a civil action against it. However, Mr. Folta argued that because more than 25 years had passed since his exposure to asbestos at Ferro, his claim would be barred by the 25-year repose period and is not “compensable” under the Act, leaving him without any remedy if not allowed to proceed in state court. The Illinois Supreme Court affirmed that the Act’s 25-year statute of repose acts as a complete bar, and yet still held that the Act provided Mr. Folta’s exclusive remedy against his employer. The Court noted the question of “compensability” turned on whether the type of injury sustained would fall within the scope of the Act, not whether there is an ability or possibility to recover benefits under the Act. Given that Mr. Folta’s injury was compensable, the Act provided his exclusive remedy, and his claim under the Act was time-barred by the 25-year statute of repose.

While acknowledging that the outcome may be a harsh result as to the plaintiff, leaving him with no remedy against his employer for his latent disease, the Court in Folta noted its job is not to find a compromise, but to interpret the statutes as written, suggesting if a different balance should be struck, it would be the duty of the legislature to do so. And that is what happened in 2019, when the Illinois Senate and House introduced two new statutes carving out exceptions to the exclusive remedy provisions for both the Workers’ Compensation and Workers’ Occupational Diseases Acts. Under the new statutes, the Acts no longer prohibit workers with latent diseases or injuries from pursuing their claims after the repose period in civil court. The new statute added to the Workers Occupational Disease Act, 820 ILCS 310/1.1, states:

Permitted civil actions. Subsection (a) of Section 5 and Section 11 do not apply to any injury or death resulting from an occupational disease as to which the recovery of compensation benefits under this Act would be precluded due to the operation of any period of repose or repose provision. As to any such occupational disease, the employee, the employee’s heirs, and any person having standing under the law to bring a civil action at law, including an action for wrongful death and an action pursuant to Section 27-6 of the Probate Act of 1975, has the nonwaivable right to bring such an action against any employer or employers.

When Governor J.B. Pritzker signed the bill into law in May 2019, he issued a statement, indicating the purpose of the revised legislation is to allow workers to “pursue justice,” given that in some cases, the 25-year limit is shorter than the medically recognized latency period of some diseases, such as those caused by asbestos exposure. The impact on employers, however, was not addressed. And employers were left with questions, including critically, whether this new change to the law can apply retroactively, when the statute itself is silent as to the temporal scope. Having relied on the provisions of the Acts in place at the time for basic and critical business decisions, including procurement of appropriate insurance and establishment of wages and benefits, employers cannot now go back in time and change those decisions to offset the increased liability which they now face. Further, following Folta, employers have a vested defense in the Acts’ exclusivity and statute of repose provisions. So, retroactive application of the new statutes could impose new liabilities not previously contemplated and could strip defendant employers of their vested defenses, violating Illinois’ due process guarantee. Anticipating plaintiffs’ firms would file latent disease claims against employers in civil court going forward, and with decades of case law to support prospective application only, it was just a matter of time before the issue reached further judicial scrutiny.

And that brings us to the Illinois Supreme Court’s January 24, 2025 decision in the matter of Martin v. Goodrich, 2025 IL 130509. Mr. Martin worked for BF Goodrich Company (“Goodrich”) from 1966 to 2012, where he was exposed to vinyl chloride monomer and vinyl chloride-containing products until 1974. He was diagnosed with angiosarcoma of the liver, a disease allegedly caused by exposure to those chemicals, in December of 2019, passing away in 2020. His widow filed a civil lawsuit against Goodrich alleging wrongful death as a result of his exposure, invoking the new exception found in section 1.1 of the Act to bring the matter in civil court. In response, Goodrich moved to dismiss the case based on the Act’s exclusivity provisions, arguing that section 1.1 did not apply because Section 1(f) was not a statute of repose. Alternatively, Goodrich argued that using the exception to revive Martin’s claim would infringe its due process rights under the Illinois Constitution. The district court denied Goodrich’s motion, and Goodrich asked the court to certify two questions to the US Court of Appeals for the Seventh Circuit for interlocutory appeal: first, whether section 1(f) is a statue of repose for purposes of section 1.1, and second, if so, whether applying section 1.1 to Martin’s suit would violate Illinois’ constitutional due process. Finding the questions impact numerous cases and Illinois’ policy interests, the Seventh Circuit certified the questions, and added a third question: if section 1(f) falls within the section 1.1 exception, what is the temporal reach? Answering these questions, the Illinois Supreme Court held that (1) the period referenced in section 1(f) is a period of repose, (2) the exception in section 1.1 applies prospectively pursuant to the Statute on Statutes, and therefore, (3) it does not violate Illinois’ due process guarantee.

But what did the Court mean when it held that the exception in section 1.1 applies prospectively? Goodrich argued that prospective application would mean that the exception in section 1.1 does not apply to this case, because the last exposure was in 1976, before the amendment was made, and the defendant had a vested right to assert the statute of repose and exclusivity provisions of the Act, which would prohibit the civil suit. The Court pointed out, however, that the amendment did not revive Mr. Martin’s ability to seek compensation under the Act, such that the employer’s vested statute of repose defense would apply. Rather, the amendment gave him the ability to seek compensation through a civil suit outside of the Act. So, the question becomes only whether the employer has a vested right to the exclusivity defense, such that applying section 1.1 would violate due process. The Court held that the exclusivity provisions of the Act are an affirmative defense, such that the employer’s potential for liability exists unless and until the defense is established. And a party’s right to a defense does not accrue until the plaintiff’s right to a cause of action accrues. Applying the new statute prospectively, the Court found the cause of action could be filed in civil court, because the relevant time period for considering applicability of the affirmative defense of the Act’s exclusivity is when the employee discovers his injury. Since Mr. Martin’s cause of action accrued when he was diagnosed in December of 2019, which was after section 1.1 was added, Goodrich did not have a vested exclusivity defense, so Mr. Martin’s claim may proceed without violating due process.

While the court did not apply the new statute retroactively, the effect is essentially the same from the employers’ perspective, as latent injury claims will be allowed to proceed in civil court, as long as the injuries were discovered after expiration of the repose period and after the new statutes went into effect in May of 2019. This was not the outcome defendant employers were hoping to receive, but it is what the Court decided. So, unless or until the legislative tides change again, Illinois employers should be aware of the potential for civil suits for employees’ latent injury or disease claims.

President Trump Enacts Regulatory Freeze and Halts Public Communications for Federal Agencies

On January 20, 2025, President Donald Trump signed a memorandum titled, “Regulatory Freeze Pending Review,” imposing a regulatory freeze on all federal agencies.
The key points of the regulatory freeze are as follows:
- Do not Propose or Issue Any New Rules: Agencies cannot propose or issue any new rules in any manner, including sending them to the Office of the Federal Register (OFR), until they are reviewed and approved by a department or agency head appointed by the President.
- Automatically Withdrawing Unpublished Rules: Any rules that have been sent to the OFR but have not yet been published must be immediately withdrawn to be reviewed by a department head or agency head appointed by the President.
- Delay Effective Date of Already Published Rules: For rules that have been published but have not yet taken effect, agencies are to consider postponing their effective date for 60 days to review any questions of fact, law, or policy. During this period, agencies may open a comment period for public input and consider further delaying the rules if necessary.
The freeze applies not only to rules but also to any substantive agency action, including Advanced Notices of Proposed Rulemaking (ANPR), Notice of Proposed Rulemaking, notices of inquiry, and any agency statement of general applicability that sets forth a policy on any regulatory or technical issue.
This freeze will impact all recently proposed rules by requiring them to undergo a review process, which may lead to the rules being withdrawn, modified, or delayed in implementation. The following recently proposed rules or finalized but not yet effective rules issued by FDA include:
- Revoking the use of red dye No.3 in food and ingested drugs;Proposed rule regarding front-of-package nutrition labeling;Final rule on the nutrient content claim “healthy”; and
- Final rule on requirements for additional traceability (FSMA 204).
Alongside the regulatory freeze, President Trump has directed federal agencies to temporarily stop all public communications. This includes press releases, social media updates, and other public statements. The pause is in effect through February 1.
Keller and Heckman will continue to closely monitor any changes made to pre-existing proposed or finalized rules and any new executive orders or rules promulgated by the new administration.

…But Wait, There’s More!

In 2025, eight additional U.S. state privacy laws will go into effect, joining California, Colorado, Connecticut, Montana, Oregon, Texas, Utah, and Virginia:

Delaware Personal Data Privacy Act (effective Jan. 1, 2025)
Iowa Consumer Data Protection Act (effective Jan. 1, 2025)
Nebraska Data Privacy Act (effective Jan. 1, 2025)
New Hampshire Privacy Act (effective Jan. 1, 2025)
New Jersey Data Privacy Act (effective Jan. 15, 2025)
Tennessee Information Protection Act (effective July 1, 2025)
Minnesota Consumer Data Privacy Act (effective July 31, 2025)
Maryland Online Data Privacy Act (effective Oct. 1, 2025)

While many of these eight state privacy laws are similar to current privacy laws in effect, there are some noteworthy differences that you will need to be mindful of heading into the New Year. Additionally, if you did not take Texas, Oregon and Montana into consideration in 2024, now is the time to do so!

Here is a roadmap of key considerations as you address these additional state privacy laws.

1. Understand What Laws Apply to Your Organization

To help determine what laws apply to your organization, you need to know the type and quantity of personal data you collect and how it is used. Each of the eight new state laws differ with their scope of application, as their thresholds vary based on the 1) number of state residents whose personal data controlled or processed and 2) the percentage of revenue a controller derives from the sale of personal data.

Delaware, New Hampshire, and Maryland have the lowest processing threshold – 35,000 consumers.

Nebraska’s threshold requirements are similar to Texas’ threshold requirements: the law applies to any organization that operates in the state, processes or sells personal data, and is not classified as a small business as defined by the U.S. Small Business Administration.

Notably, Maryland and Minnesota will apply to non-profits, except for those that fall into a narrow exception.

See our chart at the end of this article for ease of reference.

2. Identify Nuances

Organizations will need to pay particular attention to Maryland’s data minimization requirements as it is the strictest of the eight. Under Maryland, controllers will have unique obligations to meet, including the following:

Limit the collection or processing of sensitive data to what is “reasonably necessary and proportionate to provide or maintain a specific product or service requested by the consumer to whom the data pertains.”
Cannot process minors’ (under 18 years old) personal data for targeted advertising.
A broad prohibition on the sale of sensitive data.

If a controller engages in the sale of sensitive data, under Texas’ privacy law, which went into effect in July 2024, requires controllers to include the following notice in the same place your privacy policy is linked: “NOTICE: We may sell your sensitive personal data.” Similarly, if a controller engages in the sale of biometric personal data, the following notice must be included in the privacy policy: “NOTICE: We may sell your biometric personal data.” Nebraska requires companies to obtain opt-in consent before selling sensitive data. Maryland prohibits the sale of sensitive data altogether.

Minnesota takes data inventory a step further, requiring companies to maintain an inventory of personal data processed and document and maintain a description of the policies and procedures that they adopt to comply with the act.

3. Refine Privacy Rights Management

All states provide consumers with the right to access, delete, correct (except Iowa), and obtain a copy of their personal data.

Minnesota’s law provides consumers with two additional rights:

The right to request the specific third parties to whom a business has disclosed personal data. Controllers may choose to respond to such a request either by providing the names of the specific third parties to which it has disclosed the consumer’s personal data or the name of third parties to which it has disclosed any personal data.
The right to question the results of a controller’s profiling, to the extent it produced legal effects. Consumers will have the right to be informed of the reason that the profiling resulted in a specific decision and be informed of the actions the consumers may take to secure a different decision in the future.

Aligning with California and Utah, Iowa requires controllers to provide notice and an opportunity to opt out of the processing of sensitive data.

Interestingly, Iowa does not affirmatively establish a right to opt-out of online targeted advertising.

4. Conduct Data Privacy Impact Assessments

Most state privacy laws require controllers to conduct data privacy impact assessments for high-risk processing activities such as the sale of personal data, targeted advertising, profiling, and sensitive data processing. Nebraska, Tennessee, Minnesota, and Maryland follow Oregon by including any processing activities that present a heightened risk of harm to a consumer. Maryland takes this a step further in requiring the assessment include an assessment of each algorithm that is used.

5. Update Privacy Notices

All state privacy laws require privacy notices at the time of collecting personal data. It is essential you keep your privacy notice up-to-date and ensure (at a bare minimum) it covers data categories, third-party sharing, consumer privacy rights options, and opt-out procedures. Minnesota also requires controllers to provide a “reasonably accessible, clear, and meaningful” online privacy notice, posted on its homepage using a hyperlink that contains the word “privacy.”

As state privacy laws stack up, having a structured, adaptable, and principles-based approach paves the path to sustainable compliance.

Make 2025 the year your privacy program doesn’t just meet the minimum—it excels.

Click here to view the 2025 US State Privacy Laws Applicability Chart

Holy Hemp: New Jersey Court Partially Invalidates Hemp Law

On Oct. 10, 2024, a New Jersey Federal District Court made a big decision on hemp. The Court largely invalidated New Jersey’s recent attempt to tighten controls on “intoxicating hemp products” like Delta-8 and Delta-10, which were previously sold in gas stations, smoke shops, and convenience stores without much oversight. The state had put forward amendments aimed at restricting these products to those over 21 and regulating them like cannabis. New Jersey argued that it was time to clamp down on these sales, citing public health concerns and the rising number of minors getting their hands on these potent, unregulated products.

NJ Gov. Phil Murphy had signed off on these amendments despite admitting the law wasn’t perfect. For him, protecting minors was the priority. And today, the Court shared that sentiment—partially. It kept in place only the part that prevents the sale of these products to minors.

As for the rest of the amendment? The Court struck it down. The reason? It found that New Jersey’s approach violated federal law, essentially treating hemp products from out-of-state differently from those produced locally under the New Jersey Cannabis Regulatory Commission’s new process. This selective control crossed the line, according to the Dormant Commerce Clause of the Constitution and provisions in the Federal Farm Act, which stops states from blocking the transport of hemp products.

The Court’s decision made it clear that New Jersey does have the power to regulate these sales, but the amendments need legislative fine-tuning to meet federal standards. So, while New Jersey’s push to regulate intoxicating hemp is on pause, this is far from over.

Here’s where the decision makes things complicated for sellers: By Oct. 12, shops were supposed to pull these hemp products from the shelves, including Delta-8 drinks and THC-A gummies. That means, until New Jersey’s Cannabis Regulatory Commission issues new rules, those products are off-limits.

For anyone in the hemp or cannabis business in New Jersey, it’s a loud reminder—stay compliant, stay updated, and be ready to adapt quickly to changes.

by: Benjamin Sheppard of Norris McLaughlin P.A.
©2024 Norris McLaughlin P.A., All Rights Reserved

For more news on Hemp Legality, visit the NLR Biotech, Food, & Drug section.

Consumer Privacy Update: What Organizations Need to Know About Impending State Privacy Laws Going into Effect in 2024 and 2025

Over the past several years, the number of states with comprehensive consumer data privacy laws has increased exponentially from just a handful—California, Colorado, Virginia, Connecticut, and Utah—to up to twenty by some counts.

Many of these state laws will go into effect starting Q4 of 2024 through 2025. We have previously written in more detail on New Jersey’s comprehensive data privacy law, which goes into effect January 15, 2025, and Tennessee’s comprehensive data privacy law, which goes into effect July 1, 2025. Some laws have already gone into effect, like Texas’s Data Privacy and Security Act, and Oregon’s Consumer Privacy Act, both of which became effective July of 2024. Now is a good time to take stock of the current landscape as the next batch of state privacy laws go into effect.

Over the next year, the following laws will become effective:

Montana Consumer Data Privacy Act (effective Oct. 1, 2024)
Delaware Personal Data Privacy Act (effective Jan. 1, 2025)
Iowa Consumer Data Protection Act (effective Jan. 1, 2025)
Nebraska Data Privacy Act (effective Jan. 1, 2025)
New Hampshire Privacy Act (effective Jan. 1, 2025)
New Jersey Data Privacy Act (effective Jan. 15, 2025)
Tennessee Information Protection Act (effective July 1, 2025)
Minnesota Consumer Data Privacy Act (effective July 31, 2025)
Maryland Online Data Privacy Act (effective Oct. 1, 2025)

These nine state privacy laws contain many similarities, broadly conforming to the Virginia Consumer Data Protection Act we discussed here. All nine laws listed above contain the following familiar requirements:

(1) disclosing data handling practices to consumers,

(2) including certain contractual terms in data processing agreements,

(3) performing risk assessments (with the exception of Iowa); and

(4) affording resident consumers with certain rights, such as the right to access or know the personal data processed by a business, the right to correct any inaccurate personal data, the right to request deletion of personal data, the right to opt out of targeted advertising or the sale of personal data, and the right to opt out of the processing sensitive information.

The laws contain more than a few noteworthy differences. Each of the laws differs in terms of the scope of their application. The applicability thresholds vary based on: (1) the number of state residents whose personal data the company (or “controller”) controls or processes, or (2) the proportion of revenue a controller derives from the sale of personal data. Maryland, Delaware, and New Hampshire each have a 35,000 consumer processing threshold. Nebraska, similar to the recently passed data privacy law in Texas, applies to controllers that that do not qualify as small business and process personal data or engage in personal data sales. It is also important to note that Iowa adopted a comparatively narrower definition of what constitutes as sale of personal data to only transactions involving monetary consideration. All states require that the company conduct business in the state.

With respect to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), Iowa’s, Montana’s, Nebraska’s, New Hampshire’s, and Tennessee’s laws exempt HIPAA-regulated entities altogether; while Delaware’s, Maryland’s, Minnesota’s, and New Jersey’s laws exempt only protected health information (“PHI”) under HIPAA. As a result, HIPAA-regulated entities will have the added burden of assessing whether data is covered by HIPAA or an applicable state privacy law.

With respect to the Gramm-Leach-Bliley Act (“GLBA”), eight of these nine comprehensive privacy laws contain an entity-level exemption for GBLA-covered financial institutions. By contrast, Minnesota’s law exempts only data regulated by GLBA. Minnesota joins California and Oregon as the three state consumer privacy laws with information-level GLBA exemptions.

Not least of all, Maryland’s law stands apart from the other data privacy laws due to a number of unique obligations, including:

A prohibition on the collection, processing, and sharing of a consumer’s sensitive data except when doing so is “strictly necessary to provide or maintain a specific product or service requested by the consumer.”
A broad prohibition on the sale of sensitive data for monetary or other valuable consideration unless such sale is necessary to provide or maintain a specific product or service requested by a consumer.
Special provisions applicable to “Consumer Health Data” processed by entities not regulated by HIPAA. Note that “Consumer Health Data” laws also exist in Nevada, Washington, and Connecticut as we previously discussed here.
A prohibition on selling or processing minors’ data for targeted advertising if the controller knows or should have known that the consumer is under 18 years of age.

While states continue to enact comprehensive data privacy laws, there remains the possibility of a federal privacy law to bring in a national standard. The American Privacy Rights Act (“APRA”) recently went through several iterations in the House Committee on Energy and Commerce this year, and it reflects many of the elements of these state laws, including transparency requirements and consumer rights. A key sticking point, however, continues to be the broad private right of action included in the proposed APRA but absent from all state privacy laws. Only California’s law, which we discussed here, has a private right of action, although it is narrowly circumscribed to data breaches. Considering the November 2024 election cycle, it is likely that federal efforts to create a comprehensive privacy law will stall until the election cycle is over and the composition of the White House and Congress is known.

USCIS Improvements Cut Naturalization Processing Time

USCIS is processing naturalization cases faster than they have in years, and the agency is managing to cut down on its naturalization backlog. Given the current average timing, eligible green card holders who applied early in the summer 2024 might be sworn in in time to vote in the upcoming November elections.

Of course, field offices vary in processing times, but USCIS stated it was effectively eliminating the net backlog of naturalization applications and reducing the median processing time from 10.5 months to as little as five months. This is a 50 percent drop in processing time since 2022, achieving the agency’s longstanding goal and significantly reducing waiting times for most individuals seeking U.S. citizenship. Naturalization has always been a target of note in the agency’s backlog reduction effort. This was achieved by increasing capacity, improving technology, and expanding staffing.

Naturalization cases often increase ahead of elections. Voting is not the only personal benefit of citizenship. Immigrants who become U.S. citizens may also serve on juries, travel on a U.S. passport, bring family members to the U.S. more easily, apply for certain federal jobs, run for federal office, become eligible for certain federal grants, scholarships and benefits, and, importantly, have the right to remain in the U.S. that cannot be taken away. Beyond that, findings show that naturalized citizens have higher employment rates and earn between 50 and 70 percent more than noncitizens. Increasing the number of citizens also helps the economy in general. It leads to an increase in tax revenue and greater home ownership.

When President Joe Biden came into office, he issued an executive order to reduce naturalization barriers to strengthen the integration of new Americans. About 100,300 naturalization petitions were denied in FY 2023, a 10 percent drop from the 111,600 petitions denied in FY 2022. The Biden Administration also made the naturalization application shorter and, while it raised the naturalization fee, a number of discounts are available.

Eligibility requirements for naturalization include age, continuous residence, physical presence, jurisdiction, knowledge of U.S. history, civics, and English, and good moral character.

BIOSECURE Act: Anticipated Movement, Key Provisions, and Likely Impact

Last night, the House of Representatives passed the BIOSECURE Act (BIOSECURE or the Act) by a bipartisan vote of 306 to 81.

The BIOSECURE Act prohibits federal agencies from procuring or obtaining any biotechnology equipment or service produced or provided by a biotechnology company of concern. Subject to some exceptions, it also prohibits federal agencies from contracting with a company that uses equipment or services produced or provided by a biotechnology company of concern. Further, the Act prohibits recipients of a loan or grant from a federal agency from using federal funds to purchase equipment or services from a biotechnology company of concern.

The Senate version of BIOSECURE, sponsored by Sens. Gary Peters (D-MI) and Bill Hagerty (R-TN), was voted out of the Senate Committee on Homeland Security and Governmental affairs with bipartisan support in March 2024. Given its passage in the House last night, the BIOSECURE Act is likely to be signed into law by the end of the year. The House version of BIOSECURE is likely to be the version that becomes law. President Biden is unlikely to veto the Act given its bipartisan support, his previous executive actions to support domestic biotechnology development, and his Administration’s approach towards competition with China.

The Act defines “biotechnology company of concern” as any entity that:

is subject to the jurisdiction, direction, control, or operates on behalf of the government of a foreign adversary (defined as China, Cuba, Iran, North Korea, and Russia);
is involved in the manufacturing, distribution, provision, or procurement of a biotechnology equipment or service; and
poses a risk to U.S. national security based on:
- engaging in joint research with, being supported by, or being affiliated with a foreign adversary’s military, internal security forces, or intelligence agencies;
- providing multiomic data obtained via biotechnology equipment or services to the government of a foreign adversary; or
- obtaining human multiomic data via the biotechnology equipment or services without express and informed consent.

Somewhat unusually, the Act names specific Chinese companies as automatically qualifying as “biotechnology companies of concern”:

BGI (formerly known as the Beijing Genomics Institute);
MGI;
Complete Genomics;
WuXi AppTec; and
WuXi Biologics.

Both categories include any subsidiary, parent, affiliate, or successor entities of biotechnology companies of concern.

The Act also has very broad definitions of “biotechnology equipment or service.” The definition of equipment encompasses any machine, device, or subcomponent, including software that is “designed for use in the research, development, production, or analysis of biological materials.” The definition of services is similarly broad.

The BIOSECURE Act also requires the Office of Management and Budget (OMB) to publish a list of additional biotechnology companies of concern. The list is prepared by the Secretary of Defense in coordination with the Secretaries of the Departments of Health and Human Services, Justice, Commerce, Homeland Security, and State, as well as the Director of National Intelligence and National Cyber Director. This list of companies must be published by OMB within one year of BIOSECURE’s enactment and reviewed annually by OMB in consultation with the other Departments.

Guidance and Regulatory Authorities

OMB is also tasked with developing guidance and has 120 days from enactment of the statute to do so for the named companies. For the list of biotechnology companies of concern, OMB’s guidance must be established within 180 days after the development of the list.

Beyond OMB, the Act requires the Federal Acquisition Regulatory Council to revise the Federal Acquisition Regulation (FAR) to incorporate its prohibitions. The FAR regulations must be issued within one year of when OMB establishes its guidance.

For named companies the Act’s prohibitions are effective 60 days after the issuance of the FAR regulations. For companies placed on the biotechnology company of concern list, the effective date for the Act’s prohibitions is 80 days after the issuance of FAR regulations.

Impact on Existing Business Relationships

In response to stakeholder concerns about disrupting existing commercial relationships and triggering delays in drug development, the House version of the BIOSECURE Act provides a five-year unwinding period for contracts and agreements entered into before the Act’s effective dates. Contracts entered into after the Act’s effective dates do not qualify for the five year unwinding period.

Process for Designating Companies

BIOSECURE specifies the process for designating a biotechnology company of concern. Critically, the Act does not require OMB to notify a company prior to the Department of Defense making the designation. Rather, a company will receive notice that it is being designated and placed on the biotechnology company of concern list. Moreover, the criteria for listing will only be provided “to the extent consistent with national security and law enforcement interests.” Thus, companies may face a circumstance where they are not provided the evidence supporting their designation.

Once a company receives the notice, it will have 90 days to submit information and arguments opposing the listing. The Act does not require a hearing or any formal administrative process. If practicable, the notice may also include steps the company could take to avoid being listed, but it is not required.

Safe Harbor, Waivers and Exceptions

The Act only has one safe harbor for biotechnology equipment or services that were formerly but no longer provided or produced by a biotechnology company of concern. This safe harbor seems intended to allow a biotechnology company of concern to sell their ownership of a product or service to another company without prohibitions applying to the new owner.

Agency heads may waive the Act’s prohibitions on a case-by-case basis, but only with the approval of OMB acting “in coordination with the Secretary of Defense.” Waivers must be reported to Congress within 30 days of being granted. The waiver may last for up to a year with an additional “one time” extension of 180 days allowed if an agency head determines it is “in the national security interests of the United States.” The 180-day extension must be approved by OMB and the agency head must notify and submit a justification to Congress within 10 days of the waiver being granted.

The Act has only two exceptions. First, its prohibitions do not apply to intelligence activities. Second, the prohibitions do not apply to health care services provided to federal employees, members of the armed services, and government contractors who are stationed in a foreign country or on official foreign travel.

Impact and Considerations for Clients

1. Increased Risk of Partnerships with Chinese Companies and Researchers:

Pharmaceutical and biotechnology companies that receive federal funding or contract with federal agencies should be prepared to wind down business ties to biotechnology companies in China. Impacted companies need to begin evaluating the risk to their supply chains, manufacturing capacity, and R&D pipelines in the event a business partner is listed.

Universities in the United States and other research institutes that receive federal funding will also need to undertake a similar assessment of their research partners and collaborators based in China.

2. Loss of CDMO capacity:

Wuxi App Tec is a large, global provider of contract development and manufacturing (CDMO) services to the life sciences industry. According to the New York Times “[b]y one estimate Wuxi has been involved in developing one-fourth of the drugs used in the United States.” BIOSECURE would effectively ban Wuxi from conducting business in the United States, and if passed, risks causing delays, shortages, and cost increases as companies seek to transition to other CDMOs. It will likely take years for competitors to replace the lost CDMO capacity.

3. Fate of Wuxi U.S. Facilities:

Wuxi has a large presence in the United States. It operates 12 facilities and employs almost 2,000 people. Normally, Wuxi would be expected to sell its U.S.-based facilities. However, based on Tiktok’s experience, it is unclear if the Government of China will permit Wuxi to sell its facilities as opposed to dismantling and/or relocating facilities outside of the United States.

4. OMB’s Management of Biotechnology Companies of Concern List

OMB does not typically manage processes like the one envisioned by BIOSECURE. How OMB interprets the broad criteria for listing companies will be critical. Which Departments, beyond the Department of Defense, will have the greatest influence on OMB’s decision making and how open OMB is to evidence from companies seeking to avoid listing will also need to be watched closely. Until OMB starts preparing its guidance and the FAR regulations are proposed, it is hard to anticipate the rate at which new companies will be added to the list. How the process established by BIOSECURE will interact with or leverage existing entity lists will be another development to closely monitor.

5. Retaliation by China

BIOSECURE’s passage is likely to trigger a response from the Government of China. Responses could range from imposing its own export controls to using the country’s sweeping national security laws to harass United States businesses and their employees. Companies doing business in China, particularly those in the pharmaceutical or biotech industries need to be prepared.

AI Regulation Continues to Grow as Illinois Amends its Human Rights Act

Following laws enacted in jurisdictions such as Colorado, New York City, Tennessee, and the state’s own Artificial Intelligence Video Interview Act, on August 9, 2024, Illinois’ Governor signed House Bill (HB) 3773, also known as the “Limit Predictive Analytics Use” bill. The bill amends the Illinois Human Rights Act (Act) by adding certain uses of artificial intelligence (AI), including generative AI, to the long list of actions by covered employers that could constitute civil rights violations.

The amendments made by HB3773 take effect January 1, 2026, and add two new definitions to the law.

“Artificial intelligence” – which according to the amendments means:

a machine-based system that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments.

The definition of AI includes “generative AI,” which has its own definition:

an automated computing system that, when prompted with human prompts, descriptions, or queries, can produce outputs that simulate human-produced content, including, but not limited to, the following: (1) textual outputs, such as short answers, essays, poetry, or longer compositions or answers; (2) image outputs, such as fine art, photographs, conceptual art, diagrams, and other images; (3) multimedia outputs, such as audio or video in the form of compositions, songs, or short-form or long-form audio or video; and (4) other content that would be otherwise produced by human means.

The plethora of AI tools available for use in the workplace continues unabated as HR professionals and managers vie to adopt effective and efficient solutions for finding the best candidates, assessing their performance, and otherwise improving decision making concerning human capital. In addition to understanding whether an organization is covered by a regulation of AI, such as HB3773, it also is important to determine whether the technology being deployed also falls within the law’s scope. Assuming the tool or application is not being developed inhouse, this analysis will require, among other things, working closely with the third-party vendor providing the tool or application to understand its capabilities and risks.

According to the amendments, covered employers can violate the Act in two ways. First, an employer that uses AI with respect to – recruitment, hiring, promotion, renewal of employment, selection for training or apprenticeship, discharge, discipline, tenure, or the terms, privileges, or conditions of employment – and which has the effect of subjecting employees to discrimination on the basis of protected classes under the Act may constitute a violation. The same may be true for employers that use zip codes as a proxy for protected classes under the Act.

Second, a covered employer that fails to provide notice to an employee that the employer is using AI for the purposes described above may be found to have violated the Act.

Unlike the Colorado or New York City laws, the amendments to the Act do not require a impact assessment or bias audit. They also do not provide any specifics concerning the notice requirement. However, the amendments require the Illinois Department of Human Rights (IDHR) to adopt regulations necessary for implementation and enforcement. These regulations will include rules concerning the notice, such as the time period and means for providing same.

We are sure to see more regulation in this space. While it is expected that some common threads will exist among the various rules and regulations concerning AI and generative AI, organizations leveraging these technologies will need to be aware of the differences and assess what additional compliance steps may be needed.

Congress Passes ADVANCE Act to Accelerate Deployment of Advanced Nuclear Reactors

On June 18, the Senate passed the Accelerating Deployment of Versatile, Advanced Nuclear for Clean Energy (ADVANCE) Act as a section of the Fire Grants and Safety Act (S.B. 870). The Senate approved House amendments to the bill with a vote of 88-2, opposed only by Senators Edward Markey (D-MA) and Bernie Sanders (I-VT). The ADVANCE Act has diverse backing from industry, government, and nonprofit stakeholders, and its passage reflects strong bipartisan support for promoting advanced nuclear reactors, which offer carbon-free dispatchable energy generation for both electricity and industrial applications. The ADVANCE Act now heads to President Biden, who is expected to sign the act into law.
The ADVANCE Act is the latest in a series of recent legislative and regulatory developments aimed at bolstering the development of a technology that may be necessary to meet the nation’s growing energy demand. Advanced reactors promise improvements over conventional, much larger light water reactors. These improvements include additional safety features, lower waste yields, and operational flexibility that can complement integration with intermittent renewable energy or energy storage. One category of advanced reactors, small modular reactors (SMR), is of particular interest; SMRs hold the potential of fitting within the footprint of industrial applications.
In 2019, President Trump signed into law the Nuclear Energy Innovation and Modernization Act (NEIMA), which directed the Nuclear Regulatory Commission (NRC) to streamline its licensing process for advanced reactors and modified the fee structure for traditional and advanced reactors. The passage of the ADVANCE Act builds on NEIMA and provides even more support to deploy advanced nuclear reactors efficiently and successfully.

Key Provisions of the ADVANCE Act

PROMOTING NEW NUCLEAR TECHNOLOGIES

Reduced Fees for Advanced Nuclear Reactor Application Reviews. The Act amends NEIMA and sets a specific fee reimbursement rate for NRC’s review of advanced nuclear reactor licensing applications. While applicants are responsible for direct program salaries and benefits for the nuclear reactor safety program, the costs associated with indirect program and agency support expenses will not be passed onto applicants.
Prizes for Advanced Nuclear Reactors. To incentivize the successful development and deployment of advanced nuclear reactors, the Act establishes multiple prizes. The first entities to successfully deploy the specified types of advanced nuclear reactors can receive federal funding to cover the licensing and permitting costs associated with deployment.
Development, Qualification, and Licensing of Advanced Nuclear Fuel Concepts. The Act directs the NRC to improve its ability to qualify and license advanced nuclear fuel. The NRC must collaborate with the Department of Energy (DOE) to test and demonstrate accident-tolerant fuels and advanced nuclear reactor fuel concepts; operate a knowledge-sharing database for agencies and the private sector; and ensure both NRC and DOE have the technical expertise to support advanced nuclear fuel from the research stage through commercial application. A report detailing these efforts must be submitted to Congress within two years.
Licensing and Oversight for Nuclear Facilities on Brownfields and Retired Fossil-Fuel Plant Sites. The Act directs the NRC to identify and report on regulatory, guidance, or policy changes to streamline licensing reviews and oversight for nuclear facilities at brownfields and retired fossil-fuel electric generation sites. Within two years, the NRC must adopt strategies and initiate rulemaking to achieve these efficiency improvements. This provision recognizes the advantage of using existing power grid infrastructure to bring nuclear facilities online and the potential of advanced reactor construction to create more high-paying jobs for former fossil-fuel industry workers.
Licensing and Regulation of Microreactors and Nonelectric Applications of Nuclear Technology. The Act directs the NRC to develop strategies and guidance for licensing and regulating microreactors, covering items such as oversight and inspections, emergency preparedness, risk analysis methods, and the transportation of fueled microreactors. Additionally, the Act directs the NRC to submit a report to Congress detailing unique licensing issues or requirements for nonelectric applications of nuclear energy, along with a proposed budget and timeline for implementing regulatory guidance.

STRENGTHENING THE NUCLEAR WORKFORCE, FUEL CYCLE, SUPPLY CHAIN, AND INFRASTRUCTURE

Nuclear Energy Traineeship Program. The Act directs the NRC to coordinate with trade schools and institutions of higher education to establish a competitive nuclear energy traineeship program. The program must provide training that meets the critical mission needs of the NRC and nuclear workforce needs.
NRC Hiring and Compensation Improvements. The Act includes provisions to ensure the NRC is prepared to review licenses safely and successfully should the demand for NRC licensing and oversight services increase. Specifically, the Act empowers the NRC Chair to appoint up to 120 exceptionally well-qualified individuals into the excepted service and up to 20 exceptionally well-qualified individuals into term-limited positions during each fiscal year. In addition, the Act allows the NRC to determine the compensation for these positions without regard to the General Schedule classification and pay rates, subject to some limitations. The NRC may also award hiring bonuses and performance bonuses.
Biennial Reporting on Spent Nuclear Fuel and High-Level Radioactive Waste. The Act requires the Secretary of Energy to submit a report to Congress no later than January 1, 2026, and biennially thereafter, that describes spending related to (1) breaches of contract under the Nuclear Waste Policy Act of 1982 and (2) storage, management, and disposal of spent nuclear fuel and high-level radioactive waste (including the projected lifecycle costs for such activities). The report must also describe mechanisms and recommendations to improve accounting of liabilities and lifecycle costs for spent fuel and radioactive waste. Additionally, the report must describe any activities taken in the previous fiscal year by DOE with respect to interim storage and the development and deployment of technologies that enhance the safe transportation and storage of spent nuclear fuel or high-level radioactive waste.
Report on Advanced Manufacturing and Construction Methods. The Act directs the NRC to submit a report to Congress within 180 days on advanced manufacturing and construction techniques for nuclear energy projects. The report must, among other things, assess licensing issues, identify safety standard gaps, and provide recommendations to use the existing regulatory framework or engage in new rulemaking to support advanced manufacturing and construction methods.

IMPROVING NRC EFFICIENCY AND EFFECTIVENESS

Updated NRC Mission Statement. The Act provides that the NRC must update its mission within a year to include that licensing and regulation will be conducted “in a manner that is efficient and does not unnecessarily limit” the civilian use of radioactive materials, the benefits of civilian use of radioactive materials, or the benefits of nuclear energy technology to society.
Periodic Review of Performance Metrics and Milestones. The Act amends NEIMA and directs the NRC to review its performance metrics and milestones at least once every three years and to revise them as necessary to reflect the most efficient metrics and milestones reasonably achievable.
Nuclear Licensing Efficiency. The Act mandates that the NRC establish techniques and guidance for evaluating nuclear reactor license applications that support efficient, timely, and predictable regulatory reviews and the safe use of nuclear reactors.
Modernization of Environmental Reviews. To streamline the approval of new nuclear reactor license applications, the Act directs the NRC to improve the efficiency, timeliness, and predictability of NEPA environmental reviews through the expanded use of categorical exclusions, environmental assessments, and generic environmental impact statements. The NRC must submit a report on these efforts to Congress within 180 days.
Report on Oversight and Inspection Program Improvements. The Act requires the NRC to provide a report to Congress within a year that identifies potential improvements to NRC’s oversight and inspection programs for nuclear reactors and materials. The report must assess options to maximize program efficiency through the use of risk-informed, performance-based procedures; information technologies; staff training; improved planning; and licensee innovations that may advance nuclear reactor operational efficiency and safety.

ADVANCING INTERNATIONAL NUCLEAR LEADERSHIP

Export and Innovation Activities. The Act directs the NRC to support interagency and international coordination related to nuclear reactor import and export licensing. Specifically, the Act directs the NRC to engage in international coordination to promote (1) international technical standards for licensing and regulating nuclear reactor design, construction, and operation; (2) competent nuclear regulatory organizations and frameworks in countries seeking to develop civil nuclear industries; and (3) exchange programs and training for foreign countries to improve their regulation and oversight of nuclear reactors and radioactive materials. The Act empowers the NRC to establish an “International Nuclear Export and Innovation Branch” to support these efforts.
DOE Global Nuclear Energy Assessment. The Act directs the Secretary of Energy to conduct a study in consultation with the Secretary of State, Secretary of Commerce, the Administrator of the Environmental Protection Agency, and the NRC that evaluates the global status of the civilian nuclear energy industry and its supply chains. The study must provide recommendations to strengthen the United States’ engagement with nuclear energy in foreign policy and modernize regulatory requirements to improve domestic supply chains of civilian nuclear energy.
Prohibitions on Russian and Chinese Enriched Uranium. The Act prohibits possession and ownership of enriched uranium fuel fabricated by an entity in Russia or China. A person may obtain a license to possess or own such fuel, but the Act provides that the NRC may only issue such a license in consultation with the Secretaries of Energy and State.
Foreign Ownership of Nuclear Facilities. Under the Atomic Energy Act, nuclear reactor licenses could not be issued to foreign corporations and other entities. The Act modifies this restriction and allows the NRC to issue licenses to governments, corporations, citizens, and foreign nationals of Organization of Economic Cooperation and Development member countries and India if issuance is not contrary to national security or public health and safety.

Other Recent Developments

DOE Funding for Small Modular Reactors. On June 17, DOE issued a Notice of Intent to distribute $900 million to support the deployment of small modular reactors (SMRs). Part of the funding comes from President Biden’s Bipartisan infrastructure Law.
Reappointment of NRC Chair. On June 18, the current Chairman of the NRC, Christopher Hanson, was sworn in for a second term – running through 2029. In his confirmation hearings, Senators pressed him to work harder on NRC reform.
NRC Rulemaking for Advanced Reactors. In response to NEIMA, the NRC has drafted proposed revisions to create a risk-informed, performance-based, and technology-inclusive framework for advanced reactors. An analysis by Van Ness Feldman lawyers found that the NRC has substantial headroom within its Congressional safety mandate to reduce the risk aversion and restrictiveness in its licensing and permitting process.

House and Senate Hold Hearings on EPA’s FY 2025 Budget Request

On April 30, 2024, the House Appropriations Subcommittee for Interior, Environment, and Related Agencies held a hearing on the fiscal year (FY) 2025 budget request for the U.S. Environmental Protection Agency (EPA). The Senate Appropriations Subcommittee for the Interior, Environment, and Related Agencies held a separate hearing on EPA’s FY 2025 budget request on May 1, 2024, and the Senate Committee on Environment and Public Works held its own hearing on May 8, 2024. On May 15, 2024, the House Energy and Commerce Subcommittee on Environment, Manufacturing, and Critical Materials held a hearing. EPA Administrator Michael S. Regan testified before both of the House Subcommittees, the Senate Subcommittee, and the Senate Committee (written testimony is hyperlinked).

April 30, 2024, House Subcommittee Hearing

During the April 30, 2024, House Subcommittee hearing, Ranking Member Chellie Pingree (D-ME) asked for an update on EPA’s risk assessment of per- and polyfluoroalkyl substances (PFAS) in biosolids. Regan stated that EPA is working on issuing it in final in 2024, and it will include a focus on certain PFAS to help EPA understand better the specific risks posed to farmers and the uptake in crops and livestock. Regan noted that EPA is working with the U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) to research the risk from biosolids application. EPA intends to hold the polluters responsible for the PFAS accountable and does not want farmers, water systems, or taxpayers in affected communities to bear the burden of the contamination.

As reported in our November 3, 2023, blog item, on November 2, 2023, EPA announced that it granted a petition filed under Section 21 of the Toxic Substances Control Act (TSCA) to address the use of the chemical N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine (6PPD) in tires. Representative Derek Kilmer (D-WA) asked whether EPA still planned to issue an advance notice of proposed rulemaking (ANPRM) under TSCA Section 6 by the end of 2024 to obtain more information to inform a subsequent regulatory action. Regan stated that EPA expects to issue the ANPRM by fall 2024.

May 1, 2024, Senate Subcommittee Hearing

During the May 1, 2024, Senate Subcommittee hearing, Senator Martin Heinrich (D-NM) asked Regan to explain how EPA will address PFAS contamination under the FY 2025 budget request. Regan noted that EPA recently issued its first-ever National Primary Drinking Water Regulation (NPDWR), which will reduce PFAS exposure to over 100 million people. EPA also announced grants available to help smaller communities comply with the NPDWR. According to Regan, EPA needs the resources and staff to have a comprehensive approach to protect water quality from PFAS. Regan stated that EPA would use the funding to continue to collect scientific evidence and to study how to design technology and health-based standards to protect as many people as possible from different forms of PFAS.

Senator Gary Peters (D-MI) noted that during a 2023 Senate hearing, Regan testified that EPA had an additional 29 PFAS on its radar for a similar drinking water update and asked Regan about the status of the rulemaking. Regan stated that through the Unregulated Contaminant Monitoring Rule, EPA is monitoring drinking water in communities across the United Sates for these 29 PFAS and that EPA intends to pursue regulation for these PFAS.

Senator Patty Murray (D-WA), Chair of the Senate Appropriations Committee, asked Regan about the key funding increases included in the FY 2025 budget request for some of EPA’s core programs. Regan stated that the increases are intended to allow EPA to keep up with recent progress that it has made. While EPA recently issued the NPDWR for six PFAS, there are an additional 29 PFAS being monitored, and thousands more. EPA wants to ensure the safety of chemicals before they hit the market, and that is one of the places where EPA has a deficit in terms of staffing. According to Regan, EPA is getting more requests from agricultural communities about herbicides and pesticides.

Senator Katie Britt (R-AL) stated that EPA’s recent Endangered Species Act (ESA) proposals, such as the Herbicide Strategy, could impose hundreds of millions of dollars in new restrictions on farmers. Britt asked Regan how EPA would implement Congress’s bipartisan instructions in the FY 2024 appropriations report to consider best available data on pesticide usage, conservation practices, and real-world studies on spray drift and water concentrations. Regan testified that previous EPA decisions spanning decades and court rulings have put EPA in a precarious position. According to Regan, EPA is speaking with the farming and agricultural community and has come up with strategies that have received positive feedback. Britt asked whether EPA would consider appointing designated non-federal representatives to help EPA meet its ESA responsibilities. Regan responded that EPA needs more staff and resources to respond to court decisions and that the particular EPA office is down to levels from the early 2000s. Regan stated that he would need to talk through the use of non-federal representatives and agreed to discuss the issue with Britt.

Subcommittee Chair Jeff Merkley (D-OR) asked Regan what Congress can do to accelerate a solution to replace 6PPD with something that works as well without harming salmon. Regan stated that EPA intends to publish an ANPRM by fall 2024 and that EPA is also researching mitigation efforts to fill in the gap until it can take regulatory action.

Ranking Member Lisa Murkowski (R-AK) noted that in its FY 2024 budget request, EPA proposed a significant decrease in discretionary funding because of new revenues coming in from the Superfund tax, while the FY 2025 request includes additional funding for the program. Murkowski asked Regan for his view of the long-term funding outlook for the Superfund program. Regan testified that the tax collections for the first two years were lower than forecasted by the U.S. Department of the Treasury. Because of the gap, for FY 2025, EPA has requested additional funding.

May 8, 2024, Senate Committee Hearing

Senator Cynthia Lummis (R-WY) described EPA’s designation of perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) as flawed, stating that this would place the financial burden on passive receivers such as water utilities. More information on the designation and on EPA’s PFAS Enforcement Discretion and Settlement Policy Under CERCLA is available in our April 23, 2024, memorandum.

Committee Chair Thomas R. Carper (D-DE) asked Regan to describe the impact that the FY 2024 funding levels had on the TSCA program and what EPA could accomplish if it received the full amount requested in the FY 2025 budget request and maximized revenue collection through the recently updated TSCA fees rule. Regan stated that EPA received a small increase for TSCA in the FY 2022 and 2023 budgets, and it more than doubled the number of chemical reviews that it did each month. Without the funding in the FY 2025 budget request, EPA will see slower approval of new chemistries, especially for those companies in the semi-conductor, automotive, and battery sectors.

May 15, 2024, House Subcommittee Hearing

During the hearing held by the House Energy and Commerce Subcommittee on Environment, Manufacturing, and Critical Materials, Subcommittee Ranking Member Paul Tonko (D-NY) asked Regan what EPA is doing to address the backlog of new chemical reviews and what Congress can do to support EPA. Regan stated that with the budget increases that EPA received in 2022 and 2023, it more than doubled the number of new chemicals reviewed each month. According to Regan, EPA has reduced the backlog by half and prioritized new chemistries for the semi-conductor, automotive, and battery manufacturing sectors. According to Regan, without the funding in the FY 2025 budget request, EPA will see slower approval of new chemicals.

Representative Frank Pallone (D-NJ), Ranking Member of the Energy and Commerce Committee, noted that the reinstated Superfund tax has brought in lower receipts than projected by the Treasury and asked how EPA is adapting to the difference between the Treasury’s forecast and the actual funds collected. Regan testified that EPA is working with the Treasury Department to refine its estimates. According to Regan, the $300 million in the FY 2025 budget request will fill in the gap between the projected and actual tax receipts. Without the additional funding, Regan stated that there would be a slowdown in EPA’s ability to clean up Superfund sites. Pallone then asked Regan what the designation of PFOA and PFOS as CERCLA hazardous substances and EPA’s enforcement policy mean for different sectors. Regan responded that EPA is focused on the manufacturers responsible for the PFAS and will not pursue enforcement actions against sectors such as farmers or water systems.

Representative Randy Weber (R-TX) asked about EPA’s final rule amending the TSCA risk evaluation framework and its removal of the definition of “best available science.” Regan stated that he would have to get more context to respond to Weber. More information on EPA’s final rule is available in our May 14, 2024, memorandum.

Representative Dan Crenshaw (R-TX) asked Regan to comment on the almost 400 premanufacture notifications (PMN) awaiting a risk determination and the more than 90 percent that have passed the statutory deadline of 90 days. According to Regan, the issue predates the Biden-Harris Administration. Regan repeated that with the additional resources from Congress in 2022 and 2023, EPA has more than doubled the reviews completed each month.

Representative John Curtis (R-UT) noted that applications in EPA’s New Chemicals Program have dropped from 600 annually to just over 200 and that in the last two calendar years, EPA made 95 and 101 determinations, respectively. According to Curtis, although EPA is required by law to return fees if it misses deadlines, it has never returned the fee to an applicant when EPA has missed the deadline because applicants coincidentally suspend or withdraw their applications before the deadline. Curtis asked Regan to explain the coincidence of PMNs being suspended or withdrawn just in time to allow EPA to keep the money. Regan stated that he was unaware that applications were being withdrawn from EPA and committed to looking into it. Curtis stated that he has been told that EPA has effectively threatened applicants by phone to suspend or withdraw their applications and stated he would like Regan to look into this and report back. Regan committed to doing so. Curtis followed up by asking about EPA’s assumption that it can charge user fees covering 25 percent of the TSCA program’s budget, regardless of the cost. Regan responded that he is not sure that he agrees with the premise and that he needs to look at EPA’s performance with the budget that it did receive. Regan agreed to have a deeper conversation with Curtis on the topic.

Commentary

The hearings for EPA’s FY 2025 budget request were similar to the hearings for EPA’s FY 2024 budget request. Republicans pressed EPA on why it needs additional funding, criticizing the cost and reach of its current rulemakings, while Regan highlighted EPA’s obligations under federal statutes, including the Clean Water Act, the Safe Drinking Water Act, TSCA, the Federal Insecticide, Fungicide, and Rodenticide Act, and the ESA, as well as recent court decisions. On balance, no new information emerged.

Category: Legislation

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