Category: Legislation

…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:

  1. Delaware Personal Data Privacy Act (effective Jan. 1, 2025)
  2. Iowa Consumer Data Protection Act (effective Jan. 1, 2025)
  3. Nebraska Data Privacy Act (effective Jan. 1, 2025)
  4. New Hampshire Privacy Act (effective Jan. 1, 2025)
  5. New Jersey Data Privacy Act (effective Jan. 15, 2025)
  6. Tennessee Information Protection Act (effective July 1, 2025)
  7. Minnesota Consumer Data Privacy Act (effective July 31, 2025)
  8. 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:

  1. 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.
  2. 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

Copyright © 2024 Womble Bond Dickinson (US) LLP All Rights Reserved.
For more on Privacy Laws, visit the NLR Communications Media Internet section

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:

  1. Montana Consumer Data Privacy Act (effective Oct. 1, 2024)
  2. Delaware Personal Data Privacy Act (effective Jan. 1, 2025)
  3. Iowa Consumer Data Protection Act (effective Jan. 1, 2025)
  4. Nebraska Data Privacy Act (effective Jan. 1, 2025)
  5. New Hampshire Privacy Act (effective Jan. 1, 2025)
  6. New Jersey Data Privacy Act (effective Jan. 15, 2025)
  7. Tennessee Information Protection Act (effective July 1, 2025)
  8. Minnesota Consumer Data Privacy Act (effective July 31, 2025)
  9. 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.

©2024 Epstein Becker & Green, P.C. All rights reserved.
For more on Data Privacy, visit the NLR Communications Media Internet section.

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.

Jackson Lewis P.C. © 2024
For more on USCIS, visit the NLR Immigration section

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.

© 2024 Foley & Lardner LLP
For more on Biotechnology, visit the NLR Biotech Food Drug section

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.

Jackson Lewis P.C. © 2024

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.
 
© 2024 Van Ness Feldman LLP

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.

©2024 Bergeson & Campbell, P.C.
For more news on EPA’s 2025 Budget Request, visit the Environmental, Energy & Resources section.

Continuing Forward: Senate Leaders Release an AI Policy Roadmap

The US Senate’s Bipartisan AI Policy Roadmap is a highly anticipated document expected to shape the future of artificial intelligence (AI) in the United States over the next decade. This comprehensive guide, which complements the AI research, investigations, and hearings conducted by Senate committees during the 118th Congress, identifies areas of consensus that could help policymakers establish the ground rules for AI use and development across various sectors.

From intellectual property reforms and substantial funding for AI research to sector-specific rules and transparent model testing, the roadmap addresses a wide range of AI-related issues. Despite the long-awaited arrival of the AI roadmap, Sen. Chuck Schumer (D-NY), the highest-ranking Democrat in the Senate and key architect of the high-level document, is expected to strongly defer to Senate committees to continue drafting individual bills impacting the future of AI policy in the United States.

The Senate’s bipartisan roadmap is the culmination of a series of nine forums held last year by the same group, during which they gathered diverse perspectives and information on AI technology. Topics of the forums included:

  1. Inaugural Forum
  2. Supporting US Innovation in AI
  3. AI and the Workforce
  4. High Impact Uses of AI
  5. Elections and Democracy
  6. Privacy and Liability
  7. Transparency, Explainability, Intellectual Property, and Copyright
  8. Safeguarding
  9. National Security

The wide range of views and concerns expressed by over 150 experts including developers, startups, hardware and software companies, civil rights groups, and academia during these forums helped policymakers develop a thorough and inclusive document that reveals the areas of consensus and disagreement. As the 118th Congress continues, it’s expected that Sen. Schumer will reach out to his counterparts in the US House of Representatives to determine the common areas of interest. Those bipartisan and bicameral conversations will ultimately help Congress establish the foundational rules for AI use and development, potentially shaping not only the future of AI in the United States but also influencing global AI policy.

The final text of this guiding document focuses on several high-level categories. Below, we highlight a handful of notable provisions:

Publicity Rights (Name, Image, and Likeness)

The roadmap encourages senators to consider whether there is a need for legislation that would protect against the unauthorized use of one’s name, image, likeness, and voice, as it relates to AI. While state laws have traditionally recognized the right of individuals to control the commercial use of their so-called “publicity rights,” federal recognition of those rights would mark a major shift in intellectual property law and make it easier for musicians, celebrities, politicians, and other prominent public figures to prevent or discourage the unauthorized use of their publicity rights in the context of AI.

Disclosure and Transparency Requirements

Noting that the “black box” nature of some AI systems can make it difficult to assess compliance with existing consumer protection and civil rights laws, the roadmap encourages lawmakers to ensure that regulators are able to access information directly relevant to enforcing those laws and, if necessary, place appropriate transparency and “explainability” requirements on “high risk” uses of AI. The working group does not offer a definition of “high risk” use cases, but suggests that systems implicating constitutional rights, public safety, or anti-discrimination laws could be forced to disclose information about their training data and factors that influence automated or algorithmic decision making. The roadmap also encourages the development of best practices for when AI users should disclose that their products utilize AI, and whether developers should be required to disclose information to the public about the data sets used to train their AI models.

The document also pushes senators to develop sector-specific rules for AI use in areas such as housing, health care, education, financial services, news and journalism, and content creation.

Increased Funding for AI Innovation

On the heels of the findings included in the National Security Commission on Artificial Intelligence’s (NSCAI) final report, the roadmap encourages Senate appropriators to provide at least $32 billion for AI research funding at federal agencies, including the US Department of Energy, the National Science Foundation, and the National Institute of Standards and Technology. This request for a substantial investment underscores the government’s commitment to advancing AI technology and seeks to position federal agencies as “AI ready.” The roadmap’s innovation agenda includes funding the CHIPS and Science Act, support for semiconductor research and development to create high-end microchips, modernizing the federal government’s information technology infrastructure, and developing in-house supercomputing and AI capacity in the US Department of Defense.

Investments in National Defense

Many members of Congress believe that creating a national framework for AI will also help the United States compete on the global stage with China. Senators who see this as the 21st century space race believe investments in the defense and intelligence community’s AI capabilities are necessary to push back against China’s head start in AI development and deployment. The working group’s national security priorities include leveraging AI’s potential to build a digital armed services workforce, enhancing and accelerating the security clearance application process, blocking large language models from leaking intelligence or reconstructing classified information, and pushing back on perceived “censorship, repression, and surveillance” by Russia and China.

Addressing AI in Political Ads

Looking ahead to the 2024 election cycle, the roadmap’s authors are already paying attention to the threats posed by AI-generated election ads. The working group encourages digital content providers to watermark any political ads made with AI and include disclaimers in any AI-generated election content. These guardrails also align with the provisions of several bipartisan election-related AI bills that passed out of the Senate Rules Committee the same day of the roadmap’s release.

Privacy and Legal Liability for AI Usage

The AI Working Group recommends the passage of a federal data privacy law to protect personal information. The AI Working Group notes that the legislation should address issues related to data minimization, data security, consumer data rights, consent and disclosure, and the role of data brokers. Support for these principles is reflected in numerous state privacy laws enacted since 2018, and in bipartisan, bicameral draft legislation (the American Privacy Rights Act) supported by Rep. McMorris Rogers (D-WA), and Sen. Maria Cantwell (D-WA).

As we await additional legislative activity later this year, it is clear that these guidelines will have far-reaching implications for the AI industry and society at large.

© 2024 ArentFox Schiff LLP
For more on AI Policy, visit the NLR Communications, Media & Internet section.

Will Hemp Save the World, Before the Government Kills It?

There is a great line in the wonderful film Charlie Wilson’s War, where Charlie Wilson (played remarkably by the inimitable Tom Hanks) describes the successful, if relatively covert, involvement of the United States government in the Soviet-Afghan War: “These things happened. They were glorious and they changed the world… and then we f***d up the endgame.”

With the next Farm Bill somewhere on the horizon, I believe we are approaching a similar moment for the future of hemp. I believe the future of hemp is glorious and that it can change the world. What will we do to the endgame?

This is an analysis about the current state of hemp and whether that industry will revolutionize the world before the government relegates it back to the ash heap of history. It just so happens to dovetail with my personal experience representing clients in connection with the hemp business.

In the Beginning…

Back in the “stone age” (circa 2017) when I decided I wanted to be a cannabis lawyer, I began with a focus on hemp. [As a brief aside, telling people in Alabama you practice cannabis law in 2017 must have been what Noah felt like when he was telling people it was about to start raining.]

The 2014 Farm Bill, which for the first time legalized “industrial hemp” as distinct from marijuana under the Controlled Substances Act and allowed state agricultural departments and universities to license the production of hemp, cracked the door for a nascent and limited hemp market, and it was a remarkable time to advise new hemp operators and investors about how to maximize this opportunity within the contours of the law.

At the same time, I was regularly receiving calls from existing clients, colleagues within the firm, and strangers about how their non-cannabis companies should conduct themselves when approached by hemp companies who wanted to do business with them. The latter category included banks, insurance companies, real estate companies, and myriad companies who had questions about how their employees’ use of hemp interplayed with the companies’ existing drug testing policies. Most of the time the companies were reluctant to have anything to do with hemp, but the conversations were interesting, and it was clear that most companies realized the landscape was changing. It was the Wild West, and I was having a ball.

Rocket Fuel

Enter the 2018 Farm Bill and the explosion of the hemp industry. The 2018 Farm Bill dropped the word “industrial” and defined “hemp” as:

the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.

In addition to removing the limitations from the 2014 Farm Bill licensing, the 2018 Farm Bill also moved oversight authority from the Department of Justice and DEA to the USDA and FDA.

The 2018 Farm Bill was a tectonic shift, and we recognized the new regime’s potential almost immediately, predicting the following:

  • Increased “smart” money and research. Because hemp has been a Schedule I substance along with marijuana for decades, many sophisticated sources of funding have abstained from financing the industry. This placed hemp at a competitive disadvantage to other commodities and prevented hemp from reaching its full potential. Now that hemp can be manufactured and sold without substantial legal risks, look for the money to flow toward this underserved sector. Publicly traded companies, private equity firms, venture capitalists and other investment groups will all take significant stakes in both the manufacturing and selling of hemp and hemp-derived products. In addition to traditional commercial development efforts, much of this cash is likely to be spent to hire top researchers to develop proprietary strands of hemp to meet a range of product applications and to take steps to protect the resulting intellectual property.
  • Explosion of hemp and hemp-derived products. Fueled in large part by this injection of financing from sophisticated investors, there is likely to be an explosion in the ways that hemp is used. Hemp already has hundreds — if not thousands — of known uses, and that number should grow substantially once the industry is exposed to the market forces that come with smart money and increased research. The biggest winner may be the hemp-derived CBD business. Hemp-derived CBD is a compound believed to have significant therapeutic benefits without an appreciable psychoactive component. The Washington Post has reported that “dozens of studies have found evidence that [CBD] can treat epilepsy as well as a range of other illnesses, including anxiety, schizophrenia, heart disease, and cancer.” One industry analysis predicts that the hemp-CBD market alone could hit $22 billion by 2022. The health and wellness sector should see particular hemp-related activity and growth in the coming years.
  • Increased ancillary services provided to hemp-related businesses. Because hemp has been included within the definition of marijuana under federal law for decades, most banks, law firms and other service providers have avoided providing services to hemp businesses to avoid the risk of charges of money laundering or conspiring to violate state and federal drug laws. The absence of such service providers has fostered a great deal of uncertainty in an area where certainty and clarity have been sorely needed. With hemp’s new legal status, look for professional service providers to enter the market in 2019 and beyond. Of course, entities looking to provide services to hemp-related businesses should take adequate precautions to ensure those businesses are only producing federally legal hemp.
  • Consolidation and integration. An interesting phenomenon in “legal” marijuana states has been the rapid consolidation and integration of marijuana growers, processors and dispensaries. Some states have mandated vertical integration (e.g., the growers are the sellers) through regulation. And a number of large cannabis companies have acquired grow operations or multi-unit dispensaries rather than establish a cannabis presence in a state from scratch. The hemp industry is likely to follow a similar path, both through government regulation and because larger companies are likely to seek to obtain sufficient quantities of hemp through consolidation and vertical integration. Accordingly, attorneys and investors should anticipate significant merger and acquisition activity in the coming years.
  • Federal regulations and state regimes. The 2018 Farm Bill does not create an entirely unregulated playing field for hemp. Over the coming months, the U.S. Department of Agriculture and Food and Drug Administration will issue regulations implementing the 2018 Farm Bill. State governments will also unveil plans governing the testing, labeling and marketing of hemp-related products, as well as the licensing and monitoring of hemp-related businesses.

I’m proud to say that we were pretty much on the money with these projections, and countless studies and data confirm that hemp can be a viable product with countless form factors that help shape the global economy.

That is when I realized that I might be able to make a career as a cannabis lawyer.

The Good with the Bad

Of course, the development of the hemp industry has not been without controversy – in fact it may be the controversy that has spurred much of the development.

I would be lying to you if I told you that every hemp or hemp-derived product was designed with the best of intentions or contained appropriate mechanisms to ensure consumer safety. There are certainly hemp-derived products on the market that have not been subjected to sufficient product development and testing, and that are being marketed in ways that rightfully should concern policymakers and the public. Novel, psychoactive cannabinoids that fall within the bounds of the terms, if perhaps not the spirit, of the Farm Bill fill the shelves of stores around the country with little to no mechanisms for enforcement. That should change, and Americans should have confidence that the products made available to them are safe and effective.

In response to this proliferation, a number of states have enacted rules and regulations restricting the production and sale of certain hemp-derived cannabinoids. A number of those rules – for example, age and purity restrictions for psychoactive cannabinoids – seem well-intentioned, and we expect to see more of those unless and until the federal government takes further action.

On occasion, however, it appears that the motivations of policymakers may be less pure. It is no secret amongst those in the cannabis industry that marijuana licensees in states that have legalized marijuana are no fans of the unregulated hemp-derived psychoactive industry. After all, marijuana companies are subject to astronomical taxes and endure regulatory costs that make turning a profit far more difficult than if they were able to offer a product that offered a somewhat similar “high” without the institutional overhead and headwinds. Florida may be the clearest and most recent example. With adult-use marijuana widely expected to become law in Florida soon, the state legislature recently passed a law largely prohibiting delta-8 and delta-10.

On the other hand, it would be wrong, even lazy, to suggest that the development of hemp-based products has been without substantial benefits to society as a whole. Entrepreneurs are developing hemp-based substitutes for any number of the most common products used around the globe, meaning that the addressable market for hemp is everyone on earth and beyond.

A younger version of me once wrote, in comparing the addressable market for marijuana to that of hemp:

Hemp, on the other hand, has the potential to dwarf marijuana in the global market. Unlike its sister plant, hemp has the capacity to replace products we use every day without us even realizing it. For example, hemp can provide a substitute for concrete, plastic, fuel, automotive parts, clothes, etc. These are products nearly all consumers need but they neither realize nor care what the products are made of, as long as they work. In that way, while the market for marijuana is limited to consumers looking to purchase marijuana, the market for hemp includes anyone who purchases products that can be manufactured by hemp. In part for these reasons, experts predict four to five times growth in the industrial hemp market in the next five years.

I stand by those words. I am convinced that hemp can change the world.

But I am equally convinced that local, state, and federal governments can, without the appropriate consideration for hemp’s benefits, relegate the plant back to its prohibition era status and deny the world its many benefits. The policy choices made by state governments, and perhaps most importantly by the federal government during the next Farm Bill, could fundamentally alter the future of hemp. Will it be a soon-forgotten shooting star that dazzled the world for a decade and then burned out, or will we look back at the past decade as the renaissance of one of civilization’s oldest and most versatile plants?

Conclusion

I’ll end where I began because Philip Seymour Hoffman’s work is revered by the Budding Trends community (and anyone with taste), and because the film’s ominous conclusion is a message for anyone who wants to see the hemp industry thrive in the years ahead.

As Hanks’ character celebrates the Afghan defeat of the Soviets, the hardened CIA analyst played by Hoffman offers this parable:

On his sixteenth birthday the boy gets a horse as a present. All of the people in the village say, “Oh, how wonderful!”

The Zen master says, “We’ll see.”

One day, the boy is riding and gets thrown off the horse and hurts his leg. He’s no longer able to walk, so all of the villagers say, “How terrible!”

The Zen master says, “We’ll see.”

Some time passes and the village goes to war. All of the other young men get sent off to fight, but this boy can’t fight because his leg is messed up. All of the villagers say, “How wonderful!”

The Zen master says, “We’ll see.”

The message behind this story is pretty clear. We’re prone to jump to conclusions about whether something is “good” or “bad.” We are especially quick to label something as “bad.” The reality is that things can be either good or bad, both good and bad, or neither. When it comes to whether Congress and the states will recognize hemp’s great potential, I guess we’ll see.

© 2024 Bradley Arant Boult Cummings LLP
For more on Hemp, visit the NLR Biotech, Food, Drug section.