Tag: biden admin

Locking Tik Tok? White House Requires Removal of TikTok App from Federal IT

On February 28, the White House issued a memorandum giving federal employees 30 days to remove the TikTok application from any government devices. This memo is the result of an act passed by Congress that requires the removal of TikTok from any federal information technology. The act responded to concerns that the Chinese government may use data from TikTok for intelligence gathering on Americans.

I’m Not a Federal Employee — Why Does It Matter?

The White House Memo clearly covers all employees of federal agencies. However, it also covers any information technology used by a contractor who is using federal information technology.  As such, if you are a federal contractor using some sort of computer software or technology that is required by the U.S. government, you must remove TikTok in the next 30 days.

The limited exceptions to the removal mandate require federal government approval. The memo mentions national security interests and activities, law enforcement work, and security research as possible exceptions. However, there is a process to apply for an exception – it is not automatic.

Takeaways

Even if you are not a federal employee or a government contractor, this memo would be a good starting place to look back at your company’s social media policies and cell phone use procedures. Do you want TikTok (or any other social media app) on your devices? Many companies have found themselves in PR trouble due to lapses in enforcement of these types of rules. In addition, excessive use of social media in the workplace has been shown to be a drag on productivity.

Article By J. William Manuel and Anne R. Yuengert of Bradley Arant Boult Cummings LLP

For more communications, media, and internet legal news, click here to visit the National Law Review.

© 2023 Bradley Arant Boult Cummings LLP

Administration’s WOTUS Rule Muddies Jurisdictional Waters

The U.S. Environmental Protection Agency and the U.S. Army Corps of Engineers have issued a new definition of “waters of the United States” (WOTUS), which becomes effective on March 20. The regulated community is watching this new definition of WOTUS because it will determine federal jurisdiction under the Clean Water Act.

For example, projects involving oil or natural gas development or pipeline construction require federal permitting for impacts from crossing, or otherwise disturbing, WOTUS. Generally speaking, the more impacts to such federally regulated streams and wetlands, the more complicated, expensive and lengthy the Corps Section 404 permitting.

In addition to determining the scope of federal permitting for the dredging/filling of streams and wetlands, the WOTUS definition also determines the scope of several other federal regulations, including regulations associated with National Pollutant Discharge Elimination System permitting, Spill Prevention, Control and Countermeasure plans and federal spill reporting. Although WOTUS is not defined in the CWA, the WOTUS definition appears in 11 different federal regulations.

Overview And Background

The agencies have promoted this final rule as establishing a “durable definition” that will “reduce uncertainty” in identifying WOTUS. However, this definition does not appear to provide much-needed clarity. Rather, generally speaking, the new definition codifies the approach that the agencies already have been informally utilizing to determine WOTUS, for example, relying on the definition of WOTUS from the late 1980s, as interpreted by subsequent U. S. Supreme Court decisions (such as the 2006 case, Rapanos v. United States). Challenges to the new definition are already underway.

The definition of WOTUS has been debated for nearly two decades, starting with several U. S. Supreme Court cases, which addressed the meaning of the 1980s WOTUS definition. This 1980s definition is very brief and is open to much interpretation because it does not include any defined terms. As discussed further below, rather than providing clarity, the U.S. Supreme Court decisions introduced additional uncertainty by offering more than one test for determining WOTUS.

Subsequently, Presidents Obama and Trump each introduced their own WOTUS definitions. President Barack Obama introduced the Clean Water Rule (CWR) in 2015, and President Donald Trump introduced the Navigable Waters Protection Rule (NWPR) in 2020.

Not surprisingly, the CWR entailed a broader interpretation of WOTUS, based heavily of Justice Anthony Kennedy’s significant nexus test in Rapanos, while the NWPR was based heavily on Justice Antonin Scalia’s “relatively permanent waters” test in Rapanos. Both the CWR and the NWPR were immediately and significantly challenged. Neither rule remains in effect.

Current Status

The Biden administration published its draft definition of WOTUS on Dec. 7. The final rule was published in the Federal Register on Jan. 18. The agencies’ approach to interpreting WOTUS relies heavily on both of the frequently discussed tests identified in the Rapanos decision. In Rapanos, Justice Scalia issued the plurality opinion, which held that WOTUS would include only “relatively permanent, standing or continuously flowing bodies of water” connected to traditional navigable waters, and to “wetlands with a continuous surface connection to such relatively permanent waters” (such as adjacent wetlands).

Justice Kennedy, however, advanced a broader WOTUS interpretation in his concurring opinion, which was based on the concept of a “significant nexus” (for instance, wetlands should be considered as WOTUS “if the wetlands, either alone or in combination with similarly situated lands in the region, significantly affect the chemical, physical and biological integrity of other covered water”). President Biden’s new definition directly quotes and codifies these tests as regulations that may be relied upon to support a WOTUS determination.

While this new WOTUS definition may not be, conceptually, a significant change to how the agencies regulate streams and wetlands, the new definition may expand the agencies’ interpretation of a wetland that is “adjacent” to a WOTUS, through its lengthy discussion of adjacent wetlands in the final rule’s preamble.

The new definition also may expand how the agencies determine whether a water body will “significantly affect” a WOTUS, by providing a definition of “significantly affect,” which enumerates five factors to assess and five functions to consider in evaluating whether a potentially unregulated water will have a “material influence” on a traditionally navigable water.

Factors include distance from the traditionally navigable water, hydrologic factors and climatological variables. Functions include contribution of flow and retention and attenuation of runoff. Both the factors and the functions are broad and open to interpretation, which may lead to the agencies asserting jurisdiction over more water bodies. The new definition also codifies that the effect of the potentially regulated water must be evaluated alone “or in combination with similarly situated waters in the region,” which likely will broaden how the agencies evaluate the potential regulation of ephemeral and isolated water bodies.

Supreme Court And Congress

Publication of this definition, at this time, is likely a preemptive move by the agencies in advance of the Supreme Court’s impending decision in Sackett v. EPA, a case in which the court will, again, weigh in on the definition of WOTUS.

In Sackett, landowners in Idaho have had a long-standing challenge to an administrative order issued against them for allegedly filling wetlands without a permit. The Sacketts assert that Justice Kennedy’s significant nexus test in Rapanos is not the appropriate test to delineate wetlands as WOTUS, and that, under the test identified by Justice Scalia, the wetlands on their property are not WOTUS.

In 2021, the U.S. Court of Appeals for the Ninth Circuit ruled against the Sacketts’ position and held that the “significant nexus” test in the Kennedy concurrence was the controlling opinion from Rapanos. The Sacketts petitioned the U.S. Supreme Court to consider whether Rapanos should be revisited to adopt the plurality’s test for wetland jurisdiction under the CWA. However, the Supreme Court instead will consider the narrow issue of whether the Ninth Circuit “set forth the proper test for determining whether wetlands are WOTUS.”

Some have speculated that the U.S. Supreme Court’s opinion may support a narrower interpretation of WOTUS than the agencies have been implementing. For example, if the court narrows or eliminates the “significant nexus” test, the decision will create even more uncertainty in identifying WOTUS and may invalidate the Biden administration’s definition. The Sackett opinion is expected by this summer.

In a letter dated Jan. 30, 25 Republican governors asked President Biden to delay implementation of the new WOTUS definition until the U.S. Supreme Court issued the Sackett decision. The governors oppose the new definition and claim that it is, among other things, ill-timed, burdensome and overbroad. The governors assert that delaying implementation of the new definition until after the issuance of the Sackett decision will minimize the number of changes to the definition in a short time. The governors stated that multiple revisions would “impose an unnecessary strain on farmers, builders and every other impacted sector of the American economy.”

Consistent with the sentiments of the Republican governors, in early February, Republican members of Congress, led by Senator Shelley Moore Capito, R-W.V., and representatives Sam Graves, R-Mo., and David Rouzer, R-N.C., announced that they intended to use the Congressional Review Act to formally challenge the new WOTUS definition through a joint resolution of disapproval. The hearing was held on Feb 8.

The CRA provides Congress a mechanism to vote to disapprove agency rules that go beyond the authority Congress granted to federal agencies and to send the resolution to the president, who can approve or veto the resolution. If passed, the joint resolution of disapproval could invalidate the rule and prohibit an agency from issuing a rule that is in substantially the same form without further congressional authorization. President Biden is expected to veto any such joint resolution of disapproval.

Consistent with Obama’s CWR and Trump’s NWPR, the new WOTUS definition already has been challenged in the U.S. District Court of the Southern District of Texas by Texas and 18 industry groups, including the American Petroleum Institute, claiming that the new definition is “unworkable” and in conflict with the CWA (see accompanying story, page 30). These challenges may result in the stay or vacatur of the new definition. If this occurs, the agencies may, again, revert back to the current WOTUS definition.

Article By Lisa M. Bruderly of Babst, Calland, Clements & Zomnir, P.C.

For more environmental legal news, click here to visit the National Law Review.

© Copyright Babst, Calland, Clements and Zomnir, P.C.

As White House Loses House Majority, what is Next for H-1B Visa Program?

The H-1B is a popular and highly-sought-after visa category for skilled foreign workers seeking to work in the United States. It has been the subject of much debate and controversy over the years, and recent changes in the political landscape have added new uncertainties and challenges to the H-1B visa process. This blog post explores the impact of the Biden administration on changes to the H-1B visa, as well as the role of the new Republican majority in the House of Representatives in shaping the future of the H-1B visa program.

What is the H-1B Visa?

The H-1B is a temporary, nonimmigrant visa category that allows employers to petition on behalf of highly-educated foreign professionals who work in specialty occupations that require at least a bachelor’s degree. These jobs are generally in the fields of science, technology, engineering, and mathematics (“STEM”), enhancing American competitiveness in the global economy. In fact, in an effort to be even more competitive, the Biden administration recently expanded eligible fields of study that qualify under the program, as described in greater detail on this blog.

The H-1B visa allows U.S. employers to fill critically important jobs in the United States with foreign workers.  While many critics of the H-1B argue that it potentially limits job opportunities for U.S. workers, many others suggest that H-1B workers offer critical support to the U.S. economy. In fact, according to the American Immigration Counsel, H-1B recipients provided critical assistance during the COVID-19 pandemic, with many doctors, scientists, and nurses present in the U.S. on the H-1B visa, including individuals who assisted with the development of vaccines.

Biden Administration and its Relationship with Immigration Reform

One of the key priorities of the Biden administration has been to modernize and improve the U.S. immigration system, including the H-1B visa program. To this end, the Biden administration has taken steps to make the H-1B visa process more accessible and efficient for skilled foreign workers, including increasing the number of visas available, increasing transparency and consistency in the lottery process, and streamlining the application process.

According to a recent article by Forbes, Senator Richard Durbin (D-IL) and Senator Alex Padilla (D-CA) are expected to return as Senate Judiciary Committee chair and immigration subcommittee chair, respectively. It is expected that Sen. Chuck Grassley (R-IA) will no longer be ranking member on the Senate Judiciary; Sen. Lindsey Graham (R-SC) likely will hold that position. Just last year, Senator Grassley blocked an exemption from green card limits for certain foreign nationals with PhDs in STEM fields – a move that frustrated employers and universities alike.

Although Democrats hold the majority in the Senate, the House now features a Republican majority, which may complicate immigration reform efforts on Capitol Hill.

Republicans on Capitol Hill Seek to Counter Democratic Efforts on Immigration

The new Republican majority in the House of Representatives may pose a challenge to the Biden administration’s efforts to reform the H-1B visa program. Republicans have traditionally been more critical program and have pushed for reforms that would restrict the number of visas available and make it more difficult for foreign workers to come to the United States.

Sen. Tom Cotton (R-AR) has been a vocal critic of the H-1B program, stating that it is used to hire cheap foreign labor at the expense of American workers. Similarly, Sen. Grassley has expressed concerns about the impact of the program on American workers, claiming that while the visa was intended to help American businesses recruit the best and brightest talent from around the world, it’s too often been used to import cheaper foreign labor and displace American workers.

Given these differing perspectives, the future of the H-1B visa program will likely continue to be a source of political debate and controversy in the United States. However, it is clear that both sides of the political aisle agree that it needs to be reformed in some way, whether to make it more accessible and efficient for skilled foreign workers, or to better protect the interests of American workers.

Currently, the H-1B process in the United States is in a state of flux, with the Biden administration taking steps to modernize and improve the program, while the new Republican majority in the House of Representatives raises concerns about its impact on American workers. Whether the program will ultimately be reformed to better serve the interests of foreign workers, American workers, or both remains to be seen, but clearly this issue will continue to be a major source of political debate and controversy in the United States for the foreseeable future.

Article By Raymond G. Lahoud of Norris McLaughlin P.A.

For more immigration legal news, click here to visit the National Law Review.

©2023 Norris McLaughlin P.A., All Rights Reserved

DHS Guidelines Give Protection from Deportation to Undocumented Workers Who Report Labor Violations

If an employer hires undocumented workers, are they covered under the U.S. employment laws? Initially, employers must complete Form I-9s for all new employees and cannot hire workers who are unable to establish that they’re authorized to work. But once hired, the script flips and undocumented workers generally enjoy the same legal protections as the rest of the workforce (e.g., Title VII, FLSA, etc.). Undocumented workers, however, are often reluctant to make complaints to or cooperate in investigations with the EEOC, the Department of Labor, or other labor agencies, even when they have a legitimate beef with their employer. Why? It may be at least in part because they fear that they’ll be hauled into immigration court and deported. But now, the Biden administration has given those workers a possible safety valve.

Last month, the Department of Homeland Security released guidelines providing a process for undocumented workers to seek deferred action from removal (deportation) when they report a violation to a labor agency or cooperate in an agency investigation. In some circumstances, the individuals who utilize this process may also be eligible for temporary work authorization. Although each request for deferred action will be decided on a case-by-case basis, it’s clear that the purpose of this new process is to encourage undocumented workers to report labor violations and assist with agency investigations.

How Does the Process Work?

The U.S. Citizenship and Immigration Services (USCIS) will manage the process using a centralized intake system. If an undocumented worker makes a complaint to the EEOC, the DOL, or other labor agency, or assists the agency with an investigation, that worker can request deferred action from removal by submitting certain required documents. Among other things, the worker must submit his or her own statement setting forth the basis for the request, as well as a supporting “statement of interest” from the involved labor agency. According to the guidelines, the agency’s “statement of interest” should provide details about the nature of its investigation, how the worker may be helpful to that investigation, and how granting the worker’s request for deferred action would support the agency’s enforcement interests.

If the worker is already in removal proceedings or subject to an order of removal, the request for deferred action will be forwarded to ICE for determination. Otherwise, USCIS will adjudicate the request. Either way, USCIS or ICE will exercise its discretion on a case-by-case basis. In certain cases, the interested agency may also ask that the worker’s request be adjudicated on an expedited basis.

If an undocumented worker’s request is approved, the grant of deferred action will normally be good for two years, although it is subject to termination at any time. When submitting the request, the worker may also apply for temporary employment authorization on USCIS Form I-765. Approved applications for employment authorization, while not guaranteed, will typically allow the individual to work for the entire period of deferred action. Subsequent requests to extend the worker’s deferred action can be made if the labor agency continues to have an investigative or enforcement interest in the worker’s matter.

What’s the Practical Impact?

This is less clear. Will undocumented workers take advantage of this new process in significant numbers? The guidelines offer some potential protection, but the approval of an individual worker’s request is not automatic and, even if approved, the grant of deferred action is temporary.  Notably, the guidelines do not provide any long-term path to lawful status. And, because the guidelines have been issued without Congressional or regulatory action, they are subject both to being challenged in the courts and to being revoked in two years if there’s a change in the White House. Will undocumented workers feel comfortable using this process in the face of all this uncertainty? Stay tuned.

Article By Keith Covington and Anne R. Yuengert of Bradley Arant Boult Cummings LLP

For more immigration legal news, click here to visit the National Law Review.
© 2023 Bradley Arant Boult Cummings LLP

First Major Overhaul of Cosmetics Regulation Since FDR Administration

As part of the Consolidated Appropriations Act, 2023, President Biden signed into law the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”). This is the first major reform of cosmetics regulation since the Federal Food, Drug, and Cosmetic Act (“FDCA”) became law in 1938.[1] MoCRA implements new compliance requirements on the cosmetics industry and also significantly expands the U.S. Food and Drug Administration’s (“FDA”) authority to oversee and regulate cosmetics.

New Obligations for Cosmetics Industry

MoCRA imposes the following new requirements on “responsible persons”[2] and “facilities.”[3] We note that certain of these regulatory requirements may differ for entities considered small businesses under MoCRA.

  • Facility Registration and Product Disclosure. All facilitates (domestic or foreign) that manufacture or process cosmetic products for distribution in the United States must register with FDA by December 29, 2023. Registration is biennial. Further, responsible persons must annually submit cosmetic product listings to FDA and disclose key product information, such as ingredients.
  • Adverse Event Recording and Serious Adverse Event Reporting. Generally, responsible persons must keep records of any adverse events related to products used in the United States for six years and submit any “serious adverse events” to FDA within 15 days of the responsible person’s receipt of the report. MoCRA broadly defines what constitutes a serious adverse event, when compared to other FDA regulatory product categories (e.g., dietary supplements).[4]
  • Labeling Requirements. To improve the reporting of adverse events, responsible persons must include contact information on product labels. Additionally, product labels must identify any fragrance allergens in the product. Labels for products intended for use only by licensed professionals must also indicate that only licensed professionals may use the product.
  • Safety Substantiation Requirement. Responsible persons must ensure that a product is “safe” and keep records “adequately substantiating” the product’s safety.[5] Products without adequate safety substantiation may be considered adulterated under the FDCA. MoCRA also contains a provision stating that it is the sense of Congress that animal testing should not be used for safety testing on cosmetic products and should be phased out with the exception of appropriate allowances.

Increased FDA Oversight of Cosmetics

MoCRA significantly expands FDA’s enforcement authority over the cosmetics industry.

  • Issue Mandatory Recalls. FDA now has mandatory recall authority if the agency concludes there is a reasonable probability that a cosmetic is adulterated or misbranded and the use of the cosmetic will cause serious adverse health consequences or death.
  • Access Records. If FDA has a reasonable belief that a cosmetic product (or one of its ingredients) is adulterated and presents a threat of serious adverse health consequences or death, the agency has authority to access records relating to that product.
  • Suspend Facilities. FDA may suspend a facility’s registration if the agency determines that a cosmetic product manufactured or processed by that facility has a reasonable probability of causing serious adverse health consequences or death and there is a reasonable belief that other products from the same facility may be similarly affected.
  • Federal Preemption. MoCRA explicitly preempts any state or local laws that differ from the federal cosmetics framework regarding facility registration and product listing, good manufacturing practices (“GMPs”), records, recalls, adverse event reporting, or safety substantiation.

Forthcoming FDA Rulemakings and Reports

MoCRA directs FDA to promulgate rules regarding the following three issues. Importantly, the cosmetics industry will have opportunities to provide comment on the proposed rules.

  • GMPs. FDA must establish GMP regulations consistent with national and international standards. Cosmetic products manufactured or processed under conditions that do not meet FDA’s forthcoming GMP regulations may be considered adulterated. The agency must issue a proposed rule by December 29, 2024 and a final rule by December 29, 2025.
  • Fragrance Allergens. FDA must publish regulations to identify fragrance allergens. Cosmetic product labels that do not include fragrance allergen disclosures required by such regulations may be considered misbranded under the FDCA. The agency must issue a proposed rule by June 29, 2024 and a final rule no later than 180 days after the public comment period.
  • Talc. FDA must issue regulations to establish required standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.

In addition to the above rulemakings, FDA must issue a report within the next three years on the use of per- and polyfluoroalkyl substances (“PFAS”) in cosmetic products.

Footnotes

  1. MoCRA amends Chapter VI of the FDCA.
  2. A “responsible person” is defined as a manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of that product.
  3. “Facilities” are defined as any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States. MoCRA specifically exempts from registration certain facilities, such as those that (i) only label, relabel, package, hold, or distribute cosmetics products; and (ii) manufacture or process products solely for use in research and evaluation.
  4. “Serious adverse events” are defined as adverse events that result in (i) death; (ii) a life-threatening experience; (iii) inpatient hospitalization; (iv) a persistent or significant disability or incapacity; (v) a congenital anomaly or birth defect; (vi) infection; or (vii) significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance); or that require – based on reasonable medical judgment – a medical or surgical intervention to prevent one of the outcomes described above.
  5. “Safe” is defined as a cosmetic product (and its ingredients) that is not injurious to users under the labeling or customary/usual usage. A cosmetic product (or its ingredients) should not be considered injurious solely because it can cause minor and transient reactions or minor and transient skin irritations in some users. Further, “adequate substantiation” of safety means tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support the product’s safety to a reasonable certainty.

Article By Christopher Hanson of Nelson Mullins. Paul Clowes, Law Clerk in the Greenville office, contributed to the drafting of this post.

For more biotech, food, and drug legal news, click here to visit the National Law Review.

Copyright ©2023 Nelson Mullins Riley & Scarborough LLP

Office of Science and Technology Policy Requests Public Input on Biotechnology Regulation

  • The Office of Science and Technology Policy (OSTP) issued a request for information (RFI) today in which it invites public comment on the Coordinated Framework for the Regulation of Biotechnology (the “Coordinated Framework”).
  • The Coordinated Framework, which is a Federal regulatory policy for ensuring the safety of biotechnology products, was first issued in 1986, updated in 1992— to affirm that federal regulation should focus on characteristics of the product and the environment into which it being introduced, and not on the process by which it is produced—and then updated again in 2017 to clarify the roles of EPA, FDA, and USDA. And, in September of this year, Executive Order 14081 directed the three agencies to clarify and streamline regulations to support the safe of use of biotechnology products.
  • Accordingly, the RFI requests comment on seven questions related to the Coordinated Framework. The questions include a request for comment on identification of any regulatory gaps, inefficiencies, or uncertainties; data or information to improve any identified issues; and new or emerging biotechnology products that the agencies should be prepared to address. Comments to the RFI are due by February 3, 2023. Also, on January 12, 2023, OTSP will host a virtual event in which it will listen to public feedback on the RFI.

Article By Food and Drug Law at Keller and Heckman

For more food, drug, and biotechnology legal news, click here to visit the National Law Review.

© 2022 Keller and Heckman LLP

Reinventing the American Road Trip: What the Inflation Reduction Act Means for Electric Vehicle Infrastructure

The Inflation Reduction Act of 2022 (“IRA”) signifies a turning point in domestic efforts to tackle climate change. Within the multibillion-dollar package are robust investments in climate mitigation initiatives, such as production tax credits, investment tax credits for battery and solar cell manufacturers, tax credits for new and used electric vehicles (“EV”)1, automaker facility transition grants, and additional financing for the construction of new electric vehicle manufacturing facilities.2 One thing is abundantly clear, the IRA’s focus on stimulating domestic production of electric vehicles means that the marketplace for electric vehicles will see a dramatic change. The Biden Administration has set an ambitious target of 50% of EV sale shares in the U.S. by 2030. However, if electric vehicles are going to achieve mass market adoption, a central question remains — where is the infrastructure to support them?

Addressing gaps in EV Supply and EV Infrastructure

As it stands, the shortage of charging infrastructure is a substantial barrier in the push for mass consumer adoption of EVs.3 Experts estimate that in order to meet the Biden Administration’s EV sale target by 2030, America would require 1.2 million public EV chargers and 28 million private EV chargers by that year.4 Department of Energy data shows that approximately 50,000 EV public charging sites are currently operational in the United States.5 In comparison, gasoline fueling stations total more than 145,000.6 However, federal legislation such as the Bipartisan Infrastructure Law (“BIL”) passed earlier this year signifies a clear commitment to remedying this disparity. The BIL establishes a National Electric Vehicle Infrastructure Formula Program (“NEVI”) to provide funding to States and private entities to deploy EV-charging infrastructure and to establish an interconnected network to facilitate “data collection, access and reliability.”7 The Federal Highway Administration, the federal agency charged with implementing NEVI, proposed minimum standards and requirements that states must meet to spend NEVI funds:

  • Installation, operation and maintenance by qualified technicians of EV infrastructure

  • Interoperability of EV charging infrastructure

  • Network connectivity of EV charging infrastructure

  • Data collection pertaining to pricing, real-time availability and accessibility8

The goal of the proposed rule is to secure EV charging infrastructure that works seamlessly for industrial, commercial and consumer drivers. Combining the historic investments in clean energy and climate infrastructure in the BIL and IRA, the federal government has jumpstarted what will be a fundamental shift in how consumers use transportation. Earlier this week, the Biden Administration announced more than two-thirds of EV Infrastructure Deployment Plans from States, the District of Columbia and Puerto Rico have been approved ahead of schedule under NEVI.9 With this early approval, these states can now unlock more than $900 million in NEVI funding from FY22 and FY23 to help build EV chargers across highways throughout the country.10

Section 13404’s Alternative Fuel Refueling Property Credit

Building up the U.S. capacity to build EVs, and then ensuring people can use said vehicles more easily by shoring up EV infrastructure is a crucial facet of the Inflation Reduction Act. Section 13404 of the IRA provides an Alternative Fuel Refueling Property Credit that targets the accelerated installation of EV charging infrastructure and assets.11 Section 13404 extends existing alternative fuel vehicle refueling property credit through 2032, and significantly restructures the credit by allowing taxpayers to claim a base credit of 6% for expenses up to $100,000 (for each piece refueling property located at a given facility) so long as the property is placed in service before Jan. 1, 2033.12 However, the alternative fuel property must be manufactured for use on public streets, roads and highways, but only if they are (1) intended for general public use, or (2) intended for exclusive use by government or commercial vehicles and (3) must be located in a qualifying census tract (i.e., low-income communities or non-urban areas).13 From a job creation standpoint, the IRA also provides an alternative bonus credit for taxpayers that meet certain wage requirements during the construction phase.14

The Future of EV Infrastructure

EV stations in city streets, parking garages and gas stations will become a prominent part of the nation’s infrastructure as it moves towards a green future. The effort will require coordination among municipal, state and federal policymakers. Even more, electric utilities must ensure that local infrastructure can support the additional strain on the grid. Utilities also have a direct interest in a cleaner, efficient, and less overburdened grid. Federal tax incentives, like the IRA, and subsides from states and local ordinances are integral to the implementation and construction of these networks. The private sector has already taken steps to do its part. In a recent study conducted by consulting company AlixPartners, as of June 2022, automakers and suppliers expect to invest at least $526 billion to fund the transition from gasoline powered vehicles to EVs through 2026.15 This is double the five-year EV investment forecast of $234 billion from 2020-2024.16 Even more, according to Bloomberg, not including deals that have disclosed financials, more than $4.8 billion has already been invested in the EV charging industry this year in the form of debt financing and acquisitions.17 Driven by fast growth and robust availability of government funds, financiers and large companies seeking to acquire EV charging companies, sense immense opportunity.18

FOOTNOTES

1“Electric Vehicle” is used interchangeably with the acronym “EV” throughout this article.

2 Isaacs-Thomas, I. (2022, August 11). What the Inflation Reduction act does for green energy. PBS. https://www.pbs.org/newshour/science/what-the-inflation-reduction-act-do…

3 Consumer Reports (2022, April). Breakthrough Energy: A Nationally Representative Multi-Mode Survey. https://article.images.consumerreports.org/prod/content/dam/surveys/Cons…

4 Kampshoff, P., Kumar, A., Peloquin, S., & Sahdev, S. (2022, August 31). Building the electric-vehicle charging infrastructure America needs. McKinsey & Company. https://www.mckinsey.com/industries/public-and-social-sector/our-insight…

5 U.S Department of Energy. (2022). Alternative Fueling Station Locator. Alternative Fuels Data Center: Alternative Fueling Station Locator. https://afdc.energy.gov/stations/#/find/nearest?fuel=ELEC&ev_levels=all&…

6 American Petroleum Institute. (n.d.). Service station FAQs. Energy API. https://www.api.org/oil-and-natural-gas/consumer-information/consumer-re…

7 U.S. Department of Transportation/Federal Highway Administration. (n.d.). Bipartisan Infrastructure Law – National Electric Vehicle Infrastructure (NEVI) formula program fact sheet: Federal Highway Administration. U.S. Department of Transportation/Federal Highway Administration. https://www.fhwa.dot.gov/bipartisan-infrastructure-law/nevi_formula_prog…

8 The Office of the Federal Register of the National Archives and Records Administration and the U.S. Government Publishing Office. (2022, June 22). National Electric Vehicle Infrastructure Formula Program. Federal Register. https://www.federalregister.gov/documents/2022/06/22/2022-12704/national…

9 United States Department of Transportation. (2022, September 14). Biden-Harris Administration announces approval of First 35 state plans to build out EV charging infrastructure across 53,000 miles of Highways. United States Department of Transportation. https://highways.dot.gov/newsroom/biden-harris-administration-announces-…

10 See Id.

11 As a note, “refueling property” is property used for the storage or dispensing of clean-burning fuel or electricity into the vehicle fuel tank or battery.  Clean-burning fuels include CNG, LNG, electricity, and hydrogen.

12 Inflation Reduction Act of 2022, H.R. 5376, 117th Cong. § 13404 (2022); See also Wells Hall III, C., Holloway, M. D., Wagner, T., & Baldwin, E. (2022, August 10). Nelson Mullins tax report–Senate passes Inflation Reduction Act. Nelson Mullins Riley & Scarborough LLP. https://www.nelsonmullins.com/idea_exchange/alerts/additional_nelson_mul…

13  Id.

14  Id.

15 AlixPartners, LLP. (2022, June 22). 2022 Alixpartners global automotive outlook. AlixPartners. https://www.alixpartners.com/media-center/press-releases/2022-alixpartne… See also Lienert, P. (2022, June 22). Electric vehicles could take 33% of global sales by 2028. Reuters. https://www.reuters.com/business/autos-transportation/electric-vehicles-…

16 Id.

17 Fisher, R. (2022, August 16). Electric car-charging investment soars driven by EV Growth, government funds. Bloomberg. https://www.bloomberg.com/news/articles/2022-08-16/car-charging-investme…

18 Id.

Article By Lawrence L. Ostema and Jeffrey E. Joseph of Nelson Mullins

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Copyright ©2022 Nelson Mullins Riley & Scarborough LLP

Draft SEC Five-Year Strategic Plan Emphasizes Importance of Climate Disclosures

Recently, the SEC issued its five-year strategic plan for public comment.  This strategic plan covers a wide variety of topics, ranging from adapting to new technology to plans for increasing internal SEC workforce diversity.  Significantly, this draft strategic plan stated that “the SEC must update its disclosure framework,” and highlighted three areas in which it should do so: “issuers’ climate risks, cybersecurity hygiene policies, and their most important asset: their people.”

The SEC has already undertaken steps to enact these proposed updates to its disclosure requirements for public companies.  Notably, this past March it proposed draft climate disclosure rules, which provoked a significant response from the public–including widespread criticism from many companies (as well as praise from environmental organizations).  The fact that the SEC chose to highlight these rules in its (draft) five-year strategic plan indicates the depth of the commitment it has made to these draft climate disclosures, and further suggests that the final form of the climate disclosures is unlikely to be significantly altered in substance from what the SEC has already proposed.  This statement reinforces the commitment of Chairman Gensler’s SEC and the Biden Administration to financial disclosures as a method to combat climate change.

“The markets have begun to embrace the necessity of providing a greater level of disclosure to investors. From time to time, the SEC must update its disclosure framework to reflect investor demand. Today, investors increasingly seek information related to, among other things, issuers’ climate risks, cybersecurity hygiene policies, and their most important asset: their people. In order to catch up to that reality, the agency should continue to update the disclosure framework to address these areas of investor demand, as well as continue to take concrete steps to modernize the systems that support the disclosure framework, to make public disclosures easier to access and analyze and thus more decision-useful to investors. . . . Across the agency, the SEC must continually reassess its risks, including in new areas such as climate risk, and document necessary controls.”

Article By Jacob H. Hupart of Mintz

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©1994-2022 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.

The Inflation Reduction Act: How Do Tribal Communities Benefit?

On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022 (“IRA”), ushering in substantial changes for tax law, climate resilience, healthcare, and more in the United States. According to the Biden administration’s press release, the new $750 billion legislation aims to lower everyday costs for families, insist that corporations pay their fair share, and combat the climate crisis. During the signing ceremony, President Biden stated, “With this law, the American people won and the special interests lost […] For a while people doubted whether any of that was going to happen, but we are in a season of substance.”

Notably, the legislation provides significant provisions for tribal communities and the Bureau of Indian Affairs. Once the funding is appropriated by Congress, it will be directed toward drought mitigation programs, fish hatcheries, modernization of electric systems, and more for Native communities, including ones in Alaska and Hawaii.

How the Inflation Reduction Act of 2022 Supports the Environment and Tribal Communities

The Inflation Reduction Act of 2022 contains an array of provisions, including the reduction of drug prices, the lowering of energy costs, and, notably, federal infrastructure investments that benefit Native communities. Andrew M. VanderJack and Laura Jones, Co-Coordinators of Van Ness Feldman’s Native Affairs Practice, highlight the most significant facets of the bill: “This legislation provides some opportunities specifically for tribes and tribal entities, including programs related to climate resiliency and adaptation, electrification, and drought relief. For example, the Emergency Drought Relief program for Tribes extends direct financial assistance to tribal governments to address drinking water shortages and to mitigate the loss of tribal trust resources.”

Pilar Thomas, Partner in Quarles & Brady’s Energy, Environment & Natural Resources Practice Group, expanded on the most significant inclusions for Tribes: “[…] the creation of a Direct Pay tax credit payment program that allows Tribes to receive a payment equal to the clean energy technology tax credits – especially for solar, wind, storage, geothermal and EV charging stations; […] direct funding for electrification and climate resiliency through DOI and USDA; […] access to the greenhouse gas reduction fund, environmental and climate justice grants; and expanded energy efficiency tax benefits and rebates for tribes and tribal members.”

“Tribal governments are also eligible to apply for other programs such as the Clean Vehicle Credit program, the Energy Efficient Commercial Buildings Deduction, and the State and Private Forestry Conservation Programs,” noted Mr. VanderJack and Ms. Jones.

How the 2022 Inflation Reduction Act Has Been Received by Tribal Communities

The 2022 Inflation Reduction Act has received a warm reception from groups such as the National Indian Health Board and Native Organizers Alliance, who laud the bill’s potential to improve environmental, medical, and economic conditions for tribal communities, some of whom still lack access to electricity or clean water. The increase in funding will allow tribes to use green energy technology to increase climate resilience and decrease individual energy costs, while reducing the effects of environmental racism with risk assessments for drinking water and climate hazards. These infrastructural changes will stimulate economic development by creating new jobs. “With critical investments in the Inflation Reduction Act, we’re making sure the federal government steps up to support Native-driven climate resilience, advance tribal energy development, and fulfill its trust responsibility to Native communities,” said Senator and Senate Committee on Indian Affairs Chairman Brian Schatz.

“This legislation will result in hundreds of millions of funding available for Tribes, and non-profits that work with tribes and tribal communities to support the clean energy transition for tribal communities, reduce energy costs for tribal members, and create jobs,” said Ms. Thomas of Quarles & Brady. “The IRA will provide a substantial down payment for every tribe to take advantage of clean energy technologies, energy efficiency and energy savings, and climate resilient solutions for their communities and tribal members individually.  The new projects, technology implementation and economic development opportunities are substantial and will create long term community and economic development sustainable improvements in tribal communities.”

Some groups feel that the new legislation does not go far enough. In an open letter to President Biden, Senate Majority Leader Chuck Schumer, and House Speaker Nancy Pelosi, Indigenous-led advocacy organization NDN Collective argued that Congress’ hesitance to fully reject fossil fuels undermines the stated goals of addressing climate change, a misstep that could disproportionately affect tribal communities at the frontlines of the environmental crisis. “We believe that moving away from investments in the fossil fuel and other extractive industries and reallocating the funding to further research and development will help us find the solutions we need for true decarbonization and large-scale equitable carbon emissions reductions,” the collective stated. “We are already aware of innovative, Indigenous-led solutions that just need the proper funding and support to be scaled and replicated.”

Challenges in Getting the 2022 Inflation Reduction Act Passed

Up to this point, the Inflation Reduction Act has faced significant challenges in Congress. The legislation is the product of extensive compromise over the Build Back Better Act within the Democratic party. The Build Back Better Bill was initially estimated to cost over $3 trillion, and ultimately, the Inflation Reduction Act was passed with a budget of $750 billion. Senator Joe Manchin of West Virginia held back his support of the bill until late July, and Republicans successfully blocked an aspect of the bill that would have capped the price of insulin for Americans with private health insurance. When presented to Congress, the vote was split by party lines with every Republican voting against the bill. Biden has criticized Republicans for this decision, saying at the signing of the Inflation Reduction Act, “every single Republican in the Congress sided with the special interests in this vote — every single one.”

Challenges for tribal governments remain as well, specifically concerning the IRA’s implementation. “Despite the incredible opportunity for tribes, major barriers remain including tribal internal capacity and capabilities, [and] federal regulatory hurdles (such as BIA leasing and easement approvals),” said Ms. Thomas.

“[…] Navigating the complexities of each program and actually obtaining funding is always the challenge,” said Mr. VanderJack and Ms. Jones of Van Ness Feldman. “Tribes and tribal entities should engage directly, whenever possible, with the grant funding agencies to make sure proposals are tailored to fit both program requirements and community needs.”

Early Assessment of How the IRA will Impact Tribal Communities

The Inflation Reduction Act, ultimately, provides meaningful resources and investments for tribal communities in a variety of ways. While the provisions are not as significant as COVID-19 relief and infrastructure funding that tribal governments have received in previous years, the new legislation is nonetheless beneficial. “While the federal grant funding is relatively small, the potential major impact is the ability to access funding through tax credit payments and rebates,” said Ms. Thomas. “This mechanism is critical as it is simplifies tribes’ access to funding (rather than, for example, seeking to obtain funding through the competitive grant programs).”

Article By Chandler Ford, Casey Karthaus, Crissonna Tennison, and Shelby Garrett of The National Law Review / The National Law Forum LLC.

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Biden Administration Seeks to Clarify Patient Privacy Protections Post-Dobbs, Though Questions Remain

On July 8, two weeks following the Supreme Court’s ruling in Dobbs v. Jackson that invalidated the constitutional right to abortion, President Biden signed Executive Order 14076 (E.O.). The E.O. directed federal agencies to take various actions to protect access to reproductive health care services,[1] including directing the Secretary of the U.S. Department of Health and Human Services (HHS) to “consider actions” to strengthen the protection of sensitive healthcare information, including data on reproductive healthcare services like abortion, by issuing new guidance under the Health Insurance and Accountability Act of 1996 (HIPAA).[2]

The directive bolstered efforts already underway by the Biden Administration. A week before the E.O. was signed, HHS Secretary Xavier Becerra directed the HHS Office for Civil Rights (OCR) to take steps to ensure privacy protections for patients who receive, and providers who furnish, reproductive health care services, including abortions.[3] The following day, OCR issued two guidance documents to carry out this order, which are described below.

Although the guidance issued by OCR clarifies the privacy protections as they exist under current law post-Dobbs, it does not offer patients or providers new or strengthened privacy rights. Indeed, the guidance illustrates the limitations of HIPAA regarding protection of health information of individuals related to abortion services.

A.  HHS Actions to Safeguard PHI Post-Dobbs

Following Secretary Becerra’s press announcement, OCR issued two new guidance documents outlining (1) when the HIPAA Privacy Rule may prevent the unconsented disclosure of reproductive health-related information; and (2) best practices for consumers to protect sensitive health information collected by personal cell phones, tablets, and apps.

(1) HIPAA Privacy Rule and Disclosures of Information Relating to Reproductive Health Care

In the “Guidance to Protect Patient Privacy in Wake of Supreme Court Decision on Roe,”[4] OCR addresses three existing exceptions in the HIPAA Privacy Rule to the disclosure of PHI without an individual’s authorization and provides examples of how those exceptions may be applied post-Dobbs.

The three exceptions discussed in the OCR guidance are the exceptions for disclosures required by law,[5]  for purposes of law enforcement,[6] or to avert a serious threat to health or safety.[7]

While the OCR guidance reiterates that the Privacy Rule permits, “but does not require” disclosure of PHI in each of these exceptions,[8] this offers limited protection that relies on the choice of providers whether to disclose or not disclose the information. Although these exceptions are highlighted as “protections,” they expressly permit the disclosure of protected health information. Further, while true that the HIPAA Privacy Rule itself may not compel disclosure (but merely permits disclosure), the guidance fails to mention that in many situations in which these exceptions apply, the provider will have other legal authority (such as state law) mandating the disclosure and thus, a refusal to disclose the PHI may be unlawful based on a law other than HIPAA.

Two of the exceptions discussed in the guidance – the required by law exception and the law enforcement exception – both only apply in the first place when valid legal authority is requiring disclosure. In these situations, the fact that HIPAA does not compel disclosure is of no relevance. Certainly, when there is not valid legal authority requiring disclosure of PHI, then HIPAA prohibits disclosure, as noted as in the OCR guidance.  However, in states with restrictive abortion laws, the state legal authorities are likely to be designed to require disclosure – which HIPAA does not prevent.

For instance, if a health care provider receives a valid subpoena from a Texas court that is ordering the disclosure of PHI as part of a case against an individual suspected of aiding and abetting an abortion, in violation of Texas’ S.B. 8, then that provider could be held in contempt of court for failing to comply with the subpoena, despite the fact that HIPAA does not compel disclosure.[9] For more examples on when a covered entity may be required to disclose PHI, please see EBG’s prior blog: The Pendulum Swings Both Ways: State Responses to Protect Reproductive Health Data, Post-Roe.[10]

Notably, the OCR guidance does provide a new interpretation of the application of the exception for disclosures to avert a serious threat to health or safety. Under this exception, covered entities may disclose PHI, consistent with applicable law and standards of ethical conduct, if the covered entity, in good faith, believes the use or disclosure is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public. OCR states that it would be inconsistent with professional standards of ethical conduct to make such a disclosure of PHI to law enforcement or others regarding an individual’s interest, intent, or prior experience with reproductive health care. Thus, in the guidance, OCR takes the position that if a patient in a state where abortion is prohibited informs a health care provider of the patient’s intent to seek an abortion that would be legal in another state, this would not fall into the exception for disclosures to avert a serious threat to health or safety.  Covered entities should be aware of OCR’s position and understand that presumably OCR would view any such disclosure as a HIPAA violation.

(2) Protecting the Privacy and Security of Individuals’ Health Information When Using Personal Cell Phones or Tablets

OCR also issued guidance on how individuals can best protect their PHI on their own personal devices. HIPAA does not generally protect the privacy or security of health information when it is accessed through or stored on personal cell phones or tablets. Rather, HIPAA only applies when PHI is created, received, maintained, or transmitted by covered entities and business associates. As a result, it is not unlawful under HIPAA for information collected by devices or apps – including data pertaining to reproductive healthcare – to be disclosed without consumer’s knowledge.[11]

In an effort to clarify HIPAA’s limitation to protect such information, OCR issued guidance to protect consumer sensitive information stored in personal devices and apps.[12] This includes step-by-step guidance on how to control data collection on their location, and how to securely dispose old devices.[13]

Further, some states have taken steps to fill the legal gaps to varying degrees of success. For example, California’s Confidentiality of Medical Information Act (“CMIA”) extends to “any business that offers software or hardware to consumers, including a mobile application or other related device that is designed to maintain medical information.”[14] As applied, a direct-to-consumer period tracker app provided by a technology company, for example, would fall under the CMIA’s data privacy protections, but not under HIPAA. Regardless, gaps remain as the CMIA does not protect against a Texas prosecutor subpoenaing information from the direct-to-consumer app. Conversely, Connecticut’s new reproductive health privacy law,[15] does prevent a Connecticut covered entity from disclosing reproductive health information based on a subpoena, but Connecticut’s law does not apply to non-covered entities, such as a period tracker app. Therefore, even the U.S.’s most protective state privacy laws do not fill in all of the privacy gaps.

Alongside OCR’s guidance, the Federal Trade Commission (FTC) published a blog post warning companies with access to confidential consumer information to consider FTC’s enforcement powers under Section 5 of the FTC Act, as well as the Safeguards Rule, the Health Breach Notification Rule, and the Children’s Online Privacy Protection Rule.[16] Consistent with OCR’s guidance, the FTC’s blog post reiterates the Biden Administration’s goal of protecting reproductive health data post-Dobbs, but does not go so far as to create new privacy protections relative to current law.

B.  Despite the Biden Administration’s Guidance, Questions Remain Regarding the Future of Reproductive Health Privacy Protections Post-Dobbs

Through E.O. 14076, Secretary Becerra’s press conference, OCR’s guidance, and the FTC’s blog, the Biden Administration is signaling that it intends to use the full force of its authorities – including those vested by HIPAA – to protect patient privacy in the wake of Roe.

However, it remains unclear how this messaging will translate to affirmative executive actions, and how successful such executive actions would be. How far is the executive branch willing to push reproductive rights? Would more aggressive executive actions be upheld by a Supreme Court that just struck down decades of precedent permitting access to abortion? Will the Biden Administration’s executive actions persist if the administration changes in the next Presidential election?

Attorneys at Epstein Becker & Green are well-positioned to assist covered entities, business associates, and other companies holding sensitive reproductive health data understand how to navigate HIPAA’s exemptions and interactions with emerging guidance, regulations, and statutes at both the state and Federal levels.

Ada Peters, a 2022 Summer Associate (not admitted to the practice of law) in the firm’s Washington, DC office and Jack Ferdman, a 2022 Summer Associate (not admitted to the practice of law) in the firm’s Boston office, contributed to the preparation of this post. 

[1] 87 Fed. Reg. 42053 (Jul. 8, 2022), https://bit.ly/3b4N4rp.

[2] Id.

[3] HHS, Remarks by Secretary Xavier Becerra at the Press Conference in Response to President Biden’s Directive following Overturning of Roe v. Wade (June 28, 2022), https://bit.ly/3zzGYsf.

[4] HHS, Guidance to Protect Patient Privacy in Wake of Supreme Court Decision on Roe (June 29, 2022),  https://bit.ly/3PE2rWK.

[5] 45 CFR 164.512(a)(1)

[6] 45 CFR 164.512(f)(1)

[7] 45 CFR 164.512(j)

[8] Id.

[9] See Texas S.B. 8; e.g., Fed. R. Civ. Pro. R.37 (outlining available sanctions associated with the failure to make disclosures or to cooperate in discovery in Federal courts), https://bit.ly/3BjX4I2.

[10] EBG Health Law Advisor, The Pendulum Swings Both Ways: State Responses to Protect Reproductive Health Data, Post-Roe (June 17, 2022), https://bit.ly/3oPDegl.

[11] A 2019 Kaiser Family Foundation survey concluded that almost one third of female respondents used a smartphone app to monitor their menstrual cycles and other reproductive health data. Kaiser Family Foundation, Health Apps and Information Survey (Sept. 2019), https://bit.ly/3PC9Gyt.

[12] HHS, Protecting the Privacy and Security of Your Health Information When Using Your Personal Cell Phone1 or Tablet (last visited Jul. 26, 2022), https://bit.ly/3S2MNWs.

[13] Id.

[14] Cal. Civ. Code § 56.10, Effective Jan. 1, 2022, https://bit.ly/3J5iDxM.

[15] 2022 Conn. Legis. Serv. P.A. 22-19 § 2 (S.B. 5414), Effective July 1, 2022, https://bit.ly/3zwn95c.

[16] FTC, Location, Health, and Other Sensitive Information: FTC Committed To Fully Enforcing the Law Against Illegal Use and Sharing of Highly Sensitive Data (July 11, 2022), https://bit.ly/3BjrzNV.

Article By Alaap B. Shah, Allen R. Killworth, Marylana Saadeh Helou, and Devon Minnick of Epstein Becker & Green, P.C.

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