Tag: regulations

NJDEP Publishes New Climate Change Rule Proposal

Substantial changes to NJDEP’s use Coastal, Flood Hazard, Wetland and Stormwater regulatory programs are coming that will severely impact proposed and existing development. NJDEP published its Protecting Against Climate Threats (PACT) Resilient Environments and Landscapes (REAL) rule in the August 5, 2024 New Jersey Register and has up to a year to adopt the proposed amendments.

The proposal is extensive and will implement sweeping regulatory changes across various regulatory permitting programs, affecting new development and redevelopment, and substantial improvements to existing development. The proposal relies on several reports and studies commissioned or prepared by NJDEP, including the NJ Scientific Report on Climate Change (NJ Climate Science Report), the New Jersey Climate Change Alliance Science and Technical Advisory Panel (STAP) “Rising Seas and Changing Coastal Storms” report prepared by Rutgers University, and two rainfall studies in 2021, which predict a less than 17% chance that sea level rise (“SLR”) will exceed 5.1 feet by Year 2100, and that the State’s precipitation rates and intensity are expected to increase through the Year 2100. DEP is using this very conservative less than 17% chance as the basis for these proposed rules.

NJDEP will establish a regulatory Inundation Risk Zone (IRZ) largely in coastal areas along tidal waters that are predicted to be at risk of daily inundation or standing flood waters of up to 5.1 feet (by Year 2100). The extent of the IRZ is determined by adding 5 feet to the calculated mean higher high water (MHHW) line elevation. Projects in the IRZ involving new residential development, critical buildings and substantial improvements to existing structures will need to meet onerous enhanced risk assessment criteria including an alternatives analysis designed to avoid the risk (a/k/a discourage building). The rule will also establish a new Climate Adjusted Flood Elevation (CAFE) in tidal flood hazard areas, which represents a 5-foot addition to FEMA’s 100-year flood elevation based on NJDEP’s very conservative SLR predictions.

Numerous other proscriptive measures are proposed. Some of the more noteworthy provisions are listed below.

General 

  • New burdens will be imposed regarding pre-commencement work notices, including that such notices be made no more than 14 days in advance of the start of work in addition to reporting requirements for completion of work. In our experience, notices similar to these are simply filed and are merely a regulatory burden.

Coastal 

  • Non-mainland (barrier island) coastal centers will be extinguished and, in many cases, strict new impervious cover limitations (3%) and vegetative preserve/plantings requirements will become applicable. This makes development or redevelopment in most of the barrier islands improbable, if not impossible.
  • A 3% cover limit will be applicable even in designated centers for lands identified as a Coastal Environmentally Sensitive Area, even if these areas can be otherwise developed with permits from discrete programs such as wetlands or flood hazard areas.
  • Construction continuation rights beyond the permit expiration date in the CAFRA Individual Permit context will be curtailed based on new requirements to justify the continuation based on the reasonable financial investment of the permittee “in proportion to the project as a whole”.
  • The CAFRA infill exception for a single-family house or duplex in a coastal high hazard area and erosion hazard area will be removed for parcels in the IRZ.

Wetlands 

  • Limitations and mitigation requirements will be enhanced with respect to wetland buffers and permitting.
  • New conditions will be imposed for wetland general permits requiring stormwater compliance for projects that are a major development, in contrast to the current rules which only require stormwater compliance if the wetland and/or buffer impacts are considered major development thresholds.
  • The rules will require General Permit applicants to demonstrate “no other practicable configuration” that would avoid or reduce the impacts to wetlands, effectively holding General Permit applicants to standards similar to the alternatives analysis required for an Individual Permit, contrary to the purpose of the General Permit program as a streamlined approval process.
  • Wetland buffer averaging plan approvals will impose onerous conditions requiring placement of conservation restrictions on the entire wetland and buffer complex, whether or not a project has only limited impacts and additional future regulated activities would otherwise be allowed under NJDEP’s rules, but for the conservation restriction.

Flood Hazard 

  • Permittees will need to recertify that flood hazard areas remain unchanged if work is not commenced within 180 days after a permit is issued, and the work must involve elements of permanent construction of a habitable structure and not only site clearing/preparation, excavation, roadwork or construction of accessory structures (garages). If flood hazard conditions have changed, the project may need to be revised to address the changed conditions, and NJDEP approval obtained before the approved work may occur.
  •  A FEMA Letter of Map Revision approval will be required for certain projects involving minimal flood elevation increases before NJDEP will take action on the permit application. This will add a substantial period of time to the review since FEMA is not required to make a decision within a specified time period, unlike DEP which must adhere to the 90-day law time periods for decision making.
  •  Single-family home subdivisions with more than two units will be held to the same access road elevation requirements currently applicable only to muti-residential and critical buildings, and NJDEP is removing the minimal flexibility currently afforded to redevelopment projects that allows for access roads to be up to a foot below the applicable flood elevation where it is not feasible to elevate. This will make many developments and redevelopments infeasible. There is no clarity on the issue of how far dry access must extend for it to be approvable by DEP.
  • New criteria will be imposed for access roads including that they must accommodate two-way traffic of motor vehicles providing access to and from each building for the duration of the flood.
  • The current restriction on construction of a single-family home on a lot created after 2007 in a fluvial flood hazard area if there is already an existing habitable building or authorization for same from NJDEP will be extended to multi-residence buildings.
  • Critical and multi-residence buildings will be required to grade pedestrian areas outside of the building footprint to 1 foot above CAFE subject to certain non-feasibility conditions.
  • Limitations and mitigation requirements will be enhanced with respect to riparian buffers and permitting, including removal of the current exemptions for disturbance in truncated riparian zones and along manmade channels conveying stormwater.
  • The land area subject to 150-foot riparian zone buffers associated with threatened or endangered species habitat is being expanded. Activities within 25 of top of bank will be curtailed.
  • A permit will be required to conduct horizontal directional drilling below riparian zones (or wetlands), and enhanced permitting requirements will be imposed for solar panels in a flood hazard area.
  • A Verification will need to be obtained for projects impacting riparian zones.

Stormwater 

  • Stormwater requirements will be enhanced including new requirements on redevelopment of 80% TSS removal for stormwater runoff for new and redeveloped motor vehicle surface (increased from 50% for redeveloped impervious surfaces).

The proposed amendments do nothing meaningful to incentivize development opportunities in areas outside of the IRZ or CAFE. The FHA hardship provisions do not provide meaningful opportunities for relief, and in fact, the proposal imposes new conditions making it even less likely that hardship relief may be obtained.

Legacy (previously, grandfathering) provisions remain consistent with current NJDEP rules and depend largely on securing relevant approvals or the filing of a complete application before the rules become effective. Applications submitted before the effective date and declared technically complete will qualify for legacy status.

Three public hearing dates are scheduled (September 5, 12 and 19, 2024) and comments on the rule proposal must be submitted by November 3, 2024. If you have questions regarding qualification for legacy status or how the forthcoming rules may affect your project, please contact one of the attorneys in our Environmental Department. A courtesy copy of the draft proposal can be found  here.

© 2024 Giordano, Halleran & Ciesla, P.C. All Rights Reserved
For more news on State Climate Change Laws, visit the NLR Environmental & Energy Resources section.

Michigan Employers Take Note: New Ruling Impacts Paid Leave and Minimum Wage

Today, July 31, 2024, the Michigan Supreme Court released a highly anticipated opinion in the case of Mothering Justice v. Nessel. This case assessed the constitutionality of the Michigan Legislature’s 2018 “adopt-and-amend” strategy under which the Legislature adopted, and then immediately changed, two ballot proposals that would otherwise have been included on the November 2018 ballot for decision by Michigan voters. The ballot proposals pertained to Michigan minimum wage and paid sick leave requirements, and were originally entitled the Earned Sick Time Act (ESTA) and Improved Workforce Opportunity and Wage Act (IWOWA). The Legislature’s “adopt-and-amend” action had narrowed the original ballot proposal language, and resulted instead in the enactment of the Michigan Paid Medical Leave Act (PMLA) and current minimum wage provisions in effect since early 2019.

After years of legal challenge, the Michigan Supreme Court reversed a 2023 decision of the Michigan Court of Appeals, and ruled that the “adopt-and-amend” approach utilized by the Michigan Legislature violated the Michigan Constitution. The Court determined both of the ballot initiatives as originally adopted by the Legislature should be reinstated in lieu of current, amended versions. In the interests of justice and equity, the Court ordered the reinstatement to occur, but only after a time period the same as that which employers would have been provided to prepare for the new laws absent their improper amendment.

Therefore, significant new legal requirements will become effective February 21, 2025. These include:

  1. The paid leave ballot proposal as initially adopted by the Legislature in 2018, in the form of the ESTA, is reinstated effective February 21, 2025, in place of the PMLA. All covered employers must amend existing paid leave policies or implement new leave policies as applicable that comply with the ESTA by February 21, 2025. Key elements of the ESTA include:
    • All Michigan employers, except for the U.S. government, are covered.
    • All employees of a covered employer, rather than only certain categories of employees as provided under the PMLA, are covered.
    • Covered employers must accrue sick time for covered employees, at a rate of at least one hour of earned sick time for every 30 hours worked.
    • Employers with 10 or more employees, as defined by the ESTA, must allow employees to use up to 72 hours of paid earned sick time per year.
    • Employers with fewer than 10 employees, as defined by the ESTA, must provide up to 40 hours of earned paid sick time, and are permitted to provide remaining earned sick leave up to the required 72 hours per year on an unpaid basis, rather than paid.
    • Employers may not prohibit the carryover or cap the accrual of unused earned sick time.
    • Employers may limit the use of earned sick time in any year to 72 hours.
  2. The minimum wage ballot proposal as originally adopted by the Legislature in 2018, in the form of the IWOWA, is also effective February 21, 2025, subject to a phase in of certain requirements that remains to be determined at this time. The IWOWA will replace the narrower amendments that previously were enacted and took effect in 2019. Key provisions effective February 21, 2025, include:
    • The state minimum wage rate will be $10.00 plus the state treasurer’s inflation adjustment, which has yet to be calculated and released.
    • Future increases will be calculated annually based on inflation as specified in the IWOWA.
    • The existing “tip credit” provisions employers of tipped employees currently utilize to calculate whether they have been paid minimum wage will be phased out over a period of years and eliminated entirely by February 21, 2029.
    • Employees will have expanded rights as to how they are compensated for overtime work, including “comp time” as an alternative to customary payment of overtime wages.

The above will be applicable absent further judicial, legislative, or voter-driven constitutional action that prescribes a different course. As to judicial action, opportunities for appeal or rehearing of a state Supreme Court decision are limited and discretionary. As to voter-driven constitutional action, such as a referendum, the timing of the Court’s decision may well not permit for such action to be included on the 2024 ballot, even if sufficient support for such action were shown.

In terms of any legislative action to amend, such action could only occur in a future legislative session, meaning January 2025 or later. As to the level of support required, because the ballot proposals were adopted by the Legislature rather than approved by a majority of Michigan voters in an election process, the normal requirements will apply. Had the ballot proposals been approved by a majority of Michigan voters in the election, a 75% supermajority of both houses of the Legislature would have been required for any amendment passage.

© 2024 Varnum LLP

by: Luis E. Avila, Maureen Rouse-Ayoub, Stephanie R. Setterington, Elizabeth Wells Skaggs, Hannah A. Cone, and Ashleigh E. Draft of Varnum LLP

For more news on Michigan Employment Laws, visit the NLR Labor & Employment law section.

Confused About the FCC’s New One-to-One Consent Rules– You’re Not Alone. Here Are Some FAQs Answered For YOU!

Heard a lot about what folks are concerned about in the industry. Still seems to be a lot of confusion about it. So let me help with some answers to critical questions.

None of this is legal advice. Absolutely critical you hire a lawyer–AND A GOOD ONE–to assist you here. But this should help orient.

What is the new FCC One-to-One Ruling?

The FCC’s one-to-one ruling is a new federal regulation that alters the TCPA’s express written consent definition in a manner that requires consumers to select each “seller”–that is the ultimate good or service provider–the consumer chooses to receive calls from individually.

The ruling also limits the scope of consent to matters “logically and topically” related to the transaction that lead to consent.

Under the TCPA express written consent is required for any call that is made using regulated technology, which includes autodialers (ATDS), prerecorded or artificial voice calls, AI voice calls, and any form of outbound IVR or voicemail technology (including ringless) using prerecorded or artifical voice messages.

Why Does the FCC’s New One-to-One Ruling Matter?

Currently online webforms and comparison shopping websites are used to generate “leads” for direct to consumer marketers, insurance agents, real estate agents, and product sellers in numerous verticals.

Millions of leads a month are sold by tens of thousands of lead generation websites, leading to hundreds of millions of regulated marketing calls by businesses that rely on these websites to provide “leads”–consumers interested in hearing about their goods or services.

Prior to the new one-to-one ruling website operators were free to include partner pages that linked thousands of companies the consumer might be providing consent to receive calls from. And fine-print disclosures might allow a consumer to receive calls from business selling products unrelated to the consumer’s request. (For instance a website offering information about a home for sale might include fine print allowing the consumer’s data to be sold to a mortgage lender or insurance broker to receive calls.)

The new one-to-one rule stop these practices and requires website operators to specifically identify each good or service provider that might be contacting the consumer and requires the consumer to select each such provider on a one by one basis in order for consent to be valid.

Will the FCC’s One-to-One Ruling Impact Me?

If you are buying or selling leads, YES this ruling will effect you.

If you are a BPO or call center that relies on leads– YES this ruling will effect you.

If you are a CPaaS or communication platform–YES this ruling will effect you.

If you are a telecom carrier–YES this ruling will effect you.

If you are lead gen platform or service provider–YES this ruling will effect you.

If you generate first-party leads–Yes this ruling will effect you.

When Does the Rule Go Into Effect?

The ruling applies to all calls made in reliance on leads beginning January 27, 2025.

However, the ruling applies regardless of the date the lead was generated. So compliance efforts need to begin early so as to assure a pipeline of available leads to contact on that date.

In other words, all leads NOT in compliance with the FCC’s one-to-one rule CANNOT be called beginning January 27, 2025.

What Do I have to Do to Comply?

Three things:

i) Comply with the rather complex, but navigable new one-to-one rule paradigm. (The Troutman Amin Fifteen is a handy checklist to assist you);

ii) Assure the lead is being captured in a manner that is “logically and topically” related to the calls that will be placed; and

iii) Assure the caller has possession of the consent record before the call is made.

© 2024 Troutman Amin, LLP
For more news on FCC Consent Regulations, visit the NLR Communications, Media, & Internet section.

Third Time’s a Charm? SEC & CFTC Finalize Amendments to Form PF

On February 8, the Securities and Exchange Commission (SEC) and Commodity Futures Trading Commission (CFTC) jointly adopted amendments to Form PF, the confidential reporting form for certain registered investment advisers to private funds. Form PF’s dual purpose is to assist the SEC’s and CFTC’s regulatory oversight of private fund advisers (who may be both SEC-registered investment advisers and also registered with the CFTC as commodity pool operators or commodity trading advisers) and investor protection efforts, as well as help the Financial Stability Oversight Council monitor systemic risk. In addition, the SEC entered into a memorandum of understanding with the CFTC to facilitate data sharing between the two agencies regarding information submitted on Form PF.

Continued Spotlight on Private Funds

The continued focus on private funds and private fund advisers is a recurring theme. The SEC recently adopted controversial and sweeping new rules governing many activities of private funds and private fund advisers. The SEC’s Division of Examinations also continues to highlight private funds in its annual examination priorities. Form PF is similarly no stranger to recent revisions and expansions in its scope. First, in May 2023, the SEC adopted requirements for certain advisers to hedge funds and private equity funds to provide current reporting of key events (within 72 hours). Second, in July 2023, the SEC finalized amendments to Form PF for large liquidity fund advisers to align their reporting requirements with those of money market funds. And last week, this third set of amendments to Form PF, briefly discussed below.

SEC Commissioner Peirce, in dissent:

“Boundless curiosity is wonderful in a small child; it is a less attractive trait in regulatory agencies…. Systemic risk involves the forest — trying to monitor the state of every individual tree at every given moment in time is a distraction and trades off the mistaken belief that we have the capacity to draw meaning from limitless amounts of discrete and often disparate information. Unbridled curiosity seems to be driving this decision rather than demonstrated need.”

Additional Reporting by Large Hedge Fund Advisers on Qualifying Hedge Funds

These amendments will, among other things, expand the reporting requirements for large hedge fund advisers with regard to “qualifying hedge funds” (i.e., hedge funds with a net asset value of at least $500 million). The amendments will require additional disclosures in the following categories:

  • Investment exposures, borrowing and counterparty exposures, currency exposures, country and industry exposures;
  • Market factor effects;
  • Central clearing counterparty reporting;
  • Risk metrics;
  • Investment performance by strategy;
  • Portfolio, financing, and investor liquidity; and
  • Turnover.

While the final amendments increase the amount of fund-level information the Commission will receive with regard to individual qualifying hedge funds, at the same time, the Commission has eliminated the aggregate reporting requirements in Section 2a of Form PF (noting, in its view, that such aggregate information can be misleading).

Enhanced Reporting by All Hedge Funds

The amendments will require more detailed reporting on Form PF regarding:

  • Hedge fund investment strategies (while digital assets are now an available strategy to select from, the SEC opted not to adopt its proposed definition of digital assets, instead noting that if a strategy can be classified as both a digital asset strategy and another strategy, the adviser should report the strategy as the non-digital asset strategy);
  • Counterparty exposures (including borrowing and financing arrangements); and
  • Trading and clearing mechanisms.

Other Amendments That Apply to All Form PF Filers

  • General Instructions. Form PF filers will be required to report separately each component fund of a master-feeder arrangement and parallel fund structure (rather than in the aggregate as permitted under the existing Form PF), other than a disregarded feeder fund (e.g., where a feeder fund invests all its assets in a single master fund, US treasury bills, and/or “cash and cash equivalents”). In addition, the amendments revise how filers will report private fund investments in other private funds, “trading vehicles” (a newly defined term), and other funds that are not private funds. For example, Form PF will now require an adviser to include the value of a reporting fund’s investments in other private funds when responding to questions on Form PF, including determining filing obligations and reporting thresholds (unless otherwise directed by the Form).
  • All Private Funds. Form PF filers reporting information about their private funds will report additional and/or new information regarding, for example: type of private fund; identifying information about master-feeder arrangements, internal and external private funds, and parallel fund structures; withdrawal/redemption rights; reporting of gross and net asset values; inflows/outflows; base currency; borrowings and types of creditors; fair value hierarchy; beneficial ownership; and fund performance.

Final Thoughts

With the recent and significant regulatory spotlight on investment advisers to private funds and private funds themselves, we encourage advisers to consider the interrelationships between new data reporting requirements on Form PF and the myriad of new regulations and disclosure obligations being imposed on investment advisers more generally (including private fund advisers).

The effective date and compliance date for new final amendments to Form PF is 12 months following the date of publication in the Federal Register.

Robert Bourret also contributed to this article.

©2024 Katten Muchin Rosenman LLP

by: Adam Bolter of Katten 

For more SEC and CFTC news, visit the NLR Securities & SEC section.

FDA Lists Regulations Under Development and Updates Priority Guidance Topics for Foods Program

  • The U.S. Food and Drug Administration’s (FDA’s) Foods Program has posted a new website listing regulations it plans to publish by October 2024 and long-term regulations it is prioritizing for publication at a later date. Additionally, FDA has updated the list of guidance topics it is considering and expects to publish by the end of 2024.
  • Regulations are officially announced in the Unified Agenda of Regulatory and Deregulatory Actions published each spring and fall. Some of the regulations FDA has listed on its website include use of the “healthy” nutrient content claim, the use of ultrafiltered milk in cheese and cheese related products, and front-of-package nutrition labeling, among others.
  • The following five topics have been added to the list of guidance documents the FDA expects to publish by the end of December 2024:
    • Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula; Draft Guidance for Industry;
    • Action Levels for Lead in Food Intended for Babies and Young Children: Guidance for Industry;
    • The Food Traceability Rule: Questions and Answers; Draft Guidance for Industry;
    • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 12: Preventive Controls for Chemical Hazards: Draft Guidance for Industry; and
    • Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition 2): Draft Guidance for Industry
  • Public comments on the list of guidance topics can be submitted to www.regulations.gov using Docket ID FDA-2022-D-2088.
© 2024 Keller and Heckman LLP
For more on the FDA, visit the NLR Biotech, Food, Drug section.

EPA Updates TSCA Inventory, Plans Next Update in Summer 2023

The U.S. Environmental Protection Agency (EPA) announced on February 16, 2023, that the latest Toxic Substances Control Act (TSCA) Chemical Substance Inventory is now available on its website. The TSCA Inventory is a list of all existing chemical substances manufactured, processed, or imported in the United States. According to EPA, this update to the public TSCA Inventory is part of its biannual posting of non-confidential Inventory data. EPA plans the next regular update of the TSCA Inventory for summer 2023.

EPA states that the TSCA Inventory contains 86,685 chemicals, of which 42,170 are active in U.S. commerce. Other updates to the Inventory include new commercial activity data, unique identifier data, and regulatory flags (e.g., significant new use rules and test orders). EPA notes that additionally, several hundred substances are now listed with their specific chemical identities after having been moved from the confidential portion of the Inventory to the public portion as part of EPA’s TSCA confidential business information (CBI) review efforts.

Lastly, EPA reminds TSCA submitters to check regularly for any correspondence relating to their submissions in EPA’s Central Data Exchange (CDX). EPA states that it sends “critical and time-sensitive information regarding confidentiality claims through CDX, and failing to open this correspondence can delay the Agency’s processing of those claims.”

Article By Lynn L. Bergeson and Carla N. Hutton of Bergeson & Campbell, P.C.

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

©2023 Bergeson & Campbell, P.C.

Colorado Legalizes Therapeutic Psychedelics – Now What?

Ten years after Coloradans voted for their state to be one of the first to legalize recreational cannabis, Colorado is again making history as the second state in the country to legalize therapeutic psychedelics for adults.

Colorado voters narrowly approved Proposition 122 with nearly 53% of the votes (as of the morning of November 14th 97% of the votes have been counted). Their vote thus enacted the Natural Medicine Health Act of 2022 (NMHA) which legalizes supervised or facilitated therapeutic sessions for adults twenty-one years and older using certain psychedelic plants and fungi. Click here for our initial takeaways and a high-level summary of key provisions of the NMHA.

Now that therapeutic psychedelics are legal in Colorado, what should be expected next? Below are key dates and next steps as Colorado navigates implementation of the NMHA.

  • The Colorado Department of Regulatory Agencies (DORA) must establish the Natural Medicine Advisory Board (Board) and appoint initial members to the Board by January 31, 2023. The Board must have 15 members who will be appointed by the Governor with the consent of the Colorado Senate. The primary role of the Board is to advise DORA as to implementation of the NMHA program.
  • By September 30, 2023, and annually thereafter, the Board must make recommendations to DORA on certain areas related to natural medicine, such as recommendations related to product safety, herm reduction, and cultural responsibility, training programs, educational and experiential qualifications for facilitators, regulatory considerations for each type of natural medicine and the rules to be promulgated by DORA.
  •  DORA has until January 1, 2024 to adopt rules and establish the qualifications, education and training requirements that facilitators must meet prior to providing natural medicine services to participants.
  • By September 30, 2024, DORA must adopt rules to implement the NMHA program and begin accepting applications for licensure of facilitators, healing centers, entities to test natural medicines, and any categories of licensure as determined by DORA.
  • Once applications are accepted, DORA must make decisions on licensure applications within 60 days of receiving an application.
  • From the launch of the NMHA program until June 1, 2026, “natural medicines” are limited to psilocybin and psilocyn. After June 1, 2026, upon recommendation by the Board, DORA may add one of more of the following to types of natural medicines that can be provided under the NMHA program: dimethyltryptamine, Ibogaine, and Mescaline (excluding peyote).

A notable takeaway and something to watch for in the forthcoming rules is a focus on social equity. Seemingly applying lessons learned from the rollout of the state’s cannabis program, the NMHA expressly requires DORA to prioritize equity and inclusivity as it establishes rules to implement the NMHA program. Specifically, DORA is required to adopt rules which: (i) establish procedures, policies and programs to ensure the NMHA program is equitable and inclusive; (ii) promote the licensing of and provision of natural medicine services to (a) persons from communities that have been disproportionally harmed by high rates of controlled substances (including cannabis); (b) persons who face barriers to access to health care; (c) persons who have traditional or indigenous history with natural medicines; and (d) persons who are veterans by, offering, at a minimum reduced fees for licensure and training, incentivizing the provision of natural medicine services at a reduced cost to low income individuals, and incentivizing geographic and cultural diversity in licensing and the provision of and availability of natural medicine services.

In addition, DORA is prohibited from imposing unreasonable financial or logistical barriers that would prevent individuals with lower income from applying for a license and individuals are limited to having a financial interest in five healing centers. Currently, the definition of “individuals” does not include corporations. However, DORA could establish a rule which includes corporations in this limitation and would arguably level the playing field in this budding market.

We will continue to monitor developments and closely follow the rulemaking process as Colorado designs and implements this historical new program.

Article By Lauren P. Carboni of Foley & Lardner LLP

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

© 2022 Foley & Lardner LLP

UK Prohibits Certain Investment in Russia

From 19 July 2022,1 it is a violation of UK financial sanctions for any person who knows or has reasonable cause to suspect that they are carrying out, directly or indirectly, certain investment activity in Russia. These prohibitions follow the UK Government’s 6 April 2022 announcement of its intention to introduce an outright ban on all new outward investment in Russia.

The prohibitions are subject to exceptions and do not impact acts undertaken to satisfy obligations under a contract concluded before 19 July 2022, or an ancillary contract necessary for the satisfaction of that contract, subject to notifying Her Majesty’s Treasury at least five working days before the day on which any related act is carried out. There is also the option to apply for a specific Treasury licence, such as to enable humanitarian assistance activity or if connected with the provision of medical goods or services.

Furthermore, General Licence INT/2022/2002560 has been granted, taking effect from 19 July 2022 and expiring on 26 July 2022, allowing a seven-day wind-down period in respect of the prohibited activities.

What Is Prohibited?

The Regulations prohibit:

  • Directly or indirectly establishing any joint venture with a person connected with Russia;
  • Opening representative offices or establishing branches or subsidiaries in Russia;
  • Directly or indirectly acquiring any ownership interest in Russian land and persons connected with Russia for the purpose of making funds or economic resources available directly or indirectly to, or for the benefit of, persons connected with Russia;
  • Directly or indirectly acquiring any ownership interest in or control over a relevant entity or persons (other than an individual) with a place of business in Russia for the purpose of making funds or economic resources available, directly or indirectly, to, or for the benefit of, persons connected with Russia; and
  • The provision of investment services directly related to all the activities summarised above.

Definitions

A “person connected with Russia” means:

  • any individual or group of individuals who are ordinarily resident or located in Russia, or an entity which is incorporated or constituted under Russian law or domiciled in Russia;2

and is not:

  • A Schedule 2 Entity, as detailed in the Regulations;3 or
  • An entity domiciled outside of Russia or a branch, or subsidiary, of such a non-Russian entity.4

A “branch”5 means, in relation to a person other than an individual, a place of business which forms a legally dependent part of that person and which carries out all or some of the transactions inherent in the business of that person.

A “relevant entity”6 means a person, other than an individual, which has a place of busines located in Russia, but is not a person connected with Russia.

A person directly or indirectly “acquiring any ownership interest in or control over a person or entity”7 means:

  • Acquiring any share in the person or entity;
  • Acquiring any voting rights in the person or entity;
  • Acquiring any right to appoint or remove a majority of the board of directors of the person or entity; or
  • Acquiring any means of ensuring that the affairs of the person or entity are conducted in accordance with the wishes of the person.

Exceptions

The exceptions8 introduced enables a person to deal directly or indirectly with:

  • A transferable security otherwise prohibited by Regulation 16;
  • A relevant security issued by a person connected with Russia; or
  • A relevant security issued by a relevant entity.

Full definitions of the terms above are included within Regulation 60ZZA.

From 19 July 2022,1 it is a violation of UK financial sanctions for any person who knows or has reasonable cause to suspect that they are carrying out, directly or indirectly, certain investment activity in Russia. These prohibitions follow the UK Government’s 6 April 2022 announcement of its intention to introduce an outright ban on all new outward investment in Russia.

The prohibitions are subject to exceptions and do not impact acts undertaken to satisfy obligations under a contract concluded before 19 July 2022, or an ancillary contract necessary for the satisfaction of that contract, subject to notifying Her Majesty’s Treasury at least five working days before the day on which any related act is carried out. There is also the option to apply for a specific Treasury licence, such as to enable humanitarian assistance activity or if connected with the provision of medical goods or services.

Furthermore, General Licence INT/2022/2002560 has been granted, taking effect from 19 July 2022 and expiring on 26 July 2022, allowing a seven-day wind-down period in respect of the prohibited activities.

What Is Prohibited?

The Regulations prohibit:

  • Directly or indirectly establishing any joint venture with a person connected with Russia;
  • Opening representative offices or establishing branches or subsidiaries in Russia;
  • Directly or indirectly acquiring any ownership interest in Russian land and persons connected with Russia for the purpose of making funds or economic resources available directly or indirectly to, or for the benefit of, persons connected with Russia;
  • Directly or indirectly acquiring any ownership interest in or control over a relevant entity or persons (other than an individual) with a place of business in Russia for the purpose of making funds or economic resources available, directly or indirectly, to, or for the benefit of, persons connected with Russia; and
  • The provision of investment services directly related to all the activities summarised above.

Definitions

A “person connected with Russia” means:

  • any individual or group of individuals who are ordinarily resident or located in Russia, or an entity which is incorporated or constituted under Russian law or domiciled in Russia;2

and is not:

  • A Schedule 2 Entity, as detailed in the Regulations;3 or
  • An entity domiciled outside of Russia or a branch, or subsidiary, of such a non-Russian entity.4

A “branch”5 means, in relation to a person other than an individual, a place of business which forms a legally dependent part of that person and which carries out all or some of the transactions inherent in the business of that person.

A “relevant entity”6 means a person, other than an individual, which has a place of busines located in Russia, but is not a person connected with Russia.

A person directly or indirectly “acquiring any ownership interest in or control over a person or entity”7 means:

  • Acquiring any share in the person or entity;
  • Acquiring any voting rights in the person or entity;
  • Acquiring any right to appoint or remove a majority of the board of directors of the person or entity; or
  • Acquiring any means of ensuring that the affairs of the person or entity are conducted in accordance with the wishes of the person.

Exceptions

The exceptions8 introduced enables a person to deal directly or indirectly with:

  • A transferable security otherwise prohibited by Regulation 16;
  • A relevant security issued by a person connected with Russia; or
  • A relevant security issued by a relevant entity.

Full definitions of the terms above are included within Regulation 60ZZA.

FOOTNOTES

1 Regulation 18B introduced via The Russia (Sanctions) (EU Exit) (Amendment) (No. 12) Regulations 2022 [2022 No. 801], in force as of 19 July 2022.

2 Regulation 19A(2), The Russia (Sanctions) (EU Exit) Regulations 2019 [2019 No. 855] – as amended.

3 See pp. 123-124.

4 Regulation 16(4D), Ibid.

5 Regulation 18B(8), The Russia (Sanctions) (EU Exit) (Amendment) (No. 12) Regulations 2022 [2022 No. 801].

6 Regulation 18B(8), Ibid.

7 Regulation 18B(8), Ibid.

8 Regulation 60ZZA, Ibid.

Article By Annabel Thomas, Jo Rickards, Gavin Costelloe, Bethany Histed, Kara M. Bombach, and Erik de Bie of Greenberg Traurig, LLP

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

©2022 Greenberg Traurig, LLP. All rights reserved.

Colorado PFAS Act Likely Just the Beginning of New PFAS Chemical Regulation

Key Takeaways

  • How does the recent increase in state regulation of PFAS chemicals in consumer products impact your business?
  • Potential federal regulations of PFAS chemicals
  • Need for implementation of quality control practices
  • How best to identify and correct improper use of PFAS chemicals in consumer products

Introduction

Colorado has become the most recent state to regulate the use of PFAS chemicals in consumer products. It is important that manufacturers and retailers become aware of these restrictions now to avoid future compliance issues since the state regulations of PFAS chemical use are not the same state to state. Further the compliance issues imposed by state regulations will be compounded if the federal government fulfills its promise to regulate PFAS chemicals. Multiple federal agencies have indicated that such federal regulations may be forthcoming in the near future.

Definition of PFAS

Per- and polyfluoroalyyl substances (PFASs, CnF2n+1–R) are a group of man-made chemicals that includes PFOA, PFOS and GenX chemicals.1 These chemicals are widely used, long lasting chemicals that contain components that break down very slowly over time. PFAS chemicals are used to make fluoropolymer coatings and products that resist heat, oil, stains, grease, and water. These can include clothing, furniture, adhesives, food packaging, and many other products.2 Because of their widespread use and persistence in the environment, many PFAS are found in the blood stream of people and animals all over the world and are present at low levels in a variety of food products and in the environment.

Colorado Joins a Growing List of States to Implement PFAS Regulations for Consumer Products

Colorado recently adopted into law the Perfluoroalkyl and Polyfluoroalkyl Chemcials Consumer Protection Act (the “Colorado PFAS Act”)3, which regulates the use of perfluoroalkyl and polyflupralkyl substances (“PFAS chemicals”) in certain consumer products. The Colorado General Assembly concluded that such regulation is necessary upon the determination that “PFAS chemicals pose[] a significant threat to the environment of the state and the health of its residents.”4 Accordingly, by its terms, the Colorado PFAS Act was implemented into law in order “to create a regulatory scheme that phases out the sale or distribution of certain products and product categories in the state that contain intentionally added PFAS chemicals.”5 In furtherance of this goal, the Colorado PFAS Act will phase out the sell and distribution of certain consumer products that contain “intentionally added PFAS chemicals” from January 1, 2024 through January 1, 2027.6

These phase out regulations within the Colorado PFAS Act are consistent with a national trend of states regulating the sale and distribution of consumer products containing PFAS chemicals. For example, the Colorado PFAS Act establishes that Colorado is now one of at least 8 states that will regulate the sale and distribution of “food packaging” that contains intentionally added PFAS chemicals.

Beyond the differing timeline in the above chart, it is important to note these regulations are not synonymous since the term “food packaging” is defined differently by each regulating state.

Ignorance Is No Defense

The Colorado PFAS Act also does not allow ignorance on the contents of a commercial product as prohibiting the enforcement of its regulations. It is true that the Colorado PFAS Act prohibits the sell and distribution of certain products that contain “intentionally added PFAS chemicals.”7 However, the Colorado PFAS Act defines “intentionally added PFAS chemicals” as “PFAS chemicals that a manufacturer has intentionally added to a product and that have a functional or technical effect on the product.”8 Here the “intent” element necessary to trigger the regulations of the Colorado PFAS Act is the intent to add any chemistry which includes any listed PFAS chemicals. The Colorado PFAS Act defines “product” to “include” any product components.”9 Thus, a “manufacturer” of consumer goods must understand all additive materials to its products through each stage of the supply chain.

Likely Federal regulation by the end of the year (2022)10

The EPA is expected to propose a regulation for groups of PFAS in drinking water in the Fall of 2022 before the Agency’s statutory deadline in March 2023. A final rule is anticipated in Fall 2023 after considering public comments on the proposal. In a new health advisory, EPA reduced the acceptable levels for two PFAS (perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA)) in drinking water from 70 parts per trillion down to just 0.004 parts per trillion for PFOA and 0.02 parts per trillion for PFOS.11 Issuing a health advisory is generally considered to be a preliminary step in the process of setting maximum contaminant levels.12 Some states have set their own enforceable drinking water standards for PFOA and PFOS. Vermont, Michigan, and New Jersey have all set limits ranging from 8 to 20 parts per trillion for both chemicals.13 The issuance of the health advisory by the EPA will have States reevaluating their own regulations to conform with the standards set by the Agency.14

By Winter 2022 the EPA plans to leverage federally-issued NPDES permits to reduce PFAS discharges and will propose monitoring requirements at facilities where PFAS are expected or suspected to be present in wastewater and storm water discharges, using its recently published analytical method 1633, which covers 40 unique PFAS. EPA will issue new guidance recommending that state-issued permits that do not already include monitoring requirements for PFAS use the method 1633 at facilities where PFAS is expected or suspected to be present in wastewater and storm water discharges. In addition, the new guidance will recommend the full suite of permitting approaches that EPA will use in federally-issued permits. The EPA expects to publish a multi-laboratory validation method to detect up to 40 specific PFAS compounds in eight environmental matrices with the Department of Defense online by Fall 2022.

Discussion of Proposed RCRA and CERCLA changes

a. Proposed RCRA Changes15

In recent months, EPA has set the stage for greater regulation and firm federal standards PFAS chemicals that could significantly impact cleanup requirements. In October of 2021, the EPA responded to a petition from Governor Michelle Lujan Grisham of New Mexico to tackle PFAS contamination under the Resource Conservation and Recovery Act (RCRA). EPA outlined plans to initiate rulemaking process for two new actions under the hazardous waste law. The first rulemaking effort will initiate the process to propose adding four PFAS chemicals as RCRA Hazardous Constituents under Appendix VIII, by evaluating the existing data for these chemicals and establishing a record to support a proposed rule. The four PFAS chemicals EPA will evaluate are: perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), perfluorobutane sulfonic acid (PFBS), and GenX. Adding these chemicals as RCRA hazardous Constituents would ensure they are subject to corrective action requirements and would be a necessary building block for future work to regulate PFAS as a listed hazardous waste. The second rulemaking effort will clarify in EPA regulations that the RCRA Corrective Action Program has the authority to require investigation and cleanup for wastes that meet the statutory definition of hazardous waste, as defined under RCRA section 1004(5). This modification would clarify that emerging contaminants such as PFAS can be cleaned up though the RCRA corrective action process.

b. Proposed CERCLA Changes16

In June 2021, EPA restarted the process to designate PFOA and PFOS as Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) hazardous substances. A proposed rule was expected in the Spring of 2022, no such rule has been proposed. According the EPA’s “PFAS Strategic Roadmap” a final rule is expected in the Summer of 2023 and EPA is currently developing a Notice of Proposed Rulemaking to designate PFOA and PFOS as CERCLA hazardous substances. Such designations would require facilities across the country to report on PFOA and PFOS releases that meet or exceed the reportable quantity assigned to these substances. The hazardous substance designations would also enhance the ability of federal, Tribal, state, and local authorities to obtain information regarding the location and extent of releases. EPA or other agencies could also seek cost recovery or contributions for costs incurred for the cleanup.

The designation PFOA and PFOS as a hazardous substance under CERCLA could substantially impact existing and new cleanup sites. Site owners and responsible parties who release PFOA or PFAS, and possibly other PFAS chemicals will be obligated to report releases, quantify the location and amounts released to stakeholders, and may be liable for partial or total cleanup. Regulatory changes may also delay cleanup and add significant analytical costs for companies who need to evaluate PFAS in various media prior to releases of any kind to waste streams. The designation of PFAS as hazardous substances has not yet been ratified at a federal level. However, several states (e.g., Washington DOE) have enacted Public Health Goals for surface and drinking waters and cleanup standards – several that incorporate federal hazardous substances lists, ensuring that the impending PFAS regulations will extend beyond federally designated cleanup sites.

The Importance of Following the Discussion Leading up to New TSCA Regulations17

The Toxics Release Inventory (TRI) helps the EPA compile data and information on releases of certain chemicals and supports decisions by companies, regulatory agencies, and the public. The EPA intends to implement a rulemaking in 2022 to categorize the PFAS on the TRI list as “Chemicals of Special Concern” and remove the de minimis eligibility from supplier notification requirements for all “Chemicals of Special Concern.” It is expected for the EPA to continue to update and add to the list of PFAS subject to the TRI. EPA’s proposed rule would require all manufacturers (including importers) of PFAS in any year since 2011 to report information related to chemical identity, categories of use, volumes manufactured and processed, byproducts, environmental and health effects, worker exposure, and disposal. There is still opportunity for public comments as the rule is not set to finalize until January of 2023.

Industries Should Take Protective Measures

Both the implementation of the Colorado PFAS Act and the recent actions of the EPA establish that the time for manufacturers and retailers to act is now. Specifically, manufacturers and retailers should implement quality control practices directed towards identifying—and where necessary altering—the chemical contents of their consumer products.

To implement such quality control practices, manufacturers and retailers should review their wastewater handling processes and insurance policies for periods of past PFAS chemicals use. These previous processes and insurance policies likely identify the specific components of PFAS chemicals that were deemed to violate state waste water regulations, as well as the internal changes implemented to eliminate the use of such chemicals. Similar practices can likely be implemented in the sale and distribution of consumer products that include PFAS chemicals. Manufacturers and retailers should implement practices now to limit exposure and costs once regulation of PFAS consumer products become both effective and more prevalent. If you have any questions regarding PFAS regulations, please contact the authors of this article.

ENDNOTES

1 Zhanyun Wang et al., A Never-Ending Story of Per- and Polyfluoroalkyl Substances (PFASs)?, 51 ENV’L SCI. TECH. 2508.

2 CTR. FOR DISEASE CONTROL AND PREVENTION, https://www.cdc.gov/biomonitoring/PFAS_FactSheet.html (last visited June 24, 2022).

3 C.R.S.A. § 25-15-601 et seq.

4 C.R.S.A. § 25-15-602(1)(a).

5 C.R.S.A. § 25-15-602(2).

6 C.R.S.A. §§ 25-15-604(1), (3)-(4).

7 C.R.S.A. § 25-15-604(1), (3), and (5).

8 C.R.S.A. § 25-15-603(12)(a).

9 C.R.S.A. § 25-15-603(20)(b).

10 All information gathered in this section coms from: ENV’L PROT. AGENCY https://www.epa.gov/system/files/documents/2021-10/pfas-roadmap_final-508.pdf (last visited June 24, 2022).

11 Juan Carlos Rodriguez, 3 Takeaways from EPA’s Guidance on PFAS in Drinking Water, Law360 (June 22, 2022, 8:48 PM EDT).

12Id.

13Id.

14Id.

15 Information on RCRA changes comes from: EPA Press Release, responding to New Mexico Governor’s petition to tackle PFAS contamination under RCRA (Oct. 26, 2021).

16 All information gathered in this section coms from: EPA, PFAS Strategic Roadmap: EPA’s Commitments to Action 2021-2024 (Oct. 2021).

17 Information comes from: EPA (last visited June 24, 2022).

 

Article By Daniella D. Landers, Michael J. Sullivan, and Brendan H. White of Womble Bond Dickinson (US) LLP. Audrey Capra, Summer Associate, also contributed to this alert.

Copyright © 2022 Womble Bond Dickinson (US) LLP All Rights Reserved.

ERIC Files Amicus Brief Rebutting DOL Attempt to Create New Regulations in Lawsuit, Petitions US Supreme Court on Seattle Healthcare Case

Read on below for coverage of recent law firm news from McDermott Will & Emery.

ERIC Files Amicus Brief Rebutting DOL Attempt to Create New Regulations in Lawsuit

McDermott Will & Emery’s Andrew C. Liazos, Michael B. Kimberly and Charlie Seidell recently filed an amicus brief in the US Court of Appeals for the 10th Circuit on behalf of the ERISA Industry Committee (ERIC). McDermott filed the brief in response to a US Department of Labor (DOL) amicus brief that advanced a novel interpretation of its regulations which, if adopted through litigation, would change longstanding procedures for benefit determinations under self-funded medical plans sponsored by large employers. The amicus brief focuses on key arguments against the DOL’s attempted regulatory reinterpretation, including that:

  • DOL may not rewrite its regulations outside of notice-and-comment rulemaking;
  • DOL’s interpretation of its own regulations is inconsistent with the plain text of the regulations;
  • There are good policy reasons underlying differential treatment of healthcare and disability benefits determinations; and
  • DOL’s interpretation of the regulations in its amicus brief is not entitled to deference under the Supreme Court decision in Kisor.

Read ERIC’s amicus brief here.

Read ERIC’s statement here.

ERIC Petitions US Supreme Court on Seattle Healthcare Case

McDermott Will & Emery’s Michael B. Kimberly, Sarah P. Hogarth and Andrew C. Liazos, are co-counsel on a petition for certiorari before the Supreme Court of the United States on behalf of the ERISA Industry Committee (ERIC). The petition calls for review of ERIC’s legal challenge to the City of Seattle’s hotel healthcare “play or pay” ordinance. The ordinance mandates hospitality employers make specified monthly healthcare expenditures for their covered local employees if their healthcare plans do not meet certain requirements. The petition demonstrates that Seattle’s ordinance is a clear attempt to control the benefits provided under medical plans in violation of the preemption provision under the Employee Retirement Income Security Act of 1974, as amended (ERISA). This case is of significant national importance. Several other cities have proposed making similar changes, and complying with these types of ordinances will substantially constrain the ability of employers to control the terms of their medical plans on a uniform basis. ERIC’s petition is joined by several trade associations, including the US Chamber of Commerce, the American Benefits Council and the Retail Industry Leaders Association.

Read ERIC’s petition for writ of certiorari here.

Read ERIC’s statement here.

 

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