Tag: regulations

Biden Revisions to the NEPA Regulations Now in Effect

The Biden Administration is amending the federal regulations for implementing the National Environmental Policy Act (NEPA) to reverse certain changes made by the Trump Administration. The first set of amendments took effect last Friday on May 20, 2022.

As background, the Council for Environmental Quality (CEQ) first issued the NEPA implementing regulations in 1978. They remained unchanged for more than 40 years until the Trump Administration published its 2020 rule updating the regulations to facilitate “more efficient, effective, timely NEPA reviews.” Developers, construction companies, and other businesses generally supported these changes with the hope they would streamline a lengthy process that often significantly delays projects. However, environmentalists opposed the changes, fearing they would weaken important protections, including those aimed at reducing climate change impacts and protecting natural resources. Upon taking office, the Biden Administration immediately began an effort to reverse parts of the 2020 rule.

The Biden amendments will be issued in two phases. The “Phase One” rule was published on April 20, 2022, and is in effect as of May 20, 2022. The “Phase Two” rule, which is expected to include more comprehensive revisions, will be issued “over the coming months”.

 The Phase One rule reinstates the following three key provisions of the NEPA regulations:

1.  Statement of Purpose and Need, and Scope of Reasonable Alternatives (40 CFR 1502.13)

Under NEPA, an agency’s statement of purpose and need informs the range of alternative actions analyzed in an environmental assessment (EA) or environmental impact statement (EIS). The NEPA regulations historically required agencies to consider “reasonable alternatives not within the jurisdiction of the lead agency.” The 2020 rule updates, however, instructed agencies to limit the statement of purpose and need, and therefore the range of alternatives, to only those that are consistent with the applicant’s goals and the agency’s statutory authority.

The Phase One rule removes these limitations to re-establish federal agencies’ discretion to consider a variety of factors, including a range of reasonable alternatives that are not entirely consistent with the goals of the project applicant. Accordingly, federal agencies may again coordinate with communities and project proponents to evaluate alternatives that could minimize environmental and public health costs, but extend beyond the scope of the agency’s authority or do not serve the applicant’s goals.

2.  Agency Implementing Regulations (40 CFR 1507.3)

The Phase One rule also removes language that could limit agencies’ standards and procedures for implementing NEPA rules that extend beyond CEQ regulatory requirements. This update reestablishes CEQ regulations as the “floor” for NEPA environmental review, and restores the agency’s discretion and flexibility to tailor NEPA procedures to align with specific agency and public needs. In contrast, the 2020 rule would have made the CEQ regulations a “ceiling” for NEPA requirements, effectively restricting agencies’ discretion to develop and implement procedures beyond requisite CEQ regulations.

3.  Scope of Effects (40 CFR 1508.1(g))

Finally, the Phase One rule restores the definition of “effects” that requires agencies to consider the historic categories of “reasonably foreseeable” direct, indirect, and cumulative effects. The 2020 rule, in contrast, limited the scope of this analysis to effects with a “reasonably close causal relationship,” and included language indicating that agencies were only required to consider direct effects, had discretion to consider indirect effects, and should not consider cumulative effects in NEPA review. The Phase One rule change thus ensures that agencies’ NEPA documents will evaluate all relevant environmental impacts resulting from the agency decision.

Here, the Phase One rule reversal is particularly impactful in terms of an agency’s consideration of climate change, where cumulative effects tend to be substantially greater than the effects of the individual project. The Phase One update confirms CEQ’s view that climate change impacts are adequately considered in evaluating direct, indirect and cumulative effects.

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Except for reinstating these three key provisions, the Phase One rule does not affect other changes made by the 2020 rule.  The Biden Administration plans to introduce more comprehensive changes as part of the forthcoming Phase Two rule. These changes, which are anticipated to be more controversial and draw additional public attention, are expected to address environmental justice, public participation, and streamlining provisions, including the use of plain language, deadlines, page limits, and inter-agency coordination.

Article By Alexander L. Merritt and Kathryn C. Kafka of Sheppard, Mullin, Richter & Hampton LLP

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

Copyright © 2022, Sheppard Mullin Richter & Hampton LLP.

CEQ Reverses First Set of Trump-Era NEPA Regulatory Reforms

On April 20, 2022, the White House Council on Environmental Quality (CEQ) published a final rule rolling back minor regulatory changes to the National Environmental Policy Act (NEPA) review process that it had promulgated in 2020. The new rule reverts to the language of CEQ’s original 1978 NEPA regulations but otherwise does not substantially alter the regulatory landscape. This is the first of an anticipated two-step process as identified in CEQ’s October proposed rule. The next regulatory proposal is expected to “more broadly revisit” the 2020 regulations and propose further changes to promote environmental justice, climate change, and other Biden administration “objectives.”

The Phase 1 final rule attracted significant public comment and media coverage, but in practice, it should not meaningfully affect NEPA reviews. The regulatory changes themselves are very confined. The final rule features three main components:

Purpose & Need/Alternatives

NEPA reviews of proposed federal agency actions begin by defining a statement of purpose and need and identifying a reasonable range of alternatives. In doing so, agencies routinely give substantial weight to the project proponent’s objectives, rather than reinventing what is proposed. The 2020 rule had codified that longstanding policy by adding language expressly directing federal agencies to consider their statutory authority and the goals of the project proponent when formulating statements of purpose and need and identifying a reasonable range of alternatives that could meet the purpose and need. The new final rule deletes reference to the applicant’s goals to avoid perceived “bias” and restore “flexibility.” Yet, the final rule does not prohibit agencies from considering the applicant’s goals, and instead recognizes they remain “important.” The final rule also retains the fundamental NEPA concept that a “reasonable” alternative must “meet the purpose and need for the proposed action.”

Individual Agency NEPA Regulations

While CEQ’s regulations apply across the federal government, individual federal departments and agencies also have their own rules and procedures for implementing NEPA specific to the particular types of actions they typically undertake. CEQ oversees these agency efforts. To promote consistency in agency NEPA reviews, including those involving multiple agencies, the 2020 rule sought to restrict agencies from adopting requirements stricter than CEQ’s rules. The new Phase I rule removes this ceiling. To be clear, this change does not allow agency-specific NEPA rules and procedures to conflict with CEQ’s regulations, but it does increase the potential for inconsistencies in the application of NEPA procedures across federal agencies. That said, many federal agencies developed their own NEPA regulations and procedures years ago, did not amend those regulations and procedures in response to the 2020 rule, and are not expected to substantially alter their procedures at least while CEQ is still developing its future Phase 2 rule.

Effects

The 2020 rule simplified the regulatory definition of “effects” or “impacts” of the proposed action and alternatives to eliminate separate terms for “direct,” “indirect,” and “cumulative” effects, and to clarify which effects are “reasonably foreseeable.” It specifically provided that a “but for” causal relationship is insufficient to attribute an effect to a proposed project, while excluding potential effects from analysis “if they are remote in time, geographically remote, or the product of a lengthy causal chain” or if they are beyond the agency’s control. But the 2020 rule did not preclude consideration of cumulative impacts or climate change and allowed for their incorporation as part of the baseline for the “no action” alternative. The new Phase 1 rule simply reverses those minor changes including restoring the separate “effects” definitions. This reversion may foster more expansive indirect and cumulative impacts analysis in NEPA documents akin to the analyses developed before the 2020 rule. However, particularly because the 2020 rule did not overrule case law overwhelmingly requiring consideration of cumulative impacts and climate change, the practical implication of these changes should be minimal.

© 2022 Beveridge & Diamond PC
For more regulatory updates, visit the NLR Administrative & Regulatory section.

Agriculture Groups Sue FDA on Chlorpyrifos Ban

  • As previously reported, the Environmental Protection Agency (EPA) published a final rule on August 30, 2021 that revoked all tolerances for the pesticide chemical chlorpyrifos on raw agricultural commodities; the rulemaking was driven by toxicity concerns, primarily concerning exposure in children. The tolerances are set to expire on February 28, 2022, effectively banning the use of chlorpyrifos on food crops. In light of the expiration, FDA published a guidance document to assist food producers and processors that handle foods which may contain chlorpyrifos restudies.
  • In October of 2021, agriculture stakeholders submitted formal written objections and a request to stay the tolerance revocations to EPA. More than 80 stakeholders signed the document, arguing that significant harms would result from banning chlorpyrifos and urging the agency to stay implementation of the rule until objections were formally addressed by EPA.
  • Agriculture stakeholder groups are now seeking a court injunction against EPA’s ban on chlorpyrifos. On February 10, 2022, agricultural trade groups representing thousands of members filed a lawsuit against EPA before the Eight Circuit Court of Appeals, alleging that the agency ignored its own scientific findings regarding 11 high-benefit and low-risk crop uses for chlorpyrifos and that the revocation will cause irreparable damage. It remains to be seen how EPA will respond to the lawsuit.

Article By Food and Drug Law Practice Group at Keller and Heckman LLP

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

© 2022 Keller and Heckman LLP

The Time Has Come for Trademark Modernization Act Regulations

On Dec. 18, 2021, regulations implementing the Trademark Modernization Act of 2020 (TMA) went into effect. Trademark owners and practitioners should be aware of the new procedures and ensure they are ready for the changes.

Trademark Modernization Act Regulations

Our posts “Three Things to Know About the Trademark Modernization Act of 2020” and “The Trademark Modernization Act of 2020: New Rules and Procedures” from March and May 2021, respectively, gave an overview of the changes that will be implemented with the act. Most notably, the TMA provides for new procedures to challenge trademark registrations based on nonuse – expungement, and reexamination. It is intended that the new ex parte expungement and reexamination proceedings will be faster and more efficient alternatives to cancellation procedures before the Trademark Trial and Appeal Board. You can read the final rule here.

Another significant change is the requirement for filers to verify their identity with the United States Patent and Trademark Office (“USPTO”). This is part of the USPTO’s efforts to protect the integrity of the register and combat fraudulent filings, which have been on the uptick. Beginning in early 2022, the following must verify their identity with the USPTO using one of the verification options that includes an electronic process by ID.me

Trademark owners and corporate officers not represented by an attorney, US-licensed attorneys (including in-house counsel), and Canadian attorneys or agents are required to verify their identity. Paralegals and other support staff working for an attorney must be sponsored by a verified attorney. Trademark owners who are represented by an attorney do not currently need to verify their identities to sign electronic forms sent by their attorney; however, if the representation by that attorney ends, the owners will need to submit to the verification process.

It is important that trademark holders and practitioners prepare for these new policies and procedures to ensure they can complete filings on a timely basis.

Article By Danielle M. DeFilippis of Norris McLaughlin P.A.

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

©2021 Norris McLaughlin P.A., All Rights Reserved

Sweeping Executive Order on Deregulation Seeks to Spur Post-Pandemic Economy

President Trump signed an Executive Order (Order) this week to alter or eliminate regulations that the Administration maintains hamper economic recovery as the nation emerges from the COVID-19 pandemic.

The Regulatory Relief to Support Economic Recovery Order calls on agencies across the federal government to use emergency authorities provided under the Administrative Procedures Act to swiftly rescind, modify, waive or provide exemptions from regulations and other requirements that inhibit job creation and economic growth.  It further calls on agencies to consider permanently rescinding or modifying any regulations that were temporarily halted in response to COVID-19. The Order notes that it does not change agencies’ statutory obligations.

The Order also directs enforcement discretion by agencies for businesses that make good-faith attempts to follow agency guidance and regulations during the pandemic.  It establishes the following “principles of fairness” that are to be followed in enforcement and adjudication:

  • The Government should bear the burden of proving an alleged violation of law; the subject of enforcement should not bear the burden of proving compliance.
  • Administrative enforcement should be prompt and fair.
  • Administrative adjudicators should be independent of enforcement staff.
  • Consistent with any executive branch confidentiality interests, the Government should provide favorable relevant evidence in possession of the agency to the subject of an administrative enforcement action.
  • All rules of evidence and procedure should be public, clear, and effective.
  • Penalties should be proportionate, transparent, and imposed in adherence to consistent standards and only as authorized by law.
  • Administrative enforcement should be free of improper Government coercion.
  • Liability should be imposed only for violations of statutes or duly issued regulations, after notice and an opportunity to respond.
  • Administrative enforcement should be free of unfair surprise.
  • Agencies must be accountable for their administrative enforcement decisions.

Finally, the Order instructs agencies to provide pre-enforcement rulings, permitting businesses to ask an agency for a determination on whether some proposed conduct in the business’s response to COVID-19 is allowable.

IMPLICATIONS AND OUTLOOK

The Order is consistent with the longstanding stated desire by the Administration to reduce regulatory burdens.  It has the potential to alter the regulatory landscape across a wide array of industries. The Order could impact virtually any regulation from the numerous government agencies that promulgate rules, including financial regulations, environmental protections, and agricultural production and distribution guidelines, among many others.

In addition to ordering the rescission or modification of current regulations, the White House is calling on agencies to speed up the rulemaking process, including moving proposed rulemakings to interim final rules with immediate effect. This will likely draw resistance and possibly litigation from organizations that have already opposed the Administration’s approach on regulatory reforms.

The Order’s provisions on pre-enforcement rulings supersedes the provisions contained in Section 6 of Executive Order 13892, which establishes principles for using guidance in civil administrative enforcement, in an effort to provide faster compliance feedback to companies looking to reopen so they can proceed with the confidence that doing so will not trigger violations of the governing laws or regulations.

The “principles of fairness” detailed above seek to provide another level of legal cover for regulated entities. However, the extent to which the Order would provide protection for businesses against pandemic-related liability would be limited.  This has been a particularly challenging issue among lawmakers as the next legislative response package is developed.  While Senate Majority Leader Mitch McConnell (R-KY) has stated that liability protections for business must be included in the next relief bill, House Speaker Nancy Pelosi (D-CA) opposes such provisions.

Although it remains to be seen how agencies will respond to the Order, it is likely that they will look to the businesses and industries they regulate to assist them in identifying regulations that should be rescinded or modified.

© 2020 Van Ness Feldman LLP

For more on government regulations, see the National Law Review Administrative and Regulatory law section.

DOT Issues Notice of Enforcement Discretion Regarding the Transportation of Hand Sanitizers to Address COVID-19

On April 2, 2020, the U.S. Department of Transportation (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) issued a Notice of Enforcement Discretion (Notice) that provides temporary relief from certain aspects of the DOT Hazardous Materials Regulations (HMR) that normally apply to the transportation of ethyl alcohol or isopropyl alcohol-based hand sanitizers. [1]

Due to the Coronavirus Disease 2019 (COVID-19) public health emergency, demand for hand sanitizer has reached unprecedented levels. Many of these sanitizers are classified as Class 3 flammable liquids due to the alcohol content, which would trigger certain marking, labeling, packaging, documentation, and other compliance obligations for shippers (and carriers) under the DOT HMR. Although the DOT HMR already provide some regulatory relief for certain ethyl alcohol products in 49 CFR 173.150(g), this does not cover isopropyl alcohol products and it does not cover ethyl alcohol products in larger containers. To facilitate the availability of these products, PHMSA is providing temporary relief from certain HMR requirements.

The Notice indicates that the relief applies to companies producing hand sanitizer under a recently issued Food and Drug Administration (FDA) Guidance document and to those who subsequently transport the hand sanitizer. [2]

Importantly, it applies only to highway shipments (by private, common, or contract carriers by motor vehicle) and not shipments by air, vessel, or rail.

If parties follow the procedures for preparing hand sanitizer for shipment set forth in the Notice (as compared to all of the requirements specified in the HMR), PHMSA will not take enforcement action for violations of the HMR. The Notice provides separate procedures for shipping small quantities (< 1 gallon/container or 8 gallons/package) and for larger quantities (> 8 gallons to 119 gallons/package) of hand sanitizer.

© 2020 Keller and Heckman LLP

For more on manufacture & transportation of emergency medical supplies for the COVID-19 pandemic, see the National Law Review Coronavirus News section.

U.S.EPA Announces National “PFAS Action Plan”

The United States Environmental Protection Agency (U.S.EPA) acting Administrator, Andrew Wheeler, held a press conference at EPA Region III in Horsham, Pennsylvania on Feb. 14, 2019, to announce the U.S.EPA’s PFAS Action Plan. Wheeler indicated that similar announcements of and press conferences relating to the PFAS Action Plan were being held simultaneously in each of the U.S.EPA’s ten regional offices, underlying the importance of the announcement. Wheeler stated that the Agency’s plan was the most comprehensive cross-agency plan introduced by the U.S.EPA.

Acting Administrator Wheeler highlighted five key elements of the PFAS Action Plan:

  1. U.S.EPA has initiated actions to develop a Maximum Contaminant Level, or MCL, for PFAS, and specifically for two PFAS compounds, PFOS and PFOA, by the end of 2019. Wheeler stated that this would be the first substance to have an MCL established since the Safe Drinking Water Act was amended in 1996. Wheeler added that the U.S.EPA maintains that the 70 parts per trillion (ppt) standard is a federally enforceable groundwater standard, despite misconceptions to the contrary.

  2. U.S.EPA will continue to pursue enforcement actions utilizing the existing Health Advisory Level for PFAS of 70 ppt or 70 nanograms per liter.

  3. U.S.EPA will expand monitoring and data gathering related to PFAS, including adding PFAS to the toxics release inventory, which should generate additional information on the extent of PFAS in the industry and in the environment. Wheeler indicated that U.S.EPA is using enhanced mapping tools to identify where and in what communities PFAS is in the groundwater and in the environment.

  4. U.S.EPA will expand research into the impacts of PFAS on human health and the environment, studying fate and transport issues associated with PFAS. Wheeler stated that U.S.EPA wants to “close the gap” on the science related to PFAS, including the more recently manufactured perfluourinated compound known as “GenX”,

  5. U.S.EPA will develop a “risk communication toolbox” that will provide information to the public and the regulated community more clearly.

Copyright © 2019 Godfrey & Kahn S.C.
For more Environmental News, check out the National Law Review’s Environmental Type of Law page.

EPA Issued Proposed Rule to Add Hazardous Waste Aerosol Cans to Universal Wastes Regulated under RCRA

On March 6, 2018, the U.S. Environmental Protection Agency (EPA) issued a proposed rule (pre-publication version available here) to add hazardous waste aerosol cans to the category of universal wastes regulated under the federal Resource Conservation and Recovery Act (RCRA) regulations (Title 40 of the C.F.R., Part 273), entitled Increasing Recycling: Adding Aerosol Cans to the Universal Waste Regulations.  EPA cites as authority for this change Sections 2002(a), 3001, 3002, 3004, and 3006 of the Solid Waste Disposal Act, as amended by RCRA, as amended by the Hazardous and Solid Waste Amendments Act (HSWA).  EPA states the streamlined Universal Waste regulations are expected to:

  • Ease regulatory burdens on retail stores and other establishments that discard aerosol cans by providing a clean, protective system for managing discarded aerosol cans;
  • Promote the collection and recycling of aerosol cans;
  • Encourage the development of municipal and commercial programs to reduce the quantity of these wastes going to municipal solid waste landfills or combustors; and
  • Result in an annual cost savings of $3.0 million to $63.3 million.

As aerosol cans are “widely used for dispensing a broad range of products” including pesticides, the proposed rule may have implications for chemical companies that create and distribute pesticide products marketed in aerosol cans.  Hazardous waste aerosol cans that contain pesticides are also subject to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requirements, including compliance with the instructions on the product label.  Under 40 C.F.R. Section 156.78, a flammability label statement is required for pressurized pesticide product products that states “Do not puncture or incinerate container,” but EPA’s 2004 determination (that will be posted to Docket No. EPA-HQ-OLEM-2017-0463 on www.regulations.gov for this proposed rule) allows for the puncturing of cans.  The proposed rule states:

  • EPA issued a determination that puncturing aerosol pesticide containers is consistent with the purposes of FIFRA and is therefore lawful pursuant to FIFRA section 2(ee)(6) provided that the following conditions are met:
    • The puncturing of the container is performed by a person who, as a general part of his or her profession, performs recycling and/or disposal activities;
    • The puncturing is conducted using a device specifically designed to safely puncture aerosol cans and effectively contain the residual contents and any emissions thereof; and
    • The puncturing, waste collection, and disposal, are conducted in compliance with all applicable federal, state and local waste (solid and hazardous waste) and occupational safety and health laws and regulations.
  • EPA anticipates that this 2004 FIFRA determination would not be affected by the proposed addition of hazardous waste aerosol cans to the universal waste rules.

Comments will be due 60 days after the proposed rule’s publication in the Federal Register.

 

©2018 Bergeson & Campbell, P.C.
Read more news on the National Law Review Biotech Type of Law page.

U.S. Restrictions on Travel to and Trade With Cuba Return

Effective November 9, 2017, new regulations took effect limiting U.S. travel and trade with Cuba. 

Decades ago, the United States imposed a commercial embargo on Cuba. The embargo existed in one form or another until 2015, when the United States eased some of its restrictions on trade and travel. Then, on June 16, 2017, President Trump signed the National Security Presidential Memorandum (NSPM) on Strengthening the Policy of the United States Toward Cuba. In accordance with the NSPM, the U.S. Department of State has now published a list of restricted entities associated with Cuba. The list names entities with which direct financial transactions will “generally be prohibited” under the Cuban Assets Control Regulations. The entities on the list are those that are “under the control of, or acting for or on behalf of, the Cuban military, intelligence, or security services or personnel with which direct financial transactions would disproportionately benefit such services or personnel at the expense of the Cuban people or private enterprise in Cuba.” Numerous hotels and tourism agencies, as well as retail shops popular with tourists, are included on the list. As a result, U.S. citizens will again have to travel as part of a group that is accompanied by a group representative and licensed by the U.S. Department of the Treasury.

The new restrictions will not impact certain existing transactions. Contracts that were in place and travel arrangements that were made prior to the new rule taking effect may move forward.

This post was written by Natalie L. McEwan of Ogletree, Deakins, Nash, Smoak & Stewart, P.C., All Rights Reserved.,© 2017
For more Antitrust Law legal analysis, go to The National Law Review 

U.S. Department of Education Delays Certain Gainful Employment Disclosure Requirements

In its latest action regarding the “Gainful Employment” regulations promulgated under the Obama administration, late on June 30, 2017, the U.S. Department of Education (“the Department”) announced a delay in certain disclosure requirements that were to have taken effect on July 1, 2017. This announcement occurred through Electronic Announcement #106, a pre-publication draft Federal Register notice (which will appear in the Federal Register on July 5, 2017) and an official press release.

The Gainful Employment regulations require all education programs offered by proprietary institutions of higher education, and non-degree programs offered by public and private nonprofit institutions, to meet specific debt-to-earnings measures in order to remain eligible for federal student financial aid. Additionally, the regulations require institutions to provide extensive informational disclosures to students regarding their Gainful Employment programs, and to issue warnings to students when a program is in danger of losing its eligibility for federal student financial aid. As described in a previous alert, the Department announced on June 16, 2017, that it will establish a negotiated rulemaking committee to develop proposed revisions to the Gainful Employment regulations; however, that prior announcement did not alter the effectiveness of the current regulations.

Through this latest announcement, the Department has now delayed until July 1, 2018, the requirements for institutions to include a link to the required Gainful Employment program disclosure template in all promotional materials, to provide a copy of the required template to all students on an individual basis, and to receive acknowledgements from individual students that they received the template. Importantly, institutions are still required as of July 1, 2017, to incorporate the new Gainful Employment program disclosure template into their website descriptions of educational programs offered.

Please also note that unless an institution submitted a timely notice of intent to appeal its programs’ Gainful Employment measures to the Department in late January, this latest action does not affect the regulatory requirement to issue student warnings for programs in danger of losing federal student financial aid eligibility because of those measures.

This post was written by John R. Przypyszny and Jonathan D. Tarnow of Drinker Biddle & Reath LLP.