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Daniel W. Wolff

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Dan Wolff is a litigator and regulatory problem solver. He is a partner in Crowell & Moring's Washington, D.C. office and chairs the firm's Administrative Law & Regulatory Practice. Dan works with clients across a wide spectrum of regulated industries, counseling them on their rights and obligations under a number of federal regulatory programs and in responding to government enforcement actions. Dan appears regularly in federal district and appellate courts, frequently in matters arising under the Administrative Procedure Act and other federal statutes, or which pose constitutional questions. He also litigates commercial and products liability cases in both federal and state venues.

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Last month, in Seife v. U.S. Food and Drug Administration, the U.S. Court of Appeals for the Second Circuit became the first appellate court to address a significant question left unanswered by the Supreme Court’s 2019 decision in Food Marketing Institute v. Argus Leader Media: what impact, if any, did the 2016 FOIA Improvement Act (“FIA”) have on FOIA Exemption 4?  The answer: a submitter of information ostensibly subject to Exemption 4 must demonstrate competitive harm—though not “substantial” harm—resulting from disclosure in order to invoke the exemption.

Argus clarified the applicability of Exemption 4, which protects from disclosure “trade secrets and commercial or financial information obtained from a person [that is] privileged or confidential.”  5 U.S.C. § 552(b)(4).  The Argus Court rejected the longstanding National Parks test, which applied Exemption 4 only where the submitter of such information could demonstrate “substantial competitive harm” resulting from its disclosure.  Instead, the Argus Court held Exemption 4 applied, at the very least, where the submitter of such information kept it confidential and submitted it to the government with an assurance of privacy.  Given the difficulties inherent in establishing “substantial competitive harm,” Argus was welcome news for contractors seeking Exemption 4 protection.  (We have previously written about Argus and the district court decisions that followed.) 

In 2016, Congress enacted the FIA in response to concerns that FOIA’s exemptions were being overused. The FIA amended FOIA to allow for an exemption’s invocation only if “the agency reasonably foresees that disclosure would harm an interest protected by an exemption” or if disclosure is “prohibited by law.”  5 U.S.C. § 552(a)(8)(A).  Since Argus, multiple plaintiffs have argued the FIA effectively codified the National Parks test.  (Argus considered a FOIA dispute that commenced prior to the passage of the FIA; the Court there had no reason to address the question.)…

Continue Reading Second Circuit Holds FOIA Exemption 4 Still Requires Showing of “Competitive Harm” Resulting from Disclosure, Though Not a “Substantial” One

On November 4, 2021, the Occupational Safety and Health Administration (“OSHA”) released its much-anticipated COVID-19 Vaccination and Testing Emergency Temporary Standard (“ETS”) requiring employers with 100 or more employees to ensure that their employees are either vaccinated by January 4, 2022, or submit to weekly testing.  According to OSHA, employees who are unvaccinated face a “grave danger” from COVID-19, including the more contagious Delta variant.  The ETS notes that COVID-19 is highly transmissible—particularly in workplaces where multiple people interact throughout the day often for extended periods of time—and exposure to COVID-19 can result in death or illness, with some individuals experiencing long-term health complications.  OSHA has determined that vaccination is the most effective way to protect these employees.

The ETS will take effect immediately upon publication in the Federal Register, which is scheduled for November 5, 2021.  The ETS will apply in those states where OSHA is responsible for regulating workplace safety and health.  Per OSHA regulations, states that have their own OSHA-approved occupational safety and health plans will have 15 days to notify OSHA of the action they will take and 30 days to adopt the ETS or promulgate standards that OSHA considers at least as effective as its ETS.

The OSHA ETS is part of a sweeping policy of the Biden Administration to get more American workers vaccinated.  In addition to this ETS, the Centers for Medicare & Medicaid Services (“CMS”) released today a Vaccination Interim Final Rule (“IFR”) requiring workers at healthcare facilities participating in Medicare or Medicaid to be fully vaccinated.  Both the OSHA and CMS actions follow on the heels of Executive Order 14042 mandating that certain federal contractors and subcontractors require their covered employees to receive vaccinations against COVID-19, with limited exceptions for those who cannot be vaccinated for legally-protected reasons, and OSHA’s June 10, 2021 ETS directed toward protecting healthcare workers in particular from COVID-19.  Our previous alert on OSHA’s June 10, 2021 ETS is available here, and our alerts regarding Executive Order 14042 are available here.  OSHA excludes from coverage under the ETS those employers who are subject to the CMS rule or the Executive Order 14042 mandate.

Although the ETS is very detailed—490 pages in all—the key takeaways and deadlines for compliance are below.
Continue Reading OSHA Publishes Vaccine Requirements for Employers with 100 or More Employees

In a string of recent cases following the Supreme Court’s 2019 decision in Food Marketing Institute v. Argus Leader Media, multiple courts have held that a party submitting information to the government need not demonstrate it obtained an assurance of confidentiality from the government in order for the agency to justify withholding that information…

On July 29, 2021, the Small Business Administration announced in an FAQ that it is discontinuing any reliance on the Loan Necessity Questionnaires, which the SBA had required of each borrower, that together with its affiliates, received Paycheck Protection Program loans with a principal amount of $2 million or greater. As we’ve previously discussed,…

The Occupational Safety and Health Administration (OSHA) issued interim guidance for enforcing the recording of occupational illnesses requirements, specifically for cases of coronavirus (COVID-19). This guidance rescinds OSHA’s earlier guidance providing for enforcement discretion on COVID-19 complaints arising outside of healthcare or emergency response employers. As of May 26, 2020, and until further notice, OSHA…

On April 27, the U.S. Supreme Court issued a decision in Maine Cmty. Health Options et al v. United States, ruling in favor of Maine and companion insurers in the long running Affordable Care Act §1342 “risk corridors” litigation, and confirming the government’s obligation to pay insurers approximately $13 billion for their work related…

On March 10, 2020, the Occupational Safety and Health Administration (OSHA) issued Guidance for employers to prevent occupational exposures to the coronavirus. In doing so, OSHA reminds employers that while no specific standard governs occupational exposure to the coronavirus, the Occupational Safety and Health Act’s General Duty Clause, 29 U.S.C. § 654 (a)(1), requires employers to provide their employees with a workplace free from recognized hazards likely to cause death or serious physical harm.

The Guidance contains recommendations and describes safety and health standards that, if followed, could help employers reduce potential enforcement actions for employees who may be exposed to COVID-19 in the workplace. While recognizing it may not be possible to eliminate a COVID-19 outbreak hazard, the Guidance lists what OSHA believes to be effective protective measures (from most to least effective): engineering controls, administrative controls, safe work practices (a type of administrative control), and personal protective equipment (PPE).
Continue Reading OSHA Issues Guidance to Employers on Preventing Worker Exposure to Coronavirus (COVID-19)

In a recent decision, the Court of Federal Claims rejected the Government’s motion to dismiss a lawsuit filed under the Tucker Act seeking to recover “risk corridors” payments pursuant to §1342 of the Affordable Care Act. In Health Republic Insurance Co. v. U.S. (Jan. 10, 2017), the Court held that “HHS is required to make…