The United States District Court for the Northern District of California has found that the Food and Drug Administration (FDA) clearly exceeded the deadlines set by Congress for promulgating regulations under the Food Safety and Modernization Act of 2010 (FSMA). Rather than impose its own arbitrary deadline, the court sent the parties in Center for… Continue Reading
Tag Archives: Administrative Procedure Act
Homeland Security & Labor Issue H-2B Regulations: Authority Solved?
Posted in Agency Authority, Judicial Review & Remedies, Regulatory ProcessThe Department of Homeland Security (DHS) and the Department of Labor (DOL) moved quickly – perhaps too quickly – to resolve legal authority issues raised by recent court decisions vacating low-skilled worker visa (H-2B) regulations by adopting a “joint” interim final rules (IFR) that is available for public inspection and will be published in tomorrow’s… Continue Reading
Court Requires FDA to Grant ‘Plan B’ OTC Status – Authority Issues
Posted in Agency Authority, Constitutional Issues in RegulationsA judge of the United States District Court for the Eastern District of New York has ordered the Department of Health and Human Services (HHS) Food and Drug Administration (FDA) to make “Plan B” – the post-intercourse, pre-fertilization contraceptive “morning after” pill – available over the counter (OTC) rather than by prescription to individuals under… Continue Reading
11th Circuit Holds Labor Department Has No Authority to Issue H-2B Rules
Posted in Agency Authority, Judicial Review & Remedies, Regulatory ProcessToday the United States Court of Appeals for the Eleventh Circuit affirmed the decision of the United States District Court for the Northern District of Florida enjoining the Department of Labor (DOL) from enforcing its non-immigrant non-agricultural unskilled labor visa program (H-2B) in Bayou Lawn and Landscape Services v. Solis. The court found that the… Continue Reading
EPA’s Tier 3 Vehicle Emission Reduction Proposed Rule: Good, Bad, …
Posted in Regulatory ProcessLast week’s major administrative law milestones are not over, but this post is a little different: plaudits and pans for the Environmental Protection Agency (EPA) regulatory process. EPA released its pre-publication, long awaited, much debated, and massive Control of Air Pollution From Motor Vehicles: Tier 3 Motor Vehicle Emission and Fuel Standards proposed rule on… Continue Reading
More Alien Worker Wage Rules Vacated under APA: What H-2B Rules Apply?
Posted in Agency Authority, Judicial Review & Remedies, Regulatory ProcessWhile much attention in the immigration arena has focused on a new employment verification document, the potentially rapid filling of the professional employees (H-1B) temporary visa quota, and the apparent conflict over determining wage rates for foreign workers that may be stalling Senate negotiators, wage methodology for the unskilled workers temporary visa category (H-2B) is… Continue Reading
Letters to a Senator: 8th Cir. says EPA violated APA Requirements
Posted in Judicial Review & Remedies, Regulatory ProcessOccasionally, an opinion begs to be quoted, and so no further introduction is needed to the United States Court of Appeals for the Eighth Circuit’s March 25, 2013, opinion in Iowa League of Cities v. EPA: The Iowa League of Cities (“League”) seeks direct appellate review of two letters sent by the Environmental Protection Agency… Continue Reading
Administration’s Failing Grades 3: Educational Race to the Bottom?
Posted in Judicial Process, Judicial Review & RemediesThe Department of Education (ED) took one step last week in its attempt to better regulate the “for profit” colleges, universities, and other schools: ED published a revision of a preamble to rules that the United States Court of Appeals for the District of Columbia Circuit remanded because the prior explanation was inadequate. Amending a… Continue Reading
APA Circuit Split – Notice and Comment Good Cause Bypass in SORNA Retroactivity Regulations
Posted in Judicial Review & Remedies, Regulatory ProcessThe United States Court of Appeals for the Third Circuit, on remand from the United States Supreme Court (SCOTUS) in United States v. Reynolds, summarized and joined the complex circuit split on three Administrative Procedure Act (APA) questions applied to the retroactivity of the Sex Offender and Registration Notification Act’s (SORNA) registration requirements. The first… Continue Reading
Monday Morning Regulatory Review – 2/25/13
Posted in Constitutional Issues in Regulations, Judicial Review & RemediesLitigation over President Obama’s recess appointments took several additional steps last week and few significant rules were published. One rule worth noting is a Department of Health and Human Services (HHS) follow-up final rule establishing standards for essential health benefits under the Patient Protection and Affordable Care Act. Two Department of Labor cases also deserve… Continue Reading
First FDA Food Safety Proposed Rules Released: A Long, Long Road Ahead
Posted in Executive - OMB Review, Regulatory Flexibility & Small Business, Regulatory ProcessThe Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA) completed review of the first of the long-awaited major Department of Health and Human Services (HHS) Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) “first wave” proposed rules: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls… Continue Reading
2012 Year End Review: Top 10 Most Read Posts & Thoughts for 2013
Posted in Judicial Review & Remedies, Regulatory ProcessA year of writing this blog – and 115 … now 116 posts – warrants a traditional end-of-year review and prospective for next year. For the Federal Regulations Advisor to be useful, it must be responsive to you, its readers. Top 10 Posts: Popularity is often fickle, skewed toward longevity and against recent posts, but… Continue Reading
4th Circuit Reinforces APA Requirements in Rejecting Alien Worker Wage Appeal
Posted in Judicial Review & Remedies, Regulatory ProcessThe United States Court of Appeals for the Fourth Circuit turned aside workers attempts to collect back wages from a time while the Obama Administration Department of Labor (DOL) had attempted to “suspend” a Bush Administration rule through a deficient Administrative Procedure Act (APA) notice and comment process. North Carolina Growers Ass’n v. United Farm… Continue Reading
CFTC Pool Operator Rule Upheld – Broader Lessons Need Consideration
Posted in Executive - OMB Review, Judicial Review & Remedies, Regulatory Flexibility & Small Business, Regulatory ProcessThe United States District Court for the District of Columbia granted the agency summary judgment in Investment Company Institute v. Commodity Futures Trading Commission (CFTC), leaving intact the Commodity Pool Operators and Commodity Trading Advisors: Compliance Obligations final rule (as corrected) (the “pool” rule). Plaintiffs claimed that the CFTC had violated the Administrative Procedure Act… Continue Reading
Monday Morning Regulatory Review – 12/10/12
Posted in Executive - OMB Review, Judicial Review & RemediesRegulatory activity continued to pick up speed last week, with the Environmental Protection Agency (EPA) submitting three rules for Office of Management and Budget (OMB) review, while OMB completed one time-sensitive review. The Department of Health and Human Services (HHS) published an economically significant Patient Protection and Affordable Care Act (ACA) proposed rule on benefit… Continue Reading
Monday Morning Regulatory Review – 12/3/12
Posted in Regulatory ProcessRule submission to and completions by the Office of Management and Budget (OMB) began to pick up speed last week. Most significant, OMB quickly completed review of a legally significant Environmental Protection Agency (EPA) logging road final rule – a subject of oral argument this morning at the Supreme Court and about which Congress has… Continue Reading
Deepwater Horizon – Agency Actions, Injunctions, and (Not) Contempt
Posted in Judicial Review & RemediesOn April 20, 2010, the Deepwater Horizon exploded and sent a gusher of oil into the Gulf of Mexico. Deepwater Horizon also sent a gusher of litigation into the federal courts: the recent decision in Hornbeck Offshore Services, LLC v. Salazar illustrates the care needed in seeking and enforcing an injunction against an agency of… Continue Reading
Monday Morning Regulatory Review – 11/19/12
Posted in Judicial Review & Remedies, Regulatory Flexibility & Small Business, Regulatory ProcessActivity at the Office of Management and Budget (OMB) has begun to pick up after the election – the Patient Protection and Affordable Care Act (ACA) regulations lead the way. On the other hand, another court ordered an exemption from the mandatory contraceptive coverage regulation ahead of Department of Health and Human Services (HHS) submitting… Continue Reading
District Court Vacates Hospital Disproportionate Share Payment “Rule”
Posted in Judicial Review & RemediesIn yesterday’s episode of the Medicare hospital disproportionate share (DSH) payment saga, the United States District Court for the for the District of Columbia vacated a Department of Health and Human Services (HHS) “policy” adopted in a 2004 final rule preamble that was not adopted as a rule until 2007. Allina Health Services v. Sebelius… Continue Reading
Monday Morning Regulatory Review – 11/12/12
Posted in Executive - OMB Review, Judicial Review & RemediesOn Election Night, the Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA) was reviewing 147 significant rules, proposed rules, and other notices. With the election over, the floodgates have now cracked. OMB’s docket has suddenly grown to 158, and we may expect to see many more rules – and perhaps… Continue Reading
Monday Morning Regulatory Review – 10/22/12
Posted in Constitutional Issues in Regulations, Judicial Review & Remedies, Regulatory ProcessThe cupboard is getting bare as we approach the election. The Office of Management and Budget (OMB) completed review on no (“0”) proposed or final rules last week, but at least the Department of the Treasury (DOTr) updated its Iranian assets blocking regulations and Department of Health and Human Services (HHS) submitted its calendar year… Continue Reading
Monday Morning Regulatory Review – 10/15/12
Posted in Judicial Process, Judicial Review & Remedies, Regulatory ProcessLast week a number of small events, mostly in the courts. The Environmental Protection Agency (EPA)’s long awaited CAFÉ regulation finally published in the Federal Register; a suit was filed to invalidate the Securities and Exchange Commission (SEC)’s extractive industries reporting rule, the Department of Justice (DOJ) sought further review of decisions in Food and… Continue Reading
SCOTUS to Decide on Deference to Agency Jurisdiction Interpretations
Posted in Judicial Review & RemediesThe United States Supreme Court agreed to review the United States Court of Appeals for the Fifth Circuit decision in City of Arlington, Texas v. FCC, limited to the question of whether courts should apply Chevron deference in reviewing an agency’s determination of its own jurisdiction. This grant of certiorari sets the stage for resolution… Continue Reading
Delicate Technicalities of Judicial Review of Final Agency Action
Posted in Judicial Process, Judicial Review & RemediesSeveral weeks ago, this blog alluded to a court of appeals criticism of its district court that focused on the nature of the remedy in judicial review of final agency action under the Administrative Procedure Act (APA): that the court enjoined a rule when it should have set the rule aside. This criticism may seem… Continue Reading