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The new hazardous waste pharmaceutical management standards established by EPA’s Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine (“Rule”) are already effective in some states. Other states must adopt the rule by July 1, 2021 or, if a statutory amendment is required prior to the state’s adoption, by July 1, 2022. Based on this, all “healthcare facilities”[1] and “reverse distributors,”[2] as defined by the Rule, will ultimately be required to comply with the Rule (as adopted in each state).
Continue Reading “Unauthorized Waste” Reporting Under EPA’s Hazardous Pharmaceutical Waste Rule

On February 20, 2020, the U.S. Environmental Protection Agency (EPA) announced its intent to publish a preliminary regulatory determination under the Safe Drinking Water Act (SDWA) for perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS). Publication will initiate a 60-day notice and comment period that represents the first step toward the adoption of Maximum Contaminant Levels (MCLs) and Maximum Contaminant Level Goals (MCLGs) for PFOA and PFOS, two of the best-understood and most common compounds under the umbrella of perfluoroalkyl substances (PFAS).

Continue Reading Safe Drinking Water Act: EPA to Issue Regulatory Determination for PFOA/PFOS

New federal reporting requirements for per- and polyfluoroalkyl substances (PFAS) went into effect on January 1, 2020. The National Defense Authorization Act for FY 2020 (NDAA), signed into law on December 20, 2019, required EPA to add certain PFAS to the federal Toxics Release Inventory (TRI) list of reportable chemicals.

The NDAA identified fourteen specific PFAS chemicals for addition to the TRI list, and directed EPA to add other substances that met two criteria: (1) they were subject to a significant new use rule (SNUR) under the Toxic Substances Control Act (TSCA) on or before December 20, 2019, and (2) they were identified as active in commerce on the TSCA Inventory that was published in February 2019. Among the new additions are some of the best-known and most-studied substances, including PFOA (perfluorooctanoic acid), PFOS (perfluorooctane sulfonate), and GenX chemicals (including hexafluoropropylene oxide dimer acid).


Continue Reading Toxic Release Inventory Expanded to Include PFAS, with 160 New Reportable Chemicals and Counting

On January 27, EPA published a preliminary list of manufacturers that are potentially subject to a fee obligation under the Toxic Substances Control Act (“TSCA”). This is a follow-up notice to EPA’s designation of 20 additional substances as High Priority Substances in December, for which the agency will now go through a risk evaluation, including:

Continue Reading EPA Publishes Preliminary List of Manufacturers Subject to TSCA Risk Evaluation Fees

On November 15, EPA posted its pre-publication version of the Final Rule re-classifying aerosol cans as “universal waste” under the Resource Conservation and Recovery Act (RCRA), which finalizes EPA’s March 16, 2018 proposal (83 Fed. Reg. 11,654).  As discussed in our prior blog post regarding the proposal, many aerosol cans have historically been classified as hazardous waste because of their ignitability, and thus often are subject to stringent regulations related to handling, transportation, and disposal.

Universal waste is a sub-category of RCRA regulated hazardous waste that allows certain widely generated products, such as batteries, certain pesticides, and lamps, to qualify for less stringent regulation than the traditional hazardous waste regime.  The Final Rule is intended by EPA to ease regulatory burdens on retail stores and others that discard hazardous waste aerosol cans by providing an optional pathway for streamlined waste management treatment; promote the collection and recycling of these cans; and encourage the development of municipal and commercial programs to reduce the quantity of aerosol cans going to municipal solid waste landfills or combustors. 
Continue Reading EPA Finalizes Rule Classifying Aerosol Cans as Universal Waste

For most federal rules, you don’t need a map to figure out in which states they’re the current law.  But you do for the 2015 “Clean Water Rule,” which significantly expanded the reach of the Clean Water Act by redefining the term “waters of the United States.”  That’s one reason why, on September 12, 2019, the U.S. Environmental Protection Agency and the U.S. Army Corps of Engineers released a new rule to repeal the Clean Water Rule and restore prior regulations.  This “repeal rule” will take formal effect 60 days after its publication in the Federal Register.

Continue Reading EPA and Army Corps Repeal 2015 Clean Water Rule

On June 13, 2019, EPA published a final rule that revises its release notification requirements under the Emergency Planning and Community Right-to-Know Act (EPCRA).  Specifically, the revision exempts from EPCRA reporting air emissions from animal waste at farms.  While these air emissions are now exempt from reporting requirements, releases from animal waste to other water and land must still be reported.
Continue Reading EPA Excludes Farm Animal Waste from EPCRA Air Emissions Reporting Obligations

Today U.S. EPA finalized new hazardous waste regulations in its final Management Standards for Hazardous Waste Pharmaceuticals rule.  In brief, the rule creates a new Subpart P to 40 Code of Federal Regulations Part 266, which is specific to hazardous waste pharmaceuticals.  The rule applies to all “healthcare facilities” (such as hospitals and retail pharmacies) and “reverse distributors.”   The rule requires that all healthcare facilities and reverse distributors manage hazardous waste pharmaceuticals in accordance with the new subpart P regulations.  We are carefully reviewing the final rule and implications to clients, as well as implications to state hazardous waste requirements.

Continue Reading EPA Finalizes Hazardous Waste Pharmaceuticals Rule

On April 26, 2018, a North Carolina jury awarded 10 neighbors $51 million in the first North Carolina hog farming case to be heard before U.S. District Judge W. Earl Britt.  Almost a week later on May 9, 2018, Judge Britt reduced the jury’s award of $23 million in punitive damages to nearly $3 million in punitive damages because of a North Carolina state law that limits punitive damages to $250,000-per-plaintiff.  This was the first case tried of 26 lawsuits brought by 500 neighbors complaining about hog operations in eastern North Carolina against Smithfield Foods, the world’s largest pork producer.

Continue Reading Punitive Damages in North Carolina Hog Farm Cases Reduced