RCRA Regulation of Hazardous Waste Pharmaceuticals –Proposed Rule Forthcoming this Summer

Written by
On March 19, 2015, EPA sent its proposed rule, “Management Standards for Hazardous Waste Pharmaceuticals,” to the White House Office of Management and Budget (OMB) for pre-publication review.  This review may take up to 90 days (barring a one-time 30-day extension).  Unless OMB returns the rule to EPA for reconsideration, we expect the proposed rule to be released this summer.  This rule will have major implications for the pharmaceutical reverse distribution industry and the management of non-dispensable pharmaceuticals at health care facilities. The fall 2014 Unified Agenda states that [...]Read more

Fourth Circuit Court of Appeals Affirms Summary Judgment to Georgia Power

Written by
The Fourth Circuit Court of Appeals affirmed today the lower court’s grant of summary judgment to Georgia Power in the Ward Transformer Superfund Site litigation.  While this opinion focuses on whether Georgia Power’s sale of used transformers to Ward Transformer constituted an arrangement for disposal of PCB-containing oil, the court’s analysis includes a number of findings related to arranger liability generally.  This opinion is the first Court of Appeals decision to address the test for arranger liability post Burlington, and may impact a number of other pending CERCLA cases and enforcement [...]Read more

Update on Pharmaceutical “Take-Back” Legislation: Counties Forge Ahead; California Waits for Direction from the Supreme Court

Written by
Between Washington and California, the West Coast once again pushes the envelope in drug take-back legislation, while state action – which may level the playing field – has taken a backseat, waiting for the United States Supreme Court to determine whether to grant certiorari in Pharmaceutical Research and Manufacturers of America (PhRMA), et al. v. County of Alameda. At the end of December, the pharmaceutical industry petitioned the Supreme Court to reverse a September 30, 2014 Ninth Circuit appellate ruling that mandates that the industry pay for the County’s take-back program. On January [...]Read more

CARB’s March 2, 2015 Reporting Deadline is Approaching Fast – Do you need an extension?

Written by
The reporting deadline for makers of consumer products, office supply products, garden supply, pool, personal care, automotive, and many other product types (see full list of product categories in Appendix A) is fast approaching. We previously blogged and released an Advisory about the CARB (California Air Resources Board) reporting requirement and the need to think about protecting your product’s trade secrets. It is possible the March 2, 2015 reporting deadline will be extended.  Even if it is not, CARB has stated that it will consider extensions of this deadline on a case-by-case basis. But [...]Read more

EPA to Begin Enforcing New Low Sulfur Fuel Standards for Vessels

Written by and
EPA is increasing enforcement of vessel pollution cases—specifically violations of fuel sulfur standards—in the North American and U.S. Caribbean Emissions Control Areas ("ECAs"), as demonstrated through its recent release of the “EPA Penalty Policy for Violations by Ships of the Sulfur in Fuel Standard and Related Provisions.”  This policy outlines how EPA will calculate penalties assessed for violations of Act to Prevent Pollution from Ships, the law that implements MARPOL, Annex VI.  The release of this policy coincides with the December 31, 2014 significant reduction in fuel sulfur [...]Read more

California State Water Board Workshop on Changes to Industrial Stormwater General Permit

Written by
The California State Water Resources Control Board (“State Water Board”) held a workshop today to discuss significant changes to the General Permit for stormwater associated with industrial activity. The new General Permit, as discussed in an April 2, 2014 Alston & Bird LLP post, takes effect July 1, 2015. Notable changes in General Permit requirements are listed in the State Water Board’s Summary of Significant Changes. Among other prominent changes, the new General Permit makes it mandatory for dischargers to submit and certify all reports electronically on the SMARTS system, requires [...]Read more

OEHHA Releases Formal Rulemaking Draft for Prop 65 Warning Regulations

Written by
The California Office of Environmental Health Hazard Assessment (OEHHA) released its formal rulemaking draft of Prop 65 warning regulations today. The public comment period begins Friday, January 16, and closes Wednesday, April 8. Uniquely for this rulemaking, OEHHA intends to post comments as they are received instead of waiting until the comment period closes. One of the key changes is the proposal that 12 chemicals (the so-called “dirty dozen” - see Section 25602) be specifically included in Prop 65 warnings: acrylamide, arsenic, benzene, cadmium, carbon monoxide, chlorinated tris, [...]Read more

Trade secret protection for mandatory California consumer product survey?

Written by
Every company listed on a label of a consumer or commercial product sold or supplied for use in California in 2013 must complete and submit a survey to the California Air Resources Board by March 2, 2015.  Makers of hair sprays, cleaning products, floor waxes, insecticides, paints, as well as numerous other categories of products must submit their data in CARB’s electronic survey system, called the Consumer Product Reporting Tool (CPRT) and for formulators, the CPRT-F.  See Appendix A in the survey instructions for a full list of product categories.  The survey is unprecedented in its scope [...]Read more

DEA Releases Regulations Implementing the Secure and Responsible Drug Disposal Act

Written by
The Department of Justice (DOJ), Drug Enforcement Administration (DEA) released a final rule that implements the Secure and Responsible Drug Disposal Act of 2010, also referred to as the “Disposal Act.” The new regulations take effect on October 9, 2014. They provide additional options for ultimate users to dispose of controlled substances, and create a voluntary role for industry registrants, i.e. “collectors,” which are entities that ultimate users can transfer controlled substances to for disposal. An “ultimate user” includes a person a controlled substance is prescribed to; [...]Read more

Makers of Beauty, Hygiene, Furniture, Cleaning, Clothing, Fishing, Office Machinery and Building Products – GET READY! Future Regulated Product Categories Selected by California

Written by
Under the California Safer Consumer Product Regulations, maker of products that are selected as “priority products” will be invited to participate in a grueling paperwork-laden regulatory process, that involves multiple notifications, alternatives analyses, chemical hazard and environmental assessments for the entire lifecycle of making their product from raw material extraction, manufacturing, transportation, use by consumer and ultimate disposal of product. Read more about the requirements here or here. In August 2014, the California Department of Toxic Substance Control ("DTSC") held [...]Read more