EPA Released its Proposed Management Standards for Hazardous Waste Pharmaceuticals Rule

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Today, EPA released its proposed Management Standards for Hazardous Waste Pharmaceuticals Rule.  A pre-publication copy is available here. The proposed rule, if finalized, will add a subpart P under 40 CFR part 266, which applies to the management of hazardous waste (HW) pharmaceuticals at healthcare facilities and pharmaceutical reverse distributors.  All pharmaceutical reverse distributors will be required to manage HW pharmaceuticals under this subpart, not 40 CFR part 262.  Subpart P creates a new category of hazardous waste entities, pharmaceutical reverse distributors – such entities [...]Read more

OEHHA Releases New Prop 65 Proposals that Will Increase Label Obligations for Businesses Selling Products into California, Particularly for Food Producers and Sellers

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On Friday, August 28, 2015, the California Office of Environmental Health Hazard Assessment (“OEHHA”) released four pre-regulatory proposals under Prop 65 that, if passed, would likely significantly expand the overall obligations of certain businesses to meet Prop 65 warning label requirements.  Prop 65, known officially as The Safe Drinking Water and Toxic Enforcement Act of 1986, requires businesses to provide warnings for an exposure to a listed chemical known by the state to cause cancer or reproductive toxicity. Specifically, the OEHHA pre-regulatory proposals released Friday would [...]Read more

New Proposals from California Governor: Will CEQA Be Fixed? Or Will it Get More Complex and Unwieldy?

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The California Governor’s Office is seeking input on their proposals to update the CEQA Guidelines by October 12, 2015.   They have released a discussion draft – which is a pre-regulatory process to get input on some of the proposals before actually proposing them in a formal rulemaking.   A copy of the preliminary discussion draft, along with other background information, is available here: http://opr.ca.gov/s_ceqaguidelines.php. The CEQA Guidelines provide the regulatory rules for the preparation of environmental review documents for all public and private development proposals (e.g., [...]Read more

California Expands Oil Spill Prevention Regulation Inland: Releases Emergency Regs for OSRO Ratings

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On Friday, July 10, the California Department of Fish and Wildlife’s Office of Spill Prevention and Response (OSPR) released updated emergency Oil Spill Response Organization (ORSO) Rating regulations as part of OSPR’s expanded authority under SB 861. SB 861, passed through the California legislature in June of last year, extends oil spill protections previously available only to California’s coastal and marine waters to all inland waters of the state.  The bill was passed in direct response to rising shipments of crude oil and petroleum products across state lands.  Among other changes, [...]Read more

Bipartisan TSCA Reform Bill Sails Through House

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Last night, the U.S. House of Representatives passed the TSCA Modernization Act of 2015 (H.R. 2576) with a near-unanimous vote of 398-1. The bipartisan bill now heads to the Senate, where a competing bill (S. 697) advanced last month. Lawmakers will have to resolve key differences between the bills before sending to President Obama. H.R. 2576 would update the 40-year old Toxic Substances Control Act for the first time. The bill’s key provisions remove cost as a factor in EPA’s chemical safety assessments, afford EPA more power to order new chemical safety data, and aim to create a more uniform [...]Read more

The Floodgates Are Open for EPR Laws

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Last week, the United States Supreme Court denied industry’s petition for certiorari in Pharmaceutical Research and Manufacturers of America (PhRMA), et al. v. County of Alameda. The petitioners contended that Alameda’s Safe Drug Disposal Ordinance violated the dormant commerce clause by requiring pharmaceutical companies to finance a drug take-back program. The impact of the Court’s denial—which lets stand a Ninth Circuit ruling upholding the ordinance—will be widespread, both for the pharmaceutical industry, and more broadly, for extended producer responsibility (EPR) laws and ordinances [...]Read more

SB 657 – California Attorney General Gearing up for Enforcement Actions

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Perhaps you have just received a letter from the California Attorney General seeking your voluntary participation in an on-line survey regarding your company’s compliance with the supply chain and anti-slavery and anti-human trafficking disclosures required by the California Transparency in Supply Chains Act? Be careful.   Compliance with SB 657 was required by January 1, 2012 for certain companies that sell goods in California with annual worldwide gross receipts over $100 million.  In 2012, compliance consisted of make 5-6 disclosures on a company’s website – its business homepage [...]Read more

Global Manufacturers Take Note: DTSC’s Safer Consumer Products Priority Product Work Plan Released Today

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The final version of the California Safer Consumer Products (SCP) Priority Product Work Plan for 2015-2017 can now be viewed on the California Department of Toxic Substances Control’s (DTSC’s) website. The goal of the SCP program is to identify specific products containing potentially harmful chemicals and to ask manufacturers to determine (1) whether the chemicals are necessary; and (2) whether there are safer alternatives. The Work Plan issued in final form today identifies product categories from which such so-called “Priority Products” will be researched and selected for the next [...]Read more

Significant Expansion of Judicial Review Under the Clean Water Act

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Today, the Eighth Circuit Court of Appeals issued a precedent-setting decision in Hawkes v. United States Army Corps of Engineers, holding that jurisdictional determinations issued under the Clean Water Act are subject to immediate judicial review. Under the Clean Water Act, the discharge of dredged or fill material into navigable waters requires a permit from the United States Army Corps of Engineers (other types of discharges require a permit from the United States Environmental Protection Agency or its state-agency designates). Although on its face seemingly straightforward, the question [...]Read more

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

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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