Category Archives: Supply Chain

Prop 65 Warning Regulations Adopted

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Today, September 2, 2016, the California Office of Environmental Health Hazard Assessment (OEHHA) published its notice of adoption of amendments to Prop 65 - essentially overhauling Title 27 of the California Code of Regulations, Article 6, which governs the warning requirements of the Safe Drinking Water and Toxic Enforcement Act The new regulations are not effective until August 30, 2018. In the interim, businesses have the option of complying either with the current regulation, or the provisions of the new regulation. OEHHA has published a side-by-side comparison of the newly adopted [...]Read more

California – New Prop 65 Product Label Requirements Likely to be Adopted

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Today, May 17, 2016, OEHHA released a second set of revisions to its proposed regulations to change the warning labeling requirements for Prop 65.  This is the first major change to the words required on product labels and shelf signs and catalogues selling products into California in several decades.  OEHHA has been working on these warning wording and method changes since 2013.  The most recent proposal commenced in November 2015, and has gone through several public comment periods and revisions.  Today’s May 17th revision is probably the last set of revisions before adoption.  Comments [...]Read more

I See a Prop 65 Label On This Product, But What Does It Mean? New California Website to Explain

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At the beginning of 2016, the State of California (OEHHA) adopted a new regulation to give itself authority to create and operate a website to provide information about the Prop 65 labels the public sees on everyday products and in everyday locations such as restaurants, gas stations and airports.  New section 25205 allows OEHHA to post information about pathways of exposure to chemicals in products and strategies to avoid exposure, while also providing a disclaimer that OEHHA cannot assure the accuracy of anything it posts.   It creates a petition process for manufacturers, sellers and the [...]Read more

Short Comment Period for Revised Prop 65 Warning Regulations

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On Friday, March 25, 2016, the California Office of Environmental Health Hazard Assessment (OEHHA) released another set of proposed revisions to the Prop 65 warning label regulations. The comment period is very short – only 15 days.  Members of the public have only until April 11, 2016 at 5:00 p.m. PST to submit comments on the revised regulations.  Requests to extend the comment period are pending, but not guaranteed. OEHAA initiated formal rulemaking for the revisions to Prop 65 warning label regulations in January 2015. That proposal was repealed and replaced with new proposed regulations [...]Read more

County-Level Pharmaceutical Take-Back Programs May Be Spreading in California and Illinois

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Los Angeles County, the nation’s largest County, has proposed a pharmaceutical take-back ordinance that would require businesses to finance a local government program for disposal of unwanted medications and potentially hazardous medical products like needles and syringes. Under the draft ordinance, termed the “Los Angeles County Pharmaceuticals and Sharps Collection and Disposal Stewardship Ordinance,” certain manufacturers, producers, or distributors of covered medications and supplies would be responsible for designing, implementing and financing the collection program. At its March 22, [...]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

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