It’s not very often that manufacturers and many environmental groups agree on a chemical safety regulation. But that’s what’s happening with the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which passed the Senate late last week, and would reform the Toxic Substances Control Act (TSCA).
Continue Reading Non-Toxic Reform: Senate Passes TSCA Revisions

When a company sells a consumer product that poses a potential hazard to consumers, federal law requires that a report be filed with the U.S. Consumer Product Safety Commission (CPSC). 15 U.S.C. § 2064(b). Companies who fail to do so risk severe civil penalties. After the company’s report has been filed, the CPSC offers companies one of two tracks: (1) the Standard Track, in which the CPSC (eventually) makes a Preliminary Determination (PD) of whether the product is defective; or (2) the Fast Track, in which the company can request to conduct a recall and, in exchange, the CPSC will refrain from making an official determination of defect and help speed the process along.

For years, the Fast Track process has been a winning formula for CPSC and companies alike. The CPSC saves engineering and bureaucratic resources because it no longer has to conduct a full-blown investigation. Similarly, a company who wants to improve their product and/or protect consumers can launch a national campaign within a few weeks of filing to address problems with the product.
Continue Reading Falling off the Fast Track: CPSC’s new “Stop Sale” Demand

The FDA has issued new draft guidance that may make it easier for pharmaceutical companies to develop and market drugs to treat alcoholism.  The proposed guidance provides that the FDA may approve drugs that help patients improve their drinking behavior, even if the drugs do not help patients achieve complete sobriety.  The draft guidance is being issued consistent with FDA’s “good guidance practices” regulation (21 CFR 10.115) and will, when finalized, “represent the Agency’s current thinking on the development of drugs for the treatment of alcoholism and appropriate endpoints for clinical trials of drugs to treat alcoholism.”  The guidance “does not create or confer any rights for or on any person and does not operate to bind FDA or the public.”

For years, abstinence from any alcohol consumption has been the common goal of clinical trials to develop drugs to treat alcoholism.  According to the FDA, however, abstinence has been considered an “unattainable threshold” and “a hindrance to clinical development for drugs to treat alcoholism.”  The FDA’s new draft guidance, entitled Alcoholism:  Developing Drugs for Treatment Guidance for Industry, recognizes that other outcomes besides sobriety (called “surrogate endpoints”) may still be effective at treating alcoholism.  Thus, the draft guidance provides that drugs to treat alcoholism may be approved if they are clinically proven to help patients:

Continue Reading FDA Issues New Draft Guidance That May Ease Approval for Drugs to Treat Alcoholism

California’s Office of Environmental Health Hazard Assessment (OEHHA) recently released new revisions to Proposition 65’s “safe harbor” warning language regulations.  Under OEHHA’s proposal, businesses selling goods in California will no longer be able to rely on the standard simple warning language that has been used for decades.  Instead, business will be required to issue new Prop 65 warnings.  A public hearing will be held on March 25, 2015 to discuss the new revisions. 

The new warning language includes:
Continue Reading Proposed Changes To Prop 65 Warning Requirements Will Increase Burden on Manufacturers

The Consumer Product Safety Commission (CPSC) has made it clear time and time again that product manufacturers may not make product design changes for safety reasons, without considering whether those changes need to be reported to the CPSC.  Failing to comply can lead to millions of dollars in fines.

Under Section 15 of the Consumer Product Safety Act, product manufacturers and importers must report substantial product hazards to the CPSC.  The CPSC tends to view design changes responding to injury reports as proof that the company “knows” the product had a safety issue.  If the company does not immediately report the underlying injury situation to CPSC, it faces severe fines.
Continue Reading Concealed Design Changes Once Again Result in Heavy CPSC Fine

Driverless cars could soon become a reality on our streets and highways. The technology for autonomous vehicles is developing quickly and states are beginning to enact regulation in anticipation of the arrival of driverless cars. Several major companies are developing prototype autonomous vehicles including General Motors, Mercedes-Benz, Google, Audi AG, Toyota Motor Company and Oxford University. The Institute of Electrical and Electronics Engineers (IEEE) has estimated that up to 75 percent of all vehicles will be autonomous by 2040.

But, in the last year, various news sources have reported that fear of increased liability may limit the roll out of driverless cars. As the Wall Street Journal explained, when there is no driver, the possible targets of a lawsuit expands to the company that designed the technology, the car’s owner, the passenger who failed to intervene, or the auto maker, to name a few. U-T San Diego reported that some experts believe the issue of liability, if not solved, could delay or even prevent the widespread use of driverless cars.
Continue Reading Driverless Cars and State Regulations: On The Road to Liability

“Compliance” has become a buzzword for companies across the American economy, most commonly in the general corporate (e.g., Sarbanes-Oxley) or employment (e.g., Department of Labor) contexts.  Unfortunately, too many consumer product companies do not have a written plan for meeting their hazard and incident reporting requirements to the Consumer Product Safety Commission (CPSC).

Multiple companies this year have been hit with penalties — some of them in the millions of dollars —for failing to report troublesome incidents and for making safety-related design changes without notifying CPSC.
Continue Reading CPSC Reporting Compliance: Do You Have a Plan?

The Food and Drug Administration (FDA) recently proposed new regulations on electronic cigarettes (“e-cigarettes”), including banning the sale of such products to children under age 18.  But according to more than two dozen state attorneys general, the FDA’s proposed regulations do not go far enough.
Continue Reading Proposed New E-Cigarette Regulations Not Sufficient For More Than Two Dozen State Attorneys General

On May 9, 2014 the United States Environmental Protection Agency (USEPA) issued an Advance Notice of Proposed Rulemaking under Section 8 of the Toxic Substances Control Act seeking public comment on whether companies must disclose the chemicals used in hydraulic fracturing (fracking).  Read the related May 12, 2014 post by clicking here. The USEPA

The National Highway Traffic Safety Administration (“NHTSA”) issued a final rule requiring vehicle manufacturers to install rear view cameras in all vehicles by May 1, 2018.  Will this new rule lead to new avenues of litigation risk and potential liability for vehicle manufacturers?  If past history is a guide, the answer may well be yes.

This new rule, announced on April 7, 2014, applies to all vehicles under 10,000 pounds gross vehicle weight, excluding motorcycles and trailers.   NHTSA established a 48-month phase-in period for manufacturers to equip vehicles with rear view cameras.  The phase-in period runs from May 1, 2016 to May 1, 2018.  The rear view cameras must have a 10-foot by 20-foot field of view directly behind the vehicle.  Small volume and multi-stage vehicle manufacturers are excluded from the phase-in but must comply with all requirements by May 1, 2018.
Continue Reading Rear-View Liability: NHTSA Issues New Rule Requiring Rear Visibility Technology