You’ll Scream, All Right.

On April 20, 2015, Blue Bell Creameries voluntarily recalled all of its products including ice cream, frozen yogurt, sherbet and frozen snacks.  The company did so after sampling of chocolate chip cookie dough ice cream produced on March 17, 2015 and March 27, 2015 was found to contain listeria monocytogenes.  The bacteria causes listeriosis, an infection that is life-threatening, particularly to pregnant women and their newborns, adults 65 and older and people with weakened immune systems.  The Center for Disease Control in Atlanta has recommended that consumers not eat any Blue Bell brand products and that institutions and retailers not serve or sell them.  As of April 21, 2015, ten cases of listeriosis (including three deaths), have been identified in four states (Arizona, Kansas, Oklahoma and Texas), an outbreak believed to be related to the recalled products.

Not So Easy to Ride THIS Bicycle.

Spring is upon us and thoughts turn to spending time outdoors…walking, jogging, bicycling. But be careful if you plan to climb aboard your expensive two-wheeler. The Trek company of Waterloo, Wisconsin just recalled about 900,000 of its bicycles equipped with front disc brakes sold in the United States and 98,000 in Canada. According to the company, an open quick release lever (black or silver) on the front wheel hub can come into contact with the front disc brake assembly, causing the front wheel to come to a sudden stop or separate from the bicycle, posing a risk of injury to the rider. The recall involves all models from years 1999 through 2015 costing between $480 and $1,650. Models with front quick release levers that do not open a full 180 degrees from the closed position are not included in this recall. The recall was prompted by three incident reports, one occurrence resulting in quadriplegia, one in facial injuries and one in a fractured wrist. Trek has committed to remedy the problem by having authorized dealers install new quick releases on front wheels at no charge to the consumer.

“One Package of Flu Medication…Unleaded, Please.”

On April 16, 2015, the Suffolk County Commissioner of Health Services, Dr. James Tomarken, warned parents that a powdered product marketed to treat influenza, fever, sneezing and nasal discharge in infants and children may contain excessive levels of lead. The product, Bo Ying Compound, is manufactured by Eu Yan Sang (Hong Kong) Ltd., is labeled in Chinese and English, and is marketed in retail outlets and online. “Parents and caregivers should not use Bo Ying Compound, Commissioner Tomarken said, “due to the potential risk of lead poisoning.” “Those caregivers who have the product in their homes should discard it, and those who may have already given Bo Ying Compound to their children should consult a health care provider for evaluations and possible blood lead testing,” the Commissioner stated. The warning was apparently prompted by the Maryland Department of Health and Mental Hygiene having found elevated lead levels in samples taken from two stores in the state. In 2014, the New York City Department of Health and Mental Hygiene received a report of lead poisoning in an 18-month-old child who was given Bo Ying Compound. The New York City Department of Health and Mental Hygiene analyzed samples of this product collected in New York City and also found elevated levels in the product.

The CDC has stated that “no safe blood lead level in children has been identified.” It estimates that approximately one-half million U.S. children between the ages of 1 and 5 have blood lead levels above 5 micrograms per deciliter (µg/dL), the reference point at which the agency recommends that public health actions be initiated. Exposure to lead has long been believed to cause serious damage to the central nervous system, the kidneys and the immune system. In children (whose brains and nervous systems are developing), chronic exposure to lead, even at low levels, is associated with impaired cognitive function, including reduced IQ, behavioral difficulties, and other problems.

The Tsk-Tsk-Tsk Story of TSCA

The Toxic Substances Control Act (“TSCA”), regulates the dissemination of existing and new chemicals. Its three goals have always been to: 1) “assess and regulate new commercial chemicals before their entrance into the market”; 2) “regulate chemicals which were already existing in 1976 that posed an unreasonable risk to health or to the environment”; and 3) regulate the distribution and use of these chemicals. It prohibits the manufacture or importation of chemicals that are not on the TSCA Inventory of “existing” chemicals (or those subject to one of many exemptions). Producers must submit pre-manufacturing notification (“PMN’S”) to the EPA at least 90 days prior to creating or importing new chemicals for commercial purposes. The federal agency reviews the PMN’S and if it finds an “unreasonable risk to human health or the environment,” it may limit or ban production of the new substance.

When TSCA was passed in 1976, it “grandfathered in” some 60,000 substances that were already in use, making them exempt from review. The law makes it very difficult for the EPA to deem a substance “dangerous” and regulate it as such: in fact, of the 84,000 chemicals now registered for use in the United States, only 200 have been tested and the EPA has only banned five as “dangerous.” As a result of the federal government’s inaction in this area, individual states have banned certain chemicals, creating a regulatory quagmire in which manufacturers have to comply with different standards in different territories.

The law has faced considerable criticism and calls for reform from manufacturers and environmental advocates alike. In 2009, chemical producers called for the law to be “modernized” into a more centralized regulation…to avoid inconsistencies and ambiguities and to avoid the stifling of innovation and job creation. At the same time, environmental groups and state agencies have argued for tighter controls and labeling. In response to public concerns, manufacturers started to incorporate “screening mechanism(s) to diminish and/or prevent the marketing of products containing chemical substances that could potentially adversely affect human health and the environment.” Additionally, the demand for sustainable products has forced the market, to some degree, to adopt more green chemistry. Since 2003, 18 states have passed 71 laws regarding chemicals, and the state of California, in particular, implemented the Green Chemistry Initiative (“CGCI”) in an effort to increase innovation and reduce or eliminate hazardous substances to human health and the environment.

Clearly, technological advancement and invention of new chemicals is ahead of TSCA regulation in the United States. In 2013, two Senators proposed the Chemical Safety Improvement Act (“CSIA”), as TSCA’s first major bipartisan overhaul. The CSIA would have established a new safety standard of “no unreasonable risk of harm to human health or the environment will result from exposure to a chemical substance” under “intended conditions of use.” The standard was consistent with TSCA, balancing the potential risks and benefits. If it had passed, the new law would have required the EPA to: 1) use an evaluative framework for decision-making that employs the “best available science” and “science-based criteria;” 2) propose a screening process and selection criteria to identify substances as either “high” or “low” priority for safety assessment and determination; 3) conduct a safety assessment for each high priority substance; 4) determine whether the chemical meets the safety standard under intended conditions of use; 5) eliminate the long regulatory process to obtain information from companies regarding their chemicals; 6) grant the EPA additional flexibility to take action on unsafe chemicals; and 7) require the EPA to declare chemicals “likely to be safe” before they can come to market. The law has yet to be passed. And so the tragic story of TSCA continues.

Time to Cut the Cord…or at least, Make it Safe?

There are corded window blinds in nearly 17 million American households with children under the age of six-years-old. The Consumer Product Safety Commission and Journal of the American Medical Association have stated that more than 768 children have been strangled to death since 1973. Despite two industry window blind retrofit/recall programs cords remain dangerous and defective, killing one child every two weeks. On March 31, 2015, the CPSC recalled about 200,000 Blinds To Go custom made window shades because the “chain or cord loop can slip out of the hold-down device and pose a strangulation hazard for small children.” The hold-down device on the recalled shades is a clear, P-shaped plastic hook. The cord or chain loop clips into the device and the hook is screwed to the side of the wall or window during installation. The device was shipped with the roller shades with Sidewinders, Smartlift pleated and cellular shades, Panel Tracks shades and Serenity shades.