Clemmer died on May 6, 2008 of severe burns over more than half of his body, 26 days after his MK lighter failed to extinguish and burst into flames in his pocket. Clemmer was at work on a Thursday in April, when he lit a cigarette, and placed the MK lighter in his pocket. Seconds later, the MK lighter exploded, engulfing his torso in flames. Although he was severely burned, he managed to call his brother, Ricky, who hurried over and drove him to the nearest fire station.

A quick-thinking employee, who later reported to work that day, snapped photos of the incident scene. He found the bay door to the machine shop wide open, signs of something burned and a lighter on the floor. Instinctively understanding that something was amiss, he captured the state of the workplace: charred remains of Clemmer’s clothing, the MK lighter, a single cigarette and a pack of Carnival cigarettes.

Today, the Clemmer family, through their lawyer Craig Sico, called on the U.S. Consumer Product Safety Commission to seek a recall of MK lighters, manufactured by the Chinese firm Zhuoye Lighter Company Ltd. and sold by the millions in the U.S. The Clemmers also asked the CPSC to bring the U.S. in line with other industrialized nations and implement a mandatory lighter safety standard, similar to the voluntary industry standard, which is already required in Canada and the European Union.

In 2006, the CPSC considered, but failed to take action on a request by the U.S. lighter industry trade group to make mandatory the voluntary standard American Society for Testing and Materials (ASTM) F400, first adopted in 1975.

Malfunctions from Cheap Imports

An expert examination of the MK lighter found both design and manufacturing defects that allowed debris on the globe seal, preventing the lighter from completely sealing its orifice. This allows gas to continue flowing – just enough to keep a flame burning that is too small to be seen behind the wind screen. In addition, a poorly manufactured metering pad can allow liquid butane to flow unevenly through the orifice. Over time, butane can pass through the orifice in liquid form instead of evaporating into ignitable gas. In the Clemmer incident, the MK lighter’s poorly manufactured globe seal and metering pad allowed the liquid to escape and seep into his clothing. The heat of his body caused the liquid butane to evaporate, which expanded its volume by about 60 times. Once the gas reached its flammable limits, it was ignited by the lighter’s small unextinguished flame.  It is notable that this particular lighter design also incorporates an adjustable flame device which has been abandoned by most major lighter manufacturers because of the additional explosion hazards they pose.

The results of this examination dovetail with research conducted by the CPSC as it weighed the adoption of a lighter safety standard. In 2006, the CPSC staff estimated that about 1 billion lighters are produced, domestically and abroad each year. In the U.S., imports account for more than 75 percent of the U.S. market, with Chinese-made lighters accounting for 58 percent of imports. The CPSC tested 92 different lighters collected at various retail outlets to assess their conformance to the voluntary standard. It found that the “inexpensive and disposable lighters had conformance rates at or below 40 percent. Among countries, lighters from China had the lowest conformance rate at 30 percent.”

The CPSC’s analysis of injuries and economic damage found that malfunctioning lighters cause about 917 injuries and $31 million in societal costs per year. Given the low per-unit cost of manufacturing disposable lighters, representatives of the U.S. trade group said that bringing sub-standard lighters into compliance with the voluntary standard would only cost manufacturers “a penny or two” per unit.

CPSC Declines to Regulate

In November 2001, as cheap imports flooded the market, the Lighter Association petitioned the CPSC to make mandatory ASTMF400. In a briefing package prepared for the Commission in April 2004, the staff noted , but nonetheless recommended that the CPSC deny the petition:

“Staff believes that the available data do not support a rulemaking proceeding, based primarily on the low risk of death or injury from lighter malfunctions, and uncertainty as to the level of voluntary standard conformance among lighters involved in the incidents.”

Nonetheless, then-Commissioners Hal Stratton and Thomas Moore voted 2-0 to overrule staff and publish an Advance Notice of Proposed Rulemaking on a safety standard for lighters. In April 2005, the ANPRM was published. A year later, the CPSC published a notice announcing its intention to extend the period for considering a new rule for another 12 months. In August 2006, the staff submitted a status report containing the results of their testing, the compliance costs and injury data, but still drew no firm conclusions:

“Based on market information on lighters, weighted estimates of conformance with ASTM

F-400 for lighters sold in the U.S. in 2005 range from 55 percent to 58 percent. Although estimated annual societal costs associated with lighter malfunctions total $3 1 million, benefits that might be achieved by a mandatory standard based on the provisions of ASTM F-400 are uncertain.”

The commission took no action, and the rulemaking died.

The current U.S. lighter safety standard only addresses a lighter’s child-resistance, and the CPSC has decided to settle for recalling malfunctioning lighters. The agency has recalled cigarette lighters for failing to self-extinguish at least five since 1988, the most recent in 2000.

Clemmer Case Attracts Other Complaints

The Clemmer family filed a civil action against the Zhuoye Lighter Company and settled its claims against the company’s American subsidiary. The family’s case against the Chinese company is still pending. Meanwhile, news of the lawsuit spurred four other people to contact the family’s attorneys, Sico, White, Hoelscher & Braugh, a Corpus Christi, Texas law firm, to relate their own near-misses and injuries with an MK lighter that failed to extinguish.

Robert McKellip, 48, of Las Vegas Nevada, suffered third-degree burns from his fingertips to his elbow, after an MK lighter exploded in his hand. In April 2008, Mr. McKellip was packing away the contents of his travel trailer in an unlighted storage unit, when he attempted to light a candle on the dining table. He struck the lighter and observed a six-inch flame shoot out of the lighter’s orifice, followed by an explosion as he held the lighter in his right hand. The flames ignited the sleeve of his shirt, which melted onto his arm. Mr. McKellip grabbed a towel, doused it with some water and wrapped his injured arm to extinguish the fire. Despite intense pain, he bicycled a quarter of a mile to his mother’s house, where she summoned emergency medical services. Mr. McKellip’s burns required an 18-day hospital stay. He sustained permanent nerve damage and still suffers pain from his injuries.

The Clemmer family maintains that if the MK lighter had met the industry standard, it would not have ignited in William Clemmer’s pocket.

“A cheap, disposable lighter killed my brother,” Ricky Clemmer said in a news release. “The CPSC had a chance as far back as 2001 to make sure that these imports were safe, and they didn’t take action. Now is the time to fix it. Recall these dangerous lighters and set minimum safety standards so that others don’t have to suffer from these preventable tragedies.”

Researchers from the University of Illinois, College of Medicine, Saint Francis Medical Center, Bradley University; and the Neurological Institute sought to measure how the physical characteristics of riders, including height, weight and fingertip-to-fingertip length (wingspan), influenced their ability to safely control the ATV and avoid ejection. The researchers instrumented two ATVs, a Polaris Trailblazer 250 (a sport model), and a Honda FourTrax 250 (a utility model), to measure a rider’s body position in three maneuvers associated with crashes: the J-hook, the brake test, and the bump. Researchers were studying the lateral, longitudinal, and vertical dynamics in five riders of varying heights, weights, and wingspans, who had average experiences driving passenger vehicles, but no experience riding ATVs.

The study, published in the November issue of Neurosurg Focus, concluded:

“Individuals with light weights and small wingspans, such as those in the pediatric population, are under considerable risk of injury when operating an ATV due to lateral, longitudinal, and vertical operational instability.”

The researchers cited the grim toll ATVs have taken over a five year period, from 1997 to 2001, with injuries outpacing the increase in ATV use by a considerable margin. According to the US Consumer Product Safety Commission study, the number of ATV riders increased from 12 to 16.3 million (36 percent); the total number of riding hours went from 1.575 to 2.364 billion (50 percent), and the number of ATVs in use rose from 4 to 5.6 million (40 percent). Injuries, as measured by emergency room visits, however, shot up from 52,800 to 110,100 – a 109 percent increase.

These injuries occur disproportionately in riders less than 16 years of age. The study’s authors point out that children in this age-set make up only 17 percent of all ATV riders, but account for 31 percent of injuries and 26 percent of fatalities in 2001. Injured children have a high incidence of central nervous system trauma. Moreover, 85 percent of child riders rode adult-sized ATVs, and 87 percent of those injured were riding on an adult-sized ATV. In a two-year CPSC analysis of 1999-2000, 93 percent of fatalities occurred on adult-sized machines. Rollovers were associated with 40 percent of the fatalities; ejection accounted for 15 percent.

In recognition of these hazards, injury prevention advocates in Massachusetts succeeded in persuading lawmakers that children cannot safely ride ATVs. In July 2010, the state became the first in the nation to ban children under age 14 from riding ATVs, unless it is under the auspices of an organized race or event supervised by an individual 18 years or older. Teens between the ages of 14 and 16 are limited to riding ATVs or other recreational utility vehicles with an engine capacity of 90 cubic centimeters or less. ATV owners are required to register their vehicles. Although the new law will soon celebrate its first anniversary, the state has done little to enforce it, and has failed to publicize it.

Since 2009, the importation and sales of three-wheeled ATVs was banned and manufacturers have been required by the U.S. Consumer Product Safety Commission to file and implement voluntary action plans. These plans include commitments to provide safety information and guidelines regarding the appropriate age for child and adult-sized machines. The manufacturers also consented to instruct dealers not to market adult machines to child riders and conduct under-cover monitoring to ensure that dealers are complying.

In the Illinois field study, the researchers tracked the center of gravity of the ATV and the rider, allowing them to determine the weight distribution, lateral, longitudinal, and vertical displacements, and a rollover risk estimate. The J-Hook test was an adaptation of the National Highway Traffic Safety Administration designed to assess a vehicle’s lateral stability and rollover propensity. Researchers instructed riders turning to the left to suddenly veer right to gauge lateral movement under centrifugal forces – a common injury scenario involving young riders who roll the ATV while traversing level ground.

The brake test measured the longitudinal displacement of a rider in a sudden deceleration. The rider accelerated from a stop along a linear path at a certain minimum speed, and then braking suddenly at a pre-set location. This test allowed researchers to measure the longitudinal displacement of the rider while braking.

The bump test measured a rider’s vertical bounce when driving over a 3.5 inch-high bump, based on “the premise that riders’ safety is severely compromised once they are in a position in which their legs are completely extended. Any displacement beyond this boundary could cause their feet to leave the foot pegs—a condition conducive to ATV/rider separation. Similarly to longitudinal displacement, without restraint, excessive vertical displacement from the ATV seat can easily lead to rider injury.”

The field tests determined that wingspan is associated with the ability to stabilize an ATV during the J-Hook test:  “Much of this effect is probably due to the need for the ATV rider to actively engage the vehicle to mitigate against rollovers. To maintain stability, a rider must coordinate the counterintuitive shifting of his or her body weight in the opposite direction of a turn. For these procedures, a large wingspan is certainly beneficial,” the study said.

The brake and bump test demonstrated that weight was associated with less risk of ejection – but it varied according to the design characteristics of the ATV. For example, the Honda utility ATV has a more stable design, sitting lower to the ground, with a firmer suspension. The Polaris sport ATV sits higher off the ground, with a bouncier suspension and a greater distance from its foot pegs to its seat, forcing the riders’ legs in a more extended in the sitting position. The result, “a rider will have less allowable bounce before their legs will reach full extension on the Polaris.” In the bounce test, “a weight of 75 lbs. marks the weight value at which a rider becomes unsafe on the Honda when riding over a 3.75-inch bump. On the Polaris, however, this weight value is 85 lbs.”

These findings align with the conclusions of CPSC mechanical engineers, who “have noted that a child who is too light or too heavy for the vehicle may affect the center of gravity and lead to instability.” But, this testing shows that weight is not the only determinant:

“As demonstrated by our testing, ATV rider stability and safety are also based on rider wingspan and weight, which may not be adequately addressed in the new top speed–related age requirements. Based on our findings, we recommend that ATVs designed for children should have both size and weight limitations for riders included as a stratification measure.”

“The implications of this study are enormous, especially for the pediatric population, because they have been found to be 4–12 times more likely to be injured riding an ATV than adult riders,” the study’s authors said.

Saczalski was retained by Miami attorney David Bianchi on behalf of the family of Carolyn Sorenson to determine what caused a scooter seat back to break in a products liability case against the U.S. distributors of the Daytona GT3 Electric Scooter. In January 2009, 64-year-old Sorenson died from positional asphyxiation in the trash room of her condominium building, when the plastic molded seat of her mobility scooter fractured and collapsed, causing her to fall backwards. Sorenson’s lower half remained belted in what was left of the seat, while her upper torso was wedged behind her against the door frame, according to police reports.

Mobility scooters, like thousands of other consumer products, are not subject to any mandatory standards. The Daytona GTS3 Electric Scooter with the folding seat system that failed in the Sorenson incident was allegedly designed and manufactured to ISO standard 7176-8 and WC-08 of ANSI’s Rehabilitation Engineering and Assistive Technology Society of North America (ANSI/RESNA). But as design and materials tests on exemplar seats showed, the standard’s static and dynamic compliance tests do not directly address the real-world stresses to which the seats are subjected. And, contrary to the claims of the company that sold the scooter, the plastic materials used in the seat were not the pure polypropylene, but a mixture of polypropylene and recycled plastic that weakened it.

Saczalski noted that “after initial certification there is no requirement for periodic recertifications. Consequently, after a period of use and time on the market, injury risk problems may arise from design flaws, such as failure to address potential stress concentration issues associated with handicapped user tasks related to rearward loading on the plastic seat systems.”  And “in addition, increased occupant/seat injury risks of plastic seat designs may also occur in later productions of the initially certified devices due to quality control issues and manufacturing flaws associated with the use of recycled moldable plastic materials that may contain high stress concentrations introduced through material impurities and foreign particle contaminates, often found in the recycled plastic materials.”

“It’s a cheaper way to go, but you get occlusions and imperfections, and when you lean on it, the seat tends to fracture in critical areas,” Saczalski said. “The regulators should make sure the manufacturers don’t change the quality after the fact. That’s what happened here. Once they certified it, they started changing the properties of the plastic in the seat.”

Attorney Bianchi settled the case against Medical Depot and Florida Home Medical.   Bianchi submitted Saczalski’s report to the CPSC and the FDA.

Scooters and off-road vehicles – of any configuration – that are not medical devices fall under the CPSC jurisdiction.  Many mobility scooters that are marketed and sold as a medical device fall under FDA jurisdiction.

Sorenson’s seat suffered two fractures on either side of the seat base near the rear mount bolts. Saczalski tested an exemplar mobility scooter to ISO 7176-8, and found that it broke in the same spot. He also used Finite Element Analysis to examine “the stress concentration and displacement patterns associated with rearward loading of the seat.” The FEA study again verified that that those areas of the seat were high-stress regions.

“The FEA also indicated that the likely failure regions were predictable and could have been virtually eliminated with minimal changes,” Saczalski said.

While the ISO and ANSI/RESNA WC-8 standards include a pendulum impact test for seatbacks, he notes: “these standards do not explicitly consider the typical handicap normal uses such as the rearward leaning function associated with the fatal injury case, and leaning on the seatback for stability while the handicapped individual is exiting or getting off the seat. This slow loading rearward process occurs thousands of times over the use of the device and must be addressed.”

Compounding such design standards was the use of adulterated plastics in the seat. Plastics expert Dr. Duane Priddy performed a microscopic evaluation of Sorenson’s seat and the exemplar and found that the seat material was contaminated by recycled plastic mixed with the polypropylene.

According to testimony by Florida Home Medical, Sorenson’s scooter was manufactured in 2008, but it was last tested in 2003. The certification process typically occurs before the product is introduced to the market, and there is no requirement for periodic re-certifications, so design flaws discovered through use and time in service are discovered through tragedies like the death of Sorenson.

The vote was 3-2, with Commission Chairman Inez Tenenbaum, and Commissioners Robert Adler and Thomas Moore approving the final rule. Commissioner Nancy  Nord and Ann Northup opposed it.

“Today’s vote represents a major victory for consumers and supporters of open government because it will provide the public access to critical product safety information that, due to statutory restrictions on the open flow of information, the CPSC was previously required to keep behind closed doors until it had been cleared with manufacturers,” the majority wrote in a joint statement.

The database will contain reports of harm; manufacturer comments on those reports; recall information and any additional information the commission feels is in the public interest.

The reporting mechanism is open to just about any member of the public who would have knowledge of an alleged product-based injury or death – including health professionals, lawyers, public safety officials and child care providers. A mock-up of the reporting scenario, which the CPSC has presented in the past, asks the submitter for information about the harm, the product and the victim. It also asks for contact information, a description and date of the incident, the category of submitter and the type of incident.

Incomplete incident reports will not make it into the public database, including those that do not contain an identifiable consumer product, manufacturer or private labeler, a description of the harm; intrusive photographs; medical records without consent; and reports by minors without a parent or guardian’s consent.

Click on the image below to see a larger version of a mock-up of the reporting form.

Manufacturers still have some recourse to correct and respond to reports or shield certain information from public view. Manufacturers may request and the commission may grant confidential treatment for portions of a report. The commission is also obligated to pull or correct materially inaccurate and delete duplicative reports within 7 business days of determining an inaccuracy.

Nord and Northup had tried and failed to amend the final rule at the eleventh hour to narrow who could report and to enforce more controls on accuracy. Upon passage, Nord expressed her disappointment:

“I voted against the final rule on the public database because it is so flawed that it is both contrary to the statute and to good public policy. Congress directed that the database be established but, presumably, expected that we would use both good sense and practicality in carrying out its mandate. We have used neither. Further, the rule adopted today is another example of poorly conceived and excessive regulation that, sadly, has become the norm at the CPSC over the past months.”

Manufacturers likewise have been railing against the database, painting it as an apocalyptic event in the lives of their businesses. In public hearings, various industry representatives described it as a breeding ground for lawsuits, based on wild inaccuracies. Much of the hand-wringing is, no doubt, rooted in inexperience. The National Highway Traffic Safety Administration fields between 30,000-50,000 complaints from consumers each year, which are entered into a public database. To date, no automobile manufacturer has been brought down by consumer access to product complaints.

Their predictions don’t seem to take into account that any number of consumer products-rating websites and opportunities to read unfiltered customer reviews on a wide range of products sold through many Internet retailers already exist. The CPSC  searchable database will likely provide another piece of information on a product for that fraction of consumers who educate themselves before buying. For safety advocates and public health officials, it will be a valuable surveillance tool to detect design and manufacturing flaws that result in harm. The transparency will hold both the commission and manufacturers accountable for ensuring that their products can be safely used and taking action when they cannot.

In the coming months, the CPSC will begin its outreach to the public and manufacturers, holding workshops and training webinars for the latter on the business portal registration and other features. The commission will also enable the comments section, the new incident form, and the new internal technology for processing incident reports.

The database is scheduled to debut March 11.

On the eve of a vote on a Final Rule to establish the new database, U.S. Consumer Product Safety Commissioners Anne Northup and Nancy Nord, have proposed an alternative to newly mandated consumer product safety database from that recommended by the staff. In a recent blog post entitled, “A Wrong Way and a Right Way – Which Will We Choose?” Commissioner Nord details the specific aspects of the database rule that prompted this Hail Mary pass: who can submit complaints and inaccurate information.

“Congress provided us with a list of those whose complaints should go up on the public database.  We have contorted the plain language Congress used into definitions that have no meaning.  For example, Congress told us to accept complaints from “consumers.”  The majority has determined that since everyone consumes something, we need to accept complaints from everyone—no need for any relationship to the product, harm or incident.  Think plaintiff lawyers trolling for clients or unscrupulous competitors wishing to harm a product’s reputation,” Nord writes.

The corrections include a specific list who can submit a report of harm that excludes categories of submitters included in the Final Rule draft. (Hint: trial lawyers and competitors are not on it.) Nord and Northrup also nixed “investigators, professional engineers, agents of a user of a consumer product, and observers of the consumer products being used,” as well as “consumer advocates or individuals who work for nongovernmental organizations, consumer advocacy organizations, and trade associations, so long as they have a public safety purpose.”

As for solving the inaccuracy conundrum, the commissioners proposed changes that would add a lot more hurdles to submitting reports – including the first and last name of the harmed consumer, along with a complete mailing address, telephone number and e-mail address. (In the rush to get this out, they must have forgotten to ask for the consumer’s Facebook friends.)

Sorry, we’re going to have to file this one under: Sky, Not Falling.

By the by, are we looking at some kind of violation of the Administrative Procedures Act? As far we know, the Commission is five days away from a vote on a Final Rule and the comment period is closed. We believe that means that all trial balloons are – for the moment – grounded.

After taking comments from the public, and by that we mean, the remarks of a handful of advocates and consumers and the complaints of 33 trade organization reps and business owners, the U.S. Product Safety Commission is now preparing to vote on a Final Rule to establish a consumer complaint database.

The database represents a sea-change in the accessibility of consumer product information, wresting control from manufacturers, who held sway over the flow of public information for nearly three decades.

SRS President Sean Kane, who testified before the CPSC at a public hearing on the database, urged the agency to build a public database by fusing sufficient detail on the product and problem and public availability of the data in a timely fashion.

“The success of the database to meet the public interest goals and facilitate ease of use requires the agency to balance what is absolutely necessary for a minimal level of information to qualify as a “complaint,” against the detailed information demands of the agency and other stakeholders.  Like the NHTSA consumer complaint database, the consumer product database will add to the tools available for surveillance and for educating consumers who often have little viable information on the potential hazards associated with products they purchase,” Kane said in comments to the commission.

The creation of the rule began in May, with a Notice of Proposed Rulemaking. Since then, the CPSC has been striving to maintain the balance between the fears of consumer products manufacturers, the requirements of the Consumer Product Safety Improvement Act (CPSIA), and the suggestions of advocates.

A vote of the full commission is scheduled for Nov. 17.

“This is an important step forward for product safety,” Kane said. “For the first time, consumers are going to have tools, pre- and post-purchase, to evaluate a product’s safety, even in the absence of a recall.”

According to Section 212 of the CPSIA, the database must be available through the CPSC website and presented in a user-friendly format that encourages the public to report injuries and defects. In addition to consumer complaints, the database will include the reports that manufacturers and private-label firms are required to make under Section 15(c) of the CPSA and the actions the agency makes in response to that information.

Manufacturers have been none-too-happy with the way the CPSIA cut the legs out from under 6B—the bane of consumer and safety advocates. Under the Section 6B of the Consumer Product Safety Act, manufacturers controlled what negative information the CPSC could disclose. It required the CPSC to gain prior approval of a manufacturer before releasing any information, it allowed manufacturers to prevent the release of any information it deemed “inaccurate,” and allowed a manufacturer to sue the agency to prevent the release of such information.

The consumer database, the agency’s first initiative to which 6B does not apply, took the gate-keeper role from manufacturers, who lobbied hard to either make the reporting process more cumbersome for consumers or to create a counterbalance to negative reports about their products. The amendments are nips and tucks to the NPRM, but still keep the database weighted toward the needs of consumers.

For example, some commenters maintained that the minimum information required to

submit a report of harm for inclusion in the Database was not detailed enough for “those reviewing the report to understand the incident adequately, to weed out duplicate reports, and to promote investment in the report and Commission activities by the submitter.” Without meaningful information, a manufacturer couldn’t adequately respond to a complaint, rendering the database information “inaccurate.” Another argued that without complete information, the complaint shouldn’t be included at all.

The staff declined to take up those suggestions.

“Determining why an incident occurred can sometimes be a time-consuming process; yet section 6A of the CPSA, by establishing procedural requirements that are measured in days, requires reports of harm to be posted in the Database quickly. Thus, we cannot refrain from processing or publishing reports of harm to await a final determination of why an incident occurred.”

Instead, the proposed Final Rule added “category of submitter” and “incident date” fields to help users distinguish duplicate reports and provide context about the source of a complaint. It also changed the proposed rule to give manufacturers two more categories in which to dispute a complainant’s account. The original proposal let a manufacturer or private labeler claim inaccuracies based on the description of consumer product; identity of the manufacturer or private labeler; and description of the harm. The proposed Final Rule would also allow manufacturers to claim an inaccuracy in the reported incident date and category of submitter.

According to the staff’s analysis, “no more than an additional five percent of small manufacturers of consumer products will be affected by the Database rule annually. Of the roughly five percent of small manufacturers receiving incident reports, only a very small percentage of the incidents reported would merit a large investigation effort. Based on the CPSC’s Freedom of Information Act (“FOIA”) experience, it is rare that a small firm devotes substantial time and effort responding to incident reports. Thus, while it is possible that a small number of small businesses may experience a “significant” impact in investigating certain incidents, the number of small businesses experiencing such an impact would not be “substantial.”

CPSC Spokesman Scott Wolfson said that all the amendments served one purpose: to make the database as factually accurate as possible, “to ensure the highest value level of trust in the database once it goes live.”

After the Final Rule is passed, the CPSC expects to launch the database in March.

“There is a plan to do some advance testing to assess the industry’s experience and consumers experience with the database,” Wolfson said. “We are on target and on budget.”

The Thompson case underscores two continuing weaknesses in the regulatory framework meant to ensure the safety of juvenile products: long gaps between the time when a product is deemed hazardous and a recall, and the difficulty in dealing with baby products that fall outside of the CPSC regulations and are not manufactured to any voluntary or mandatory standard.

The CPSC says that the Tots In Mind recall may only be the first action it takes to protect toddlers from the design deficiencies of crib tents.

“CPSC’s Safe Sleep team is reviewing incidents with crib tents to determine the best approach to take with this product class to ensure the safety of young children,” says Scott Wolfson, the CPSC’s Director of its Office of Information and Public Affairs.

In the meantime, Crib Tents continue to be manufactured without regard to established safety standards and marketed under the presumption that they are safe to use with vulnerable populations in situations where adults are absent.

Safety Research & Strategies, which investigated the safety of cribs tents after a Virginia toddler suffered a lifelong brain injury caused by a crib-tent strangulation, turned its findings over to the CPSC. SRS President Sean Kane doesn’t believe that the recall goes far enough.

“We understand that the CPSC is restricted by their regulations in pressing the recall of an unregulated product, but the reality is that there are inherent problems with the design that are not being addressed by the recall,” Kane says.

The Long Road to a Recall

Thompson was only two years old when he attempted to climb out of a play yard covered by a crib tent – a mesh-covered dome placed over a crib or a play yard to prevent toddlers from climbing out. These mesh domes are affixed to the play yard base with plastic clips. Those intended for use in a crib are all-in-one units that sit inside the crib and attach to the crib’s side rails with a hook and loop system. Parents can place or remove their toddlers in or from the enclosure via a zippered side.

According to the CPSC, Thompson was found “hanging with his neck entrapped between the play yard frame and the metal base rod of the tent that had been partially tied by pieces of nylon rope and partially attached by clips.” The Thompsons had improvised the nylon ties, because “the child was able to pop off the clips,” the CPSC said.

The commission said that it was aware of three other incidents in which children were “able to remove one or more clips and place their necks between the tent and the playard,” but were freed without incident.

The July 15 announcement recalled 20,000 Cozy Indoor Outdoor Portable Playard Tents Plus Cabana Kits, manufactured by Tots In Mind of Salem, N.H., the only U.S. manufacturer of crib tents. The remedy was free replacement clips supplied by Tots In Mind. While Thompson’s death was amply reported by the print and broadcast media, the recall received little coverage.

The year-and-a-half lag between the Thompson death and the recall occurred because the commission was not satisfied with the company’s first proposals for corrective action.

“There were numerous proposals by the company which CPSC staff did not accept due to the concern of the safety of a child being at risk with the proposed corrective action,” Wolfson said  “We had to be sure that the  new clipping system addressed the concerns that we had. Repair kits must be submitted to the CPSC, where they are reviewed and approved by CPSC engineers.”

Lengthy investigations and negotiations with the manufacturer– conducted out of the public purview by law – is a source of frustration for safety advocates says Nancy Cowles, executive director of Kids in Danger.

“The CPSC is always pushing to get the company to agree to do a recall, and that’s part of the reason why I think they take so long,” Cowles said. “Also, so much of what the commission does is secret, so we don’t know at what point they had all the information to do a recall.”

The CPSC has other ways to alert the public about dangerous child products, says Don Mays of Consumers Union. He pointed to the commission’s recent move to get out ahead of a March recall on the Infantino Sling Rider and Wendy Bellissimo baby slings.

“There was one product responsible for three infant fatalities, but while negotiating the recall, the CPSC issued a public warning about slings and putting infants in slings, and that put the warning shot out there, instead of waiting for the remedy to be developed,” Mays says.  “I would like to see more of that, especially if they can’t fast-track a recall.”

The Problem with Crib Tents and Other Unregulated Baby Products

The greater challenge will be addressing the more general hazards associated with crib tents. Like many juvenile products, the crib tent was invented to address a specific problem that may be short-lived, but is very frustrating to parents. Caregivers may regard a crib tent as something that will prevent a fall, while ignorant of the suffocation and strangulation hazards it presents.

About a year before Thompson’s death, another toddler, Nicholas Blanco, suffered a severe and permanent brain injury when he became entrapped and strangled by a Cozy Crib Tent. On October 5, 2007, Blanco was in the crib when one of the fiberglass rods supporting the dome type cover broke and fell into the crib, pinning the boy between the support rod and the side of the crib. His mother discovered her son hanging on the outside of the crib with his neck stuck under the rod of the crib tent.

During the course of its investigation, SRS found stories of an unconfirmed death and other potential tragedies involving crib tents.  Parents described the mesh tearing at the seams or at other points or the entire structure collapsing – either pulled down by the toddler or inverting under the weight of a pet. In some cases, the parent discovered the child entangled and was able to free it before an injury occurred.

SRS not only shared these complaints with the CPSC, and wrote and wrote an article on the dangers of crib tents (see Crib Tents: Another Hazard from the World of Unregulated Child Products)

The July recall does not address these hazards and Mays says that juvenile products add-ons – such as crib tents – present “all sorts of compatibility products not foreseen by the manufacturers – it might not fit all units.”

“And when that happens, a child’s safety is at risk. If you talk about sleep environments, it becomes particularly risky,” he says.

Cowles of Kids in Danger had more specific concerns:

“My problem with this recall is that they are saying it’s a safe product and it’s not,” she says. “The commission only counts the incident involving the play yard tent. They have other reported breakages with the crib tents. This recall doesn’t say how many parents complained to Tots in Mind and how many products failed.”

Crib Safety and the CPSC

This year, the CPS began rulemaking on new mandatory standards on cribs that could include provisions covering drop side hardware, mattresses, and loose and fragile components, such as crib slats. The new rule may effectively ban one of the most common designs: drop-side cribs. The proposal was developed by the commission’s Safe Sleep Team, in conjunction with juvenile products manufacturers and ASTM International, the manufacturing standards-setting body, after studying infant incident and injury data.

CPSC’s Safe Sleep team is also charged with coordinating all crib recalls, and developing consumer education on product registration and safe sleep practices.

At last month’s CPSC meeting on agenda and priorities in fiscal year 2010, Ami Gadhia, on behalf of Consumers Union, Kids in Danger and the Consumer Federation of America, urged the commission to extend its safe sleep effort to other products such as crib tents, sleep positioners, and infant comforters and pillows.

“We are aware of deaths associated with each of these products, some of which have been recalled due to the hazard they pose to infants,” she said.

Crib tents currently are outside the express outlines of the Consumer Product Safety Improvement Act of 2008, which requires the establishment of standards and certificates of compliance for durable juvenile products that fall into 12 categories: cribs; toddler beds; high chairs, booster chairs, and hook-on chairs; bath seats; gates and other enclosures for confining a child; play yards; stationary activity centers; infant carriers; strollers; walkers; swings; and bassinets and cradles.

But, says Wolfson:

“The staff at the agency is considering another dozen juvenile products to turn into mandatory standards. We have not ruled out that this could be a product we might consider under section 104 of the Act.”

Longacre brings her technical expertise, developed over a 30-year career on a wide array of safety issues, including: medical, industrial, highway, recreational, marine, motor carrier, railroad, consumer product, and vehicle safety. She is fully experienced in the collection, analysis, and preparation of technical safety research, in conducting field investigations and in litigation support.

“SRS has a reputation for their high-quality work and it’s a great place for me to continue my career,” says Longacre.

In addition, SRS has added to its safety library Longacre’s extensive collection of technical, policy and legal documents from such agencies as the National Highway Traffic Safety Administration, the U.S. Consumer Product Safety Commission, Occupational Safety and Health Administration, and the Food & Drug Administration.

Longacre has been interested in consumer safety since her undergraduate days at the University of Maryland, where she graduated with a degree in Consumer Affairs. She has worked for the CPSC, where she participated in agency investigations on hazardous products including asbestos, aluminum wiring and hair dryers. Longacre worked for the White House’s Office of Consumer Affairs under the direction of Esther Peterson. She also served as Director of Technical Research for Dr. Robert Brenner’s Institute for Safety Analysis (TISA) and is the co-author of “Product Safety Handbook: The Manufacturer’s Guide to Legal Requirements and Management Strategies” a book written for product manufacturers, designers, engineers, and risk managers that explains compliance with product safety regulations, how to develop safe products, and how to implement safety manufacturing processes.

“Susan certainly knows her way around the safety world,” said SRS President Sean Kane. “We are delighted to welcome such an experienced and knowledgeable person to our staff.”

Perhaps that was because the Commissioners did not attend – nor did some of the database’s most strident opponents. Instead, what unfolded over two days was a work/brainstorming session, with CPSC staffers gathering the collective wisdom of the stakeholders.

Safety Research & Strategies President Sean Kane, who appeared at the behest of the Commission, was a frequent panelist. Manufacturers and public advocates (Consumers Union, Consumer Federation of America, Kids in Danger, and Public Citizen) alike hashed out what they’d like to see in the database.  Adding to the mix was panelist George Rutherford, retired CPSC staffer, who offered some sorely needed reality checks.

At least, that’s how manufacturers see it. The U.S. Consumer Products Safety Commission held the first of several public hearings Wednesday on the creation of a publicly accessible and searchable consumer complaints database, now required by the Consumer Product Safety Improvement Act.

Under the infamous Section 6B of the Consumer Product Safety Act, manufacturers basically have all the control when it comes to allowing the U.S. Consumer Product Safety Commission to disclose negative information about their products. The provision allows a company to wash any data it deems “inaccurate” and even allows a manufacturer to sue to prevent the release of such information. The creation of a publicly accessible database means that manufacturers are no longer the gatekeepers of information.

At Wednesday’s hearing, six industry representatives wasted no time in warning the commission about the barbarians at the gate: trial lawyers. The U.S. Chamber of Commerce, and attorneys for the garage door and home appliances industries carefully wrapped their arguments around the concept of “accuracy.” Rick Woldenburg, the head of an educational toy company, and a vociferous critic of the CPSIA, went for the jugular, warning that the database could become “a breeding ground” for litigation, and touch off a “feeding frenzy” at the plaintiff’s bar.

Newly-appointed Democratic Commissioner Bob Adler reminded industry that the CPSIA database was not going to be perfect, nor built on the foundation of manufacturers’ worst fears.

Lawyers from Public Citizen, the Consumers Federation of America and Consumer Union countered that a database would restore some of the balance and transparency to the process and generally applauded the mandate.

Safety Research & Strategies President Sean Kane injected some much needed reality into the proceedings. He reminded the CPSC that the National Highway Traffic Safety Administration has hosted a publicly accessible complaints database for years without bringing the auto industry to its knees. He also showed them how SRS’s model, the Vehicle Safety Information Resource Center (VSIRC) database, took the scattered NHTSA data and transformed it into a useful tool with a simple, user-friendly interface.

Newly appointed commissioner Anne Northup, who apparently was charged with handling the left field, was not persuaded. She had spent most of the hearing querying each panelist if they thought the commission could be sued for posting inaccurate information on its new database. But she tipped her hand after Kane’s presentation. Apparently Commissioner Northup actually feared for the liability of manufacturers. She accused Kane of shilling for plaintiff’s lawyers and ventured that the new database could create opportunities for lawsuits. Wielding her Blackberry like an avenging sword, Northup read from what she said was SRS’s website, with copious links to victims’ attorneys. It was not SRS’s website. But Northup wasn’t about to let the facts get in the way of her point. When Kane tried gently to correct her, she admonished him: “Don’t interrupt me.”

Kane also corrected Northup’s premise: Data doesn’t create lawsuits. Lawsuits over a death or serious injury prompt the government to collect the data to see if further action is needed, he told her.  But don’t let the facts get in your way.