Phthalates Back in the News

A petition to ban the sale of children's soft vinyl toys made with a class of plasticizers called phthalates prompted the U.S. Consumer Product Safety Commission (CPSC) last year to convene a Chronic Hazard Advisory Panel (CHAP). The panel's task is to advise CPSC on the possible health hazards of the chemicals in children's products.

The CHAP is meeting for the third time on Sept. 13 at CPSC's Bethesda, Maryland headquarters. The Commissioners granted an extension of the deadline for its final report until Feb. 28, 2001.

Rick Hinds, Legislative Director of Greenpeace, appeared at the CHAP's June meeting and told CHAP members that they had an opportunity to set a "precautionary precedent" and eliminate all vinyl in children's products.

His comments reflect the real intent of the groups pressuring governments to ban phthalates-- the elimination of all plastics. Greenpeace and a group called Health Care without Harm have been leaders in that effort. They allege that high doses of phthalates cause tumors in rats and mice, and are therefore potentially harmful to humans.

While the issue has been relatively quiet for the past several months, it definitely has not disappeared.

This month the Los Angeles Times/Washington Post News Service released a report that the federal Centers for Disease Control (CDC) in Atlanta had found phthalates in human urine at higher than expected levels. Several papers, including the Richmond Times Dispatch, played the story as an indication of a major health risk.

The story quoted John Brock, a chemist at the National Environmental Health' Center at CDC, as saying that recent tests of urine from people around the country found evidence of phthalates at higher levels than CDC scientists had anticipated.

The CDC report will be published in the October issue of Environmental Health Perspectives, and as of Sept. 1, appeared on CDC's web site.

But the report did not evoke much concern from those who have been studying the chemical for many years and are satisfied that there is no human health risk.

Dr. Gilbert Ross, medical director of the American Council on Science and Health, said the CDC report "doesn't change the scientific consensus" that phthalates are safe. Dr. Ross cited the work of the Blue Ribbon Panel of experts chaired by former Surgeon General Dr. C. Everett Koop, which concluded there was no health risk in the use of phthalates in plastics.(1)

Dr. Ross said researchers are now able to detect a myriad of substances in blood and urine--so many parts per million, per billion or per trillion, so that, in his words, "if you look for it (phthalates) you'll find it."

"Such biomarkers may be found in the body but may not have anything to do with health," he said. Ross predicted that advocacy groups such as Greenpeace and others would undoubtedly "seize upon this information to mount a new scare campaign to alarm the public."(2)

Echoing these comments, Dr. Marian Stanley of the American Chemistry Council (formerly the Chemical Manufacturers Association), and head of the Phthalate Esters Panel, said that the CDC exposure findings were "not new or unexpected."

What is new, she said, is that the measuring techniques have improved.

Dr. Stanley said the levels of phthalates found in urine, as released in the CDC report, were within the Reference Doses (RFDs), sanctioned by FDA. In effect, she said the CDC report indicates that "the use of vinyl products is fine."(3)

Phthalates have been used for more than forty years to soften vinyl, which is used in some children's toys, but also in everyday items such as food wrap, nail polish, raincoats, place mats, and car upholstery.

Last December the European Commission issued a ban on certain children's toys made with polyvinyl chloride (PVC) if they contain any one of six phthalates.(4) The EC took its action based on the so-called "precautionary principle" which is defined as taking regulatory action against any substance that is remotely suspected of being a risk to human health, despite lack of scientific evidence of harm.

Petitioned by the National Environmental Trust and others, CPSC did its own study on phthalates in children's toys more than two years go. CPSC found that the level of the chemical ingested from exposure to toys "does not even come close" to a harmful level. Nevertheless, CPSC's Chairman Ann Brown asked toy manufacturers "voluntarily" to phase out the use of the chemical. While not a mandatory rule, Brown's request is tantamount to the use of the precautionary principle at CPSC.(5)

The latest flap over phthalates could mean a new wave of extremist pressures to accomplish the goal of eliminating the use of plastics, despite lack of scientific data proving a health risk.

CPSC Issues New Report on Amusement Ride Injuries

Dr. Craig Moms, a statistician with CPSC, is the author of a new study on the rate of injury associated with amusement park rides.

The latest study was released in July, and claims that there is a "marginally significant upward trend" in fixed site amusement fide-related injuries from 1993 through 1999. Craig's study is based on estimates derived from data reported by 100 hospital emergency rooms throughout the country. The margin of error, according to the report, is plus or minus 5,600, an unheard of scope for risk analysis. Past analysis shows that 99 percent of all these injuries are minor, since only one percent of the injured were hospitalized.

Some inside CPSC say one of the flaws of the study is that it uses "false specificity," meaning that the numbers, although only estimates based on a very small sample, are used as though they are real.

Congressman Ed Markey of Massachusetts, who sponsored legislation to give CPSC jurisdiction over fixed site amusement parks, immediately released a statement citing the study as proof that there is a need for federal oversight of amusement parks.

"One third of the roller coasters in the country are never inspected by any public official," he said.

What Markey failed to note in his statement is that there is a network of state, local and private regulation of the big amusement parks. Voluntary standards governing ride safety are in place and are revised frequently. Forty-two states have laws governing ride safety. Parks also carry liability insurance, and insurance company inspectors make periodic, sometimes daily, visits to inspect the rides. Private licensed inspectors, subject to state or local oversight, inspect 93% of fixed site parks.

Apparently what bothers Markey is that the inspections are not always done by a "public" i.e., government inspection official.

Yet Markey's bill would not give CPSC authority to inspect rides either. It would, however, extend CPSC's jurisdiction so that its enforcement personnel can impose federal penalties on park management that fails to report any incident, however slight. It would also boost CPSC's annual budget by $5 million--an amount most CPSC insiders say could never cover the cost of the expanded jurisdiction.

CPSC's own numbers show that riding on a fixed site amusement park ride is still one of the safer forms of recreation. Your chance of being serious injured on an amusement park ride is one in 25 million. Your risk of a fatal injury is one in 450 million. There are not many other forms of outdoor entertainment that can match that record.

It does not look as though Markey's bill to restore CPSC jurisdiction over fixed site amusement park rides will get out of the House Commerce Committee. Reportedly, Committee Chairman, Congressman Tom Bliley, has told Markey that due to a lack of bipartisan consensus, the bill will not be reported out before the end of the current congressional session.

Escalators--Commissioners to Consider Petition

A CPSC staff briefing package listing options for addressing a petition calling for CPSC to adopt mandatory regulations for escalator safety is currently in the Office of the General Counsel for approval.(6)

Engineering staff at CPSC who worked on the package won't reveal its contents, but say they are "very happy" with the escalator industry's changes to its non-government, voluntary standard, the American Society of Mechanical Engineers (ASME) A-17. A procedural challenge to the final changes has been dropped, clearing the way for the document to become effective. Amendments to the standard go into effect as a supplemental in October, and a newer updated standard will go into effect in December. The new standard will address safety hazards associated with entrapment in the gap between the escalator stair and the stepskirt, the location responsible for most entrapment injuries.

The changes to the standard address only entrapment injuries, not falls. Falls account for about 75% of injuries, with entrapment injuries accounting for about 20%.

The new standard establishes tests to be conducted in a number of ways to determine if the measurement of the gap on a particular escalator meets the safety threshold. The current gap size allowed in the ASME standard is 3/16 of an inch, but some new model escalators will have gaps as small as 1/8 or 1/16 of an inch.

CPSC staff declined to reveal its recommendation to the Commission, but insiders say it is likely the package will favor denial of the petition, and recommend that CPSC rely on the new voluntary standard. If such is the case, CPSC will have averted any challenge over its legal jurisdiction to regulate escalators, a subject of some controversy.

The Commission will be briefed on the matter on Sept. 19, and a decision meeting is scheduled for Sept. 26.

CPSC Gets Petition to Ban Baby Bath Seats

CPSC Chairman Ann Brown told a group of reporters at a weekly National Press Club luncheon last Dec. 16 that if she had the votes she would ban baby bath seats.

"I think that baby bath seats are something that we ought to be looking at very, very seriously, because I think they encourage bad consumer behavior," she said in a question and answer period after her speech last winter.(7)

Last month, the Consumer Federation of America (CFA) and eight other groups petitioned CPSC to ban the products. The petition has been published in the Federal Register for public comment. The comment period closes Oct. 24.

Baby bath seats (or bath rings) are used to support a baby who cannot yet sit up unassisted in a regular bathtub. The device frees an adult's hands so that bathing the baby is easier. Bath seats usually come with suction cups to attach to the tub surface, with a plastic seat and openings for the baby's legs. CPSC staff collected data on 66 incidents of drowning associated with baby bath seats since 1983. In almost all cases, the drowning occurred when the parent or adult caregiver bathing the baby left the room to perform another chore, and the baby was left unattended.

The Commissioners had addressed the issue before, when CPSC staff proposed to initiate formal rulemaking on the products in 1994.

At that time, the Commissioners voted two-to-one against rulemaking and decided instead to work with the industry to begin a public information campaign to warn parents and caregivers never to leave children unattended in bathtubs.

Chairman Brown, outvoted by Commissioners Jacqueline Jones-Smith (formerly Chairman) and Mary Sheila Gall, expressed her dismay:

"I'm disappointed with the Commissioners' decision ..." she said. "... Baby bath seats ... encourage dangerous consumer behavior by instilling a false sense of security in a parent, who would normally never leave a baby alone in water -- not even for a second.... The sturdier, more durable looking the seat, the more likely the consumer is to leave the baby unattended for a moment."(8)

Oddly enough, this is the same argument now an being used by the petitioners. Relying heavily on an article from Pediatrics, in October 1997(9) on the hazards of baby bath seats, CFA's general counsel Mary Ellen Fise writes that the products "pose an unreasonable risk of injury and death to children."(10)

This may be the first product to face a CPSC ban because it is too safe.

One of the authors of the Pediatrics study was Renae Rauchschwalbe, a member of CPSC's compliance staff. The other two authors were employees of the National Institute of Child Health and Human Development and the Center for Injury Research and Policy at Johns Hopkins University, respectively. The authors acknowledge receiving funding for the research from the National Institute of Alcohol Abuse and Alcoholism and a grant from the Division of Injury Epidemiology Control of the Centers for Disease Control. Both of these are federal sources. Incident data were from CPSC.

CPSC staff person Rauchschwalbe's involvement in the research project is apparently within CPSC personnel rules. Nevertheless it is interesting that even after the Commission's two-to-one decision not to proceed, CPSC staff continued to pursue the project.

Insiders say Chairman Brown had been most unhappy about the 1994 decision and encouraged staff to continue their work on bath seat issues.

CFA's petition says that to simply blame parents or caregivers for the loss of the child in a bath seat drowning incident "absolves the product of having any causal role in the drowning incidents."

The petitioners say that the inherent design of bath seat products induces a "false sense of security" among users.

"This 'sense of security' leads to increased risk-taking behavior among those using the product even when the irresponsible nature of caregivers is taken into account."(11)

The petition cites research done by the Intermountain Injury Control Research Center at the University of Utah to support its argument. The research was conducted by Dr. Clay Mann and presented to the National Congress on Childhood Emergencies in Baltimore on Mary 27.

According to the petition, Mann's research shows that "parents and caregivers of infants that use bath seats engage in more risk taking behavior than parents and caregivers not using baby bath seats.

"Caregivers using bath seats prepare baths with deeper water and are more likely to leave a child unattended in the bath for conscious, willful reasons (e.g., to perform household chores). This study demonstrates that enhanced risk taking behavior persists even when the irresponsible nature of caregivers is taken into account. There is a false sense of safety that is propagated by having a mechanical aid to `help' hold a slippery baby upright."

While every single drowning death of an infant in a tub is regrettable, and preventable, banning the bath seat seems to be a peculiar remedy. Perhaps former Commissioner Jacqueline Jones-Smith said it best in 1994:

"Bathtubs and unattended babies are a deadly combination. No product, no device, no convenience of any kind can substitute for the physical presence of a parent or caregiver. The incidents associated with bathtub seats and rings that have occurred were all tragic and preventable events. But these were all human tragedies and not product failures. These bath seats and rings contained no manufacturing or design defects that constituted a mechanical hazard."(12)

Once the public comment period ends on Oct. 24, CPSC staff will evaluate the response and begin work on a briefing package for the Commissioners.

(1) "Clean Bill of Health for Vinyl Toys and Medical Devices," Blue-ribbon Panel chaired by Dr. C. Everett Koop Concludes Flexible Plastics "not harmful," News Release from the American Council on Science and Health, New York, N.Y., June 22, 1999.

(2) Conversation with Dr. Gilbert Ross, medical director, American Council on Science and Health, August 30, 2000.

(3) Conversation with Dr. Marian Stanley of the American Chemistry Council, Sept. 1, 2000.

(4) "EC Bans Toys With Phthalates," by Carol Dawson, a Consumer Alert Issue Brief, January 28, 2000.

(5) See also the January, 2000 issue of CPSC Monitor, p. 3, "EC Bans Phthalates in Toys, CPSC Waits for Studies."

(6) See CPSC Monitor, March, 2000, "CPSC to Consider Regulatory Proposals on Escalators, Baby Walkers."

(7) "Chairman Brown Boasts of Regulatory Success in National Press Club Speech," CPSC Monitor, Vol. 5, Issue 1, January 2000.

(8) "CPSC Votes Against Rulemaking for Baby Bath Seats," News Release from U.S. Consumer Product Safety Commission, June 15, 1994.

(9) "The Role of Bathtub Seats and Rings in Infant Drowning Deaths." By Renae Rauchschwalbe, Ruth A. Brenner and Gordon S. Smith., Pediatrics, Vol. 100., No. 4, October 1997, American Academy of Pediatrics.

(10) Petition of Consumer Federation of America, The Drowning Foundation, et al. To Ban Baby Bath Seats, before the U.S. Consumer Product Safety Commission, July 25, 2000.

(11) Ibid, Section C.

(12) "CPSC Votes Against Rulemaking for Baby Bath Seats," News Release from the U.S. Consumer Product Safety Commission, June 15, 1994.

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