Senate Committee postpones Gall's confirmation hearing; new date not set - nomination of Commissioner Mary Gall to be chair of Consumer Product Safety Commission

The Senate Commerce Committee has postponed the confirmation hearing on the President's nomination of Commissioner Mary Gall to be chairman of the U.S. Consumer Product Safety Commission (CPSC). The date was originally set for June 6.

The defection of Vermont Senator Jim Jeffords from the ranks of Republicans to become an Independent caused the leadership of the Senate to shift from Republican to Democratic control. Hence, the control of the Commerce Committee shifted from Sen. John McCain (R-Ariz.) to Sen. Ernest Hollings (D-S.Car.) Consequently, the new Democratic leadership of the committee has postponed the hearing with no new date being announced.

Currently the only Republican on the Commission, Gall has been a member of CPSC since 1991 and was confirmed by the Senate for a second term in 1999. As reported by CPSC Monitor last month, (1) her nomination was immediately opposed by Sen. Hillary Rodham Clinton (D-NY). Since that time, there have been similar attacks on Gall's record by Sen. Chris Dodd (D-Conn.) and Sen. Barbara Boxer (D-Calif.)

Gall's only offense has been to cast reasonable votes on regulatory issues and to dispute Chairman Ann Brown's escalating demands for more product reg-ulation, both by statute and by public pressure.

Gall received support from her other colleague, Commissioner Thomas Moore, who praised Gall's record and said she deserved to become chairman of the agency.

The confirmation hassle has been further complicated by the Commission's consideration of a petition to ban baby bath seats. Gall's critics had complained about her 1994 vote in which she voted in the majority when CPSC voted 2-1 not to proceed with rulemaking to ban baby bath seats.

The Commission voted May 30 on a new bath seat petition, and Gall voted with the other two Commissioners to begin rulemaking to find ways to improve the products, but said she still is opposed to an outright ban.

A spokesman for Sen. Hillary Rodham Clinton told the New York Times that Gall's current vote on the bath seat issue was unlikely to satisfy the Commis-sioner's opponents.

"The vote could be seen as a confirmation-eve conversion in light of the criticism she has been receiving,'" Jim Kennedy, Clinton's spokesman said. (2)

Most CPSC observers doubt that Gall's position was influenced by the pending confirmation hearing, but rather was a difficult decision based on her analysis of the data.

The media in general and Sen. Clinton's office both missed the real news--that Chairman Ann Brown had switched her position--heretofore strongly in favor of a ban--to rulemaking toward possible improvements in the bath seat's design.

Regulators Back Away from Ban of Bath Seats; But Advance Toward Possible Mandatory Rule

The Consumer Federation of America, joined by several other consumer groups, petitioned CPSC last year to ban baby bath seats, devices used for keeping small infants sitting upright in regular bath tubs so that adult caregivers can bathe them more easily. CFA alleged that the product was dangerous because it was too safe and lulled parents into a "false sense of security," leading them toward the risky behavior of leaving the infant unattended in the tub.

The issue has been covered extensively in CPSC Monitor, most recently in last month's issue. (3)

As noted above, the Commission voted 3-0 on May 30 to support an Advance Notice of Proposed Rulemaking (ANPR), the start of the cumbersome rulemaking process.

Misled by early media hype--no doubt sparked by the Gall nomination for Chairman--that the vote was actually to impose a ban on the seats, many in the news profession were prepared for a big story. That story did not materialize, as noted above, because Chairman Brown abandoned her earlier support for a ban, and Commissioner Mary Gall shifted her earlier reported position slightly to leave room for possible improvements to the product.

Had media bothered to read the bulky briefing package prepared by CPSC staff, it may have realized that the staff--which nearly always tries to support the Chairman's goals--nevertheless did not find evidence to support a ban. Speculation is that agency attorneys determined that the available data did not support the theory of an unreasonable risk that would sustain a legal challenge to an outright ban.

Chairman Brown is the one who resurrected the banning issue in a speech in 1999. Not long after, CFA filed its petition for CPSC to ban the devices. But at the May 23 briefing on the staff's findings, Chairman Brown suggested that she could support rulemaking for a performance standard, rather than a ban. Such improvements include new standards to improve reliability of suction cups that anchor the bath seat to the floor of the tub; standards for leg holes so that infants cannot slip through; and a stability standard that would prevent the seats from tipping over too readily.

At the decision meeting on May 30, the three Commissioners voted unanimously to begin developing a safety standard for the bath seats. As noted above, the briefing package prepared in response to the petitioners did not emphasize a ban as the most practical solution.

Gall noted that the package presented to the Commission on May 23 differed markedly from the documents prepared for the Commission in 1994.

She said: "The evidence presented to the Commission at last week's briefing revealed a very different picture about baby bath seats than was the case in 1994. The staff has collected 106 "near miss" incidents, 40 of which illustrate the hazards that bath seats can present even when a caregiver is present. In addition, the staff has several technical concepts to address the stability/retention problem, as well as the problem of leg hold openings." (4)

Gall further explained that both the law and her own regulatory philosophy dictate deferral to voluntary standards when they are adequate and it is likely there will be substantial compliance. She noted that there is a current non-government standard for baby bath seats, but called it inadequate in several respects.

"I believe that the Commission should proceed with an ANPR to investigate the possibility of developing a bath seat that resists tipping over on both non-skid and traditional bathtub surfaces." (5)

But, Commissioner Gall continued, "I hope the voluntary standards process will not be impeded by the issuance of this ANPR. I reject Chairman Brown's assertion that an ANPR has any 'magical properties.' Our staff are not wizards or sorcerers, and Commis-sioners wield no magic wand that make product hazards disappear. The least desirable result of any standard, mandatory or voluntary, is a bath seat that does what the petitioners here claim it does: induce caregivers to leave infants unattended in tubs." (6)

Gall went on to note that the staff briefing package does not recommend a ban, and that her study of the record supports her thesis that the products should not be banned.

Perhaps Gall said it best in her statement when she noted:

"Both the staff briefing package and the staff response to a letter from Dr. Kimberly Thompson, a researcher at the Harvard School of Public Health, who commented on the briefing package, conclude that infants aged 5 to 7 months are at greater risk of drowning if they are bathed with a bath seat than if they are bathed without a bath seat. I am not, however, persuaded by the staff analysis. Figures collected by the National Center for Health Statistics show that the overall numbers and the risk of infant tub drownings remained constant during the 1980's and declined during the 1990's. Ownership of baby bath seats, however, increased significantly during the 1980's and slightly during the 1990's. If the presence of baby bath seats induced caregivers to leave infants unattended in tubs, one would naturally expect that the overall numbers of drownings and the risk of drowning would increase. That has not been the case. The staff analysis of the drowning data provides little support for the hypothesis that caregivers are more inclined to leave infants unattended in tubs in the presence of a bath seat." (7)

In her statement explaining her vote for an ANPR, Chairman Brown said:

"I hope our ANPR for baby bath seats will generate the kind of burst of creative energy we saw with baby walkers, where we and industry came up with an innovative and effective technical solution." (8)

Ironically, one of the votes on which Commissioner Gall has been attacked is her stand against a rule on baby walkers, prompted by her belief that a voluntary standard would be written to resolve whatever problems existed with the products. That is exactly what happened.

Chairman Brown's reversal of her position in favor of banning bath seats a week before the May 23 briefing could not have pleased the petitioners, Consumer Federation of America, et al, who demanded a total ban.

Mary Ellen Fise, general counsel for CFA, approved the commission's action for an ANPR but told Caroline Mayer of The Washington Post that "We don't think this product can be made safely." (9)

Brown's change of heart seems ironic in view of her original demand to ban the product because it appeared to be "too safe." Now regulators seem to be moving toward making the product even safer.

A last minute comment filed by Dr. Kimberly M. Thompson, an assistant professor of Risk Analysis and Decision Science at the Harvard School of Public health, Department of Health Policy and Management, added to the arguments against a ban.

In a May 7 letter addressed to Chairman Brown, Dr. Thompson disputed some of the CPSC staff's data analysis and even suggested that banning baby bath seats might actually "lead to an overall increase in drowning death rates." (10)

An ASTM voluntary standard for baby bath seats was developed with input from CPSC staff and was published in June 1999. Currently, revisions to that standard dealing with new requirements for suction cups and latching/locking mechanisms have been balloted. The ballot was approved by the Main Committee and is now under review by the ASTM Committee on Standards. The new standard is due to be published in July 2001. (11)

The new standard requires that a warning label appear on the product, the instructions, and the packaging. (12) The label warns caregivers not to leave an infant unattended in the bath seat.

The CPSC staff briefing package agrees that no standard can eliminate all the bath seat incidents where the child is left unattended, but suggests the current ASTM standard could be improved to address some of the incidents involving tip-overs and slipping through leg openings.

The ASTM committee had earlier rejected CPSC staff's recommendation to change the leg-hole-size opening, believing that making the leg holes smaller could possibly lead to more assumptions by caregivers that infants could be left unattended briefly.

Another disagreement between the CPSC staff and ASTM is a problem with the suction cups. The devices do not attach safely to the floors of tubs with textured, non-slip surfaces. But another voluntary standard, ASTM F462--Slip Resistant Bathing Facilities--is widely used by plumbing manufacturers for most enamel-coated steel tubs. The F-462 standard was written to address falls in tubs.

Therein is the problem. Adult bathtubs used by small infants without an adult in attendance--not baby bath seats--are the hazard. It is unlikely that CPSC would initiate a banning or a performance standard for adult bathtubs.

The debate over baby bath seats, a dispute that could affect the new leadership of CPSC, addresses a much smaller risk when compared to the greater causes of fatalities to small children. Far more children die in house fires, auto accidents, falls, and pool drownings than as a result of bath seat drowning incidents, as tragic as those are.

CPSC Seeks Giant Civil Penalty from Wal-Mart and Icon for Non-Reporting of Alleged Injuries Associated with Exercise Equipment

CPSC observers were shocked late this month when the U.S. Department of Justice (DOJ) filed a lawsuit, acting on behalf of CPSC, against Wal-Mart, the nation's largest retailer, and Icon Health & Fitness of Logan, Utah, a manufacturer of home exercise equipment. The suit alleges non-reporting of incidents involving Weider and Eslo exercise gliders and seeks a $4.5 million penalty both from Wal-Mart and from the manufacturer, Icon Health and Fitness. (13)

All three Commissioners signed off on the referral to DOJ.

The lawsuit is the first against a retailer. Under CPSC's governing statute, manufacturers, distributors and retailers are obliged to report to the agency when they receive information about possible defects.

Incidents began to occur in the summer of 1996. In April 1999, Icon recalled the exercise gliders in cooperation with CPSC.

The exercise gliders allegedly caused consumers to fall. The injuries occurred when the seat collapsed to the floor after a connecting bar detached unexpectedly from the frame. The design of the product has since been changed and products being sold today do not have the defect.

Some consumers using the gliders suffered fractures and injured their lower spines. The agency charges that Wal-Mart knew of 46 incidents and 41 injuries and did not report them. Twenty-nine of the incidents occurred at Wal-Mart stores while customers were trying out the equipment. CPSC also alleged that Icon Health & Fitness knew of 86 incidents and 68 injuries but failed to report them, although it did re-design the product.

What the news stories do not reveal, however, is the behind-the-scenes maneuvering which led to the current impasse.

Industry observers say that the manufacturer, Icon, received an inquiry about the incidents from CPSC in December, 1997, and by January, 1998, it was cooperating with CPSC. Still, the recall did not occur until April 1999, mainly because of bureaucratic delays. Normally, matters such as this one are settled by companies to avoid bad publicity.

There was no opportunity to appeal the decision by CPSC staff. A settlement offer was made Dec. 8 of last year but no response was received until the end of April of this year.

Insiders allege that CPSC's compliance officers sent the Wal-Mart referral to DOJ during the transition. At the time DOJ considered CPSC's request, new Bush appointees were not yet in place and the matter was handled by career bureaucrats.

Some observers wondered how CPSC arrived at such a large civil penalty--a total of $9 million. There is a statutory cap on the amount of civil penalty the agency can collect. Today it is $1.65 million per violation, but at the time of the alleged offenses, it was $1.5 million.

CPSC charges that Wal-Mart is actually three companies: Wal-Mart, Sam's Club East, and Sam's Club West, so the agency is charging each entity with a $1.5 million civil penalty for a total of $4.5 million.

In the case of Icon, CPSC alleges that there were three separate models of the product sold, and thus charged Icon with three separate violations of $1.5 million each. Representatives of both Wal-Mart and Icon have told the media that they feel the civil penalty is not justified. A Wal-Mart spokesman, Bill Wertz, told the Washington Post that "... It's not exceptional to get claims of injury associated with exercise equipment. People use it incorrectly, assemble it incorrectly." (14)

It will be fascinating to watch how this lawsuit plays out in federal courts. CPSC Monitor will follow the proceedings for its readers.

Footnotes:

(1) "Bush to Nominate Mary Gall as CPSC Chair; Hillary Clinton Attacks Gall's Record," CPSC Monitor, Vol. 6, Issue 4, April 2001.

(2) "A Surprise as Safety Commission Votes to Draft Bath-Seat Rules," by Julian Barnes, New York Times, May 31, 2001.

(3) "Bush to Nominate Mary Gall as CPSC Chair; Hillary Clinton Attacks Gall's Record," CPSC Monitor, Vol. 6, Issue 4, April 2001.

(4) Statement of the Honorable Mary Sheila Gall in Favor of Issuance of Advance Notice of Proposed Rulemaking on Baby Bath Seats, U.S. Consumer Product Safety Commission, May 30, 2001.

(5) Ibid.

(6) Ibid.

(7) Ibid.

(8) Statement of Chairman Ann Brown in Favor of Granting the Petition and Issuing an Advance Notice of Proposed Rulemaking on Baby Bath Seats, U.S. Consumer Product Safety Commission, May 30, 2001.

(9) "CPSC Moves to Regulate Baby Bath Seats," by Caroline Mayer, The Washington Post, May 31, 2001.

(10) Thompson, Dr. Kimberly M., Assistant Professor of Risk Analysis and Decision Science, Harvard School of Public health, in a letter to CPSC Chairman Ann Brown, May 7, 2001.

(11) Kumagai, M., CPSC Division of Mechanical Engineering, in a Memo to Celestine Kiss, Project Manager for Bath Seat Petition HP00-4, March 2, 2001, contained in the CPSC Briefing Package on Baby Bath Seats, Tab G.

(12) Kumagai, M., op cit., p. 5.

(13) Wal-Mart and Exercise Equipment Manufacturer Sued for Not Reporting Product Defects: CPSC, Justice Department Seek $9 million in Fines, News Release from the U.S. Consumer Product Safety Commission, May 25, 2001.

(14) "Wal-Mart Sued by Safety Agency," by Caroline E. Mayer, The Washington Post, May 25, 2001.

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