Safety Standard for Infant Bath Seats
Notice Of Proposed Rulemaking.
Section 104(b) of the Consumer Product Safety Improvement Act of 2008 (“CPSIA”) requires the United States Consumer Product Safety Commission (“Commission”) to promulgate consumer product safety standards for durable infant or toddler products. These standards are to be “substantially the same as” applicable voluntary standards or more stringent than the voluntary standard if the Commission concludes that more stringent requirements would further reduce the risk of injury associated with the product. The Commission is proposing a safety standard for infant bath seats in response to the direction under section 104(b) of the CPSIA.
Table of Contents Back to Top
- Electronic Submissions
- Written Submissions
- FOR FURTHER INFORMATION CONTACT:
- SUPPLEMENTARY INFORMATION:
- A. Background and Statutory Authority
- 1. The Consumer Product Safety Improvement Act
- 2. Previous Commission Rulemaking Concerning Bath Seats
- B. The Product
- C. ASTM Voluntary Standard
- D. Incident Data
- E. Assessment of Voluntary Standard ASTM F 1967-08a and Description of Proposed Changes and the Proposed Rule
- 1. Section 104(b) of the CPSIA: Consultation and CPSC Staff Review
- 2. Proposed Changes to the ASTM Standard's Requirements
- a. Definition of Bath Seat (Proposed § 1215.2(b)(1))
- b. Stability Requirement
- c. Leg opening requirement (Proposed § 1215.2(b)(8) through (10))
- d. Editorial and clarifying changes (proposed § 1215.2(b)(3) and (5))
- F. Request for Comments
- G. Effective Date
- H. Regulatory Flexibility Act
- I. Environmental Considerations
- J. Paperwork Reduction Act
- List of Subjects in 16 CFR Part 1215
- PART 1215—SAFETY STANDARD FOR BATH SEATS
DATES: Back to Top
Written comments must be received by November 17, 2009.
ADDRESSES: Back to Top
You may submit comments, identified by Docket No. CPSC-2009-0064, by any of the following methods:
Electronic Submissions Back to Top
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. To ensure timely processing of comments, the Commission is no longer accepting comments submitted by electronic mail (e-mail) except through http://www.regulations.gov.
Written Submissions Back to Top
Submit written submissions in the following way:
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM submissions), preferably in five copies, to: Office of the Secretary, Consumer Product Safety Commission, Room 502, 4330 East West Highway, Bethesda, MD 20814; telephone (301) 504-7923.
Instructions: All submissions received must include the agency name and docket number for this rulemaking. All comments received may be posted without change, including any personal identifiers, contact information, or other personal information provided, to http://www.regulations.gov. Do not submit confidential business information, trade secret information, or other sensitive or protected information electronically. Such information should be submitted in writing.
Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Back to Top
Patricia Edwards, Project Manager, Directorate for Engineering Sciences, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; telephone (301) 504-7577; firstname.lastname@example.org.
SUPPLEMENTARY INFORMATION: Back to Top
A. Background and Statutory Authority Back to Top
1. The Consumer Product Safety Improvement Act
The Consumer Product Safety Improvement Act of 2008 (“CPSIA,” Pub. L. 110-314) was enacted on August 14, 2008. Section 104(b) of the CPSIA requires the Commission to promulgate consumer product safety standards for durable infant or toddler products. These standards are to be “substantially the same as” applicable voluntary standards or more stringent than the voluntary standard if the Commission concludes that more stringent requirements would further reduce the risk of injury associated with the product. Section 104(b)(2) of the CPSIA directs the Commission to begin rulemaking for two standards by August 14, 2009. In this document the Commission proposes a safety standard for bath seats. The proposed standard is substantially the same as a voluntary standard developed by ASTM International (formerly known as the American Society for Testing and Materials), ASTM F 1967-08a, “Standard Consumer Safety Specifications for Infant Bath Seats,” but the Commission is proposing some modifications to strengthen the standard.
2. Previous Commission Rulemaking Concerning Bath Seats
The Commission has been engaged in regulatory efforts for infant bath seats for several years. In July 2000, several consumer organizations petitioned the Commission to ban bath seats under the Federal Hazardous Substances Act (“FHSA”). The consumer organizations asserted that bath seats presented an unreasonable risk of injury and death due to drowning. On August 1, 2001, the Commission published an advance notice of proposed rulemaking (“ANPR”) in the Federal Register initiating a rulemaking proceeding on bath seats (66 FR 39692). The Commission issued a notice of proposed rulemaking that was published in the Federal Register on December 29, 2003 (68 FR 74878) proposing requirements for stability, leg openings, and warnings. Elsewhere in this issue of the Federal Register, the Commission has issued a notice that the Commission has terminated the bath seat rulemaking proceeding that it began under the FHSA because it has been superseded by this rulemaking required under section 104(b) of the CPSIA.
B. The Product Back to Top
Infant bath seats are used in a tub or sink to support a seated infant while he or she is being bathed. They are marketed for use with infants between the age of approximately 5 months (the time at which infants can sit up unassisted) to the age of approximately 10 months (the time at which infants begin pulling themselves up to a standing position). Currently, there are three manufacturers and one importer of bath seats active in the United States. All are members of the Juvenile Products Manufacturers Association (“JPMA”), which is the major United States trade association representing juvenile product manufacturers and importers. All produce a variety of children's products in addition to bath seats.
The exact number of bath seats currently sold or in use is not known. A 2005 survey by the American Baby Group indicated annual sales of bath seats of about 1.5 million and about 1.7 million bath seats in use. In 2000, JPMA estimated annual sales of bath seats at about one million and estimated up to 2 million bath seats in use for infants under one year of age.
C. ASTM Voluntary Standard Back to Top
ASTM F 1967, Standard Consumer Safety Specification for Infant Bath Seats, was first published in 1999. Between 2003 and 2007, the ASTM standard was subsequently revised several times to include requirements that the Commission proposed in its 2003 NPR and to exclude tub-like products.
In response to changes in the ASTM standard, product design changed significantly. The new designs use an arm that clamps onto the side of the bath tub rather than relying on suction cups for stability. The current voluntary standard for bath seats, ASTM F 1967-08a, was published in December 2008. The current version contains the same labeling, stability and leg opening requirements as the 2007 version.
JPMA provides certification programs for juvenile products, including bath seats. Manufacturers submit their products to an independent test laboratory to test the product for conformance to the ASTM standard. Currently only one bath seat model is certified to ASTM F 1967-08a.
The current ASTM standard includes performance requirements specific to bath seats to address the hazards of the bath seat tipping over or the child becoming entrapped and/or submerged in the leg openings. The standard also contains labeling requirements to address the child coming out of the bath seat.
General requirements in the current ASTM standard, none of which the Commission is proposing to modify, include:
- Requiring compliance with CPSC's standards concerning sharp points and edges, small parts, and lead paint (16 CFR parts 1303, 1500.48, 1500.49, 1500.50, 1500.51, and 1501);
- Requirements for latching and locking mechanisms;
- Requirements to prevent scissoring, shearing and pinching;
- Entrapment testing for accessible holes and openings;
- Torque/tension test for graspable components; and
- A requirement that warning labels be permanent.
The ASTM Standard's requirements specifically related to hazards posed by bath seats (some of which the Commission is proposing to modify as discussed in part E of this preamble) include:
- Test for stability performed on a test platform containing both a slip resistant surface and a smooth surface to test whether the bath seat may tip over during use;
- Requirements for restraint systems requiring passive crotch restraint to prevent a child from sliding through front or sides of the seat;
- Static load test to test whether the bath seat may break or become damaged during use;
- A requirement that suction cups (if used) adhere to the bath seat and the surface;
- A leg opening requirement to prevent children from sliding through these openings;
- A leg opening requirement restricting the expansiveness of the seating area to prevent the child from slumping and becoming entrapped in a reclined position; and
- Requirements for warning labels and instruction manual.
D. Incident Data Back to Top
From 1983 through 2008, there were 295 non-fatal bath seat incidents reported to CPSC staff. A submersion hazard was identified in 151 of these non-fatal incidents of which 116 were actual submersion incidents. (Submersion is defined as the act of placing, or the condition of being, under water. A submersion hazard indicates that submersion is possible, as a direct result of the incident. An actual submersion is when the victim actually became submerged as a result of the incident.) The remaining 143 reports were non-submersion hazards such as lacerations, limb entrapments, etc. There have been 171 reported fatalities involving bath seats for this same time frame, although more fatalities may have occurred because fatality reporting is not considered to be complete for 2006, 2007, and 2008. All of these fatalities were submersions. None of the identifiable products involved in the fatal bath seat incidents were certified to meet ASTM F 1967-08a or its predecessor, ASTM F 1967-07. Two of the non-fatal incidents involved products certified to ASTM F 1967-07, neither of which were submersion hazards, thus were not life threatening.
Of the 171 fatal incidents, 20 involved products that were identified as being certified to the 2004 version of the ASTM standard. Two of the 20 were due to the arm of the bath seat disengaging from the bath tub and 17 were due to other causes such as the child slumped over the side of the bath seat (four incidents), children found out of the bath seat in the water (seven incidents), miscellaneous causes, such as consumers not attaching the clamp to the tub side (four incidents), and overflowing bathtubs (two incidents). There was also an unknown cause for one incident.
Fifty-one of the non-fatal incidents involved bath seats certified to the 2004 version of the ASTM voluntary standard. Fifteen of these non-fatal incidents involved a bath seat that was the subject of a safety alert issued in 2005 due to component failures occurring when the bath seat was installed on non-traditional tubs. Of the remaining 36 incidents, five were considered submersion hazards, and thus could have resulted in a fatality had a caregiver not been present. These five include three arm disengagements, one entrapment where the child's torso slipped completely into one leg opening, and one case where a child was found out of the bath seat in the water. In addition, there has been another recent torso entrapment incident reported to CPSC staff in 2009.
E. Assessment of Voluntary Standard ASTM F 1967-08a and Description of Proposed Changes and the Proposed Rule Back to Top
1. Section 104(b) of the CPSIA: Consultation and CPSC Staff Review
Section 104(b) of the CPSIA requires the Commission to assess the effectiveness of the voluntary standard in consultation with representatives of consumer groups, juvenile product manufacturers and other experts. This consultation process began in October 2008 during the ASTM subcommittee meeting regarding the ASTM infant bath seat voluntary standard. Consultations between Commission staff and members of this subcommittee are still ongoing.
The Commission has reviewed the incident data and the ASTM F 1967-08a standard and conducted testing on bath seats to assess the ASTM standard. CPSC staff tested three products to the current version of ASTM F 1967-08a: Two bath seats that use only suction cups to provide stability and a third that primarily uses a clamping mechanism located on an arm that secures the bath seat to the side of the tub. The bath seat with the arm was labeled as being certified by JPMA to the ASTM standard.
Initial testing results indicated that all three products failed the stability test requirements in ASTM F 1967-08a. The two non-certified seats that use only suction cups for stability could not affix themselves to the slip-resistant surface, and thus failed.
During the testing of the JPMA certified bath seat, the arm rest of the clamping mechanism lifted up from the top surface of the side of the tub. The clamp did not disengage from the tub, but the arm rest contact points were no longer in contact with the tub surface. The bath seat remained in a tilted position from the installed and presumed “manufacturer's intended use position.” A strict interpretation of the pass-fail criteria suggests that this bath seat, as tested by CPSC staff, also does not meet the standard, but the clamp, while not in the initial position, remained clamped to the side of the bath tub. Thus, one could assert that, because the product did not tip over and did not disengage from the platform, the product complied with the standard. This result indicates that the pass/fail criteria are ambiguous and could result in passing a bath seat that could nevertheless pose a stability hazard to an infant.
The current ASTM standard requires that a soapy test solution “thoroughly saturate the coverage area” which is defined in the ASTM standard as any internal surface of the tub well or tub bottom that makes contact with the product. Staff found that spraying the soap solution on the top and outer surface contact points as well as the interior surfaces affected the final position of the bath seat and therefore could affect the results of the test.
Consistent with section 104(b) of the CPSIA, the Commission, through this proposed rule, would establish a new 16 CFR part 1215, “Safety Standard for Bath Seats.” The new part would incorporate by reference the requirements for bath seats in ASTM F 1967-08a with certain changes to specific provisions to strengthen the ASTM standard as discussed below.
2. Proposed Changes to the ASTM Standard's Requirements
While most of the requirements of the current ASTM standard are sufficient to reduce the risk of injury posed by bath seats, the Commission concludes that several provisions should be modified to make them more stringent and further reduce the risk of injury and to clarify the test procedures.
To best understand the proposed standard, it is helpful to view the current ASTM F 1967-08a standard for bath seats at the same time as the Commission's proposed modifications. The ASTM standard is available for viewing for this purpose during the comment period through this link: http://www.astm.org/cpsc.htm.
a. Definition of Bath Seat (Proposed § 1215.2(b)(1))
The Commission's 2003 NPR defined a bath seat as an article that is used in a bath tub, sink, or similar bathing enclosure and that provides support, at a minimum, to the front and back of a seated infant during bathing by a caregiver. The Commission believes that this definition is preferable to that used by ASTM which does not define the type of support because the proposed definition better clarifies what is (or is not) a bath seat.
b. Stability Requirement
Limiting the tilt of the bath seat (proposed § 1215.2(b)(2), (6) and (7)). As discussed above, during testing the Commission staff found that the clamping mechanism on one bath seat lifted from the side of the tub and continued to tip backward when force was applied, but it did not tip over. To prevent possible misinterpretation of the ASTM standard's pass/fail criteria, the Commission proposes a requirement that limits the allowable tilt angle of the bath seat during the stability test. This proposed modification would be added to sections 6.1, between sections 188.8.131.52 and 184.108.40.206, and between sections 220.127.116.11 and 18.104.22.168 of the ASTM standard. The Commission proposes that a bath seat capable of tilting 12 degrees or more during testing be considered a failure. This limit was determined after measuring, and allowing for the flexibility of, current products. Staff also considered other ASTM standards such as those for infant bouncer seats and toys. These use a 10 degree table or tilt when testing stability. The Commission is proposing a tilt angle just above that level.
Test solution application (proposed § 1215.2(b)(4)). The Commission recognizes that the outside of a tub may become wet, and this may affect the ability of a bath seat's attachment arm to remain stable. Thus, the Commission proposes that a test solution be applied to all areas where the product may make contact while in use.
Measuring water levels (proposed § 1215.2(b)(5)). When testing the stability of bath seats, Commission staff noted that it can be difficult to obtain accurate water level measurements because the unoccupied bath seat may float when the test platform is flooded. To address this, the Commission proposes to add a clarifying statement: “For the purpose of measuring the water level, the product's seating surface can be temporarily weighed down to prevent the seat from floating.”
c. Leg opening requirement (Proposed § 1215.2(b)(8) through (10))
In recent incident reports, children have fit both legs and their hips through a single leg hole of a bath seat that complies with the current ASTM standard. The torso probe specified in the current ASTM standard used to test the size of the leg openings is not sufficiently analogous to the human infant. This has resulted in a child's torso fitting through a leg hole when the ASTM torso probe does not. Because modeling the pliable features of a child's torso is not practical, the Commission proposes decreasing the size of the current rigid wood torso probe specified in the ASTM standard and specifying a larger radius on the corners. The proposal would decrease the length of the vertical and horizontal axes of the current probe by approximately 5% and round the corners more resulting in a 1.45″ radius rather than the current 1″ radius. This proposed change is accomplished through modifications to Figure 4 in the ASTM standard that shows the torso probe. The Commission believes that changes in the test probe would not restrict the utility of the product, but would still allow many possible designs for bath seats, even that which would accommodate large children.
An additional proposed change (at proposed § 1215.2(b)(8) and (9)) related to the torso probe concerns the ASTM standard's instruction in section 7.7.1 and 7.7.2 of the ASTM standard to insert the test probe “* * * in the most adverse orientation into each opening.” This language is open to interpretation as it may not always be intuitive what `the most' adverse position is. Therefore, the Commission proposes changing this wording to say that the probe needs to be inserted “in all orientations to determine if any position can create a slip through and/or entrapment hazard.”
d. Editorial and clarifying changes (proposed § 1215.2(b)(3) and (5))
Other proposed changes clarify the order of steps to be performed when conducting the stability test. For clarification of testing procedures, the Commission proposes re-ordering the steps specified in the ASTM standard for preparing the test surface and installing the bath seat. This change would clarify that the test platform should be flooded before installing the bath seat.
F. Request for Comments Back to Top
The issuance of this proposed rule begins a rulemaking proceeding under section 104(b) of the CPSIA to issue a consumer product safety standard for infant bath seats. All interested persons are invited to submit comments on any aspect of the proposed rule. Comments should be submitted in accordance with the instructions in the ADDRESSES section at the beginning of this notice.
G. Effective Date Back to Top
The Administrative Procedure Act (“APA”) generally requires that the effective date of a rule be at least 30 days after publication of the final rule. Id. 553(d). To allow time for bath seats to come into compliance, the Commission proposes that the standard would become effective six months after publication of a final rule.
H. Regulatory Flexibility Act Back to Top
The Regulatory Flexibility Act (“RFA”) generally requires that agencies review proposed rules for their potential economic impact on small entities, including small businesses. 5 U.S.C. 603.
Four firms currently market infant bath seats in the United States: A large domestic manufacturer, a small foreign manufacturer, a small domestic manufacturer, and a small domestic importer. All of these companies' bath seats are expected to require modifications to meet the proposed standard.
Modifying existing bath seats to meet the proposed standard would result in one-time product development costs and possible increased costs of production that could amount to approximately $5 to $10 per bath seat. A price increase associated with these modifications will likely reduce the quantity of bath seats demanded and hence unit sales. Alternatively, it is possible that manufacturers may not be able to (or may choose not to) produce a commercially viable bath seat that meets the proposed standard. For the small domestic manufacturer, the impact of discontinuing baby bath seat production is unlikely to be large since bath seats make up only a small portion of its juvenile products.
Since importers do not manufacture bath seats, the effect of the regulation on them would be felt indirectly, requiring a shift in suppliers rather than the design and production of a different product. The impact on the small domestic importer is expected to be small. The small domestic importer would most likely respond by discontinuing the import of its non-complying bath seat, either replacing the bath seat with a complying product or another juvenile product.
Hence, even if the cost of developing a compliant product proves to be a barrier for individual small firms, the loss of bath seats as a product category is expected to be minor and would likely be mitigated by increased sales of competing products, such as multi-stage infant bathtubs, or entirely different juvenile products.
I. Environmental Considerations Back to Top
The Commission's regulations provide a categorical exemption for the Commission's rules from any requirement to prepare an environmental assessment or an environmental impact statement as they “have little or no potential for affecting the human environment.” 16 CFR 1021.5(c)(2). This proposed rule falls within the categorical exemption.
J. Paperwork Reduction Act Back to Top
The Commission is not proposing any collections of information in this rulemaking. Therefore, the Paperwork Reduction Act, 44 U.S.C. 3501-3520, does not apply.
Therefore, the Commission proposes to amend Title 16 of the Code of Federal Regulations by adding part 1215 to read as follows:
PART 1215—SAFETY STANDARD FOR BATH SEATS Back to Top
§ 1215.1 Scope.
This part 1215 establishes a consumer product safety standard for bath seats manufactured or imported on or after (date 6 months after date of publication of a final rule in the Federal Register).
§ 1215.2 Requirements for bath seats.
(a) Except as provided in paragraph (b) of this section, each bath seat shall comply with all applicable provisions of ASTM F 1967-08a, Standard Consumer Safety Specification for Infant Bath Seats, approved November 1, 2008. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from ASTM International, 100 Bar Harbor Drive, P.O. Box 0700, West Conshohocken, PA 19428; http://www.astm.org. You may inspect a copy at the Office of the Secretary, U.S. Consumer Product Safety Commission, Room 502, 4330 East West Highway, Bethesda, MD 20814, telephone 301-504-7923, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(b) The following provisions replace, or are added to, the indicated sections of the ASTM F 1967-08a standard.
(1) Instead of section 3.1.1:“Bath seat, n—an article that is used in a bath tub, sink, or similar bathing enclosure and that provides support, at a minimum, to the front and back of a seated infant during bathing by a caregiver. This does not include products that are designed or intended to retain water for bathing.”
(2) Instead of section 6.1:“Stability—For bath seats which provide support for an occupant's back and support for the sides or front of the occupant, or both, the geometry and construction of the product shall not allow for any parts of the product to become separated from it, shall not sustain permanent damage, and shall not allow the product to tip over after being tested in accordance with 7.4. In addition, if any attachment point disengages from (is no longer in contact with) the test platform and then fails to return to its manufacturer's intended use position after being tested in accordance with 7.4, it fails the requirement. This test shall be conducted after the Mechanisms Durability test in 7.1.3. If any time during the application of force, the seat is no longer in the initial `intended use position' and is tilted at an angle of 12 degrees or more from its initial starting position, it shall be considered a failure.”
(3) Instead of section 22.214.171.124:“Prepare the test surface as follows:”
(4) Instead of section 126.96.36.199:“Using a spray bottle containing a 1:25 mixture of test solution (see table Z) to distilled water, immediately before each test run, thoroughly saturate all test platform surfaces above the water line where the product makes contact and where contact might be expected.”
(5) Instead of section 188.8.131.52:“Flood the test platform with clear water that is at an initial temperature of 100 to 105º F (37.8 to 10.6º C) and a depth of 2 in. (51 mm) above the highest point of the occupant seating surface. Install the product according to the manufacturer's instructions onto the test platform specified in 7.4.3. For the purpose of measuring the water level, the product's seating surface can be temporarily weighed down to prevent the seat from floating.”
(6) Between section 184.108.40.206 and section 220.127.116.11:“Rigidly install an inclinometer to the test bar above the location where force is to be applied. The weight of the inclinometer and the fastening method shall be less than or equal to 2.2 pounds. The inclinometer shall have a measurement tolerance of less than or equal to 0.5 degrees. Measure and record the pre-test angle of the test bar.”
(7) Between section 18.104.22.168 and section 22.214.171.124:“Measure and record the maximum angle of the test bar during the application of the 17.0 lbf load. Calculate the absolute value of the Change in Angle in degrees. Change in Angle = (Angle measured during test)—(Angle measured pre-test).”
(8) Instead of section 7.7.1:“With the bath seat in each of the manufacturer's recommended use position(s), insert the tapered end of the Bath Seat Torso Probe (see Fig. 4a) in all orientations into each opening. The probe should be inserted from the direction of the occupant seating surface. Gradually apply a force of 15 lbf (67 N) in the direction of the major axis of the probe within a period of 5s. Maintain this force for an additional 10s (see Fig. 5).”
(9) Instead of section 7.7.2:“With the bath seat in each of the manufacturer's recommended use position(s), insert the tapered end of the Bath Seat Shoulder Probe (see Fig. 6) in all orientations into each opening. The probe should be inserted from the direction of the occupant seating surface. Gradually apply a force of 15 lbf (67 N) in the direction of the major axis of the probe within a period of 5s. Maintain this force for an additional 10s (see Fig. 7). Release and apply a force of 10 lbf (44 N) to the top 1.0-in. (25-mm) perimeter of the probe in a direction vertically downward toward the seating surface over a period of 5s. Maintain this force for an additional 10s (see Fig. 8).”
(10) Instead of Figure 4:
[Graphic not available; view image of printed page]
Dated: August 25, 2009.
Secretary, U.S. Consumer Product Safety Commission.
[FR Doc. E9-20948 Filed 9-2-09; 8:45 am]
BILLING CODE 6355-01-P