Safety Standard for Frame Child Carriers Proposed Rule: 16 CFR Parts 1112 and 1230, Comment Request

CPSC announces a standard for frame child carriers, and is seeking comments.
mayo 16, 2014

Action

Notice Of Proposed Rulemaking.

 

Summary

 

The Danny Keysar Child Product Safety Notification Act, section 104 of the Consumer Product Safety Improvement Act of 2008 (CPSIA), requires the United States Consumer Product Safety Commission (Commission or CPSC) 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 frame child carriers in response to the direction under section 104(b) of the CPSIA. In addition, the Commission is proposing an amendment to the list of Notice of Requirements (NOR) issued by the Commission.

 

 

Table of Contents Back to Top

Tables Back to Top

DATES: Back to Top

Submit comments by July 30, 2014.

 

ADDRESSES: Back to Top

Comments related to the Paperwork Reduction Act aspects of the marking, labeling, and instructional literature of the proposed mandatory standard for frame child carriers should be directed to the Office of Information and Regulatory Affairs, the Office of Management and Budget, Attn: CPSC Desk Officer, FAX: 202-395-6974, or emailed to oira_submission@omb.eop.gov.

 

Other comments, identified by Docket No. CPSC-2014-0011, may be submitted electronically or in writing:

 

Electronic Submissions: Submit electronic comments to the Federal eRulemaking Portal at: http://www.regulations.gov. Follow the instructions for submitting comments. The Commission does not accept comments submitted by electronic mail (email), except through www.regulations.gov. The Commission encourages you to submit electronic comments by using the Federal eRulemaking Portal, as described above.

 

Written Submissions: Submit written submissions in the following way: Mail/Hand delivery/Courier, preferably in five copies, to: Office of the Secretary, Consumer Product Safety Commission, Room 820, 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 proposed 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 that you do not want to be available to the public. If furnished at all, 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, and insert the docket number, CPSC-2014-0011, into the “Search” box, and follow the prompts.

 

FOR FURTHER INFORMATION CONTACT: Back to Top

Patricia L. Edwards, Project Manager, Directorate for Engineering Sciences, U.S. Consumer Product Safety Commission, 5 Research Place, Rockville, MD 20850; email: pedwards@cpsc.gov.

 

SUPPLEMENTARY INFORMATION: Back to Top

I. Background and Statutory Authority Back to Top

The CPSIA was enacted on August 14, 2008. Section 104(b) of the CPSIA, part of the Danny Keysar Child Product Safety Notification Act, requires the Commission to: (1) Examine and assess the effectiveness of voluntary consumer product safety standards for durable infant or toddler products, in consultation with representatives of consumer groups, juvenile product manufacturers, and independent child product engineers and experts; and (2) promulgate consumer product safety standards for durable infant and toddler products. Standards issued under section 104 are to be “substantially the same as” the 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 term “durable infant or toddler product” is defined in section 104(f)(1) of the CPSIA as “a durable product intended for use, or that may be reasonably expected to be used, by children under the age of 5 years.” Section 104(f)(2)(I) of the CPSIA specifically identifies “infant carriers” as a durable infant or toddler product. The category of infant carriers covers a variety of products. The Commission has previously issued rules under section 104 for other infant carriers: specifically, for hand-held infant carriers and for soft infant and toddler carriers.

 

Pursuant to section 104(b)(1)(A), the Commission consulted with manufacturers, retailers, trade organizations, laboratories, consumer advocacy groups, consultants, and members of the public in the development of this proposed standard, largely through the ASTM process. The proposed rule is based on the voluntary standard developed by ASTM International (formerly the American Society for Testing and Materials), ASTM F2549-14, Standard Consumer Safety Specification for Frame Child Carriers, with one proposed modification to specify requirements for the retention system performance test to provide clear pass/fail criteria for the carrier's restraints.

 

The ASTM standard is copyrighted, but the standard can be viewed as a read-only document during the comment period on this proposal only, at: http://www.astm.org/cpsc.htm, by permission of ASTM.

 

The testing and certification requirements of section 14(a) of the Consumer Product Safety Act (CPSA) apply to the standards promulgated under section 104 of the CPSIA. Section 14(a)(3) of the CPSA requires the Commission to publish an NOR for the accreditation of third party conformity assessment bodies (test laboratories) to assess conformity with a children's product safety rule to which a children's product is subject. The proposed rule for frame child carriers, if issued as a final rule, will be a children's product safety rule that requires the issuance of an NOR. To meet the requirement that the Commission issue an NOR for the frame child carriers standard, the draft notice of proposed rulemaking (NPR) proposes to amend 16 CFR part 1112.

 

II. Product Description Back to Top

A. Definition of Frame Child Carrier

The scope section of ASTM F2549-14 defines a “frame child carrier” as “a product normally of sewn fabric construction on a tubular metal or other frame, which is designed to carry a child, in an upright position, on the back of the caregiver.” The intended occupants of frame child carriers are children who are able to sit upright unassisted and weigh between 16 and 50 pounds. Frame child carriers are intended to be worn on the back and suspended from both shoulders of the caregiver's body in a forward- or rear-facing position. This type of carrier is often used for hiking and typically closely resembles hiking/mountaineering backpacks not intended to be used for transporting children.

 

B. Market Description

CPSC staff is aware of 15 firms currently supplying frame child carriers to the U.S. market, although additional firms may supply these products to U.S. consumers. Most of these firms specialize in the manufacture and/or distribution of one of two distinct types of products: (1) Children's products, including durable nursery products; or (2) outdoor products, such as camping and hiking gear. The majority of the 15 known firms are domestic (including four manufacturers, seven importers, and one firm whose supply source could not be determined). The remaining three firms are foreign (including two manufacturers and one firm that imports products from foreign companies and distributes them from outside of the United States).

 

III. Incident Data Back to Top

CPSC's Directorate for Epidemiology, Division of Hazard Analysis, is aware of a total of 47 frame child carrier-related incidents reported to CPSC that occurred between January 1, 2003 and October 27, 2013. Although there were no fatalities in the 47 incidents, 33 injuries were reported. Twenty-eight of the reports were received through the National Electronic Injury Surveillance System (NEISS). According to reports, the oldest child involved in an incident was 3 years old. For some incidents, the age of the child was not reported because no injury was involved, or the age of the child was unknown.

 

A. Fatalities

The incident data did not include any reports of fatalities.

 

B. Nonfatalities

Among the 33 reported nonfatal injuries, there were no hospitalizations. More than half of these incidents reported a serious injury, such as a closed-head injury [1] or a fracture of the leg or face. The other reported injuries ranged from head/facial lacerations, to dislocated arms and contusions and abrasions.

 

A majority of the injuries resulted from falls from the frame child carrier. Many of the falls occurred when children slipped out of the frame child carrier through leg openings; in other scenarios, children fell out when carriers, placed on elevated surfaces, toppled over, or when caregivers fell when carrying the infant in the carrier. For other falls, the specifics of the circumstances were not reported. Certain non-fall injuries occurred when the frame child carrier tipped over due to instability when the carrier was placed upright on the floor, or from caregiver errors in placing/removing the child in or from the carrier. The remaining 14 incident reports indicated that no injury had occurred or else provided no information about any injury. However, many of the 14 incident reports described scenarios that CPSC staff believes presented the potential for a serious injury or even death.

 

C. Hazard Pattern Identification

CPSC staff reviewed all 47 reported incidents (33 with injuries and 14 without injuries) to identify hazard patterns associated with frame child carriers. Subsequently, CPSC staff considered each pattern when reviewing the adequacy of ASTM F2549-14.

 

Staff grouped the incidents into three broad categories of hazard patterns (product-related, non-product-related, and unknown); staff then further classified the incidents within each category. In order of frequency of incident reports, the hazard patterns are described below:

 

1. Product Related: Twenty-nine of the 47 incidents, including 15 of the 33 injuries, were attributed to product-related issues. The specific product-related issues were:

 

  • Structural integrity of the frame child carrier was identified as a problem in 11 (23 percent) of the 47 incidents. Reported problems included:

○ Failure of caregiver's attachment components;

 

○ Poor quality stitching on straps;

 

○ Detachment of the cloth component from the frame; and

 

○ Loose screws or breakage of the frame, which resulted in an abrasion injury.

 

A review of the data shows that each of the 11 incidents involved carriers manufactured before the initial publication of ASTM F2549 in 2006.

 

  • Stability problems of the frame child carrier were reported in nine incidents (19 percent); all nine incidents resulted in an injury to the head/face of the child. In some cases, when the carrier was placed on an elevated surface, the infant fell out of the carrier as the carrier toppled over. In other cases, when the carrier was at ground level, the infant fell along with the carrier when the carrier tipped over. All nine incidents were from NEISS reports; and thus, information about the carrier and details about the incident are unknown. Three of the nine incidents occurred before 2006, and thus, involved carriers that were manufactured before the initial publication of ASTM F2549.
  • Leg opening problems were reported in seven incidents (15 percent). In these cases, the leg holes were large enough to allow the child to slip out or almost slip out of the carrier. In a few of these incidents, the consumer also expressed concern about the potential risk of strangulation if the child were to get trapped in the process of slipping out through the opening. This category includes four injuries to the head and/or face due to a fall. Three of the seven incidents involved carriers manufactured after ASTM F2549 was first published.
  • Restraint inadequacy was reported in two incidents (4 percent); one was a NEISS incident that occurred in 2005, and the other incident occurred in 2009. In both cases, the caregiver bent over, and the restraints somehow failed to prevent the child from sliding out from the top. One injury is included in this category.

2. Non-Product-Related: Nine incidents (19 percent) involving nine injuries were not attributable to any product-related failure or defect. Five of the incidents resulted in arm dislocation injuries during the placement/removal of the child in or out of the frame child carrier. The remaining four incidents resulted in injuries (leg fracture, closed-head injury, and facial laceration, for example) when the caregiver slipped or tripped and fell, with the child in the carrier.

 

3. Unknown: There were nine NEISS incidents (19 percent) reported that provided very few scenario-specific details. Staff could not determine whether there was any product involvement or any hazardous external circumstances. All of the incidents resulted in injuries to the head and/or face due to falls.

 

D. Product Recalls

There have been two product recalls involving frame child carriers from January 1, 2003 to October 27, 2013. One recall involved 4,000 units, and the other recall involved 40 units.

 

IV. Other Relevant Standards Back to Top

A. International Standards

CPSC is aware of one international standard, EN 13209-1:2004, European/British Standard for Child use and care articles—Baby carriers—Safety requirements and test methods—Part 1: Framed back carriers, which addresses frame child carriers in a fashion similar to ASTM F2549-14. Although there are differences between the two standards, CPSC believes that the ASTM standard is more stringent in most areas and addresses most of the hazard patterns seen in the CPSC incident data. The exception is the test requirement for the occupant retention system (known as the child-restraint system in the EN standard). The EN standard has clear pass/fail requirements for restraint performance, and the ASTM standard does not. Both standards include a test procedure that rotates the carrier a full 360 degrees when occupied by a surrogate dummy. In addition, both standards include procedures that apply forces to the retention straps, attachment points, and the dummy legs. The EN standard requirement states that the dummy shall not fall completely out of the restraint system and that the attachment of the restraint system shall not break, deform, work loose, or become torn/displaced. Additionally, the EN standard requires that fasteners shall not be released or have suffered damage that impairs their operation and function. The ASTM standard does not contain any of this language, and therefore, as discussed in section V of the preamble, and as reflected in the language of the proposed § 1230.2(b)(1)(i), the Commission's proposed standard includes a modification to ASTM F2549 that would specify test criteria similar to those provided in the EN standard.

 

B. Voluntary Standard—ASTM F2549

1. History of ASTM F2549

The voluntary standard for frame child carriers was first approved and published in December 2006, as ASTM F2549-06, Standard Consumer Safety Specification for Frame Child Carriers. ASTM has revised the voluntary standard five times since then. The current version, ASTM F2549-14, was approved on January 1, 2014.

 

The original version, ASTM F2549-06, contained requirements to address the following issues:

 

  • Sharp points
  • Small parts
  • Lead in paint
  • Wood parts
  • Scissoring, shearing, pinching
  • Openings
  • Exposed coil springs
  • Locking and latching (for carriers that fold for storage, this requirement helps prevent unintentional folding)
  • Unintentional folding (for carriers with kick stands that can stand freely, this requirement helps prevent the unintentional folding of the kick stand)
  • Labeling
  • Protective components
  • Leg openings (to help prevent smaller occupants from falling out of the carrier through a single leg opening)
  • Dynamic strength (tests the frame, fasteners, and seams/stitching under dynamic conditions to help prevent breakage or separation)
  • Static load (ensures the carrier can hold three times the maximum recommended weight)
  • Stability (for carriers that can stand freely, this helps prevent an occupied carrier from tipping over during normal use)
  • Restraints (requires that all carriers have a restraint system and also provides a method for testing the restraints)
  • Handle integrity (helps prevent the handle from breaking or separating when it is pulled with three times the maximum recommended weight)

ASTM F2549-08 (approved November 1, 2008) addressed the following issues:

 

  • New flammability requirements for carriers
  • New toy accessory requirements
  • A revised unintentional folding test procedure, adding a weight load to mimic an occupant in the carrier.

ASTM F2549-09 (approved April 1, 2009) addressed the following issue:

 

  • A revised dynamic strength test procedure because some carrier designs could not be tested using the old method.

ASTM F2549-09a (approved July 1, 2009) addressed the following issue:

 

  • Change of the reference to the flammable solids requirement [16 CFR 1500.3(C)(6)(vi)] to correct an editorial error.

ASTM F2549-13 (approved November 1, 2013) addressed the following issues:

 

  • A revised leg opening test procedure to reflect the use of the product better and explain what is happening in incident reports where children were slipping through a leg opening.
  • A revised scope to include carriers rated for weights up to 50 pounds, which reflects the existing market for frame child carriers.

ASTM F2549-14 (approved January 1, 2014) addressed the following issue:

 

  • A revised dynamic strength test to accommodate the greater weight rating (which was changed in version F2549-13).

2. Description of the Current Voluntary Standard—ASTM F2549-14

We believe that the current voluntary standard, ASTM F2549-14, sufficiently addresses the primary hazard patterns identified in the incident data. The following section discusses how each of the identified hazard patterns listed above is addressed by the current voluntary standard, ASTM F2549-14.

 

Structural Integrity

ASTM F2549-14 uses a dynamic strength test and a static load test to assess the structural integrity of frame child carriers. We are aware of 11 reported incidents associated with the structural integrity of carriers that occurred before the first publication of ASTM F2549 in 2006. No incidents have been reported involving carriers manufactured since 2006. Thus, we believe that the combination of the dynamic strength and static load tests are adequate to address the issues associated with structural integrity.

 

Stability Problems

A total of nine tip-over incidents were reported to CPSC, all through hospital emergency departments with very few scenario-specific details. CPSC staff's review of these incident reports shows that three incidents involved carriers falling from elevated surfaces. The fall hazard and recommendations to mitigate this hazard, including not placing the carrier on counter tops, tables, or other elevated surfaces, are specified in a warning label requirement. The standard requires this warning label to be in a conspicuous location, visible to the caregiver each time the occupant is placed in the carrier, or when the caregiver places the product on his or her body.

 

In addition to the warning label requirement, the current voluntary standard includes a stability requirement and associated test procedure so that carriers that use a kickstand can remain in an upright position and are stable. When used correctly, a kickstand is designed to make the carrier stable so that the child can remain safely in the carrier just before and immediately after being carried by the caregiver. CPSC considers the stability test in the ASTM standard to be strong, and thus, we view the test as capable of discerning stable versus unstable carriers.

 

Based on the reasons outlined above, CPSC believes that ASTM F2549-14 adequately addresses stability issues through the use of both a warning label and a strong test requirement and associated test procedure. Thus, CPSC is not proposing any modifications to the ASTM standard to address this hazard pattern.

 

Leg Opening Problems

Leg opening problems were reported in seven incidents. In those cases, the carrier's leg holes were large enough to allow the child to slip out or almost slip out of the carrier. In a few of these incidents, the consumer also expressed concern about the potential risk of strangulation if the child slipped out through the opening. This category of incidents includes four head/face injuries from falls. A closer look revealed that four of the seven incidents occurred before the standard was published. After initial publication of the standard in October 2006, no other leg opening incidents were reported until 2012. During a 6-month period between August 2012 and January 2013, three new leg opening incidents occurred.

 

Because of the new incidents, CPSC staff began working with ASTM in spring 2013, to update the leg opening test in ASTM F2549-09a. CPSC staff collected 10 carriers from a variety of suppliers, including the carrier involved in the three incidents, and staff tested each carrier to the leg opening requirement in ASTM F2549-09a. This test requires the carrier to be adjusted to the smallest leg opening; and then a 7-pound, 16.5-inch circumference test sphere [2] is placed in the carrier. Next, the carrier is tilted until the leg opening is horizontal, and then the carrier is held in that position for an additional minute. The test is repeated for the other leg opening. To pass the test, the sphere must not pass through either leg opening. CPSC staff found that all 10 carriers that were tested passed the requirement specified in ASTM F2549-09a.

 

CPSC staff, with the help of an ASTM task group, developed a more stringent test method that addressed the recent incidents. Instead of being adjusted to the smallest leg opening, carriers were fitted around a CAMI Infant Dummy Mark II (modeled after a 50th percentile 6-month old child). Four of the 10 carriers failed the modified leg-opening test. Notably, one of the carriers that failed the modified test was associated with the recent incident reports of children falling through leg openings.

 

In fall 2013, ASTM balloted a revised test procedure for leg openings that was developed by CPSC staff and the ASTM task group. This ballot item passed and was included in the revised standard, F2549-13. With the inclusion of this recently revised leg-opening test method, CPSC believes that the current voluntary standard is now adequate to address leg-opening hazards.

 

Although we believe the current standard adequately addresses the three hazard patterns described above, we will continue to monitor incidents and work with ASTM to make any necessary future changes.

 

Restraints

There were two reported incidents of restraint inadequacy. One was a NEISS report of a child falling out of a carrier when the caregiver leaned forward. This report contained no information regarding whether the restraints were used properly or how the restraints were involved. The other incident involved an 8-month-old child who stood up and almost fell out of the carrier while the caregiver was leaning forward. In the latter incident, we do not know what happened to the shoulder straps, but the report mentioned that the restraints might have been adjusted to be too loose. There was no report that the restraints broke in any way or became loose on their own.

 

V. Proposed Change to ASTM F2549-14 in the Proposed Mandatory Standard Back to Top

ASTM juvenile product standards generally include sections that provide performance requirements and test methods. The performance requirement section spells out the pass/fail criteria associated with various requirements, while the test method section outlines the procedures for conducting the tests that need to be performed to determine whether the product meets the pass/fail criteria. Although some performance requirements do not have an associated test method, all test methods must have an associated performance (or general) requirement.

 

ASTM F2549-14 contains a performance requirement and a test procedure intended to address the hazard patterns associated with frame child carriers. However, CPSC concludes that a change to the ASTM standard's performance requirement is needed to address restraint hazards adequately. The current performance requirement associated with the retention (restraint) system for frame child carriers states:

 

6.5 Retention System:

 

6.5.1A retention system, including a shoulder restraint, shall be provided to secure the occupant in a seated position in any of the manufacturer's recommended use positions when tested in accordance with 7.5.

 

6.5.2Before shipment, the manufacturer shall attach the retention system in such a manner that it will not detach in normal usage.

 

6.5.3If the retention system includes a crotch restraint designed to work with a lap belt, it shall be designed such that its use is mandatory when the retention system is in use.

 

The retention system test procedure (section 7.5 of the standard) has three parts. Under the first part, a 45-lbf (pound-force) is applied to a single attachment point of the retention system. The second part of the test procedure requires a CAMI Infant Dummy Mark II to be placed in the carrier with the restraint system secured. Then, a 45-lbf is applied horizontally on the centerline of either leg of the dummy and repeated five times. For the third part of the test procedure, the carrier, containing the CAMI dummy, is lifted and rotated backwards 360° about the axis of the intersection of the seat back and bottom. The carrier is then rotated 360° around the axis of the side edge of the seat bottom.

 

CPSC believes that the purpose of the first two parts of the test procedure is to help ensure that the retention system and all buckles do not break, disengage, or separate at any seams. In addition, CPSC believes the purpose of the third part of the test procedure is to help ensure that the CAMI dummy does not fall out of the carrier. Therefore, CPSC concludes that the standard should express these goals as criteria to determine whether restraint systems comply with the performance requirements. However, these pass/fail criteria are not mentioned explicitly in the performance requirement section of ASTM F2549-14. CPSC believes the frame child carriers standard should include explicit pass/fail criteria. Without this change to the standard, a frame child carrier that is undergoing testing could fail the intended criteria but still be deemed to comply with the standard. Thus, correcting the standard prevents this from happening and, in effect, makes the standard more stringent. Staff consulted with representatives from two test laboratories and the ASTM subcommittee chairman about the lack of explicit pass/fail criteria in the ASTM standard's requirements for retention systems. Test laboratory personnel reported that they likely had not tested any frame child carriers that should have failed the purpose of the requirement; otherwise, the test laboratory personnel would have noted the lack of stated criteria previously.

 

Both the consulted test laboratory representatives and the ASTM subcommittee chairman agreed that the requirement should be revised so that the purpose of the restraint performance test is expressed clearly. With the help of the test laboratory personnel, staff developed a revised requirement using language found in similar requirements in the EN standard and the ASTM high chair and stroller standards. CPSC staff suggested language to explicitly require that buckles shall not break, disengage, or separate and that all fasteners cannot become damaged to the point that the restraint system will not function as a result of the test. In addition, staff suggested language that requires that the CAMI dummy not fall out of the carrier. In February 2014, staff wrote a letter to the ASTM subcommittee chairman, [3] outlining the suggested new language, and asking that the matter be discussed at the next ASTM meeting. During the April 9, 2014 ASTM subcommittee meeting, the letter (including the recommended language) was shared with the subcommittee. The subcommittee agreed to ballot the proposed language for inclusion in the next revision of the standard. Accordingly, proposed § 1230.2(b)(1)(i)(D) includes a modification to the ASTM standard's retention system performance requirement in section 6.5, by adding a new section 6.5.4 that would require that when the frame child carrier restraints are tested in accordance with section 7.5 of the voluntary standard, the restraint system and its closing means (for example, a buckle) shall not break, disengage or separate at any seam and all fasteners shall not release or suffer damage that impairs the operation and function of the restraint system. Additionally, at the end of the tests, the CAMI dummy shall not be released fully or fall out of the carrier.

 

VI. Amendment to 16 CFR Part 1112 To Include NOR for Frame Child Carriers Standard Back to Top

The CPSA establishes certain requirements for product certification and testing. Products subject to a consumer product safety rule under the CPSA, or to a similar rule, ban, standard or regulation under any other act enforced by the Commission, must be certified as complying with all applicable CPSC-enforced requirements. 15 U.S.C. 2063(a). Certification of children's products subject to a children's product safety rule must be based on testing conducted by a CPSC-accepted third party conformity assessment body. Id. 2063(a)(2). The Commission must publish an NOR for the accreditation of third party conformity assessment bodies to assess conformity with a children's product safety rule to which a children's product is subject. Id. 2063(a)(3). Thus, the proposed rule for 16 CFR part 1230, Safety Standard for Frame Child Carriers, if issued as a final rule, would be a children's product safety rule that requires the issuance of an NOR.

 

The Commission published a final rule, Requirements Pertaining to Third Party Conformity Assessment Bodies, 78 FR 15836 (March 12, 2013), codified at 16 CFR part 1112 (referred to here as part 1112) and effective on June 10, 2013, that establishes requirements for accreditation of third party conformity assessment bodies to test for conformance with a children's product safety rule in accordance with section 14(a)(2) of the CPSA. Part 1112 also codifies all of the NORs that have been issued previously by the Commission.

 

All new NORs for new children's product safety rules, such as the frame child carriers standard, require an amendment to part 1112. To meet the requirement that the Commission issue an NOR for the proposed frame child carriers standard, as part of this NPR, the Commission proposes to amend the existing rule that codifies the list of all NORs issued by the Commission to add frame child carriers to the list of children's product safety rules for which the CPSC has issued an NOR.

 

Test laboratories applying for acceptance as a CPSC-accepted third party conformity assessment body to test to the new standard for frame child carriers would be required to meet the third party conformity assessment body accreditation requirements in part 1112. When a laboratory meets the requirements as a CPSC-accepted third party conformity assessment body, the laboratory can apply to the CPSC to have 16 CFR part 1230, Safety Standard for Frame Child Carriers, included in the laboratory's scope of accreditation of CPSC safety rules listed for the laboratory on the CPSC Web site at: www.cpsc.gov/labsearch.

 

VII. 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. 5 U.S.C. 553(d). The Commission is proposing an effective date of six months after publication of the final rule in the Federal Register. Without evidence to the contrary, CPSC generally considers six months to be sufficient time for suppliers to come into compliance with a new standard, and a six-month effective date is typical for other CPSIA section 104 rules. Six months is also the period that the Juvenile Products Manufacturers Association (JPMA) typically allows for products in the JPMA certification program to transition to a new standard once that standard is published. The Commission does not expect the modification proposed for frame child carriers to cause any changes to existing products.

 

We also propose a six-month effective date for the amendment to part 1112.

 

We ask for comments on the proposed six-month effective date.

 

VIII. Regulatory Flexibility Act Back to Top

A. Introduction

The Regulatory Flexibility Act (RFA) requires that agencies review a proposed rule for the rule's potential economic impact on small entities, including small businesses. Section 603 of the RFA generally requires that agencies prepare an initial regulatory flexibility analysis (IRFA) and make the analysis available to the public for comment when the agency publishes a notice of proposed rulemaking. The IRFA must describe the impact of the proposed rule on small entities and identify any alternatives that may reduce the impact. Specifically, the IRFA must contain:

 

  • A description of, and where feasible, an estimate of the number of small entities to which the proposed rule will apply;
  • a description of the reasons why action by the agency is being considered;
  • a succinct statement of the objectives of, and legal basis for, the proposed rule;
  • a description of the projected reporting, recordkeeping, and other compliance requirements of the proposed rule, including an estimate of the classes of small entities subject to the requirements and the types of professional skills necessary for the preparation of reports or records; and
  • an identification, to the extent possible, of all relevant federal rules which may duplicate, overlap, or conflict with the proposed rule.

B. Market Description

CPSC is aware of 15 firms currently supplying frame child carriers to the U.S. market, although additional firms may supply these products to U.S. customers. Most of these firms specialize in the manufacture and/or distribution of one of two distinct types of products: (1) children's products, including durable nursery products; or (2) outdoor products, such as camping and hiking gear. The majority of the 15 known firms are domestic (including four manufacturers, seven importers, and one firm whose supply source could not be determined). The remaining three firms are foreign (including two manufacturers and one firm that imports products from foreign companies and distributes the products from outside of the United States). [4]

 

According to a 2005 survey conducted by the American Baby Group (2006 Baby Products Tracking Study), [5] 32 percent of new mothers owned a frame child carrier. Approximately 32 percent of those carriers were handed down or purchased secondhand, [6] and about 68 percent were new when acquired. This information suggests annual sales of around 870,000 frame child carriers (.32 × .68 × 4 million births per year), [7] typically costing from $100 to around $300.

 

C. Reason for Agency Action and Legal Basis for the Proposed Rule

The Danny Keysar Child Product Safety Notification Act, section 104 of the CPSIA, requires the CPSC to promulgate a mandatory standard that is substantially the same as, or more stringent than, the voluntary standard for a durable infant or toddler product. The proposed rule implements that congressional direction.

 

D. Other Federal Rules

There are two federal rules that would interact with the frame child carriers mandatory standard: (1) Testing and Labeling Pertaining to Product Certification (16 CFR part 1107); and (2) Requirements Pertaining to Third Party Conformity Assessment Bodies (16 CFR part 1112).

 

The testing and labeling rule (16 CFR part 1107) requires that manufacturers of children's products subject to children's product safety rules certify, based on third party testing, that the manufacturers' children's products comply with all applicable children's product safety rules. If a final children's product safety rule for frame child carriers is adopted by the Commission, frame child carriers will be subject to the third party testing requirements, including record keeping, when such a final frame child carriers rule becomes effective.

 

In addition, the 16 CFR part 1107 rule requires the third party testing of children's products to be conducted by CPSC-accepted test laboratories. Section 14(a)(3) of the CPSA requires the Commission to publish an NOR for the accreditation of third party conformity assessment bodies to test for conformance with each children's product safety rule. Existing NORs that have been issued by the Commission are listed in 16 CFR part 1112. Consequently, the Commission proposes to amend 16 CFR part 1112 to add the frame child carriers rule to the list of rules for which the Commission has issued an NOR.

 

E. Impact of Proposed 16 CFR Part 1230 on Small Businesses

We are aware of approximately 15 firms currently marketing frame child carriers in the United States, 12 of which are domestic firms. Under U.S. Small Business Administration (SBA) guidelines, a manufacturer of frame child carriers is categorized as small if the firm has 500 or fewer employees, and importers and wholesalers are considered small if they have 100 or fewer employees. We limited our analysis to domestic firms because SBA guidelines and definitions pertain to U.S.-based entities. Based on these guidelines, about nine of the identified 15 firms are small—three domestic manufacturers, five domestic importers, and one domestic firm with an unknown supply source. There may be additional unknown small domestic frame child carrier suppliers operating in the U.S. market.

 

Prior to the preparation of a regulatory flexibility analysis, staff conducts a screening analysis in order to determine whether a regulatory flexibility analysis or a certification statement of no significant impact on a substantial number of small entities is appropriate for a proposed rule. The SBA gives considerable flexibility in defining the threshold for “no significant economic impact.” However, staff typically uses 1 percent of gross revenue as a threshold; unless the impact is expected to fall below the 1 percent threshold for the small businesses evaluated, staff prepares a regulatory flexibility analysis. Because staff was unable to demonstrate that the proposed rule would impose an economic impact less than 1 percent of gross revenue for the affected firms, staff conducted an IRFA.

 

Small Manufacturers. Of the three small domestic manufacturers, the proposed rule is likely to have little or no impact on the two firms whose frame child carriers comply with the ASTM voluntary standard currently in effect for JPMA testing and certification purposes (ASTM F2549-09a). We anticipate that these firms will remain compliant with the voluntary standard as the standard changes because these firms follow, and in at least one case, participate actively in the voluntary standard development process. Therefore, compliance with the evolving voluntary standard is part of an established business practice. ASTM F2549-14, the version of the voluntary standard upon which the proposed rule is based, will be in effect already for JPMA testing and certification purposes, before a mandatory standard becomes final, should one be issued by the Commission; and these firms are likely to be in compliance based on their history. Because the proposed modification to the retention system requirement consists of specifying pass/fail criteria already used by test laboratories, we do not expect the modification to have an impact on firms.

 

The remaining small manufacturer would experience some economic impacts of unknown size. Based on discussions with a company representative, this firm does not know whether its products comply with the voluntary standard, having been previously unaware of the standard's existence. However, the firm indicated that it might elect to discontinue production of its frame child carriers, even if the firm's frame child carriers prove to be compliant with the proposed CPSC standard. The company believes that the burden associated with the testing and record-keeping requirements triggered by a mandatory frame child carriers standard might exceed the value of continuing production. Although this firm produces many other products, which should lessen the economic impact, and indicated that frame child carriers do not represent a large portion of the firm's product line, the firm did not convey the precise percentage of revenues that frame child carriers constitutes for this firm and thus, staff could not rule out a significant economic impact on this firm.

 

Under section 14 of the CPSA, should the Commission adopt the new frame child carriers requirements as a final rule, once the requirements become effective, all manufacturers will be subject to the additional costs associated with the third party testing and certification requirements under the testing and labeling rule (16 CFR part 1107). Third party testing will include any physical and mechanical test requirements specified in the final frame child carriers rule that may be issued; lead and phthalates testing are already required. Third party testing costs are in addition to the direct costs of meeting the frame child carriers standard.

 

Several firms were contacted regarding testing costs and one estimated that chemical and structural testing of one unit of a frame child carrier costs around $1,300. No other firms were willing or able to supply the requested testing cost information. Estimates provided by suppliers for other section 104 rulemakings indicate that around 40 percent to 50 percent of testing costs can be attributed to structural requirements, with the remaining 50 percent to 60 percent resulting from chemical testing (e.g., lead and phthalates). Therefore, staff estimates that testing to the ASTM voluntary standard could cost about $520 to $650 per sample tested ($1,300 × .4 to $1,300 × .5). These costs are consistent with testing cost estimates for products with standards of similar complexity.

 

Staff's review of the frame child carrier market shows that on average, each small domestic manufacturer supplies three different models of frame child carriers to the U.S. market annually. Therefore, if third party testing were conducted every year, third party testing costs for each manufacturer would be about $1,560 to $1,950 annually, if only one sample were tested for each model. Based on an examination of each small domestic manufacturer's revenues from recent Dun Bradstreet or Reference USAGov reports, the impact of third party testing to ASTM F2549-14 is unlikely to be economically significant for the three small domestic manufacturers (i.e., testing costs less than one percent of gross revenue). Although the testing and labeling rule (16 CFR part 1107) does not set forth a specific number of samples firms will need to test to meet the “high degree of assurance” criterion, more than 100 units per model would be required to make testing costs economically significant for the two firms with available revenue data. As described above, the third manufacturer has already indicated that the firm may exit the market because of the testing costs, even if the company's frame child carriers meet the requirements of the voluntary standard.

 

Small Importers. As noted above, there are five small importers of frame child carriers, with three of them currently importing compliant carriers. In the absence of a mandatory regulation, these three small importers of frame child carriers would likely remain in compliance with new versions of the standard. Given that the three small importers have developed a pattern of compliance with the ASTM voluntary standard as the standard evolves and that the proposed rule does not differ substantively from the voluntary standard, ASTM F2549-14, as applied by test laboratories, the three small importers of compliant products would likely experience little or no direct costs under the proposed rule.

 

Whether there is a significant economic impact on the two small importers with noncompliant frame child carriers will depend upon the extent of the changes required to come into compliance and the response of their supplying firms. Because no small importers with noncompliant frame child carriers responded to requests for information, staff cannot estimate the precise economic impact on these firms.

 

However, in general, if an importer's supplying firm supplies products that comply with the new standard, the importer could elect to continue importing the frame child carriers. Any increase in production costs experienced by the importer's suppliers as a result of changes made to meet the mandatory standard may be passed on to the importer. If an importer is unwilling or unable to accept the increased costs, or if the importer's supplier decides not to comply with the mandatory standard, at least three alternative courses of action are available. First, the importer could find another supplier of frame child carriers. This could result in increased costs as well, depending, for example, on whether the alternative supplier must modify its carriers to comply with the mandatory standard. Second, the importer could import a different product in place of frame child carriers. This alternative would help mitigate the economic impact of the mandatory standard on these firms. Finally, the importer could stop importing frame child carriers and make no other changes to its product line. As with manufacturers, all importers are subject to third party testing and certification requirements. Consequently, if the Commission adopts a final mandatory standard for frame child carriers, importers will be subject to costs similar to those for manufacturers, if the importer's supplying foreign firm(s) does not perform third party testing. It does not appear likely that these costs would have a significant economic impact on the two small domestic importers for which revenue information is available, unless around 20 units per model were required to be tested to provide a “high degree of assurance” (i.e., at 20 units tested per model, testing costs will exceed one percent of gross revenue for each of these firms, even if testing costs are estimated at the lowest level of $520). The impact on the other three small importers is unknown.

 

Alternatives. Under the Danny Keysar Child Product Safety Notification Act, one alternative that generally reduces the impact on small entities is to make the voluntary standard mandatory with no modifications. However, in the case of frame child carriers, no difference in impact would be expected because the CPSC proposed modification articulates the current standard practice of test laboratories. Thus, only products that cannot meet the requirement without the modification would fail the requirement with the modification.

 

Another way that the Commission could reduce the economic impact of any proposed regulation, including the proposed frame child carriers rule, is to allow for a later effective date. The Commission proposes a 6-month effective date, which is the least amount of time frame child carrier firms familiar with the applicable ASTM standard have indicated they would need for new product development (1.5 years was the longest estimate, with most firms suggesting a 6-month to 1-year time frame). Product redevelopment might be necessary for some noncompliant firms to meet the requirements of ASTM F2549-14; although staff does not believe that complete redesigns will be necessary based on preliminary product testing. In particular, no product modifications should be necessary to meet the proposed pass/fail criteria for the retention system performance requirement because, as already mentioned, the proposed requirement only clarifies what the test laboratories are already performing. A later effective date, more in line with the longest estimate of time required for product redevelopment, could reduce the economic impact in two ways. One, firms are less likely to experience a lapse in production, which could result if they are unable to comply within the required timeframe. Two, firms could spread costs over a longer time period, thereby reducing their annual costs, as well as the present value of their total costs. In the case of frame child carrier firms, a longer effective date would primarily benefit firms with noncompliant products.

 

F. Impact of Proposed 16 CFR Part 1112 Amendment on Small Businesses

As required by the RFA, staff conducted a Final Regulatory Flexibility Analysis (FRFA) when the Commission issued the part 1112 rule (78 FR 15836, 15855-58). Briefly, the FRFA concluded that the accreditation requirements would not have a significant adverse impact on a substantial number of small test laboratories because no requirements were imposed on test laboratories that did not intend to provide third party testing services. The only test laboratories that were expected to provide such services were those that anticipated receiving sufficient revenue from the mandated testing to justify accepting the requirements as a business decision. Moreover, a test laboratory would only choose to provide such services if it anticipated receiving revenues sufficient to cover the costs of the requirements.

 

Based on similar reasoning, amending 16 CFR part 1112 to include the NOR for the frame child carriers standard will not have a significant adverse impact on small test laboratories. Moreover, based upon the number of test laboratories in the United States that have applied for CPSC acceptance of accreditation to test for conformance to other mandatory juvenile product standards, we expect that only a few test laboratories will seek CPSC acceptance of their accreditation to test for conformance with the frame child carriers standard. Most of these test laboratories will have already been accredited to test for conformance to other mandatory juvenile product standards, and the only costs to them would be the cost of adding the frame child carriers standard to their scope of accreditation. As a consequence, the Commission certifies that the NOR amending 16 CFR part 1112 to include the frame child carriers standard will not have a significant impact on a substantial number of small entities.

 

IX. Environmental Considerations Back to Top

The Commission's regulations address whether the agency is required to prepare an environmental assessment or an environmental impact statement. Under these regulations, a rule that has “little or no potential for affecting the human environment,” is categorically exempt from this requirement. 16 CFR 1021.5(c)(1). The proposed rule falls within the categorical exemption.

 

X. Paperwork Reduction Act Back to Top

This proposed rule contains information collection requirements that are subject to public comment and review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). In this document, pursuant to 44 U.S.C. 3507(a)(1)(D), we set forth:

 

  • A title for the collection of information;
  • a summary of the collection of information;
  • a brief description of the need for the information and the proposed use of the information;
  • a description of the likely respondents and proposed frequency of response to the collection of information;
  • an estimate of the burden that shall result from the collection of information; and
  • notice that comments may be submitted to the OMB.

Title: Safety Standard for Frame Child Carriers

 

Description: The proposed rule would require each frame child carrier to comply with ASTM F2549-14, Standard Consumer Safety Specification for Frame Child Carriers. Sections 8 and 9 of ASTM F2549-14 contain requirements for marking, labeling, and instructional literature. These requirements fall within the definition of “collection of information,” as defined in 44 U.S.C. 3502(3).

 

Description of Respondents: Persons who manufacture or import frame child carriers.

 

Estimated Burden: We estimate the burden of this collection of information as follows:

 

Table 1—Estimated Annual Reporting Burden Back to Top
16 CFR Section Number of respondents Frequency of responses Total annual responses Hours per response Total burden hours
1230.2(a) 15 3 45 1 45

Estimates are based on the following:

 

Section 8.1.1 of ASTM F2549-14 requires that the name and the place of business (city, state, and mailing address, including zip code) or telephone number of the manufacturer, distributor, or seller be marked clearly and legibly on each product and its retail package. Section 8.1.2 of ASTM F2549-14 requires a code mark or other means that identifies the date (month and year, as a minimum) of manufacture.

 

There are 15 known entities supplying frame child carriers to the U.S. market that might need to make some modifications to their existing labels. We estimate that the time required to make these modifications is about 1 hour per model. Based on an evaluation of supplier product lines, each entity supplies an average of three different models of frame child carriers; [8] therefore, the estimated burden associated with labels is 1 hour per model × 15 entities × 3 models per entity = 45 hours. We estimate the hourly compensation for the time required to create and update labels is $27.71 (U.S. Bureau of Labor Statistics, “Employer Costs for Employee Compensation,” September 2013, Table 9, total compensation for all sales and office workers in goods-producing private industries: http://www.bls.gov/ncs/). Therefore, the estimated annual cost to industry associated with the labeling requirements is $1,246.95 ($27.71 per hour × 45 hours = $1,246.95). There are no operating, maintenance, or capital costs associated with the collection.

 

Section 9.1 of ASTM F2549-14 requires instructions to be supplied with the product. Frame child carriers are complicated products that generally require use and assembly instructions. Under the OMB's regulations (5 CFR 1320.3(b)(2)), the time, effort, and financial resources necessary to comply with a collection of information that would be incurred by persons in the “normal course of their activities” are excluded from a burden estimate, where an agency demonstrates that the disclosure activities required to comply are “usual and customary.” Therefore, because we are unaware of frame child carriers that generally require use instructions, but lack such instructions, we tentatively estimate that there are no burden hours associated with section 9.1 of ASTM F2549-14 because any burden associated with supplying instructions with frame child carriers would be “usual and customary” and not within the definition of “burden” under the OMB's regulations.

 

Based on this analysis, the proposed standard for frame child carriers would impose a burden to industry of 45 hours at a cost of $1,246.95 annually.

 

In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), we have submitted the information collection requirements of this rule to the OMB for review. Interested persons are requested to submit comments regarding information collection by June 16, 2014, to the Office of Information and Regulatory Affairs, OMB (see the ADDRESSES section at the beginning of this notice).

 

Pursuant to 44 U.S.C. 3506(c)(2)(A), we invite comments on:

 

  • Whether the collection of information is necessary for the proper performance of the CPSC's functions, including whether the information will have practical utility;
  • the accuracy of the CPSC's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
  • ways to enhance the quality, utility, and clarity of the information to be collected;
  • ways to reduce the burden of the collection of information on respondents, including the use of automated collection techniques, when appropriate, and other forms of information technology; and
  • the estimated burden hours associated with label modification, including any alternative estimates.

XI. Preemption Back to Top

Section 26(a) of the CPSA, 15 U.S.C. 2075(a), provides that when a consumer product safety standard is in effect and applies to a product, no state or political subdivision of a state may either establish or continue in effect a requirement dealing with the same risk of injury unless the state requirement is identical to the federal standard. Section 26(c) of the CPSA also provides that states or political subdivisions of states may apply to the Commission for an exemption from this preemption under certain circumstances. Section 104(b) of the CPSIA refers to the rules to be issued under that section as “consumer product safety rules.” Therefore, the preemption provision of section 26(a) of the CPSA would apply to a rule issued under section 104.

 

XII. Request for Comments Back to Top

This NPR begins a rulemaking proceeding under section 104(b) of the CPSIA to issue a consumer product safety standard for frame child carriers, and to amend part 1112 to add frame child carriers to the list of children's product safety rules for which the CPSC has issued an NOR. We invite all interested persons to submit comments on any aspect of the proposed mandatory safety standard for frame child carriers and on the proposed amendment to part 1112. Specifically, the Commission requests comments on the costs of compliance with, and testing to, the proposed frame child carriers safety standard, the proposed six-month effective date for the new mandatory frame child carriers safety standard, and the amendment to part 1112.

 

Comments should be submitted in accordance with the instructions in the ADDRESSES section at the beginning of this notice.

 

List of Subjects Back to Top

For the reasons discussed in the preamble, the Commission proposes to amend Title 16 of the Code of Federal Regulations as follows:

 

 begin regulatory text 

PART 1112—REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY ASSESSMENT BODIES Back to Top

1.The authority citation for part 1112 continues to read as follows:

 

Authority:

15 U.S.C. 2063; Pub. L. 110-314, section 3, 122 Stat. 3016, 3017 (2008).

 

2.Amend § 1112.15 by adding paragraph (b)(38) to read as follows:

 

§ 1112.15 When can a third party conformity assessment body apply for CPSC acceptance for a particular CPSC rule and/or test method?

* * * * *

 

(b) (38) 16 CFR part 1230, Safety Standard for Frame Child Carriers.

 

* * * * *

 

3.Add part 1230 to read as follows:

 

PART 1230—SAFETY STANDARD FOR FRAME CHILD CARRIERS Back to Top

Authority:

The Consumer Product Safety Improvement Act of 2008, Pub. L. 110-314, § 104, 122 Stat. 3016 (August 14, 2008); Pub. L. 112-28, 125 Stat. 273 (August 12, 2011).

 

§ 1230.1 Scope.

This part establishes a consumer product safety standard for frame child carriers.

 

§ 1230.2 Requirements for Frame Child Carriers.

(a) Each frame child carrier must comply with all applicable provisions of ASTM F2549-14, Standard Consumer Safety Specification for Frame Child Carriers, approved on January 1, 2014. 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/cpsc.htm. You may inspect a copy at the Office of the Secretary, U.S. Consumer Product Safety Commission, Room 820, 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) Comply with ASTM F2549-14 standard with the following exception:

 

(1) Instead of complying with section 6.5 of ASTM F2549-14, comply with the following:

 

(i) 6.5 Retention System:

 

(A) 6.5.1 A retention system, including a shoulder restraint, shall be provided to secure the occupant in a seated position in any of the manufacturer's recommended use positions.

 

(B) 6.5.2 Before shipment, the manufacturer shall attach the retention system in such a manner that it will not detach in normal usage.

 

(C) 6.5.3 If the retention system includes a crotch restraint designed to work with a lap belt, it shall be designed such that its use is mandatory when the retention system is in use.

 

(D) 6.5.4 When tested in accordance with 7.5, the restraint system and its closing means (for example, a buckle) shall not break, disengage or separate at any seam and all fasteners shall not release or suffer damage that impairs the operation and function of the restraint system. At the end of the tests, the CAMI dummy shall not be released fully or fall out of the carrier.

 

(ii) [Reserved]

 

(2) [Reserved]

 

Dated: May 12, 2014.

 

Todd A. Stevenson,

 

Secretary, Consumer Product Safety Commission.

 

 end regulatory text 

[FR Doc. 2014-11193 Filed 5-15-14; 8:45 am]

 

BILLING CODE 6355-01-P

 

Footnotes Back to Top

1. According to staff from the Directorate for Health Sciences, a closed head injury is a head injury where the skull remained intact but it can range in severity from a minor bump to a severe life-threatening traumatic brain injury.

 

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2. The test sphere size is based on the hip circumference of the smallest child likely to use the frame child carrier (3 to 5 months of age).

 

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4. Staff made these determinations using information from Dun & Bradstreet and ReferenceUSAGov, as well as firm Web sites.

 

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5. The data collected for the Baby Products Tracking Study do not represent an unbiased statistical sample. The sample of 3,600 new and expectant mothers is drawn from American Baby magazine's mailing lists. Additionally, because the most recent survey information is from 2005, the data may not reflect the current market.

 

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6. The data on secondhand products for new mothers were not available. Instead, data for new mothers and expectant mothers were combined andbroken into data for first-time mothers and data for experienced mothers. Data for first-time mothers and experienced mothers have been averaged to calculate the approximate percentage of products that were handed down or purchased secondhand.

 

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7. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC), National Center for Health Statistics, National Vital Statistics System, “Births: Final Data for 2010,”National Vital Statistics Reports Volume 61, Number 1 (August 28, 2012): Table 1. The number of births in 2010 is rounded from 3,999,386.

 

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8. This number was derived during the market research phase of the initial regulatory flexibility analysis by dividing the total number of frame carriers supplied by all frame child carrier suppliers by the total number of frame child carrier suppliers.

 

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