Consumer Product Safety Commission.
The Danny Keysar Child Product Safety Notification Act, section 104(b) of the Consumer Product Safety Improvement Act of 2008 (CPSIA), requires the United States Consumer Product Safety Commission (Commission, CPSC, or we) 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 issuing a safety standard for hand-held infant carriers in response to the direction under section 104(b) of the CPSIA. The rule would incorporate ASTM F2050-13a by reference, with one modification.
The rule will become effective on June 6, 2014. The incorporation by reference of the publication listed in this rule is approved by the Director of the Federal Register as of June 6, 2014.
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FOR FURTHER INFORMATION CONTACT:
Julio Alvarado, Compliance Officer, Office of Compliance and Field Operations, U.S. Consumer Product Safety Commission, 4330 East-West Highway, Bethesda, MD 20814; email: email@example.com.
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I. Background and Statutory Authority
The CPSIA (Pub. L. 110-314) was enacted on August 14, 2008. Section 104(b) of the CPSIA 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. 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 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. Infant carriers are one of the products specifically identified in section 104(f)(2)(H) as a durable infant or toddler product. The Commission has identified four types of products that could fall within the infant carrier product category, including: Frame backpack carriers, soft infant and toddler carriers, slings, and hand-held infant carriers. This rule addresses hazards associated only with hand-held infant carriers. Hazards associated with other types of carriers would be Start Printed Page 73416addressed in separate rulemaking proceedings.
On December 10, 2012, the Commission issued a notice of proposed rulemaking (NPR) for hand-held infant carriers. 77 FR 73354. The NPR proposed to incorporate by reference the then current voluntary standard, ASTM F2050-12, Standard Consumer Safety Specification for Hand-Held Infant Carriers, with certain modifications to strengthen the ASTM standard. One proposed modification provided for a change in the warning label to better address suffocation and restraint-related hazards. The other proposed modification addressed the testing procedures for the carry handle auto-locking requirement and specified using an aluminum cylinder as the surrogate for the occupant of the carrier rather than a CAMI Mark II 6-month infant dummy (CAMI dummy).
Since the Commission published the NPR, ASTM has revised ASTM F2050 twice. On July 1, 2013, ASTM approved an updated version of the voluntary standard, ASTM F2050-13, which includes the warning label modification proposed in the NPR. On September 1, 2013, ASTM approved another revision of the voluntary standard, ASTM F2050-13a, which includes a carry handle auto-locking performance requirement that is different than the requirement proposed in the NPR. As explained in section VII of this preamble, the Commission agrees with the auto-locking requirement in ASTM F2050-13a. The draft final rule incorporates by reference the most recent version of the ASTM standard, ASTM F2050-13a, with one modification—a clarification of the definition of “hand-held infant carrier,” to include a specific reference to both “rigid-sided” and “semi-rigid-sided” products.
II. The Product
ASTM F2050-13a defines a “hand held infant carrier” as a “freestanding, rigid-sided product intended to carry an occupant whose torso is completely supported by the product to facilitate transportation by a caregiver by means of hand-holds or handles.” The ASTM voluntary standard published in August 2012, for the first time referenced two types of hand-held infant carriers: Hand-held bassinets/cradles and hand-held carrier seats. The current ASTM voluntary standard defines “hand-held carrier seat” as a “hand-held infant carrier having a seat back that is intended to be in a reclined position (more than 10° from horizontal),” and “hand-held bassinet/cradle” is defined as “a freestanding product, with a rest/support surface to facilitate sleep (intended to be flat or up to 10° from horizontal), that sits directly on the floor, without legs or a stand, and has hand-holds or handle(s) intended to allow carrying an occupant whose torso is completely supported by the product.” Hand-held carrier seats often are used as infant car seats, or as attachments to strollers or high chairs bases. Some of the requirements in F2050-13a are different for hand-held bassinets/cradles and hand-held infant carriers because the intended position of the occupant (lying supine vs. sitting reclined) and the product designs used to accommodate the occupant can create different hazards.
A Moses basket is a freestanding product with a rest/support surface to facilitate sleep and has hand-holds or handles intended to allow carrying an occupant. Some Moses baskets are rigid-sided, but most have semi rigid sides. In the NPR, the Commission sought comment on whether Moses baskets are or should be covered by this safety standard. The Commission also asked: (1) If Moses baskets should be included in this safety standard, does the present definition cover Moses baskets, and (2) if the present definition does not cover Moses baskets, how should the standard be amended to cover Moses baskets? The Commission received no comments in response to these questions and will clarify the definition of “hand-held infant carrier” in the rule to specify that the definition includes both “rigid-sided” and “semi-rigid-sided” products.
III. Incident Data
The preamble to the NPR summarized incident data involving bassinets and cradles reported to the Commission as of June 8, 2012. 77 FR 73354 (December 10, 2012). The NPR stated that, according to reports to the CPSC, 242 incidents involving hand-held infant carriers occurred between January 1, 2007 and June 7, 2012. Of the 242 incidents, there were 36 fatalities, 60 nonfatal injuries, and 146 incidents where no injury occurred or was reported. Staff attributed the majority of the fatalities to the improper use or nonuse of the carrier's restraint system.
CPSC's Directorate for Epidemiology, Division of Hazard Analysis has updated this information to include hand-held infant carrier-related incident data reported to the Commission from June 8, 2012 through June 21, 2013. A search of the CPSC epidemiological databases showed that there were 10 new incidents related to hand-held infant carriers reported during this time frame. Seven of the 10 were fatal, and three were nonfatal. None of the nonfatal incidents involved injuries. All of the new incidents reportedly occurred in late 2011 and 2012. Reporting is ongoing, however, so the incident totals are subject to change.
A. Fatalities Reported Since the NPR
Most of the more recently reported seven fatalities involved a product-related issue. The ages of the decedents ranged from one month to 15 months. Staff attributes the majority of the fatalities to the improper use or nonuse of the carrier's restraint system. The incident reports indicate the following circumstances in these fatalities:
- Infant was unrestrained and found in a prone position with the seat tipped over;
- infant was unrestrained and found with its face pressed into the side of the seat;
- infant strangled to death when restrained by the shoulder straps only and moved forward in the seat and was caught in the throat by the chest clip that connects the shoulder straps;
- infant was strapped into a hand-held infant carrier that was placed on a bed and overturned;
- infant was reported to have become entrapped in the carrier by other unsupervised children; although information on the exact manner of entrapment was unavailable;
- insufficient information to identify conclusively a hazard pattern but may have been the result of misuse of the product;
- insufficient information to identify hazard pattern.
B. Nonfatal Incidents Reported Since the NPR
There were three hand-held carrier-related nonfatal incidents reported to the Commission from June 8, 2012 through June 21, 2013. All of the incidents occurred in 2012; none of these involved an injury. Two of the incident reports stated that the carrier handle broke. The third report was a complaint about the poor quality and design of a Moses basket carrier.
C. Hazard Pattern Identification
Staff did not identify any new hazard patterns among the 10 incident reports that CPSC staff received since the Commission published the hand-held infant carrier NPR. In order of frequency of incident reports, staff grouped the hazard patterns of the incidents reported since the NPR into the following categories:
1. Restraint issues: Three of the incidents—all fatalities—were associated with the incorrect use or nonuse of the harness straps. In two of Start Printed Page 73417these fatal incidents, the decedent was not restrained in the carrier at all. The decedents were found later to have turned over to a prone position, face down on a soft surface. One death resulted when the infant was left in the seat with only the shoulder straps connected, but unrestrained at the crotch strap, which allowed the infant to slide forward in the seat, just enough to get caught at the throat by the chest clip and become strangled.
2. Handle problems: Two incident reports state that the handle broke. One of these incidents involved a product that was already recalled for handle problems. There were no injuries reported in these incidents.
3. Issues with carrier design: There was one fatality in this category, which resulted when the occupied carrier was left on a soft surface (i.e., a bed), tipped upside down, and trapped the infant. In addition, one noninjury report complained about the poor and unsafe design of a Moses basket carrier.
4. Hazardous environment: One fatality resulted from an infant becoming trapped in the hand-held carrier by other unsupervised children. Details of the manner in which the entrapment occurred were unavailable.
5. Other product-related issue: One fatality report indicated that misuse of the product may have contributed to the incident; however, not enough information was available for CPSC staff to identify conclusively the hazard pattern involved.
6. Other/unknown issue: One fatality was reported with an undetermined official cause of death. There was insufficient evidence of any product involvement or the presence of any hazardous external circumstances.
IV. Overview of ASTM F2050
ASTM F2050, Standard Consumer Safety Specification for Hand-Held Infant Carriers, establishes safety performance requirements, test methods, and labeling requirements to minimize the identified hazard patterns associated with the use of hand-held infant carriers. The voluntary standard for hand-held infant carriers was first approved and published in August 2000, as ASTM F2050-00, Standard Consumer Safety Performance Specification for Hand-Held Infant Carriers. ASTM has revised the standard six times since then. ASTM F2050-13 was approved on July 1, 2013, and the current version, ASTM F2050-13a, was approved on September 1, 2013. The more significant requirements of ASTM F2050 include:
- Scope—describes the types of products intended to be covered under the standard.
- Testing of the handle auto-locking mechanism—is intended to prevent unintentional rotation of the carrier and resulting expulsion of the child when the caregiver picks up the carrier by the handle and the handle is not in a locked position.
- Testing of the integrity of the handle—is intended to prevent unintentional separation of the handle from the carrier while in use.
- Occupant restraints—are intended to prevent incidents in which improper use of restraints has resulted in the entrapment and strangulation of children.
- Slip-resistance requirement—is intended to prevent the carrier from sliding when placed on a slightly inclined surface.
- Warning label—is intended to address: (1) Improper use of restraints (to prevent strangulation and other injuries), and (2) improper placement of the carrier on an elevated surface (to prevent fall injuries).
The voluntary standard also includes: (1) Torque and tension tests to prevent components from being removed; (2) requirements to prevent entrapment and cuts (minimum and maximum opening size, small parts, hazardous sharp edges or points, and edges that can scissor, shear, or pinch); (3) requirements for the permanency and adhesion of labels; and (4) requirements for instructional literature.
V. The NPR and ASTM 2050-12
The NPR proposed to incorporate by reference ASTM F2050-12 as a consumer product safety standard, with two modifications:
1. Warning Label: The NPR proposed requiring a strangulation warning label to be affixed to the outer surface of the cushion or padding of a hand-held carrier seat in or adjacent to the area where the child's head would rest. Under the proposal, the warning label for hand-held carrier seats that are intended to be used as restraints in motor vehicles would include a pictogram, while the warning label for hand-held carrier seats not intended to be used as restraints in motor vehicles would not include the pictogram because these seats do not have the chest clips depicted in the pictogram.
2. Handle Auto-Lock Test: The NPR proposed a modification of the test method for preventing the carrier from rotating and spilling an unrestrained infant when a caregiver picks up the carrier and the handle is not locked in the carry position. The test method in ASTM F2050-12 required the tester to use a standard CAMI dummy as an infant surrogate. The NPR proposed a change that would require the tester to use an aluminum cylinder designed as a surrogate for a 6-month-old infant, in lieu of the CAMI dummy, because testing had revealed that the CAMI dummy could be wedged into the seat padding or otherwise manipulated, so that the CAMI dummy did not fall out during the lift test when the CAMI dummy otherwise should fall. Furthermore, the Commission was concerned that the ability to pass or fail the test based on friction or placement of the CAMI would affect the consistency and repeatability of the test results.
The NPR also asked for comments regarding whether Moses baskets should be included in this safety standard, and if so, whether we should revise the definition of “hand-held infant carrier” to cover Moses baskets.
VI. ASTM F2050-13a
ASTM approved the current voluntary standard for hand-held infant carriers, ASTM F2050-13a, on September 1, 2013. ASTM balloted the NPR's provisions concerning the warning label requirement in 2013, and the provisions are now included in the latest revision of the voluntary standard, ASTM 2050-13a.
Several comments received in response to the NPR suggested that the aluminum cylinder was not an appropriate surrogate for use in the handle auto-lock test and maintained that other surrogates, including the CAMI dummy, would produce more repeatable and consistent test results if properly placed in the carrier. After considering these comments and the results of additional testing performed since the Commission published the NPR, Commission staff determined that using the CAMI dummy, with certain modifications to the test procedure, would produce more repeatable and consistent test results. ASTM F2050-13a retains the use of the CAMI dummy as the surrogate occupant and clarifies how the dummy should be situated in the seat during testing. The revised requirement also:
- Specifies using webbing instead of hooks for lifting the carrier during the test;
- specifies that a pneumatic cylinder be used to provide the force needed for the lift; and
- narrows the lift speed range.
VII. Responses to Comments
The Commission received five comments on the NPR, including: one Start Printed Page 73418from a consumer's group (Consumers Union); one from the Juvenile Products Manufacturers Association (JPMA); and three from hand-held infant carrier manufacturers. The comments raised several issues, which resulted in ASTM changing the handle auto-lock test procedures and including guidance for the placement of the CAMI dummy in the seat during the handle-auto lock test in ASTM F2050-13a. Several commenters made general statements supporting the overall purpose of the proposed rule. All of the comments can be viewed at: www.regulations.gov, by searching under the docket number of the rulemaking, CPSC-2012-0068. Following is a summary of, and responses to, the comments.
Handle Auto-Locking Test—CAMI Dummy v. Aluminum Cylinder
Comment: Two commenters supported the proposal to use the aluminum cylinder surrogate instead of the CAMI dummy during the handle auto-locking test. The other three commenters opposed using the aluminum cylinder surrogate. Specific concerns with the cylinder included: (1) The cylinder is not the same shape as a child and can roll from side to side during testing; (2) the weight distribution and center of gravity of the cylinder are different for a child, and the cylinder can tip forward in an unrealistic manner during testing; and (3) testing with the cylinder can be dangerous because the cylinder can fall out of the carrier during testing and potentially injure a tester. The three commenters who raised concerns about using the cylinder as a surrogate in the handle auto-locking test preferred using the CAMI dummy as the surrogate for this test. One commenter suggested that whichever surrogate was specified, more detail be provided for placing the surrogate into the carrier before the lift test. One commenter suggested that CPSC should allow ASTM additional time to develop a test procedure that will provide more repeatable results.
Response: Since publication of the NPR, Commission staff has reviewed the comments, witnessed additional testing, and participated in discussions at ASTM hand-held infant carrier subcommittee and task group meetings. Based on this additional work, the Commission agrees with the three commenters who stated that using the cylinder during testing would produce unrepeatable results for some carriers. The Commission believes that most of the issues presented by use of the CAMI dummy can be addressed with clarifications and modifications to the ASTM test procedure set forth in ASTM F2050-12 so that the test produces more repeatable and reliable results. ASTM revised the requirement in the most recent version of F2050, and staff believes the revision, as now stated in ASTM F2050-13a, is adequate to address the hazards associated with unlocked carry handles. Therefore, the final rule does not does not require any changes to the carry handle auto-locking requirement but incorporates by reference the latest version of the standard, ASTM F2050-13a.
Fall Hazard Warning
Comment: One commenter recommended that the Commission strengthen the warning regarding the fall hazard to discourage more strongly caregivers placing the carrier on elevated surfaces. The language in ASTM F2050-12 (the version in effect at the time of the NPR) stated: “Fall Hazard: Child's movement can slide carrier. NEVER place carrier near edges of counter tops, tables, or other elevated surfaces.”
Response: The Commission agrees with the commenter that the fall hazard warning stated in ASTM F2050-12 was not sufficiently strong. Leaving hand-held carriers on elevated surfaces is a foreseeable behavior, and the warning language should highlight the importance of not leaving the carriers on elevated surfaces. ASTM F2050-13a revises this warning. The warning language in ASTM's `13a version is presented below:
220.127.116.11 Fall Hazard: Child's activity can move carrier. Never place carrier on counter tops, tables, or any other elevated surfaces.
The Commission agrees with the change in the ASTM standard, and thus, no further modifications are necessary in response to this comment.
Location of the Strangulation Warning Label
Comment: One commenter expressed concern that the requirement that the label be placed “in or adjacent to the area where the child's head would rest” does not specify sufficiently the proper placement of the label, and therefore, the label could be obscured when a child is in the seat. The commenter suggested requiring the label to be placed “adjacent to where the infant's head or torso would rest with or without the child installed in the seat.” The commenter explained that this change would permit the caregiver to see the warning label at all times and allow the manufacturer the space and flexibility to place the label in a location that is effective, without impacting NHTSA's airbag warning label.
Response: The requirement in ASTM F2050-13a specifying the location for the warning label mirrors NHTSA's airbag warning label requirement. The Commission believes the warning label location requirement clearly describes the proper location of the label and further believes that adopting the commenter's suggestion may create confusion regarding the placement of the label and may reduce the warning's effectiveness if a manufacturer decides to locate the label toward the lower end of the infant carrier. The Commission agrees with the current language in ASTM F2050-13a and believes that the warning label is more likely to be seen if placed on the outer surface of the cushion or padding, in or adjacent to where child's head rests, and also believes that there is sufficient area in that part of the seat to accommodate both NHTSA's and ASTM's labels independently. Therefore, the Commission declines to make the change suggested by the commenter.
Comment: One commenter suggested that the Commission look for feasible means to bolster the protection against the hazards posed by improper use of the harness restraint system, by requiring an alert mechanism that would clearly signal or indicate whether a harness restraint system is properly secured.
Response: Although alerting the user to the existence of improperly secured or unsecured harnesses would be beneficial, the Commission is uncertain how to accomplish this. Visual indicators are unlikely to get the attention of the user, and an auditory signal (similar to vehicle seat belt reminders) would require a power source that would energize the alert mechanism when the carrier is inside and outside of a vehicle. Adding a power source to the child restraint would require a redesign that may fall under NHTSA's jurisdiction.
Comment: One commenter supported the proposed six-month effective date. Another commenter requested an 18-month effective date, assuming that the final rule would reference the use of the cylinder as the surrogate for the carry handle auto-locking test. The commenter seeking an 18-month effective date expressed concern that requiring the cylinder might necessitate substantial design changes.
Response: Because the Commission has determined that the CAMI dummy will be used as a surrogate in the carry handle auto-locking test, the Start Printed Page 73419commenter's basis for requesting an 18-month effective date no longer exists. A six-month effective date should be sufficient for manufacturers of hand-held infant carriers to comply with the rule.
We did not receive any comments concerning Moses baskets. Despite the lack of comments, the Commission has determined that a revision to the definition of “hand-held infant carrier” is warranted to clarify that Moses baskets are subject to the standard. The final rule modifies the definition of “hand-held infant carrier” as follows (underline represents additional wording): “Hand-held infant carrier—a freestanding, rigid- or semi-rigid- sided product intended to carry an occupant whose torso is completely supported by the product to facilitate transportation by a caregiver by means of hand-holds or handles.”
VIII. Assessment of Voluntary Standard ASTM F2050-13a and Description of Final Rule
Consistent with section 104(b) of the CPSIA, this rule establishes new 16 CFR part 1225, “Safety Standard for Hand-Held Infant Carriers.” The new part incorporates by reference the requirements for hand-held infant carriers in ASTM F2050-13a, with one modification to clarify that semi-rigid sided products, such as Moses baskets, are included in the scope of the rule. The following discussion describes the final rule, the changes, and the additions to the ASTM requirements.
A. Scope (§ 1225.1)
The final rule states that part 1225 establishes a consumer product safety standard for hand-held infant carriers manufactured or imported on or after the date that is six months after the date of publication of a final rule in the Federal Register.
B. Incorporation by Reference (§ 1225.2)
Section 1225.2(a) explains that, except as provided in § 1225.2(b), each hand-held infant carrier must comply with all applicable provisions of ASTM F2050-13a, “Standard Consumer Safety Specification for Hand-Held Infant Carriers,” which is incorporated by reference. Section 1225.2(a) also provides information on how to obtain a copy of the ASTM standard or to inspect a copy of the standard at the CPSC. The Commission received no comments on this provision in the NPR, but the Commission is changing the language in the incorporation in the final rule to refer to ASTM F2050-13a, the current version of the ASTM standard.
C. Changes to Requirements of ASTM F2050-13a
The final rule modifies the definition of “hand-held infant carrier” to clarify that the definition includes products with semi rigid sides, as well as products that are rigid-sided. ASTM revised the hand-held infant carrier standard in 2012, to include a separate definition for “hand-held bassinets/cradles.” A Moses basket meets the definition of a “hand-held bassinet” because a Moses basket is a freestanding product with a rest/support surface that is no more than 10° from horizontal, that sits directly on the floor, without legs or a stand, and has handles or hand-holds intended to allow carrying an occupant whose torso is completely supported by the product. However, because hand-held infant carriers (of which hand-held bassinets/cradles are a subset) are defined in part as “a rigid-sided product” and many Moses baskets have flexible sides, some manufacturers and importers may have interpreted the standard as excluding semi-rigid-sided products such as Moses baskets. Because Moses baskets meet the definition of “hand-held bassinet/cradle,” and Moses baskets are not subject to any other durable children's product standard (specifically ASTM F2194-13, Standard Consumer Safety Specification for Bassinets and Cradles), the Commission has determined that Moses baskets are within the scope of the rule. The modification of the definition of “hand-held infant carrier” to include semi rigid-sided products clarifies that Moses baskets are covered by the rule.
IX. Effective Date
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). To allow time for hand-held carriers to come into compliance, the final rule provides that the standard will become effective 6 months after publication in the Federal Register for products manufactured or imported after that date.
X. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612, requires agencies to consider the impact of rules on small entities, including small businesses. Section 604 of the RFA requires that agencies prepare a final regulatory flexibility analysis when the agency promulgates a final rule, unless the head of the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The final regulatory flexibility analysis must describe the impact of the rule on small entities and identify any alternatives that may reduce the impact. Specifically, the final regulatory analysis must contain:
- A succinct statement of the objectives of, and legal basis for, the rule;
- a summary of the significant issues raised by public comments in response to the initial regulatory flexibility analysis, a summary of the assessment of the agency of such issues, and a statement of any changes made in the proposed rule as a result of such comments;
- a description of, and, where feasible, an estimate of, the number of small entities to which the rule will apply;
- a description of the projected reporting, recordkeeping, and other compliance requirements of the rule, including an estimate of the classes of small entities subject to the requirements and the type of professional skills necessary for the preparation of reports or records; and
- a description of the steps the agency has taken to reduce the significant economic impact on small entities, consistent with the stated objectives of applicable statutes, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the rule, and why each one of the other significant alternatives to the rule considered by the agency, which affect the impact on small entities, was rejected.
B. The Market
The majority of hand-held infant carriers are produced and/or marketed by juvenile product manufacturers and distributors. A potential exception is the Moses basket, which is often marketed by bedding manufacturers and distributors. The Commission estimates that currently, there are at least 47 suppliers of hand-held infant carriers to the U.S. market. Fifteen are domestic manufacturers, 22 are domestic importers, and 1 is a domestic firm with an unknown supply source. In addition, eight foreign firms distribute products from outside of the United States (four manufacturers, two importers, one retailer, and one firm with an unknown supply source). One firm, about which the staff has little information, sells hand-held infant carriers through an online marketplace. An additional 24 domestic firms supply Moses basket Start Printed Page 73420bedding, along with Moses baskets. Staff does not know the source of the Moses baskets supplied by these 24 firms.
We expect that the products of 29 of the 47 hand-held infant carrier suppliers will be compliant with ASTM F2050-13a (7 are JPMA certified to F2050; 6 claim compliance with F2050; and 16 have ASTM-compliant strollers with hand-held infant carrier attachments). We do not believe that any of the Moses baskets currently on the market comply with the voluntary standard; however, the requirements that apply to Moses baskets involve slip resistance, adding warnings, and instructional literature. Staff believes that the majority of Moses baskets on the market would not require adjustments to meet the slip resistance requirement, and that adding warnings and instructional literature would not be costly.
The product ownership data available is limited to infant car seats, which represented nearly the entire hand-held infant carrier market prior to the publication of ASTM F2050-12, which expanded the scope of the standard to include hand-held bassinets and cradles. According to a 2005 survey conducted by the American Baby Group (2006 Baby Products Tracking Study), 68 percent of new mothers own infant car seats. Approximately 25 percent of infant car seats were handed down or purchased secondhand. Thus, about 75 percent of infant car seats were acquired new. This suggests annual sales of about 2.1 million infant car seats (.68 × .75 × 4 million births per year). (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 I. Number of births in 2010 is rounded from 3,999,386.) These 2 million infant car seats represent the minimum number of units sold per year that might be affected by the hand-held infant carrier standard. We do not know how many Moses baskets and other bassinet/cradle-style carriers are sold annually.
C. Reason for Agency Action and Legal Basis for Rule
The Danny Keysar Child Product Safety Notification Act, section 104 of the CPSIA, requires the CPSC to promulgate a mandatory standard for hand-held infant carriers that is substantially the same as, or more stringent than, the voluntary standard. CPSC worked closely with ASTM to develop the new requirements and test procedures that have been added to the voluntary standard since 2010. These new requirements address several known hazard patterns and will help to reduce injuries and deaths in hand-held carriers, and they have resulted in the current voluntary standard, F2050-13a, upon which the rule is based.
The final rule modifies the definition of “hand-held infant carrier” in ASTM F2050-13a to clarify that the standard includes products with semi rigid sides, as well as products that are rigid-sided. This modification resulted from the Commission receiving no comments in response to the NPR's question whether Moses baskets should be included within the scope of this rule and the Commission's determination that Moses baskets (which typically have semi rigid as opposed to rigid sides) should be covered by the rule.
D. Requirements of the Rule
The final rule adopts the voluntary ASTM standard for hand-held infant carriers (ASTM F2050-13a), with a modification of the definition of “hand-held infant carrier,” as discussed above. Some of the more significant requirements of the current voluntary standard for hand-held infant carriers are listed below:
- Carry handle integrity—a series of endurance and durability tests is intended to prevent rigid, adjustable handles from breaking or unlocking during use.
- Carry handle auto-locking—intended to address incidents that have occurred when the rigid, adjustable handles switched positions unexpectedly.
- Restraints— intended to minimize the fall hazard associated with inclined hand-held carriers, while simultaneously minimizing the potential for injury or death in flat bassinet/cradle products where restraints can pose a strangulation hazard.
- Slip resistance—intended to prevent slipping when the hand-held infant carrier is placed on a slightly inclined surface (10 degrees).
- Marking and labeling requirements—intended to provide tracking information, as well as hazard warnings.
The voluntary standard also includes: (1) Torque and tension tests to prevent components from being removed; (2) requirements for several hand-held infant carrier features to prevent entrapment and cuts (minimum and maximum opening size, coverage of exposed coil springs, small parts, hazardous sharp edges or points, smoothness of wood parts, and edges that can scissor, shear, or pinch); (3) marking and labeling requirements; (4) requirements for the permanency and adhesion of labels; (5) requirements for instructional literature; and (6) toy accessory requirements. ASTM F2050-13a includes no reporting or recordkeeping requirements.
The final rule does not alter ASTM F2050-13a, except to clarify that the definition of “hand-held infant carrier” includes products with semi rigid sides, as well as products that are rigid-sided. We do not expect this modification to the final rule to have a negative economic impact on firms because it is a clarification of the intended scope, rather than a change. In the 2012 version of the hand-held carrier standard (F2050-12), ASTM changed the standard to include a separate definition for “bassinet-style carriers,” which may have been interpreted by some manufacturers to include Moses baskets. The Commission proposed the same scope in the NPR but requested comments on including Moses baskets. In the absence of comments, the Commission determined that Moses baskets were intended to and should be included in the scope and that the definition of a “hand-held infant carrier” should be modified to include “semi rigid-sided,” as well as “rigid-sided” products, consistent with the scope's intent.
E. Other Federal or State Rules
Two federal rules would interact with the hand-held infant carrier mandatory standard: (1) 16 CFR part 1107, Testing and Labeling Pertaining to Product Certification (1107 rule or testing rule); and (2) 16 CFR part 1112, Requirements Pertaining to Third Party Conformity Assessment Bodies (1112 rule).
The 1107 rule implementing sections 14(a)(2) and 14(i)(2) of the Consumer Product Safety Act (CPSA), as amended by the CPSIA, became effective on February 13, 2013. Section 14(a)(2) of the CPSA requires every manufacturer of a children's product that is subject to a product safety rule to certify, based on third party testing, that the product complies with all applicable safety rules. Section 14(i)(2) of the CPSA requires the Commission to establish protocols and standards: (i) For ensuring that a children's product is tested periodically and when there has been a material change in the product; (ii) for the testing of representative samples to ensure continued compliance; (iii) for verifying that a product tested by a conformity assessment body complies with applicable safety rules; and (iv) for safeguarding against the exercise of undue influence on a conformity Start Printed Page 73421assessment body by a manufacturer or private labeler.
Because hand-held infant carriers will be subject to a mandatory children's product safety rule, the product will also be subject to the third party testing requirements of section 14(a)(2) of the CPSA and the 1107 rule when the hand-held infant carrier mandatory standard and the notice of requirements (NORs) become effective.
The 1112 rule, which became effective on June 10, 2013, established requirements for the 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. The final rule also codified all of the NORs that the CPSC had published, to date. However, any new NORs require an amendment to this rule. Therefore, this rule amends 16 CFR part 1112 to establish the requirements for accepting the accreditation of a conformity assessment body to test for compliance with the hand-held infant carrier final rule.
F. Impact of the Rule on Small Business
There are at least 47 firms currently known to be marketing hand-held infant carriers in the United States, as well as 24 firms supplying Moses basket bedding and Moses baskets whose source is unknown. Under U.S. Small Business Administration (SBA) guidelines, a manufacturer of hand-held infant carriers is small if the firm has 500 or fewer employees, and importers and wholesalers are considered small, if they have 100 or fewer employees. Based on these guidelines, about 50 of the firms known to be marketing hand-held infant carriers in the United States are small firms—10 domestic manufacturers, 17 domestic importers, 1 domestic firm with an unknown supply source, and 22 firms supplying Moses basket/bedding suppliers. There may also be additional small hand-held infant carrier suppliers operating in the U.S. market.
Direct Costs From the Rule
The expected impact on small manufacturers of the standard will differ based on whether the firm's hand-held infant carriers already comply with F2050-12. Firms whose hand-held infant carriers meet the requirements of F2050-12 are likely to continue to comply with the voluntary standard as ASTM publishes new versions of the ASTM standard. In addition, firms currently in compliance are likely to meet any new standard within six months after approval because six months is the established amount of time that JPMA allows for products in JPMA's certification program to shift to a new standard. Compliance with the voluntary standard in the six-month time frame is part of an established business practice. Additionally, modifying warning labels and updating instructional literature should not result in significant expenditures for most firms. As a result, the direct impact of the rule on manufacturers whose products are likely to meet the requirements of ASTM F2050-13a (eight of ten small domestic manufacturers) is not likely to be significant. One or more firms might have to modify their carry handles to continue to pass the auto-locking test, but staff believes that a complete product redesign should not be necessary. Thus, for manufacturers whose products are likely to meet the requirements of ASTM F2050-13a (eight of ten firms), staff estimates little or no incremental impact on the costs of producing hand-held infant carriers.
For either or both of the hand-held infant carrier suppliers staff believes do not comply with the current version of the voluntary standard, however, meeting ASTM F2050-13a's requirements could necessitate product redesign. A redesign would be minor if most of the changes involve adding straps and fasteners or using different mesh or fabric; but could be more significant if changes to the frame are required, including changes to the handles. Some firms have estimated product redesigns, including engineering time, prototype development, tooling, and other incidental costs, to cost approximately $500,000. Consequently, the final rule could potentially have a significant direct impact on small manufacturers whose products currently do not conform to the voluntary standard, depending on the scope of the redesign that ultimately is necessary. Where the products need not be completely redesigned, actual costs are likely to be lower than the $500,000 level.
Even though the hand-held infant carriers sold by two firms are neither certified as compliant, nor claim compliance with F2050-12, the products may, in fact, comply with the current standard. Staff has identified many such cases with other products. To the extent that some of these firms may supply compliant hand-held infant carriers and have developed a pattern of compliance with the voluntary standard, the direct impact of the standard will be less significant than described above.
Indirect Costs From Testing and Certification
In addition to the direct impact of the standard described above, the rule will have indirect impacts. These impacts are considered indirect because they do not arise directly as a consequence of the hand-held infant carrier rule's requirements. Nonetheless, they could be significant. Once the rule becomes final and the NOR is in effect, all manufacturers will be subject to the additional costs associated with the third party testing and certification requirements. These costs will include any physical and mechanical test requirements specified in the final rule; lead and phthalates testing is already required, and hence, related costs are not included here.
Based on durable nursery product industry input and confidential business information supplied for the development of the third party testing rule, testing to the ASTM voluntary standard could cost $500-$1,000 per model sample. Testing overseas could potentially reduce some testing costs, but such testing may not always be practical.
On average, each small domestic manufacturer supplies two different models of hand-held infant carriers to the U.S. market annually. Therefore, if third party testing were conducted every year on a single sample for each model, third party testing costs for each manufacturer would be about $1,000-$2,000 annually. Based on a review of firm revenues, the impact of third party testing to ASTM F2050-13a is unlikely to be significant if only one hand-held infant carrier sample per model is necessary to comply with the third party testing requirements. However, if more than one sample would be needed to meet the testing requirements, that third party testing costs potentially could have a significant impact on one or more of the small manufacturers.
As with manufacturers of compliant hand-held infant carriers, we do not believe that the eight small importers of hand-held infant carriers currently in compliance with F2050-12 will experience significant direct impacts as a result of the final rule. In the absence of regulation, these importing firms would likely continue to their established practice of complying with the voluntary standard as the standard evolves.
Importers of hand-held infant carriers would need to find an alternate supply source if their existing supplier does not comply with the requirements of the Start Printed Page 73422rule, which may be the case with all four small importers of hand-held infant carriers, whom we believe do not comply with F2050-12. Some of these importers could react to the rule by discontinuing the import of noncomplying hand-held infant carriers, possibly discontinuing the product line altogether. However, the impact of such a decision could be mitigated by replacing the noncompliant hand-held infant carriers with compliant hand-held infant carriers. Deciding to import an alternative product would be a reasonable and realistic way to offset any lost revenue. However, for some importers, switching suppliers might not be an option.
As is the case with manufacturers, all importers will be subject to third party testing and certification requirements, and consequently, importers will incur costs similar to those for manufacturers if their supplying foreign firm(s) does not perform third party testing. The resulting costs could have a significant impact on a few small importers who must perform the testing themselves, if more than one sample per model is required.
Moses Basket Suppliers
Staff also assessed the potential impact of the rule on firms that supply Moses baskets. There are 22 known small firms supplying Moses baskets to the U.S. market. Most of these firms also supply bedding; some of them manufacture the bedding, and others act as importers. Because a separate definition for “hand-held bassinets” was added to the standard relatively recently in 2012, and some manufacturers may be uncertain whether Moses baskets (a type of hand-held bassinet) are covered by the standard because they are not rigid-sided, Moses baskets currently on the market may not have been designed to comply with this standard.
Many Moses baskets on the market, however, might be able to comply with the standard with minimal modifications. For example, although Moses baskets would not be subject to most of the hand-held carrier standard's performance requirements, Moses baskets would likely have to meet the slip-resistance requirement. Because typical Moses baskets are fabricated from textured materials, we believe that these products likely would not require modifications to meet the slip-resistance requirement (that the product does not slip on surface 10 degrees from horizontal while facing forward, sideways, and to the rear). Therefore, the biggest changes might be to add warnings and instructional literature, actions that the staff expects would not be costly.
Alternatively, Moses basket suppliers could remove themselves from the scope of the final rule by eliminating the handles from their products. Because most Moses baskets come with warnings against carrying an infant in the basket, eliminating handles would conform to those instructions.
All Moses basket manufacturers within the scope of the rule will be subject to third party testing and certification requirements. Importers of Moses baskets could experience testing costs if their supplying firm does not perform third party testing. Because Moses baskets would not be subject to most of the mechanical tests in the standard, we expect that third party testing costs, at most, will be half the amount of other types of hand-held infant carriers, or approximately $250-$500 per model sample. Review of each firm's product line reveals that most firms use only one model of Moses basket for their bedding; although some firms have up to four variations of Moses baskets. The resulting costs are unlikely to have a significant impact on firms that must perform the testing themselves.
An alternative to the rule would be to set an effective date later than six months, which is generally considered sufficient time for suppliers to come into compliance with a rule. Setting a later effective date would allow suppliers additional time to develop compliant hand-held infant carriers and spread the associated costs over a longer period of time.
XI. Environmental Considerations
The Commission's regulations address whether we are required to prepare an environmental assessment or an environmental impact statement. These regulations provide a categorical exclusion for certain CPSC actions that normally have “little or no potential for affecting the human environment.” Among those actions are rules or safety standards for consumer products. 16 CFR 1021.5(c)(1). The rule falls within the categorical exclusion.
XII. Paperwork Reduction Act
This 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 (PRA) (44 U.S.C. 3501-3521). The preamble to the proposed rule (77 FR at 73363 through 73364) discussed the information collection burden of the proposed rule and specifically requested comments on the accuracy of our estimates. Briefly, sections 8 and 9 of ASTM F2050-13a 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).
In compliance with the PRA (44 U.S.C. 3507(d)), we have submitted the information collection requirements of this rule to the OMB for review. OMB has assigned control number 3041-0158 to this information collection. The Commission did not receive any comments regarding the information collection burden of this proposal. However, the final rule makes modifications regarding the information collection burden because the number of estimated suppliers subject to the information collection burden is now estimated to be 71 firms, rather than the 43 firms initially estimated in the proposed rule.
Accordingly, the estimated burden of this collection of information is modified as follows:
Table 1—Estimated Annual Reporting Burden
|16 CFR Section||Number of respondents||Frequency of responses||Total annual responses||Hours per response||Total burden hours|
Our estimates are based on the following:
Section 8.1 of ASTM F 2050-13a requires that the name of the manufacturer, distributor, or seller, and either the place of business (city, state, and mailing address, including zip code) or telephone number, or both, be Start Printed Page 73423marked clearly and legibly on each product and its retail package. Section 8.2 of ASTM F 2050-13a requires a code mark or other means that identifies the date (month and year, as a minimum) of manufacture.
There are 71 known entities supplying hand-held infant carriers to the U.S. market. All 71 firms are assumed to use labels already on both their products and their packaging, but they might need to modify existing labels. The estimated time required to make these modifications is about 1 hour per model. Each entity supplies an average of two different models of hand-held infant carriers; therefore, the estimated burden associated with labels is 1 hour per model × 71 entities × 2 models per entity = 142 hours. We estimate the hourly compensation for the time required to create and update labels is $27.44 (U.S. Bureau of Labor Statistics, “Employer Costs for Employee Compensation,” March 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 $3,896.48 ($27.54 per hour × 142 hours = $3,896.48). There are no operating, maintenance, or capital costs associated with the collection of information.
Section 9.1 of ASTM F2050-12 requires the supply of instructions with the product. Hand-held infant carriers often require installation or assembly, and products sold without such information would not be as attractive to consumers as products supplying this information. 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 hand-held infant carriers that generally require installation or some assembly but lack any instructions to the user about such installation or assembly, we estimate that there are no burden hours associated with section 9.1 of ASTM F 2050-12 because any burden associated with supplying instructions with hand-held infant carriers would be “usual and customary” and not within the definition of “burden” under the OMB's regulations.
Section 26(a) of the CPSA, 15 U.S.C. 2075(a), provides that where 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,” thus implying that the preemptive effect of section 26(a) of the CPSA would apply. Therefore, a rule issued under section 104 of the CPSIA will invoke the preemptive effect of section 26(a) of the CPSA when the rule becomes effective.
XIV. Certification and Notice of Requirements (NOR)
Section 14(a)(2) of the CPSA requires that children's products subject to a children's 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)(2). For children's products, such certification must be based on tests on a sufficient number of samples by a third party conformity assessment body accredited by the Commission to test according to the applicable requirements. As discussed in section I of this preamble, section 104(b)(1)(B) of the CPSIA refers to standards issued under this section as “consumer product safety standards.” Accordingly, a safety standard for hand-held infant carriers issued under section 104 of the CPSA is a consumer product safety rule that is subject to the testing and certification requirements of section 14 of the CPSA. Because hand-held infant carriers are children's products, they must be tested by a third party conformity assessment body whose accreditation has been accepted by the CPSC. Notices of requirements (NORs) provide the criteria and process for our acceptance of accreditation of third party conformity assessment bodies.
The Commission published a final rule, Requirements Pertaining to Third Party Conformity Assessment Bodies, 78 FR 15836 (March 12, 2013), which is codified at 16 CFR part 1112 (referred to here as part 1112). This rule became effective on June 10, 2013. Part 1112 establishes requirements for accreditation of third party conformity assessment bodies (or laboratories) to test for conformance with a children's product safety rule in accordance with Section14(a)(2) of the CPSA. Part 1112 also codifies a list of all of the NORs that the CPSC had published at the time part 1112 was issued. All NORs issued after the Commission published part 1112, such as the hand-held infant carrier standard, require the Commission to amend part 1112. Accordingly, this rule amends part 1112 to include the hand-held infant carrier standard in the list with the other children's product safety rules for which the CPSC has issued NORs.
Laboratories applying for acceptance as a CPSC-accepted third party conformity assessment body to test to the new standard for hand-held infant carriers are required to meet the third party conformity assessment body accreditation requirements in 16 CFR 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 1225, Safety Standard for Hand-Held Infant Carriers included in the scope of accreditation of CPSC safety rules listed for the laboratory on the CPSC Web site at: www.cpsc.gov/labsearch.
In connection with the part 1112 rulemaking, CPSC staff conducted an analysis of the potential impacts on small entities of the rule establishing accreditation requirements, 78 FR 15836, 15855-58 (March 12, 2013), as required by the Regulatory Flexibility Act and prepared a Final Regulatory Flexibility Analysis (FRFA). Briefly, the FRFA concluded that the requirements would not have a significant adverse impact on a substantial number of small laboratories because no requirements are imposed on laboratories that do not intend to provide third party testing services under section 14(a)(2) of the CPSA. The only laboratories that are expected to provide such services are those that anticipate receiving sufficient revenue from providing the mandated testing to justify accepting the requirements as a business decision. Laboratories that do not expect to receive sufficient revenue from these services to justify accepting these requirements would not likely pursue accreditation for this purpose. Similarly, amending the part 1112 rule to include the NOR for the hand-held infant carrier standard would not have a significant adverse impact on small laboratories. Most of these laboratories will have already been accredited to test for conformance to other juvenile product standards, and the only costs to them would be the cost of adding the hand-held infant carrier standard to their scope of accreditation. As a consequence, the Commission certifies Start Printed Page 73424that the NOR for the hand-held infant carrier standard will not have a significant impact on a substantial number of small entities.
To ease the transition to new third party testing requirements for hand-held infant carriers subject to the standard and to avoid a “bottlenecking” of products at laboratories at or near the effective date of required third party testing for hand-held infant carriers, the Commission, under certain circumstances, will accept certifications based on testing that occurred before the effective date for third party testing.
The Commission will accept retrospective testing for 16 CFR part 1225, safety standard for hand-held infant carriers, if the following conditions are met:
Start List of Subjects
- The children's product was tested by a third party conformity assessment body accredited to ISO/IEC 17025:2005(E) by a signatory to the ILAC-MRA at the time of the test. The scope of the third party conformity body accreditation must include testing in accordance with 16 CFR part 1225. For firewalled third party conformity assessment bodies, the firewalled third party conformity assessment body must be one that the Commission, by order, has accredited on or before the time that the children's product was tested, even if the order did not include the tests contained in the safety standard for hand-held infant carriers at the time of initial Commission acceptance. For governmental third party conformity assessment bodies, accreditation of the body must be accepted by the Commission, even if the scope of accreditation did not include the tests contained in the safety standard for hand-held infant carriers at the time of initial CPSC acceptance.
- The test results show compliance with 16 CFR part 1225.
- The hand-held infant carrier was tested on or after the date of publication in the Federal Register of the final rule for 16 CFR part 1225 and before June 6, 2014.
- The laboratory's accreditation remains in effect through June 6, 2014.
List of Subjects
End List of Subjects
Therefore, the Commission amends Title 16 of the Code of Federal Regulations by amending part 1112 and adding a new part 1225 to read as follows:
PART 1112—REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY ASSESSMENT BODIES
Start Amendment Part
1. The authority citation for part 1112 continues to read as follows:End Amendment Part
Start Amendment Part
2. Amend § 1112.15 by adding paragraph (b)(34) to read as follows:End Amendment Part
Start Amendment Part
When can a third party conformity assessment body apply for CPSC acceptance for a particular CPSC rule and/or test method?
* * * * *
(34) 16 CFR part 1225, Safety Standard for Hand-Held Infant Carriers.
* * * * *
3. Add part 1225 to read as follows:End Amendment Part
PART 1225—SAFETY STANDARD FOR HAND-HELD INFANT CARRIERS
- Requirements for hand-held infant carriers.
This part establishes a consumer product safety standard for hand-held infant carriers.
Requirements for hand-held infant carriers.
(a) Except as provided in paragraph (b) of this section, each hand-held infant carrier must comply with all applicable provisions of ASTM F 2050-13a, Standard Consumer Safety Specification for Hand-Held Infant Carriers, approved on September 1, 2013. 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 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) Instead of complying with section 3.1.3 of ASTM F2050-13a, comply with the following:
(1) 3.1.3 hand-held infant carrier, n—a freestanding, rigid- or semirigid-sided product intended to carry an occupant whose torso is completely supported by the product to facilitate transportation by a caregiver by means of hand-holds or handles.
End Supplemental Information
Dated: December 2, 2013.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2013-29061 Filed 12-5-13; 8:45 am]
BILLING CODE 6355-01-P