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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations
16 CFR part 1222Safety Standard for Bedside Sleepers Comment 7: Several commenters asked for clarification regarding whether products, similar in design to inclined sleepers but marketed as a soother, rocker, or lounger, are in-scope for the rule, and suggested that such products should be in-scope due to the potential for consumer confusion as to intended uses. We also received a comment asking that inclined products for activity and transport, such as a bouncers, strollers, and swings, be excluded from the scope of the rule.
Response 7: Infant products, inclined or flat, do not fall within the scope of the final rule as long as they are not intended for sleep, and they are marketed conspicuously as not for sleep by infants up to 5 months old. This means that the product packaging, marketing materials, inserts, and instructions cannot indicate that the product is for sleep, or imply through pictures of sleeping infants that sleeping in the product is acceptable. In addition, if attended or supervised sleep is indicated, then the product would be considered within the scope of the final rule. The product name, description, and instructions also cannot include references to sleep, snooze, dream, or nap. CPSC staff would consider decorations on the product that include pictures of sleeping animals or sleeping cartoon figures to imply the product is intended for sleep. Additionally, the product must not be described as a bed.
Some of these products, such as stroller accessories, are already required by the mandatory standard for that product type to meet the bassinet standard when the product is in bassinet mode.
Comment 8: One commenter acknowledged that the scope of the rule does not include sleep positioners and requested the CPSC to better enforce the ban on sleep positioners.
Response 8: Neither CPSC, nor FDA, has a ban on sleep positioners;
however, both agencies advise consumers not to use them with infants due to the risk of suffocation. Sleep positioners are considered accessories, and not an infant sleep product under the definition proposed in the 2019
SNPR or as clarified in the final rule.
Similar to crib mattresses, sleep positioners are not intended to be used as the sole product for sleep; instead, they are used in conjunction with a sleep product, for example, to hold an infant in a position while inside a crib.
Therefore, sleep positioners do not fall within the final rule because they are not intended to provide a sleeping accommodation for an infant. The
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Commission declines to explicitly exclude sleep positioners from the final rule at this time.
c Upper Age Limit for Infants Up to 5
Months Old Comment 9: The 2019 SNPR posed a question regarding whether the Commission should remove the upper age limit from the scope of the mandatory standard, to accommodate a broad scope of infant sleep products.
Several commenters stated that the final rule should remain applicable to products intended for infants up to 5
months old. Otherwise, the commenters said new requirements addressing containment, stability, and side height would need to be added to the bassinet standard for products intended for ages 6 to 12 months, noting that the existing bassinet requirements are designed only for infants up to 5 months old.
Response 9: After further consideration, the Commission agrees that changing the scope of the final rule to remove the upper age limit, or to include products intended for infants up to 12 months old as suggested at an ASTM task group meeting, would require new performance, labeling, and testing requirements in the bassinet standard. As the commenters noted, the bassinet standard only applies to infants up to 5 months of age. Therefore, a number of requirements in the ASTM
F219416e1 bassinet standard, would need to be changed to address older, larger, and more mobile and active infants, including changes to the scope in section 1.3, the stability requirement in section 6.4, and the side height requirement in section 6.5.4.
Additionally, the final rule focuses on hazards to young infants associated with infant sleep products because infants under 5 months old are the most vulnerable, due to their limited mobility and young, developing respiratory system. Requiring currently unregulated inclined and flat sleep products to meet the bassinet standard sets minimum requirements for safe sleep. Bassinets are designed for children who are not yet mobile, and the final rule addresses the hazards seen in this population.
Older infants, i.e., 6 to 12 months old, have different needs for sleep, and the existing standards for this older age group are designed to address those needs. By 6 months of age, infants have developed enough mobility that they can perform such actions as rolling back and forth and pulling themselves up.
The Commission agrees with CPSC
staffs assessment that it is unsafe for 6
to 12 month olds to be in a confined space, such as a bassinet, for sleeping,
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as they may roll out of the product, or pull themselves out of the product.
The unregulated products on the market with which CPSC has concerns, e.g., in-bed sleepers, baby boxes, and compact bassinets, are intended for this younger, more vulnerable population. In addition, CPSC data indicate that 34
percent of the incidents involving inclined sleep products and 49 percent of the incidents involving unregulated, flat, sleep products happened to infants 0 to 5 months of age. Infants 6 to 12
months old were involved in 9 percent of inclined sleep products and 4 percent of unregulated, flat sleep product incidents, respectively. Therefore, consistent with the 2019 SNPR, the final rule limits the scope of the standard to infants up to 5 months of age. Due to the size and design of these unregulated compact/travel products, older infants should not be placed to sleep in these products, and older infants are not included within the scope of the final rule.
d Consumer Registration Rule Comment 10: A commenter expressed no objection to requiring product registration cards for products within the scope of the rule, but suggested that the Commission remain open to innovation as to the specific methods of achieving optimum product traceability, particularly now that so many products are linked to internet devices.
Response 10: In the 2009 NPR for the consumer registration rule 74 FR 30986
June 29, 2009, the Commission said it:
intends to encourage innovation in the use of the internet for product registration, and the methods of registration online are encouraged, whether through a website or email. The Commission is open to innovation in this area, but we note that section 104e of the CPSIA sets forth a process the Commission must follow to allow new technology for product registration, in lieu of the product registration card requirements in part 1130.
Comment 11: A commenter supported the Commissions amendment of the consumer registration rule, 16 CFR part 1130, to identify infant sleep products as durable infant or toddler products subject to the product registration requirements, so that freestanding sleep products without a frame, are included within the scope of part 1130.
Staff Response 11: To avoid confusion, and to ensure that all infant sleep products fall within the requirements of part 1130, the final rule updates the list of durable infant or toddler products in part 1130 to explicitly identify infant sleep products as durable infant or toddler
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