Federal Register - June 23, 2021
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Source: Federal Register
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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations
TABLE 1HAZARD PATTERNS AND INCIDENT SEVERITY ASSOCIATED WITH INFANT INCLINED PRODUCTS 20192020
INCIDENTSContinued Reported since 2019 SNPR
Total incidents
Deaths
Injuries
Issues Count
Percentage
Count
Percentage
Count
Percentage
Electrical
Non-Product-Related
Unsafe Sleep Environment
Insufficient Information
1
1
1
7
1
1
1
10
1
1
5
10
10
50
2
12
Total
71
100
10
100
17
100
Source: CPSC epidemiological databases CPSRMS and NEISS. Percentages may not add to sub-totals and totals due to rounding.
B. Flat Sleep Products In response to the 2019 SNPR, the Commission received public comments regarding the safety of non-inclined sleep products, or flat sleep products, that do not fall within an existing CPSC
sleep standard or a voluntary standard that are available in the marketplace.
Staff completed a review of CPSCs epidemiological databases, CPSRMS
and NEISS, to respond to these comments and concerns.
Flat sleep products include: In-bed sleepers, baskets that can function as hand-held carriers as well, baby boxes, compact bassinets most of which are portable for travel, and baby tents.
Based on the descriptions in the incident reports received, some have soft, puffy sides along the sleep area perimeter; others have semi-rigid sides, with mesh or soft-padded sidewalls held in place by tubular structures along the perimeter. Baby boxes have cardboard walls, while baby tents have flexible wires which provide structural support for fabric/mesh tent walls. All
of these non-inclined sleep products are flat and come with mattress pads. Some products have short legs; many can sit on the floor or can be used on a bed or a couch. The data show that some products were placed inside a standardsized crib, play yard, or bassinet.
For the final rule, we characterize the number of deaths and injuries and the types of hazards related to flat sleep products. CPSCs characterizations are based on anecdotal incident reports received by the Commission. The number of emergency department EDtreated injuries associated with flat sleep products, for the covered time frame, is insufficient to derive any reportable national estimates.14
Accordingly, we do not present injury estimates here, but include ED-treated injuries in the total count of reported incidents. Moreover, reporting is ongoing and staff considers 20192020
data incomplete, so the number of reported fatalities, nonfatal injuries, and non-injury incidents reported here may change in the future.15
1. Incident Data CPSC staff received a total of 183
incident reports related to flat sleep products available in the marketplace.
These incidents reported a date of occurrence between January 1, 2019 and December 31, 2020. Manufacturer and retailer reports submitted through CPSCs Retailer Reporting Program serve as the only source of information for 73 percent 133 out of 183 of the incidents. Of the 183 reported incidents, 11 are fatalities. Among the remaining 172 nonfatal incidents, 16 reported an injury. Additionally, staffs flat sleep product data search was limited to children age 12 months or under, because that is typically the manufacturer-recommended use age for these products. One hundred and fifteen incident reports provided the victims age; among them, 24 involved a fatality or injury. Table 2 provides the age breakdown among the 183 incident reports.
TABLE 2AGE DISTRIBUTION IN FLAT SLEEP PRODUCTS-RELATED INCIDENTS IN 20192020
All incidents
Injuries and fatalities
Age of child Frequency
Percentage
Frequency
Percentage
Unreported
OneFive Months
SixEight Months
NineTwelve Months
68
89
18
8
37
49
10
4
3
19
4
1
11
70
15
4
Total
183
100
27
100
Source: CPSC epidemiological databases CPSRMS and NEISS.
Age may be unreported under two circumstances: age was unknown, or age was not reported, because the incident involved no injury.
jbell on DSKJLSW7X2PROD with RULES2
a Fatalities The Commission is aware of 11
fatalities associated with the use of a flat sleep product, meaning flat sleep 14 According to the NEISS publication criteria, an estimate must be 1,200 or greater, the sample size must be 20 or greater, and the coefficient of variation must be 33 percent or smaller.
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surface products marketed for infant sleep that are not currently within the scope of an existing CPSC sleep standard or a voluntary standard,
reported to have occurred during the period of January 1, 2019 through December 31, 2020. Seven of the 11
15 In the reports received by CPSC, consumers referred to flat sleep products as cribs, bassinets, cosleepers, cribettes, nests, pads, or positioners. Because of the variety of terms used by consumers to describe these
productsoften unfamiliar to CPSC staffstaffs data search for this analysis was challenging, and staff believes it is possible that some relevant reports may have been missed.
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