Source: http://govpulse.us/entries/2010/07/23/2010-17594/safety-standards-for-full-size-baby-cribs-and-non-full-size-baby-cribs-notice-of-proposed-rulemaking
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govpulse | Safety Standards for Full-Size Baby Cribs and Non-Full-Size Baby Cribs; Notice of Proposed Rulemaking
Safety Standards for Full-Size Baby Cribs and Non-Full-Size Baby Cribs; Notice of Proposed Rulemaking
Section 104(b) of the Consumer Product Safety Improvement Act of 2008 (“CPSIA”) requires the United States Consumer Product Safety Commission (“CPSC,” “Commission” 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 proposing safety standards for full-size and non-full-size baby cribs in response to the direction under section 104(b) of the CPSIA.
Section 104(c) specifies that the crib standards will cover used as well as new cribs. The crib standards will apply to anyone who manufactures, distributes or contracts to sell a crib; to child care facilities, and others holding themselves out to be knowledgeable about cribs; to anyone who leases, sublets or otherwise places a crib in the stream of commerce; and to owners and operators of places of public accommodation affecting commerce.
1. Section 104(b) of the Consumer Product Safety Improvement Act
2. Section 104(c) of the CPSIA
3. Existing Mandatory Regulations for Cribs
4. Previous Commission Activities Concerning Cribs
B. The Products
2. The Market for Full-Size Cribs
3. The Market for Non-Full-Size Cribs
4. Retailers, Child Care Facilities and Places of Public Accommodation
1. Full-Size Cribs (Includes Cribs of Undetermined Size)
b. Non-Fatal Injuries
c. Hazard Pattern Identification
2. Non-Full-Size Cribs
D. Voluntary and International Standards
1. The ASTM Standards
2. International Standards
E. The ASTM 2010 Crib Standards
1. ASTM F 1169-10 Standard for Full-Size Baby Cribs
2. ASTM F 406-10 Standard for Non-Full-Size Baby Cribs
F. Assessment of Voluntary Standards ASTM F 1169-10 and ASTM F 406-10
1. Section 104(b) of the CPSIA: Consultation and CPSC Staff Review
2. Full-Size Crib Standard; ASTM F 1169-10
3. Non-Full-Size Crib Standard; ASTM F 406-10
G. Description of Proposed Changes to ASTM Standards
1. Proposed Change to the Full-Size Crib Standard (ASTM F 1169-10)
2. Proposed Changes to the Non-Full-Size Crib Standard (ASTM F 406-10)
1. Full-Size Cribs
a. The Market for Full-Size Cribs
b. Compliance Requirements of the Proposal for Full-Size Cribs
c. Impact of the Proposal Concerning Full-Size Cribs on Small Business
i. Impact on Small Manufacturers
ii. Small Importers of Full-Size Cribs
iii. Small Retailers of Full-Size Cribs
a. The Market for Non-Full-Size Cribs
b. Compliance Requirements of the Proposal for Non-Full-Size Cribs
c. Impact of the Proposal Concerning Non-Full-Size Cribs on Small Business
ii. Small Importers of Non-Full-Size Cribs
iii. Small Retailers, Day Care Centers, and Public Accommodations
K. Paperwork Reduction Act
Non-Full Size Cribs
L. Preemption
M. Certification
N. Request for Comments
Table 2—Estimated Annual Reporting Burden
Comments related to the Paperwork Reduction Act aspects of the recordkeeping, marking and instructional literature requirements of the proposed rule should be directed to the Office of Information and Regulatory Affairs, OMB, Attn: CPSC Desk Officer, FAX: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov.
Other comments, identified by Docket No. CPSC-2010-0075, may be submitted by any of the following methods:
Electronic Submissions ↑
To ensure timely processing of comments, the Commission is no longer accepting comments submitted by electronic mail (e-mail) except through www.regulations.gov.
Written Submissions ↑
Instructions: All submissions received must include the agency name and docket number for this rulemaking. All comments received may be posted without change, including any personal identifiers, contact information, or other personal information provided, to http://www.regulations.gov. Do not submit confidential business information, trade secret information, or other sensitive or protected information electronically. Such information should be submitted in writing.
Patricia Edwards, Project Manager, Directorate for Engineering Sciences, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; telephone (301) 504-7577;pedwards@cpsc.gov.
A. Background and Statutory Authority ↑
1. Section 104(b) of the Consumer Product Safety Improvement Act ↑
The Consumer Product Safety Improvement Act of 2008 (“CPSIA”, Pub. L. 110-314) was enacted on August 14, 2008. Section 104(b) of the CPSIA requires the Commission to promulgate consumer product safety standards for durable infant or toddler products. These standards are to be “substantially the same as” applicable voluntary standards or more stringent than the voluntary standards if the Commission concludes that more stringent requirements would further reduce the risk of injury associated with the product. In this document, the Commission proposes safety standards for full-size and non-full-size cribs. The proposed standard for full-size cribs is substantially the same as a voluntary standard developed by ASTM International (formerly known as the American Society for Testing and Materials), ASTM F 1169-10Standard Consumer Safety Specification for Full-Size Baby Cribs, but with one modification that strengthens the standard. The proposed standard for non-full-size cribs is substantially the same as ASTM F 406-10, Standard Consumer Safety Specification for Non-Full-Size Baby Cribs, but with several changes that strengthen the standard.
2. Section 104(c) of the CPSIA ↑
The CPSIA treats cribs differently than other durable infant or toddler products covered by section 104 of the CPSIA. Section 104(c)(2) of the CPSIA states that the section applies to any person that:
(A) manufactures, distributes in commerce, or contracts to sell cribs;
(B) based on the person's occupation, holds itself out as having knowledge or skill peculiar to cribs, including child care facilities and family child care homes;
(C) is in the business of contracting to sell or resell, lease, sublet, or otherwise place cribs in the stream of commerce; or
(D) owns or operates a place of public accommodation affecting commerce (as defined in section 4 of the Federal Fire Prevention and Control Act of 1974 (15 U.S.C. 2203) applied without regard to the phrase “not owned by the Federal Government”).
Section 104(c)(2) of the CPSIA (Pub. L. 110-314).
Section 104(c)(1) of the CPSIA makes it a prohibited act under section 19(a)(1) of the Consumer Product Safety Act (“CPSA”) for any person to whom section 104(c) applies to “manufacture, sell, contract to sell or resell, lease, sublet, offer, provide for use, or otherwise place in the stream of commerce a crib that is not in compliance with a standard promulgated under subsection (b) [of the CPSIA].” Section 104(c)(3) of the CPSIA defines “crib” as including new and used cribs, full-size and non-full-size cribs, portable cribs, and crib pens.
Thus, the crib standards will apply to owners and operators of child care facilities (including in-home child care) and public accommodations such as hotels and motels, as well as to manufacturers, distributors, and retailers of cribs. Once the standards are in effect, it will be unlawful to sell, lease or otherwise provide a crib for use that does not meet the standards. As discussed in more detail in part I below, the Commission recognizes the potentialmarket impact of this rule on some entities and invites comments on these issues.
3. Existing Mandatory Regulations for Cribs ↑
In 1973, the Commission issued mandatory regulations for full-size cribs, 38 FR 32129 (Nov. 21, 1973), which are codified at 16 CFR part 1508. The standard was amended in 1982, adding a performance requirement to address the hazard of crib cutouts, 47 FR 47534 (Oct. 27, 1982). This standard has requirements addressing crib dimensions, the spacing of crib components, hardware, construction and finishing, assembly instructions, warning statements and marking, recordkeeping, and cutouts. In 1976, the Commission issued similar regulations for non-full-size cribs, 41 FR 6240 (Feb. 12, 1976), codified at 16 CFR part 1509 (also amended in 1982 to address cutouts). According to 16 CFR parts 1508 and 1509, what principally distinguishes full-size from non-full-size cribs are the interior dimensions of the crib. Also, according to these standards, a full-size crib is intended for use in the home, and a non-full-size crib is intended for use “in or around the home, for travel and other purposes.” A full-size crib has interior dimensions of 28 ±5/8inches (71 ± 1.6 centimeters) in width by 523/8±5/8inches (133 ± 1.6 centimeters) in length. A non-full-size crib may be either smaller or larger than these dimensions. Full-size and non-full-size cribs also differ in the height of the crib side or rail. Non-full-size cribs include oversized, specialty, undersized and portable cribs. However, any product with mesh/net/screen siding, non-rigidly constructed cribs, cradles, car beds, baby baskets, and bassinets are excluded from the non-full-size crib requirements of 16 CFR part 1509.
The requirements of 16 CFR part 1508 have been included in ASTM F 1169-10, and the requirements of 16 CFR part 1509 have been included in ASTM F 406-10. However, the recordkeeping requirements in the ASTM standards are expanded from the 3-year retention period that is required in 16 CFR parts 1508 and 1509 to a 6-year retention period, which is consistent with the consumer registration provision in section 104(d) of the CPSIA. Also, as explained in part G.2 of this preamble, ASTM F 406-10 (for non-full-size cribs) places the recordkeeping provision in a non-mandatory appendix. The proposed rule would put the recordkeeping provision in the general requirements section of the non-full-size crib standard.
Elsewhere in this issue of the Federal Register, the Commission is proposing to revoke the existing CPSC regulations for full-size and non-full-size cribs, 16 CFR parts 1508 and 1509. As explained in the proposed revocation notice, the applicable ASTM standards include the requirements of 16 CFR parts 1508 and 1509. Thus, maintaining them would be redundant. Revoking the existing regulations will allow all the crib-related requirements to be together and will avoid confusion about which requirements apply to cribs.
Related to the proposed revocation of 16 CFR parts 1508 and 1509, the Commission is proposing to revise 16 CFR 1500.18(a)(13) and (14). These provisions currently state that full-size cribs that do not comply with 16 CFR part 1508 and non-full-size cribs that do not comply with 16 CFR part 1509 are banned hazardous substances under the Federal Hazardous Substances Act (“FHSA”). This notice proposes to change the references in 16 CFR 1500.18(a)(13) and (14) to refer to the crib standards the Commission is proposing.
4. Previous Commission Activities Concerning Cribs ↑
In addition to issuing 16 CFR parts 1508 and 1509, the Commission has taken other regulatory and non-regulatory actions concerning crib hazards. In 1996, the Commission published an advance notice of proposed rulemaking (“ANPR”) under the FHSA to address the hazard of crib slat disengagement, 61 FR 65996 (Dec. 16, 1996) (“1996 ANPR”). The Commission had become aware of 138 incidents, including 12 deaths due to entrapment, associated with disengagement of crib slats that were reported to the Commission between January 1985 and September 1996. After issuance of the 1996 ANPR, the CPSC staff worked with ASTM to add a provision to ASTM F 1169 to address this hazard. Elsewhere in this issue of the Federal Register, the Commission is terminating the rulemaking it began with the 1996 ANPR because the slat disengagement hazard is addressed by the standards the Commission is proposing.
More recently, the Commission's Office of Compliance staff has been involved with numerous investigations and recalls of cribs. Since 2007, CPSC has issued 40 recalls of over 11 million cribs. All but 7 of these recalls were for product defects that created a substantial product hazard, and not for violations of the federal crib regulations.
On November 25, 2008, the Commission published an ANPR discussing options to address the hazards which CPSC staff had identified in the reported crib incidents and recalls. The ANPR focused on drop side crib hardware, other hardware, assembly issues, and wood quality. Comments in response to the ANPR suggested that CPSC should look more broadly at crib safety issues to develop a comprehensive crib rule and seek to harmonize its regulations with international standards. Another comment expressed concern about the potential costs for small businesses that may sell only several hundred cribs per year. Several consumer groups supported mandating the ASTM crib standards and additionally strengthening crib regulations by such actions as banning drop sides, requiring test methods mandated by other standards, and strengthening requirements for crib hardware. The hazards discussed in the 2008 ANPR are addressed in this proposal.
On April 22, 2009, CPSC staff held a public roundtable meeting concerning crib safety to solicit input about existing voluntary and mandatory standards to help the staff in developing crib standards under section 104 of the CPSIA. Information about the crib roundtable and the presentations made by CPSC staff and others are on the Commission's Web site at http://www.cpsc.gov/info/cribs/infantsleep.html. Over 100 people attended the roundtable, including representatives from crib manufacturers, testing laboratories, consumer groups, other government agencies, and other interested stakeholders.
B. The Products ↑
1. Definitions ↑
According to existing CPSC standards and the ASTM standards, a crib is a bed designed to provide sleeping accommodations for an infant. As discussed previously, full-size cribs have specific interior dimensions (28 ±5/8inches (71 ± 1.6 centimeters) in width by 523/8±5/8inches (133 ± 1.6 centimeters) in length). Non-full-size cribs are either smaller or larger than full-size cribs. The category of non-full-size cribs includes oversized, specialty, undersized and portable cribs, but does not include any product with mesh/net/screen siding, non-rigidly constructed cribs, cradles, car beds, baby baskets, or bassinets.
2. The Market for Full-Size Cribs ↑
The CPSC staff estimates that there are currently 68 manufacturers or importers supplying full-size cribs to the United States market. Ten of thesefirms are domestic importers (15 percent), 42 are domestic manufacturers (62 percent), 7 are foreign manufacturers (10 percent), and 2 are foreign importers (3 percent). Insufficient information was available about the remaining firms to categorize them.
Based on information from a 2005 survey conducted by the American Baby Group, CPSC staff estimates annual sales of new cribs to be about 2.4 million, of which approximately 2.1 million are full-size cribs (could be an underestimate if new mothers buy more than one crib). CPSC staff estimates that there are currently approximately 591 models of full-size cribs compared to approximately 81 models of non-full-size cribs. Thus, approximately 88 percent of crib models are full-size cribs.
3. The Market for Non-Full-Size Cribs ↑
CPSC staff estimates that there are currently at least 17 manufacturers or importers supplying non-full-size cribs to the United States market. Five of these firms are domestic importers and ten are domestic manufacturers. Insufficient information is available to determine whether the remaining firms are manufacturers or importers. CPSC staff estimates that there are approximately 2.4 million cribs sold to households annually. Of these, approximately 293,000 are non-full-size cribs.
4. Retailers, Child Care Facilities and Places of Public Accommodation ↑
Section 104(c) of the CPSIA explicitly provides that the crib standards issued under this section will apply to retailers (of both new and used cribs), child care facilities, and owners and operators of places of public accommodation affecting commerce. The CPSIA defines a “place of public accommodation affecting commerce” with reference to the Federal Fire Prevention and Control Act of 1974 (but without the phrase that excludes establishments owned by the Federal Government). Thus, the definition under the CPSIA is:
any inn, hotel, or other establishment * * * that provides lodging to transient guests, except that such term does not include an establishment treated as an apartment building for purposes of any State or local law or regulation or an establishment located within a building that contains not more than 5 rooms for rent or hire and that is actually occupied as a residence by the proprietor of such establishment.
15 U.S.C. 2203(7).
CPSC staff is unable to estimate the number of retailers that may sell or provide cribs. However, the number would be some subset of approximately 24, 985 retail firms in the United States (at least 5, 292 of which sell used products). The CPSC staff estimates that there are approximately 59, 555 firms supplying day care services and 43,303 firms providing public accommodation.
C. Incident Data ↑
In November 2007, CPSC staff began a pilot project known as the Early Warning System (“EWS”) to monitor incident reports related to cribs. Between November 1, 2007 and April 11, 2010, the Commission has reports through EWS of 3,584 incidents related to cribs. The year of the incident associated with these reports ranged from 1986 through 2010. However, very few crib-related incidents that occurred before 2007 are reflected in EWS. Data from EWS is not meant to provide an estimate of all crib-related incidents that have occurred during any particular time period. Rather, because a substantial number of EWS incident reports were assigned for follow-up investigation, the EWS incidents provide a better illustration of the hazard patterns associated with incidents involving cribs than other CPSC databases could.
Of the 3,584 incidents reported through EWS, CPSC staff has clearly identified 2,395 incidents as involving full-size cribs, 64 incidents as clearly involving non-full-size cribs, and 1,125 incidents as lacking sufficient data for CPSC staff to determine whether they involved full-size or non-full-size cribs. The prevalent hazards reported in these incidents are common to all cribs, regardless of size. Given the predominance of incident reports identified as involving full-size cribs, the 1,125 incidents in which size of the crib could not be determined are grouped with the category of full-size cribs.
1. Full-Size Cribs (Includes Cribs of Undetermined Size) ↑
This section discusses incident data in the 3,520 reports from EWS involving 2,395 full-size cribs and 1,125 reports involving cribs of an undetermined size. Of these 3,520 incident reports, there were 147 fatalities, 1,675 non-fatal injuries, and 1,698 non-injury incidents. The non-injury incidents range from incidents that could have potentially resulted in injuries or fatalities to general complaints or comments from consumers. Reporting is ongoing; the number of reported fatalities, non-fatal injuries, and non-injury incidents will change in the future.
a. Fatalities ↑
Between November 1, 2007 and April 11, 2010, a total of 147 fatalities associated with full-size cribs were reported to the Commission. A majority of the deaths (107 out of 147, or almost 73 percent) were not related to any structural failure or design flaw of the crib, but fell into the following categories:
• 62 suffocation deaths related to presence of soft bedding;
• 17 asphyxiation deaths related to prone positioning of infant;
• 12 strangulation deaths related to window blind/electrical/other cords in or near crib; and
• 16 remaining deaths resulted from miscellaneous hazards, e.g., plastic bags in crib and use of nursery product accessories in crib
There were 35 fatalities attributable to structural problems of the crib. Nearly all (34 of the 35) were due to head/neck/body entrapments. Over half of these (18 out of 35) were related to drop-side failures. Almost all of the crib failures—whether they occurred due to detachments, disengagements, or breakages—created openings in which the infant became entrapped. One entrapment death resulted from a child becoming trapped between a wall and a crib while trying to climb out of the crib; there was a crib assembly problem that prevented the mattress support from being lowered sufficiently. The non-entrapment death resulted from a loose screw becoming lodged in the decedent's throat. (For five fatalities, no information on the circumstances was available.)
b. Non-Fatal Injuries ↑
Of the 3,520 incident reports involving full-size (and undetermined size) cribs, 1,675 reported a crib-related injury.