Source: https://regulations.vlex.com/vid/standard-soft-infant-toddler-carriers-501099122
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Safety Standard for Soft Infant and Toddler Carriers - March 28, 2014 - Regulations - VLEX 501099122
Federal Register, Volume 79 Issue 60 (Friday, March 28, 2014)
Federal Register Volume 79, Number 60 (Friday, March 28, 2014)
Pages 17422-17433
FR Doc No: 2014-06771
Docket No. CPSC-2013-0014
SUMMARY: The Danny Keysar Child Product Safety Notification Act, section 104 of the Consumer Product Safety Improvement Act of 2008 (CPSIA), requires the United States Consumer Product Safety Commission (Commission, CPSC, or we) to promulgate consumer product safety standards for durable infant or toddler products. Durable infant and toddler standards must 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 this final rule establishing a safety standard for soft infant and toddler carriers in response to the direction under section 104(b) of the CPSIA.
DATES: The rule will become effective September 29, 2014 and apply to product manufactured or imported on or after that date. The incorporation by reference of the publication listed in this rule is approved by the Director of the Federal Register as of September 29, 2014.
FOR FURTHER INFORMATION CONTACT: Julio A. Alvarado, Office of Compliance and Field Operations, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; telephone: 301-504-7418; email: jalvarado@cpsc.gov.
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, part of the Danny Keysar Child Product Safety Notification Act, requires the Commission to: (1) Examine and assess the effectiveness of voluntary consumer product safety standards for durable infant or toddler products, in consultation with representatives of consumer groups, juvenile product manufacturers, and independent child product engineers and experts; and (2) promulgate consumer product safety standards for durable infant and toddler products. Durable infant and toddler standards must 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.'' Section 104(f)(2)(H) of the CPSIA specifically identifies ``infant carriers'' as durable infant or toddler products. The Commission has identified at least four types of products that fall within the product category of ``infant carriers,'' including: Frame backpack carriers, hand-held infant carriers, slings, and soft infant and toddler carriers.
On April 5, 2013, the Commission issued a notice of proposed rulemaking (NPR) for soft infant and toddler carriers. 78 FR 20511. The NPR proposed to adopt as a mandatory standard the current voluntary standard for soft infant and toddler carriers, ASTM F2236-13, ``Standard Consumer Safety Specification for Soft Infant and Toddler Carriers'' (ASTM F2236-13), without alteration.
Definition of a Soft Infant and Toddler Carrier
ASTM F2236-14 defines a ``soft infant and toddler carrier'' as ``a product, normally of sewn fabric construction, which is designed to contain a full term infant to a toddler, generally in an upright position, in close proximity to the caregiver.'' Additionally, soft infant and toddler carriers are generally designed to carry a child ``between 7 and 45 pounds.'' ASTM F2236-14 explains that soft infant and toddler carriers are ``normally `worn' by the caregiver with a child positioned in the carrier and the weight of the child and carrier suspended from one or both shoulders of the caregiver. These products may be worn on the front, side, or back of the caregiver's body, with the infant either facing towards or away from the caregiver.'' Typically, children
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are carried in soft infant and toddler carriers on the front of a caregiver; but some products on the market can be configured to carry a child upright on a caregiver's front, back, or hip.
ASTM F2236-14's definition of a ``soft infant and toddler carrier'' distinguishes soft infant and toddler carriers from other types of infant carriers that are also worn by a caregiver but that are not covered under ASTM F-2236-14, specifically slings (including wraps), and framed backpack carriers. Soft infant and toddler carriers are designed to carry a child in an upright position. Slings are designed to carry a child in a reclined position. However, some slings may also be used to carry a child upright. Thus, the primary distinction between a sling and a soft infant and toddler carrier is that a sling allows for carrying a child in a reclined position. Different hazard patterns arise from carrying a child in a reclined position. Accordingly, slings are not covered by the standard for soft infant and toddler carriers. Like soft infant and toddler carriers, framed backpack carriers are intended to carry a child in an upright position. However, framed backpack carriers are distinguishable from soft infant and toddler carriers because typically, backpack carriers are constructed of sewn fabric over a rigid frame and are intended solely for carrying a child on the caregiver's back.
The preamble to the NPR summarized incident data involving soft infant and toddler carriers reported to the Commission from January 1, 1999 to September 10, 2012. 78 FR 20513 (April 5, 2013). CPSC's Directorate for Epidemiology, Division of Hazard Analysis updated this information for the final rule to include soft infant and toddler carrier-related incident data reported to the Commission from September 11, 2012 through July 15, 2013. During the September 11, 2012 to July 15, 2013 time frame, CPSC received 31 new incident reports related to soft infant and toddler carriers. Two of the incidents were fatal, and 29 were nonfatal. Twenty-four of the 29 nonfatal incidents involved injuries. The total count of reported incidents includes emergency department-treated injuries (i.e., injuries reported through the National Electronic Injury Surveillance System (NEISS)).\1\ CPSC staff cannot present national emergency department-treated injury estimates for the final rule due to insufficient numbers of NEISS incidents reported during the time period. The number of incidents occurring in 2012 and 2013 is subject to change because the CPSC continues to collect information about such incidents.
\1\ CPSC's NEISS database is a national probability sample of hospitals in the United States and its territories. Patient information is collected from each NEISS hospital for every emergency visit involving an injury associated with consumer products. From this sample, the total number of product-related injuries treated in hospital emergency rooms nationwide can be estimated.
Both reported fatalities involved suffocation. One suffocation fatality occurred in 2010. The decedent was a 17-day-old infant who was being carried in a soft infant and toddler carrier--facing the mother--
while the mother ran errands. The mother reportedly breast fed the victim while walking. The report is unclear about whether the victim was out of the carrier or in the carrier while being fed. The mother found the child nonresponsive in the carrier. The child was placed on life support, which was later removed due to the child's poor prognosis. The second suffocation fatality occurred in 2011. The decedent, a 4-month-old female, was placed prone to sleep on a bed while still in a soft infant carrier.\2\
\2\ According to CPSC Human Factors staff, this scenario represents an unsafe sleep environment. The prone sleep position is a known risk factor for SIDS, and placing an infant to sleep face down on top of a bed may increase the risk of suffocation. Sleeping in the prone position on a bed with an infant still inside a carrier may further increase the suffocation risk.
Nonfatalities
Caregiver falls (11) \3\;
\3\ All of the fall incidents were emergency department-treated injury (NEISS data) reports.
design and finish-related issues \4\ (2), (which are also among the 7 in the previous category);
\4\ Finish-related issues concern items such as material smoothness and lead content.
Structure, fit, and position issues: Seven of the 31 incidents (23 percent) were related to aspects of the leg- and torso-opening design, how the carrier held the infant, and where the soft
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infant and toddler carrier was positioned on the caregiver. Examples of scenarios reported include: an infant slipping far down into the carrier and suffering an injury when the caregiver bent over; an infant falling out of the carrier when the caregiver bent forward; and leg circulation-related injuries to the infant. Three injuries were reported in this category, including one hospitalization.
Other issues: Ten incident reports (32 percent) involved non-
product-related issues or provided insufficient information for CPSC staff to determine definitively how the product contributed to the incident. The two fatalities are included in this category--one case of an infant suffering respiratory distress while being carried facing inward, and the other case involved an infant put to sleep in a prone position on a bed while still in a soft infant and toddler carrier. In each case, CPSC staff concluded that insufficient information was reported to determine a predominant factor about the product that contributed to the death. Five reports were of incidental injuries sustained by infants while being carried around in a soft infant and toddler carrier. Examples of such incidents include an infant who hit a pole after a bus in which the child was riding suddenly accelerated and an infant who got hurt while being put into a carrier. The remaining three reports involved infants who fell out of the carrier, with no additional information specified.
The soft infant and toddler carrier NPR presented a separate national injury estimate for the 13-year period from January 1999 through December 2011. However, insufficient emergency department-
treated injuries associated with soft infant and toddler carriers in 2012 prevent derivation of reportable national estimates.\5\ In addition, until NEISS data for 2013 are finalized in spring 2014, partial estimates for 2013 are not available. Hence, injury estimates are not presented separately in this final rule. However, the emergency department-treated injuries are included in the total count of reported incidents presented in section III.C above.
\5\ 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.
We summarize the comments received on the NPR and CPSC's responses below. To make identification of the comments and our responses easier, we placed the word ``Comment,'' in parentheses, before the comment's description, and the word ``Response,'' in parentheses, before our response. Additionally, we have numbered each comment to help distinguish among comments. The number assigned to each comment is for organizational purposes only and does not signify the comment's value or importance, or the order in which we received the comment.
(Comment 1) Two commenters stated that the specified fastener strength test load of 80 pounds in section 7.7.2 of ASTM F2236-13 is too high for soft infant and toddler carriers whose manufacturer-
recommended maximum occupant weight for the product is less than 45 pounds. The commenters suggested using a sliding scale for the test load that would adjust the test load by 1 pound for every pound the carrier is rated above or below 45 pounds. For example, for soft infant and toddler carriers designed for a maximum occupant weight of 25 pounds, commenters recommended a fastener test load of 60 pounds (80 pounds minus 20 pounds) instead of an 80-pound force. One commenter stated that for carriers designed for very small occupants, it would be difficult for every load-bearing fastener to be designed to meet the 80-pound test load because such fasteners tend to be large and difficult to handle gently when close to a small infant.
(Response 1) The Commission disagrees with the commenters and declines to modify the final rule based on this comment. ASTM F2236-13 added requirements for fastener strength testing. Each unique load-
bearing fastener, except load-bearing fasteners used for a leg opening adjustment, must not break or disengage when subjected to a tensile load of 80-pound force for 5 seconds. The force is applied to the straps or soft goods on either side of the fastener. Leg opening adjustment fasteners are tested to a 45-pound force.
As noted in the NPR, CPSC staff tested fasteners on 14 different soft infant and toddler carriers, including recalled carriers. The manufacturer's recommended maximum occupant weight of the carriers tested ranged from 20 pounds to 45 pounds. CPSC staff found that most of the tested fasteners failed at loads well above the 80-pound force used in the test, while some of the fasteners on recalled products (which were rated at 26-pound maximum occupant weight) failed at 22 pounds to 55 pounds. The Commission agrees with CPSC staff that lowering the test load to a 60-pound force on a carrier rated at 25 pounds does not provide a sufficient safety factor, considering that fasteners from some recalled carriers failed at 55 pounds during testing. Based on the test results, the Commission finds that an 80-
pound test load is appropriate, even for carriers with maximum occupant weights below 45 pounds.
All of the buckle and strap fasteners on the 14 carriers that CPSC staff tested were made from plastic. CPSC staff concluded that the characteristics of the plastic used for the fasteners dictated the fastener's ability to withstand the test load. The plastic material on the fasteners that fractured at a lower load was much less ductile, resulting in the fastener fracturing instead of deforming. Accordingly, CPSC staff found that smaller fasteners were as capable as
larger fasteners at meeting the 80-pound test load. Staff concluded that fastener strength was not necessarily proportional to fastener size.
Fasteners That Support the Head
(Comment 2) Two commenters stated that fasteners that support the head should be exempt from load testing. Non-load-bearing fasteners intended to retain items such as, but not limited to, hoods, bibs, and toy rings are exempt from load testing in ASTM F2236-13. One of the commenters stated: ``head support for new born babies is critical,'' but to achieve a good, adjustable head support requires fasteners that are slim and easy to use. The commenter designs head support fasteners to carry a certain load; however, the commenter stated that these fasteners are not load bearing and should be exempt from load testing in section 6.4 of the standard.
ASTM F2236-13, the proposed standard for adoption in the NPR, stated that fasteners intended to retain items such as ``hoods, bibs and toy rings'' were exempt from testing. The ASTM subcommittee for soft infant and toddler carriers was aware of a feature called a ``sleeping hood'' that is attached to a soft infant and toddler carrier by non-load bearing fasteners. The ``sleeping hood'' feature was intended to be captured in ASTM F2236-13 Note 1 with the phrase ``hoods.'' To clarify that non-load-bearing fasteners used to retain ``sleeping hoods'' are exempt from testing, ASTM changed the word ``hoods'' in Note 1 to ``sleeping hoods.'' This revision was approved and published in ASTM F2236-13a.
Subsequently, based on a manufacturer's concern that Note 1 was still unclear about whether head adjustment fasteners that were non-
load bearing had to be tested, ASTM balloted and approved another modification to Note 1. The second modification was incorporated into ASTM F2236-14 and added ``head adjustment fasteners'' to the list of examples of fasteners exempt from testing in Note 1. The Commission agrees with the clarification and believes that these revisions to the voluntary standard address the commenters' concern.
Fastener Strap Slip During Load Testing
(Comment 3) One commenter stated that the strap slippage requirement as articulated in the standard (ASTM F2236-13, paragraphs 6.4.1 and 6.4.2) can result in a technical failure of an otherwise safe product. The commenter found that during product testing, certain straps can slip more than 1 inch but in a direction that makes the straps become tighter, not looser. The commenter asserted that this does not compromise safety. The commenter suggested that the language in paragraph 6.4.1 should be changed from ``. . . adjustable elements in straps shall not slip more than 1 in. (2.5 cm) when tested . . .'' to ``. . . adjustable elements in straps shall not loosen more than 1 in. (2.5 cm) when tested . . . .''
The Commission agrees that straps that tighten during testing should not fail the strap retention requirement in the standard. However, based on the CPSC staff's assessment, the Commission finds that use of the word ``slip'' in the standard is more accurate than ``loosen.'' The amount of strap ``slip'' through a fastener can be measured; whereas, CPSC staff is uncertain how to measure strap ``loosening.'' Additionally, the requirement for support/shoulder strap slippage during the dynamic and static load testing in paragraph 6.2 uses the same wording, which states: ``adjustable sections of the support/shoulder straps shall not slip more than 1 in. (25 mm) per strap from their original adjusted position . . .'' Therefore, the Commission will not replace the word ``slip'' with ``loosen'' in the final rule, as suggested by the commenter.
After publication of the NPR, ASTM balloted and approved a modification to the voluntary standard that addresses the commenter's concern about straps that tighten during testing. ASTM F2236-14 incorporates a revision to sections 6.2.2, 6.4.1, and 6.4.2 of the voluntary standard to state: ``straps shall not slip, in a manner that loosens the strap, by more than 1 inch.'' This modification was included in the voluntary standard, beginning with revision ASTM F2236-
Warning Text Format
(Comment 4) One commenter noted that in ASTM F2236-13, the text height requirement for the warnings provided with product instructions specified in section 9.2.2 needs to be modified to match the text height requirement for warning labels in section 8.3.1. The commenter stated that if this modification is not made, section 9.2.2 would require every letter of warning text to be at least 0.1 high, instead of only the upper case letters, as is the case in section 8.3.1.
(Response 4) The Commission agrees that the text height requirement for
warnings should be consistent throughout the standard. To address the commenter's concern, ASTM balloted and approved the following modified text in section 9.2.2, as follows (additions are shown by italics):
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(Comment 5) One commenter stated that the required warning statement should read: ``Infants, especially those under four months, can suffocate in this product if face is pressed tight against your body,'' rather than the warning statement in the proposed rule, as provided in the ASTM standard: ``Suffocation Hazard--Infants under 4 months can suffocate in this product if face is pressed tight against your body.'' The commenter said that this warning language does not adequately warn the user of the risk of suffocation for infants over four months and that the suggested warning statement will alert parents and other caregivers to a risk to older babies as well.
Identifying explicitly children who are most at risk does not suggest that others are not at risk. However, guidelines for warning labels recommend focusing on the most likely and most serious risks (Laughery and Hammond, 1999; Wogalter, 2006). Warnings about low-
probability events (i.e., older infants suffocating in soft infant carriers) may reduce the believability or arousal strength of warnings that caution of more likely risks (i.e., infants under 4 months suffocating in soft infant carriers). The Commission finds that the current ASTM warning label about the suffocation hazard is sufficient without modification.
(Comment 6) One commenter stated: ``we are concerned that raising the upper weight limits, for the purpose of ensuring that all soft infant and toddler carriers on the market are covered by the rule, brings in carriers that might have a greater risk of instability and falls due to the extra weight load relative to the weight and strength of the caregiver. We would urge the Commission to include an adequate alert to this risk in the required warnings and instructions.''
(Response 6) During the rulemaking, CPSC staff identified soft infant and toddler carriers on the market that have a manufacturer-
recommended upper weight limit of 45 pounds. The Commission believes that expanding the scope of the standard to increase the upper weight limit from 25 pounds to 45 pounds is necessary for the standard to cover all products on the market. However, for the Commission to include a warning statement about the greater risk of instability and falls involving products with higher weight limits, data must be available to demonstrate that carrying heavier children in soft infant and toddler carriers presents a greater risk of instability and falls. At this time, the available data do not support this position. Furthermore, the commenter did not provide data demonstrating that products with higher weight limits present a greater risk of instability and falls than carriers with a lower weight limit. Therefore, at this time, the Commission declines to modify the warning label as suggested by the commenter.
(Response 7) The Commission finds that sufficient incentive exists for compliant producers to label their products as compliant with the final standard for soft infant and toddler carriers. A final rule implementing testing, certification, and labeling of children's products in section 14 of the CPSA, as amended by the CPSIA, Testing and Labeling Pertaining to Product Certification, 16 CFR part 1107 (the 1107 rule), became effective on February 13, 2013. Under the 1107 rule, a manufacturer or importer may label a certified compliant product as ``Meets CPSC Safety Requirements.'' Because producers are already allowed to label compliant products as such under the 1107 rule, adding this option to the soft infant and toddler carrier standard would be redundant. The Commission declines to change to the final rule based on this comment.
(Comment 8) Two commenters address the 6-month effective date proposed in the NPR. One commenter,
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representing several advocacy groups, expressed support for the 6-month effective date. Another commenter, a soft infant and toddler carrier manufacturer, recommended a 12-month effective date, stating that the manufacturing process can take up to 6 months, and the product may be stocked in a warehouse for additional months, depending on sales.
Summary of ASTM F2236-14
A revision to Note 1 in section 6.4 to clarify that ``sleeping hoods'' are an example of non-load-bearing fasteners that are exempt from fastener strength testing.
On September 26, 2013, the ASTM F15.21 Soft Infant and Toddler Carrier subcommittee met to discuss results of the items balloted on August 23, 2013. One manufacturer wanted the voluntary standard to further clarify that fasteners used for adjusting the head portion of the carrier were exempt from fastener strength testing because such fasteners are not load bearing. As a result, the subcommittee chair developed a draft ballot item that proposed to add ``head adjustment fasteners'' to the list of examples of fasteners that are exempt from load testing listed in Note 1 of section 6.4. The subcommittee chair balloted the proposed revision to ASTM F2236-13a for concurrent ASTM Main Committee F15 and Subcommittee F15.21 consideration on November 6, 2013, with a 1-month comment period. ASTM did not receive any negative votes on the balloted revision, and approved the revised standard, ASTM F2236-14, on January 1, 2014. ASTM published ASTM F2236-14 in January 2014.
Scope. The scope of the voluntary standard was broadened in December 2012 to include soft infant and toddler carriers with an upper weight limit of up to 45 pounds. Previously, it was unclear whether carriers with upper weight limits over 25 pounds fell within the standard. Expanding the scope of the standard clarifies that all soft infant and toddler carrier products currently on the market fall within the standard. The name of the standard was changed in 2012 to include the word ``toddler,'' to clarify that toddlers can also be carried in these products. The scope of the standard also distinguishes soft infant and toddler carriers from other wearable infant carrier products. The scope provides that soft infant and toddler carriers are ``normally of sewn fabric construction,'' hold the child ``generally in an upright position,'' and ``may be worn on the front, side, or back of the caregiver's body.'' Finally, the scope of the standard states that the standard does not apply to infant slings.
Terminology. Section 3.1 of the standard includes 14 definitions to help explain general requirements and performance requirements. Section 3.1.7 of the standard explains that a ``leg opening'' is the ``opening in the soft carrier through which the occupant's legs extend when the product is used in the manufacturer's recommended use position.'' Sections 3.1.4 and 3.1.13 of ASTM F2236-14, respectively, explain that a ``dynamic load'' is the ``application of impulsive force through free fall of a weight,'' and that a ``static load'' is a ``vertically downward force applied by a calibrated force gage or by dead weights.'' Beginning in 2012, the standard included a new definition for ``carrying position'' to clarify methods for dynamic and static load testing in section 7 of the standard. Finally, in 2013, the standard was updated to include a new definition for ``fastener'' to aid in a new test for fastener strength and strap retention.
Restrictions on sharp points or edges, as defined by 16 CFR Sec. Sec. 1500.48 and .49;
Leg Openings--Tested leg openings must not permit passage of a test sphere weighing 5 pounds that is 14.75 inches in circumference.
Dynamic and Static Load--Beginning with the 2012 version of ASTM F2236, the dynamic load test was strengthened from requiring a 25-pound shot bag to be dropped, free fall, from 1 inch above the seat area onto the carrier seat 1,000 times, to requiring testing with a 25-pound shot bag, or a shot bag equal to the manufacturer's maximum occupant weight limit, whichever is heavier. Additionally, the static load test was revised--from requiring a 75-pound weight for testing--to requiring a 75-pound weight, or a weight equal to three times the manufacturer's recommended maximum occupant weight, whichever is greater, to be placed in the seat area of the carrier for 1 minute. Such revisions to the dynamic and static load tests strengthen the test requirements, by requiring that products with a maximum recommended weight of 45 pounds be tested to a 135-pound weight instead of 75 pounds, which represents an 80 percent increase in the severity of the requirement.
ASTM F2236-14 requires that testing conducted with the new required loads must not result in a ``hazardous condition,'' as defined in the general requirements, or result in a structural failure, such as fasteners breaking or disengaging, or seams separating when tested in accordance with the dynamic and static load testing methods. Additionally, the standard provides that dynamic and static load testing must not result in adjustable sections of support/shoulder straps slipping more than 1 inch per strap from their original adjusted position after testing.
Section 6.2.2 of the standard on Support/Shoulder Strap Slippage was modified beginning with ASTM F2236-13a. The modification clarifies what constitutes passing or failing the strap slippage test. Section 6.2.2 was amended to state: ``Adjustable sections of support/shoulder straps shall not slip, in a manner that loosens the strap, more than 1 in. (25 mm) per strap from their original adjusted position after dynamic and static load testing is performed in accordance with 7.2.1 and 7.2.2, respectively.'' The amendment allows straps to tighten during testing but not loosen more than 1 inch, which is the intent of the testing.
Fastener Strength and Strap Retention--ASTM F2236-14 includes a new component-level performance requirement that was added to the standard in 2013 to evaluate the strength of fasteners and strap retention to help prevent falls from a carrier. Previously, soft infant and toddler carriers were recalled due to an occupant fall hazard caused by broken fasteners that passed the static and dynamic performance requirements in the then existing standard, ASTM F2236-10. Accordingly, the performance requirement in section 6.4 of ASTM F2236-14 states that load-bearing fasteners at the shoulder and waist of soft infant and toddler carriers, such as buckles, loops, and snaps, may not break or disengage; nor may their straps slip more than 1 inch when subjected to an 80-pound pull force. Adjustable leg opening fasteners must also be tested but are subjected to lower loads, a 45-pound pull force, because these fasteners do not carry the same load as fasteners at the shoulders and waist. ASTM F2236-14 requires that when tested, fasteners must not break or disengage, and adjustable elements must not slip more than 1 inch.
Similar to the strap slip requirement in the static and dynamic load testing section of the standard, ASTM also clarified the strap slip section of the fastener strength test section in ASTM F2236-13a. Sections 6.4.1 and 6.4.2 were amended to state: ``Each unique fastener, except for leg opening adjustment fasteners as tested per 6.4.2, shall not break or disengage, and adjustable elements in straps shall not slip, in a manner that loosens the strap, more than 1 in. (2.5 cm) . . . .'' This amendment allows straps to tighten during testing but not to loosen more than 1 inch, which is the intent of the testing.
Additionally, Note 1 to section 6.4 of the standard provides that the fastener strength and strap retention testing apply only to load-
bearing fasteners. ASTM F2236-13 stated: ``Fasteners intended to retain items such as, but not limited to, hoods, bibs and toy rings, are exempt from these requirements.'' ASTM approved two changes to the language in Note 1 to clarify that several non-load-bearing features, ``sleeping hoods'' and ``head adjustment fasteners,'' are included in the list of examples exempted from fastener strength testing when such features are non-load-bearing. Note 1 in section 6.4 of ASTM F2236-14 now provides that: ``Fasteners intended to retain items such as, but not limited to, sleeping hoods, head adjustment fasteners, bibs and toy rings, are exempt from these requirements.''
Unbounded Leg Opening--The voluntary standard was updated in 2013 to clarify the unbounded leg opening test procedure to improve test repeatability. ASTM F2236-14 requires that an unbounded leg opening must not allow complete passage of a truncated test cone that is 4.7 inches long, with a major diameter of 4.7 inches and a minor diameter of 3 inches. The standard requires a test cone to be pulled through the leg opening with a 5-pound force for 1 minute.
Marking, Labeling, and Instructional Literature. ASTM F2236-14 requires that each product and its retail package be marked or labeled with certain information and warnings. The warning label requirement was updated in 2013 to address fall and suffocation hazards. ASTM F2236-14 requires that the warning label provide a fall hazard statement addressing that infants can fall through wide leg openings or out of the carrier. The standard requires the following fall-related precautionary statements be addressed on the warning label: Adjust leg openings to fit baby's legs snugly; before each use, make sure all fasteners/knots are secure; take special care when leaning or walking; never bend at waist, bend at knees; only use this carrier for children between -- lbs. and -- lbs. Additionally, ASTM F2236-14 requires that a suffocation hazard statement must address the fact that infants under 4 months old can suffocate in the carrier if the child's face is pressed tightly against the caregiver's body. The standard requires that the warning label must also address the following suffocation-related precautionary statements: Do not strap infant too tightly against your body; allow room for head movement; keep infant's face free from obstructions at all times. Products must also contain an informational statement that a child must face toward the caregiver until he
or she can hold his or her head upright. All products are required to come with instructional literature on assembly, use, maintenance, cleaning, and required warnings.
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The Administrative Procedure Act (APA) generally requires that the effective date of the rule be at least 30 days after publication of the final rule. 5 U.S.C. 553(d). The NPR proposed that the final rule would become effective 6 months after publication of a final rule in the Federal Register. Although we received one comment requesting a 12-
month effective date (comment 8 in section IV.H), the Commission finds that a 6-month effective date is sufficient time to allow manufacturers to come into compliance. Manufacturers whose products are not compliant with the standard will require some product modification; however, any necessary product modification is expected to involve minor changes, such as adding or changing straps or fasteners. Moreover, ASTM F2236-13 was adopted by ASTM in March 2013, and became effective in September 2013.
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Although the Commission is adopting ASTM F2236-14, this version of the voluntary standard is substantially the same as ASTM F2236-13. Manufacturers that are compliant with ASTM F2236-13 have already made or have begun to make the necessary modifications.
Soft infant and toddler carriers are generally produced and/or marketed by juvenile product manufacturers and distributors. Several of these firms primarily produce soft infant and toddler carriers, as well as substitute products, such as slings. CPSC Economic Analysis (EC) staff believes that there are at least 54 suppliers of soft infant and toddler carriers to the U.S. market.\6\ Thirty-nine domestic firms supply soft infant and toddler carriers to the U.S. market: 23 are domestic manufacturers; eight are domestic importers; and eight firms have unknown supply sources. In addition, 12 foreign firms supply soft infant and toddler carriers to the U.S. market. CPSC has insufficient information available to categorize the remaining three firms.\7\
\6\ Staff conducted research to identify manufacturers and importers of soft carriers. From the time of the NPR to the final rule, several firms entered the market, raising the number of suppliers from 39 in the NPR to 54 presently.
\7\ CPSC staff made these determinations using information from Dun & Bradstreet and ReferenceUSAGov, as well as the firms' Web sites.
According to a 2005 survey conducted by the American Baby Group (2006 Baby Products Tracking Study), 51 percent of new mothers own soft infant and toddler carriers.\8\ Approximately 30 percent of soft infant and toddler carriers are handed down or purchased secondhand.\9\ Thus, about 70 percent of soft infant and toddler carriers are acquired new. This estimate suggests that approximately 1.5 million soft infant and toddler carriers are sold to households annually (0.51 x 0.70 x 4.1 million births per year).\10\
\8\ The data collected for the Baby Products Tracking Study does not represent an unbiased statistical sample. The sample of 3,600 new and expectant mothers is drawn from American Baby magazine's mailing lists. Also, because the most recent survey information is from 2005, the information may not reflect the current market.
\9\ The data on secondhand products for new mothers was not available. Instead, data for new mothers and experienced mothers were combined and broken down into first-time mothers and experienced mothers. Data for first-time mothers and experienced mothers have been averaged to calculate the approximate percentage of soft infant and toddler carriers that were handed down or purchased secondhand.
\10\ 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 2009,'' National Vital Statistics Reports Volume 60, Number 1 (November 2011): Table I. The number of live births in 2009 is rounded from 4,130,665.
Many soft infant and toddler carriers have expanded their maximum weight limits in recent years to accommodate older children. However, from the lack of incident data involving children older than 2 years, CPSC staff believes that most caregivers would not be comfortable carrying older, heavier children in soft infant and toddler carriers. Based on the incident data, it appears that soft infant and toddler carriers are used during a child's first year, with some caregivers continuing to use these products into the second year. While we do not know the proportion of caregivers who continue to use these products into the second year, we estimated the numbers of soft infant and toddler carriers in use by assuming that a portion of caregivers, e.g., 25-50 percent, will continue to use carriers in the child's second year. Based on data from the 2006 Baby Products Tracking Study, approximately 2.1 million soft infant and toddler carriers are owned by new mothers. Assuming that 25-50 percent of caregivers continue to use soft infant and toddler carriers in the second year, approximately 2.6 million (2.1 million x 0.25 x 2.1 million) to 3.2 million (2.1 million x 0.50 x 2.1 million) households have soft infant and toddler carriers available for use annually. Based on Directorate for Epidemiology staff's estimate of 1,400 injuries treated nationally in emergency departments from 1999 to 2011, an average of about 108 emergency department-treated injuries involve soft infant and toddler carriers annually.\11\ Therefore, about 0.34-0.40 emergency department-treated injuries may occur annually for every 10,000 soft infant and toddler carriers available for use.
\11\ Memorandum from Risana Chowdhury, Directorate for Epidemiology, dated March 11, 2013, Subject: Soft Infant and Toddler Carrier-Related Deaths, Injuries, and Potential Injuries, and NEISS Injury Estimates; 1999-September 10, 2012. CPSC staff cannot present national emergency department-treated injury estimates for 2012 due to insufficient numbers of NEISS incidents reported during the time period, and 2013 data is not yet available. Memorandum from Risana Chowdhury, Directorate for Epidemiology, dated September 23, 2013, Subject: Soft Infant and Toddler Carrier-Related Deaths, Injuries, and Potential Injuries between September 11, 2012 and July 15, 2013.
Reason for Agency Action and Legal Basis for the Final Rule
Issues Raised by Public Comments
Section IV of this preamble contains a summary of the five comments received and the issues raised by the comments.
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In addition, 16 CFR part 1107 requires the third party testing of children's products to be conducted by CPSC-accredited laboratories. Section 14(a)(3) of the CPSA required the Commission to publish a notice of requirements (NOR) for the accreditation of third party conformity assessment bodies (i.e., testing laboratories) to test for conformance with each children's product safety rule. The NORs for existing rules are set forth in 16 CFR part 1112. The Commission is finalizing an amendment to 16 CFR part 1112 that establishes the requirements for the accreditation of testing laboratories to test for compliance with the soft infant and toddler carrier final rule.
The FRFA is limited to the 39 domestic firms known to be marketing soft infant and toddler carriers in the United States because U.S. Small Business Administration (SBA) guidelines and definitions pertain to U.S.-based entities. Under SBA guidelines, a manufacturer of soft infant and toddler carriers is small if it has 500 or fewer employees, and importers and wholesalers are considered small if they have 100 or fewer employees. Based on these guidelines, 32 of the 39 domestic firms supplying soft infant and toddler carriers to the U.S. market are small firms--18 manufacturers, six importers, and eight firms--whose supply source is unknown. Additional unknown small soft infant and toddler carrier suppliers may also operate in the U.S. market.
One purpose of the regulatory flexibility analysis is to evaluate the impact of a regulatory action and determine whether the impact is economically significant. While the SBA gives considerable flexibility in defining ``economically significant,'' CPSC staff typically uses one percent of gross revenue as the threshold for determining ``economic significance.'' CPSC staff considers any impact that is one percent or more of gross revenue is considered economically significant. SBA has accepted the one percent of gross revenue threshold and this threshold is also commonly used by agencies in determining economic significance.\12\
\12\ U.S. Small Business Administration, Office of Advocacy. A Guide for Government Agencies: How to Comply with the Regulatory Flexibility Act and Implementing the President's Small Business Agenda and Executive Order 13272. May 2012, pgs. 18-20. http://www.sba.gov/sites/default/files/rfaguide_0512_0.pdf.
Small Manufacturers: The expected impact of the final rule on small manufacturers will differ, based on whether manufacturers' soft infant and toddler carriers are already compliant with F2236-13. Although F2236-14 was published in January 2014, firms are still likely to be testing to F2236-13. However, because ASTM F2236-13, ASTM F2236-13a, and ASTM F2236-14 do not contain material differences, manufacturers in compliance with ASTM F2236-13 are likely to continue to comply with the voluntary standard.
Based on information from the durable nursery product industry and confidential business information supplied for the development of the third party testing rule, CPSC staff estimates that testing to a single ASTM voluntary standard could cost around $500-$600 per model sample. On average, each small domestic manufacturer supplies two different models of soft infant and toddler carriers to the U.S. market annually. Therefore, if third party testing to the requirements in the soft infant and toddler standard is conducted every year on a single sample for each model, third party testing costs associated for each manufacturer would be about $1,000-$1,200 annually. Based on an examination of estimates of firms' revenues from recent Dun & Bradstreet reports, the impact of third party testing is not likely to be economically significant if only one sample per model is required. However, if more than one sample is needed to meet the testing requirements, third party testing costs could have an economically significant impact on some small manufacturers (i.e., testing costs could be one percent or more of gross revenue). CPSC staff does not know exactly how many samples each manufacturer will need to test to meet the ``high degree of assurance'' criterion required by 16 CFR part 1107.
As is the case with manufacturers, all importers will be subject to third party
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testing and certification requirements, and consequently, they will experience the associated costs, if their supplying foreign firm(s) does not perform third party testing. The resulting costs could potentially have a significant impact on a few small importers that must perform the testing themselves, particularly if more than one sample per model is required.
The Commission's regulations address whether we are required to prepare an environmental assessment or an environmental impact statement. If our rule has ``little or no potential for affecting the human environment,'' the rule will be categorically exempted from this requirement. 16 CFR 1021.5(c)(1). The final rule for soft infant and toddler carriers falls within the categorical exemption.
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 (44 U.S.C. 3501-
3520). The preamble to the proposed rule (78 FR at 20520 through 20521) discussed the information collection burden of the proposed rule and specifically requested comments on the accuracy of our estimates. OMB has assigned control number 3041-0162 to this information collection. We did not receive any comment regarding the information collection burden of the proposal. However, the final rule makes modifications regarding the information collection burden because the number of estimated manufacturers subject to the information collection burden is now estimated at 54 manufacturers rather than the 39 manufacturers initially estimated in the proposed rule.
1226............................................................... 54 2 108 1 108
CPSC is aware of 54 firms that supply soft infant and toddler carriers in the U.S. market. For PRA purposes, we assume that all 54 firms use labels on their products and on their packaging already. However, firms might need to make some modifications to their existing labels. We estimate that the time required to make these modifications is about 1 hour per model. Each of the 54 firms supplies an average of two different models of soft infant and toddler carriers. Therefore, we estimate the burden hours associated with labels to be 108 hours annually (1 hour x 54 firms x 2 models per firm = 108 hours annually).
We estimate the hourly compensation for the time required to create and update labels is $27.71 (U.S. Bureau of Labor Statistics, ``Employer Costs for Employee Compensation,'' September 2013, Table 9, total compensation for all sales and office workers in goods-producing private industries: http://www.bls.gov/ncs/). Therefore, we estimate the annual cost to industry associated with the labeling requirements in the final rule to be $2,992.68 ($27.71 per hour x 108 hours = $2,992.68). This collection of information does not require operating, maintenance, or capital costs.
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 applies to final durable infant and toddler product final rules. Therefore, the final rule issued under section 104 of the CPSIA will invoke the preemptive effect of section 26(a) of the CPSA when the final rule becomes effective.
Certification and Notice of Requirements
Section 14(a) of the CPSA requires that products subject to a consumer product safety rule under the CPSA, or to a similar rule, ban, standard or regulation under any other act enforced by the Commission, must be certified as complying with all applicable CPSC-enforced requirements. 15 U.S.C. 2063(a). Section 14(a)(2) of the CPSA requires that certification of children's products subject to a children's product
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safety rule be based on testing conducted by a CPSC-accepted third party conformity assessment body. Section 14(a)(3) of the CPSA requires the Commission to publish a NOR for the accreditation of third party conformity assessment bodies (or laboratories) to assess conformity with a children's product safety rule to which a children's product is subject. The final rule for 16 CFR part 1226, ``Safety Standard for Soft Infant and Toddler Carriers,'' is a children's product safety rule that requires the issuance of a NOR.
A FRFA was conducted as part of the promulgation of the original 16 CFR part 1112 (78 FR 15836, 15855-15858), as required by the Regulatory Flexibility Act. Briefly, the FRFA concluded that the accreditation requirements would not have a significant adverse impact on a substantial number of small laboratories because no requirements were imposed on laboratories that did not intend to provide third party testing services. The only laboratories expected to provide such services are those that anticipate receiving sufficient revenue from the mandated testing to justify accepting the requirements as a business decision.
For the reasons discussed in the preamble, the Commission amends Title 16 of the Code of Federal Regulations by amending part 1112 and adding a new part 1226, as follows:
Authority: 15 U.S.C. 2063; Pub. L. No. 110-314, section 3, 122 Stat. 3016, 3017 (2008)
2. In Sec. 1112.15 add paragraph (b)(37) to read as follows:
Sec. 1112.15 When can a third party conformity assessment body apply for CPSC acceptance for a particular CPSC rule and/or test method?
PART 1226--SAFETY STANDARD FOR SOFT INFANT AND TODDLER CARRIERS
Authority: The Consumer Product Safety Improvement Act of 2008, Pub. L. 110-314, Sec. 104, 122 Stat. 3016 (August 14, 2008); Pub. L. 112-28, 125 Stat. 273 (August 12, 2011).
Sec. 1226.1 Scope.
Sec. 1226.2 Requirements for soft infant and toddler carriers.
(a) Each soft infant and toddler carrier must comply with all applicable provisions of ASTM F2236-14, Standard Consumer Safety Specification for Soft Infant and Toddler Carriers, approved on January 1, 2014. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from ASTM International, 100 Bar Harbor Drive, P.O. Box 0700, West Conshohocken, PA 19428; http://www.astm.org/cpsc.htm. You may inspect a copy at the Office of the Secretary, U.S. Consumer Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814, telephone 301-504-7923, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal regulations/ibr_
FR Doc. 2014-06771 Filed 3-27-14; 8:45 am