[Federal Register Volume 82, Number 18 (Monday, January 30, 2017)]
[Rules and Regulations]
[Pages 8671-8688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-01285]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Parts 1112 and 1228
[Docket No. CPSC-2014-0018]
Safety Standard for Sling Carriers
AGENCY: Consumer Product Safety Commission.
ACTION: Final rule.
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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 or CPSC) 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 infant slings (sling carriers) in response to the
direction of section 104(b) of the CPSIA. In addition, the Commission
is amending its regulations regarding third party conformity assessment
bodies to include the mandatory standard for slings in the list of
Notices of Requirements (NOR) issued by the Commission.
DATES: This rule is effective January 30, 2018. The incorporation by
reference of the publication listed in this rule is approved by the
Director of the Federal Register as of January 30, 2018.
FOR FURTHER INFORMATION CONTACT: Daniel Dunlap, Compliance Officer,
U.S. Consumer Product Safety Commission, 4330 East-West Highway,
Bethesda, MD 20814; telephone: 301-504-7733; email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background and Statutory Authority
The CPSIA 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 or toddler products. Standards issued
under section 104 are to be ``substantially the same as'' the
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)(1)(H) provides that the term ``durable
infant or toddler product'' includes ``infant carriers.''
In this document, the Commission is issuing a safety standard for
sling carriers.\1\ Section 104(f)(2)(H) of the CPSIA lists ``infant
carriers'' as one of the categories of durable infant or toddler
products. As indicated by a review of ASTM's standards and retailers'
Web sites, the category of ``infant carriers'' includes hand-held
infant carriers, soft infant carriers, frame backpack carriers, and
sling carriers. The Commission has issued final rules for three types
of infant carriers: Hand-held infant carriers (78 FR 73415 (December 6,
2013)), soft infant carriers (78 FR 20511 (April 5, 2013)) and frame
carriers (80 FR 11113 (March 2, 2015)). In the Commission's product
registration card rule identifying additional products that the
Commission considers durable infant or toddler products necessitating
compliance with the product registration card requirements, the
Commission specifically identified ``infant slings,'' or sling
carriers, as a durable infant or toddler product. 76 FR 68668 (December
29, 2009). Accordingly, 16 CFR 1130.2(a)(18) now specifically
identifies ``infant slings'' as a durable infant or toddler product. At
the notice of proposed rulemaking (NPR) stage, the staff briefing
package for the proposed rule included a detailed technical analysis of
the durability of sling carriers, which concluded that sling carriers
are durable
[[Page 8672]]
products. The durability of infant slings is further discussed in
section VI.G of this preamble.
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\1\ The Commission voted 3-2 to publish this notice in the
Federal Register. Chairman Elliot F. Kaye, Commissioner Robert S.
Adler, and Commissioner Marietta S. Robinson voted to approve
publication of the final rule. Commissioners Ann Marie Buerkle and
Joseph P. Mohorovic voted against publication of the final rule.
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Because the voluntary standard on infant slings, ASTM 2907-15,
Standard Consumer Safety Specification for Sling Carriers, refers to
``infant slings'' as ``sling carriers,'' this document refers to infant
slings as ``sling carriers.'' The terms are intended to be
interchangeable and have the same meaning.
On July 23, 2014, the Commission issued an NPR for sling carriers.
79 FR 42724. The NPR proposed to incorporate by reference the voluntary
standard, ASTM F2907-14a, Standard Consumer Safety Specification for
Sling Carriers, without modification.
In this document, the Commission is issuing a mandatory safety
standard for sling carriers. As required by section 104(b)(1)(A), the
Commission consulted with manufacturers, retailers, trade
organizations, laboratories, consumer advocacy groups, consultants, and
the public to develop this standard, largely through the ASTM process.
The rule incorporates by reference the most recent voluntary standard,
developed by ASTM International, ASTM F2907-15, with one modification.
In addition, the final rule amends the list of NORs issued by the
Commission in 16 CFR part 1112 to include the standard for sling
carriers. Under section 14 of the Consumer Product Safety Act (CPSA),
the Commission promulgated 16 CFR part 1112 to establish requirements
for accreditation of third party conformity assessment bodies (or
testing laboratories) to test for conformity with a children's product
safety rule. Amending part 1112 adds to the list of children's product
safety rules a NOR for the sling carriers standard.
II. Product Description
The scope section of ASTM F2907-15 defines a ``sling carrier'' as
``a product of fabric or sewn fabric construction, which is designed to
contain a child in an upright or reclined position while being
supported by the caregiver's torso.'' These products typically are
intended for children starting at full-term birth, until a weight of
about 35 pounds. The designs of infant slings vary, but the designs
generally range from unstructured hammock-shaped products that suspend
from the caregiver's body, to long lengths of material or fabric that
are wrapped around the caregiver's body. Infant slings normally are
worn with the infant positioned on the front, hip, or back of the
consumer, and with the infant facing toward or away from the consumer.
As stated in the ``sling carrier'' definition, these products generally
allow the infant to be placed in an upright or reclined position.
However, the reclined position is intended to be used only when the
infant is worn on the front of the consumer. The ability to carry the
infant in a reclined position is the primary feature that distinguishes
sling carriers from soft infant and toddler carriers, another subset of
sling carriers. The Commission has identified three broad classes of
sling carrier products available in the United States:
[ssquf] Ring slings are hammock-shaped fabric products, in which
one runs fabric through two rings to adjust and tighten the sling.
[ssquf] Pouch slings are similar to ring slings but do not use
rings for adjustment. Many pouch slings are sized, rather than
designed, to be adjustable. Other pouch slings are more structured and
use buckles or other fasteners to adjust the size.
[ssquf] Wrap slings are generally composed of a long length of
fabric, up to approximately 6 yards long, and up to 2 feet wide. A wrap
sling is completely unstructured with no fasteners or other means of
structure; instead, the caregiver uses different methods of wrapping
the material around the caregiver's body and the child's body to
support the child. Wrap-like slings mimic the manner in which a wrap
supports the child, but they use fabric in other manners, such as
loops, to reduce the need for caregivers to learn wrapping methods.
ASTM F2907 does not distinguish among the type of slings. The
voluntary standard's requirements apply equally to all slings.
III. Market Description
In the NPR, CPSC staff reported that it had identified 47 suppliers
of sling carriers to the U.S. market, including 33 companies based in
the United States and 14 foreign companies that exported directly to
U.S. customers via Internet sales or to U.S. retailers. The 33 U.S.-
based firms included 25 manufacturers, four importers, and four firms
for which the supply source was not identified. Under U.S. Small
Business Administration (SBA) definitions, all but one of the 47 firms
would be considered a ``small business.'' The NPR also noted that
``there may be hundreds more suppliers that produce small quantities of
slings.'' In response to the NPR, the Commission received comments,
including from the SBA, concerning the rule's potential impact on small
businesses. As explained further in section IX of this preamble, the
final regulatory flexibility analysis (FRFA) uses information provided
by The Baby Carrier Alliance Institute (BCIA) to expand on the
discussion in the NPR and give additional information about the rule's
possible effect on small businesses.
The market price of sling carriers varies, depending on the type of
sling carriers. Ring slings are generally the least expensive, with
prices ranging from $40 to $200, and an average price of $100.
Handwoven wraps have a price range of $200 to $800 per wrap. Machine-
woven wraps range in price from $65 to $400, with an average price of
about $150. The BCIA provided no information on pouches, but pricing is
believed to be similar to ring slings.
More recently, information provided by the BCIA confirms the role
of numerous small and very small artisanal manufacturers in the sling
market. The BCIA identified more than 324 U.S. manufacturers of slings,
wraps, and pouches, including both members and non-members of BCIA,
many of which are very small. The firms that the BCIA identified
overlap partially with the 47 suppliers identified by CPSC staff, but
the firms do not include some of the larger non-members of BCIA, some
European firms that export to the United States, and a number of small
Chinese firms. The BCIA has also identified some additional hand
weavers. Thus, the total number of manufacturers may reach 400.
According to the BCIA, about 250 of the 324 identified small sling
manufacturers had annual sales revenue of less than $10,000, and an
additional 45 had revenues of greater than $10,000, but less than
$50,000. Most of these very small manufacturers (especially those with
sales revenue of $50,000 or less annually) worked out of their home,
and had one or no employees. In a letter to CPSC concerning the sling
rulemaking, the SBA Office of Advocacy described many of these very
small manufacturers as ``stay-at-home moms that supplement their income
by creating the slings.''
According to the BCIA, a common scenario for the development of a
very small sling manufacturer starts with a mother using various slings
or soft carriers and then deciding to make her own design in her home.
Some of these home businesses grow into larger businesses that become
more specialized and sophisticated, typically designing and marketing
their own products, but having the product manufactured overseas. Based
on emails with the BCIA, and CPSC staff's review of sling Web sites,
the newer home businesses generally may not know about the sling
carrier voluntary standard or realize they may be subject to existing
federal regulations on children's products, such as the CPSIA
[[Page 8673]]
regulations on product labeling and registration cards.
The BCIA reports that dollar sales for the 324 manufacturers they
identified amount to approximately $36 million annually. Unit sales for
these manufacturers are estimated to be about 500,000 annually. Given
the exclusion of some of the larger wrap and pouch manufacturers from
the total provided by the BCIA, we estimate annual unit sales at
800,000 to 1 million and dollar sales to be about $55 million to $70
million annually.
In 2013, the CPSC conducted a Durable Nursery Product Exposure
Survey (DNPES) of U.S. households with children under age 6. Data from
the DNPES indicate that there were an estimated 7.33 million slings in
U.S. households in 2013 (with 95 percent probability that the actual
value is between 6.2 million and 8.5 million). The survey data also
indicated that about 23.4 percent of the slings in U.S. households were
currently in use (an estimated 1.72 million slings, with 95 percent
probability that the actual value is between about 1.17 million and
2.26 million).
IV. Incident Data
In the NPR briefing package, CPSC staff identified a total of 122
sling carrier-related incidents, including 16 fatalities and 54
injuries that reportedly occurred from January 2003 through October 27,
2013. Since the extraction of the data for the NPR briefing package,
CPSC staff has received 37 new reports (1 fatal and 36 nonfatal)
related to sling carriers, reported between October 28, 2013 and
September 15, 2016. Although reporting is ongoing, most of the new
reports of incidents received, thus far, show a date of occurrence in
2014. Among the incidents where the age of the victim was reported, the
children were 10 months old or younger. Among these new reports of
incidents:
[ssquf] Fatalities: The new fatality incident occurred in 2013,
when a 5-month-old was severely injured due to a lack of oxygen; the
child passed away in 2015.
[ssquf] Nonfatal incidents: Among the 36 new nonfatal incident
reports related to sling carriers, 13 reported an injury to the infant
or toddler while using the product. All of the injury victims were
infants ranging in age from 1 month to 10 months. Among the 13 nonfatal
injuries, one required hospitalization for a leg fracture following a
fall. Another skull fracture injury was reported, but hospitalization
was not mentioned. Other injuries not requiring hospitalization
included closed-head injuries, contusions/abrasions, lacerations/
scratches, and skin rash.
The number of emergency department-treated injuries associated with
sling carriers for the period covered was insufficient to derive any
reportable national estimates. Therefore, reportable injury estimates
cannot be calculated.
There were no new hazard patterns identified among the 37 reports
received by the CPSC since publication of the sling carrier NPR; the
hazards identified in the 37 new incidents are consistent with the
hazard patterns identified among the incidents present in the NPR
briefing package. Those hazard patterns were:
[ssquf] Consumer comments: Consumer concerns or observations about
perceived safety hazards of a product, a product's noncompliance with
standards, and/or contentions of unauthorized sale;
[ssquf] Caregiver missteps: Instances where the caregiver slipped,
tripped, or grabbed/dropped the child during placement into/removal out
of the carrier;
[ssquf] Miscellaneous product-related issues: Consumers complaints
about unspecified product breakage, or the poor quality of the fabric,
the ring(s), and/or the stitching used in the sling carrier;
[ssquf] Unspecified falls;
[ssquf] Problems with positioning the infant in the sling carrier;
and
[ssquf] Problems with buckles: Releasing, slipping, or breaking of
buckles, thereby causing infants to fall or nearly fall.
V. Overview of ASTM 2907
The voluntary standard for sling carriers was first approved and
published in 2012, as ASTM F2907-12, Standard Consumer Safety
Specification for Sling Carriers. ASTM has revised the voluntary
standard seven times since the initial publication. The current
version, ASTM F2907-15, was approved on October 15, 2015, and published
in November 2015. The NPR for sling carriers proposed incorporating
ASTM F2907-14a by reference; however, ASTM has revised the voluntary
standard twice since then. The revisions since the NPR are listed
below.
[ssquf] ASTM F2907-14b: This revision modified the occupant-
retention test pass/fail criteria, increasing from 1 inch to 3 inches
the amount the ring sling attachment system may slip while still
passing the standard. This ballot was open at the time of the CPSC NPR,
and the NPR requested comments on the issue. Six comments to the NPR
agreed with the change ASTM had balloted and zero disagreed.
[ssquf] ASTM F2907-15: Under this revision, the test torso for the
occupant-retention test is clothed in a ``tight-fitting, thermal knit
or waffle-weave, cotton or cotton/polyester undershirt or equivalent.''
Seven NPR comments requested a change to the NPR (which did not require
any clothing on the test torso) to increase the friction
characteristics of the test torso. This particular issue was brought to
the subcommittee by test laboratories and small manufacturers after
publication of the NPR.
VI. Response to Comments
A. Comment Overview
The NPR solicited information and comments concerning all aspects
of the proposed rule. The NPR also specifically asked for comments
regarding the proposed 12-month effective date, the changes that were
under consideration by ASTM at the time of the NPR, and the costs of
labeling. The Commission received 188 comments from 162 commenters.
Twenty-seven commenters submitted two or more comments, while two
comments were signed by multiple people. Staff divided the comments
into 11 major topic areas, and summary responses follow. The 11 major
topic areas are listed below:
[ssquf] 12-month effective date;
[ssquf] ASTM balloted item;
[ssquf] Changes to test equipment;
[ssquf] Consumer education;
[ssquf] Consumer use, misuse, and user error;
[ssquf] Durable product definition and wrap exemption requests;
[ssquf] Economic burden;
[ssquf] Existing rules: Product registration card and soft infant
and toddler carriers (16 CFR 1126);
[ssquf] Incident data;
[ssquf] Instructions and labeling;
[ssquf] Periodic testing: Costs, frequency, and necessity; and
[ssquf] Miscellaneous other.
The full comments can be found on regulations.gov.
B. 12-Month Effective Date
Comment: Six comments discussed the proposed effective date for the
rule. Of these, only one comment opposed the proposed 12-month
effective date. The commenter who opposed the 12-month period stated
the belief ``that smaller manufacturers can in fact move more quickly
and can adapt to these changes as many were involved in the writing of
the ASTM standard which is already published.'' The remaining comments,
including those from the U.S. Small Business Administration's
[[Page 8674]]
Office of Advocacy, agreed that 12 months was appropriate for this
product.
Response: Many of the commenters suggested that the testing
requirements of the rule, which will not go into effect until the
effective date of the rule, will result in a substantial economic
burden to very small producers. This conclusion is supported by the
analysis presented in the Final Regulatory Flexibility analysis (FRFA).
Consistent with the Commission's proposal, the final rule provides a
12-month effective date, longer than the 6-month period the Commission
usually provides for rules under section 104 of the CPSIA. The 12-month
effective date will give needed time for some very small producers,
which are frequently home-based and have limited experience dealing
with regulatory processes. This will allow these producers additional
time to learn how to comply with the testing and recordkeeping
requirements, as well as spread out the testing costs over a longer
period.
C. ASTM Balloted Item
Comment: Six commenters expressed support for the changes made to
testing for ring slings published in ASTM F2907-14b, the version of the
sling carrier standard published following CPSC's NPR, and which
resulted from the ballot that was open at the time of the NPR. One
commenter posed a question related to the change: ``If this
recommendation is being made to allow slippage up to 3 on ring slings,
then would that recommendation be made on wraps as well?''
Response: The Commission agrees with the comments favoring adopting
the change. CPSC staff tested the revision in ASTM F2907, which was
published as ASTM F2907-14b, and staff found that the increase from 1
inch to 3 inches did not decrease the stringency of the standard. The
dual-ring lock mechanism on ring slings is unique to those products,
and to maintain the strength of the dual-ring lock, the fabric must be
under tension. During normal use, this tension is maintained from the
weight of the child. During testing, the dual-ring lock is repeatedly
exposed to tension, then release, as the test torso moves up and down.
Due to the nature of the dual-ring lock, this allows the fabric to
creep through the dual-ring lock. However, some fabric creep does not
appear to compromise the overall ability of the sling to contain the
child. The test still maintains the requirement that the dual-ring lock
cannot completely release. Staff found that this fabric creep was
unique to the dual-ring lock. Regarding wraps, there was generally
little, if any, fabric creep; and in general, the testing only
tightened the knots. Because some fabric creep is normal in a dual-ring
lock but should not occur with other attachment mechanisms, staff
concluded that the change published in ASTM F2907-14b did not affect
the stringency. During ASTM task group discussions before balloting
this revision, the task group discussed the question of other
attachment mechanisms and concluded that the change should apply only
to ring slings because of the unique dual-ring lock mechanism.
D. Changes to Test Equipment
Comment: Seven comments addressed the surface of the test torso.
Two commenters asked to ``make the dummy less slippery and more
accurate to real-life scenarios''; three commenters requested a fabric
or fabric-covered test torso; and two commenters suggested changing the
test torso pending the outcome of ASTM task group discussions.
Response: In June 2015, 8 months after the close of the NPR comment
period, ASTM F15.21 balloted another change to the test methods. The
proposal was to clothe the test torso in ``a tight-fitting, thermal
knit or waffle-weave, cotton or cotton/polyester undershirt or
equivalent.'' The ballot item passed and was approved by ASTM on
October 15, 2015. CPSC staff repeated testing using the specified shirt
and found no significant changes in the test results. Before this
ballot item, the ASTM standard did not specify the surface material of
the test torso. Thus, test torso surface materials varied among test
labs, including wood, metal, and fiberglass. Although the ballot item
rationale was based on mimicking real-life conditions in which the
caregiver would be clothed when using the sling, CPSC staff expects
that standardization of the test torso surface will also increase the
repeatability and reliability of test results among test labs.
For these reasons, the Commission agrees with the comments and
concludes that ASTM F2907-15 is the most appropriate version of the
standard to codify as a final rule.
Comment: Two comments suggested using an anthropomorphic mannequin
(i.e., a weighted doll with head, neck, arms and legs), instead of a
sand bag during the occupant-retention test and a shot-filled bag
during the dynamic test.
Response: Currently, only the restraint test, Section 7.6, uses an
anthropomorphic mannequin, specifically the CAMI Infant dummy. For the
occupant-retention and dynamic tests, test masses provide the
flexibility to fit into a variety of slings, no matter the
configuration of the sling. As discussed in the briefing package and
public hearing accompanying the NPR, staff and the ASTM committee
investigated using a more anthropomorphic mannequin and found that the
readily available anthropomorphic mannequin used in many ASTM standards
(i.e., the CAMI mannequin) cannot accurately represent the manner in
which a child sits in a sling. Developing a new mannequin that is
flexible enough to fit into all types of slings would be time- and
resource-intensive, without necessarily increasing the stringency or
repeatability of the standard.
E. Consumer Education
Comment: Twenty-six comments expressed that education was all that
was needed, instead of regulation or product testing. Sixteen comments
discussed the critical role education plays in the safe use of sling
carriers, and many of these comments identified education as a key
component of preventing user error. Twelve additional comments made
more general statements that the focus should be on education, or else
they expressed a general sentiment supporting education. One specific
commenter (-0137) supported consumer education, but felt ``this should
be a discussion amongst creators and the safety groups. This should not
just be a decision made by the CPSC . . .''
Response: The Commission agrees that educating caregivers who use
sling carriers is extremely important. The Commission acknowledges that
most sling carriers, and especially wrap carriers, require the
caregiver to position the child and the fabric in ways that are both
practical and safe, and that the skill needed to use a sling properly
is not necessarily intuitive to many caregivers. The Commission also
agrees that excellent instructions, training, and support are available
from baby-wearing educators and other persons with experience and
knowledge of the safe use of the product. However, section 104 of the
CPSIA requires CPSC to: (1) Examine and assess voluntary safety
standards for durable infant or toddler products, and to (2) promulgate
mandatory consumer product safety standards that are ``substantially
the same as'' the voluntary standards or more stringent than the
voluntary standards if the Commission determines that more stringent
standards would further reduce the risk of injury associated with these
products. Therefore, an educational program,
[[Page 8675]]
alone, would not satisfy the direction in section 104. The Commission
concludes that the requirements for the instructions and product
labeling provide a framework that each manufacturer can tailor to the
recommended-use positions for their specific slings. This will require
that each sling includes the minimum information needed for proper use
of the product and that the required on-product positioning label will
follow the product throughout its lifecycle.
Comment: Seven commenters specifically mentioned the baby-wearing
community (e.g., local baby-wearing groups, Facebook baby-wearing
groups, or Babywearing International, a nonprofit organization whose
mission is to promote baby-wearing education and support) as a resource
available for new caregivers to learn about the use of sling carriers.
Response: The Commission agrees that the groups mentioned provide a
valuable resource to promote the safe use of sling carriers and
encourages the groups to continue their work. Staff urges members and
groups to become involved with the ASTM International F15.21
subcommittee on sling carriers, which currently includes members
representing sling manufacturers, sling industry groups, testing
laboratories, and child-safety advocates. Through this voluntary
standards consensus process, all voices can be heard in the effort to
develop a robust voluntary standard, which forms the basis of the
mandatory standards promulgated by CPSC under the Danny Keysar Child
Product Safety Notification Act.
Comment: Ten commenters suggested a joint public educational
campaign among the CPSC and manufacturers, industry groups, or the
baby-wearing community. One comment suggested an educational campaign,
but did not mention partnering. One comment specifically suggested that
the Commission sponsor an educational campaign in conjunction with the
final rule and that the informational campaign focus on ``specific
risks that can only be addressed through proper usage and close
attention to the infant'' (-0172).
Response: Although an educational campaign is outside the scope of
the rule, a joint informational campaign may be an avenue to provide
safety information to sling users.
Comment: Six commenters suggested standardizing and regulating
education materials and packaging, with two commenters saying that such
standardization and regulation of education materials should be the
only requirement. One additional commenter expressed general support
for ASTM requirements for instructional materials, and another
commenter suggested requiring informational brochures.
Response: The rule incorporates by reference ASTM F2907-15; section
9 of ASTM F2907-15 requires instructions to be provided with each sling
and for these instructions to include some standard content, including
information on assembly, adjustment, restraint systems (if applicable),
maintenance, cleaning, storage, and use. However, education alone does
not address the hazards posed by material failures, such as ripped
fabric and broken hardware, nor does an educational program require
that all sling carriers be sold with instructions and on-product
warning labels that will follow the product through its lifecycle. The
rule, by referencing ASTM F2907-15, requires instructions to contain
images of each manufacturer's recommended carrying position, all
warnings that are required to be on the product, and additional safety-
related instructions and information, such as the minimum and maximum
weight of the child for which the sling is intended, the importance of
checking for damaged seams and hardware, and the warning never to use
the sling when balance or mobility is impaired.
F. Consumer Use, Misuse, and User Error
Comment: Seventy-one comments discussed consumer use or the role of
user error in the reported incidents. Sixty-four comments made general
statements asserting that injuries resulted from user error; five
comments suggested that manufacturers were not responsible for misuse;
and three comments discussed the benefits of using sling carriers. In
addition, several commenters raised other issues related to consumer
use or user error.
Response: CPSC agrees that many incidents suggest that caregiver
behavior plays a vital role in the proper use of sling carriers. In
addition, the Commission agrees that, due to the unique nature of sling
carrier products, educating caregivers is the primary method to address
user error. The Commission concludes that the warnings and instruction
requirements are the best way, within CPSC's authority, to educate
consumers. In addition, reasonably foreseeable misuse is one of the
factors that CPSC must consider. The Commission encourages
manufacturers to provide the best instructions and warnings to address
foreseeable misuses of their products. For products where a design
change could prevent a possible misuse, that is preferable; however,
for sling carriers, education, including instructions and warnings, may
be the best way to address certain foreseeable user errors. Finally,
although it is difficult to quantify the benefits mentioned in these
comments, the Commission appreciates the examples that commenters
provided.
Comment: One commenter (-0185) suggested that the reclined position
should not be a recommended-use position; another commenter (-0041)
recommended not showing ``advanced carries'' in instructions, and
instead, recommended having the instructions show ``an unsafe carry.''
Response: The ability to use a sling in the reclined position is
one of the key factors differentiating soft infant and toddler carriers
from sling carriers. The unstructured nature of many sling carriers
suggests that it could be reasonable and foreseeable that caregivers
will place a child in a position other than perfectly upright. The
instructions and warnings are key to giving caregivers the information
they need to position a child properly, including positions with a
slight recline. In addition, the on-product label requirement in ASTM
F2907-15 calls for examples of improper positioning.
G. ``Durable Product'' Definition and Wrap Exemption Requests
Comment: Numerous commenters requested that wraps be exempted from
any new regulations on sling carriers. Eight commenters suggested that
slings should not be considered durable products.
Response: The Commission considered the possibility of exempting
wraps and other all-fabric carriers without load-bearing hardware or
seams. However, exclusion of wraps would preclude any educational or
labeling requirements for these products, along with third party
testing requirements. A large number of commenters stressed the
importance of educational materials, which CPSC considers to include
instructions and warnings. In addition, the NPR included an analysis
explaining why the Commission concluded that sling carriers, including
wraps, are a type of infant carrier, a product specifically identified
as a ``durable infant or toddler product'' in section 104(f)(2)(H) of
the CPSIA. Specifically, the Commission considered the following
factors in the initial determination:
[ssquf] Age of children carried in sling carriers.
[cir] One reported incident victim was 3 years old, which
demonstrates that
[[Page 8676]]
these products are used past the first year of life.
[cir] The voluntary standard (F2907) defines a ``sling carrier''
for use up to 35 pounds. Three-year-old children are likely to still be
within this weight limit, and some 4- and 5-year-old children may be
less than 35 pounds.
[ssquf] Durability of sling carrier parts.
[cir] Although wraps and pouch slings are all-fabric products, ring
slings, modifications of wraps and pouch slings, and other products
that meet the definition of a ``sling carrier'' also contain parts that
are considered durable from an engineering perspective and suggest that
they were selected for long-term use. In addition, the test methods in
ASTM F2907 combine to ensure that slings meet a minimum level of
durability.
[ssquf] Reuse of sling carriers.
[cir] Two incidents involved a hand-me-down sling carrier. One
sling was reported to have been received from a relative, and the other
sling carrier was reported to have been used for the infant's older
sibling.
[cir] Preliminary data from CPSC's durable nursery product survey
indicate that only 4 percent of respondents throw away used sling
carriers; and 96 percent of respondents save the sling carrier for
later use, sell the sling carrier, or give away the sling carrier. In
addition, the CPSC's durable nursery products survey indicated that
approximately one-fifth of sling carrier frequent users obtain their
sling carrier second hand.
[cir] With 96 percent of survey respondents to CPSC's durable
nursery products survey indicating that the sling carrier was saved or
otherwise passed on to another caregiver, it is foreseeable that some
sling carriers are likely to be used by more than one child. In
addition, sling carriers appear to be bought and sold on resale
markets.
[ssquf] Recalls of sling carriers.
[cir] CPSC issued a recall in March 2008, regarding a certain sling
carrier that was manufactured in March and April 2007. CPSC received
reports of incidents involving sling carriers subject to the recall
more than 5 years after the recall announcement.
[cir] CPSC issued a recall in March 2010, regarding a different
sling carrier that was sold from 2003 to 2010. That recall was reissued
as a safety alert 2 years later because the sling carriers subject to
the recall were found in the marketplace.
No commenters provided data suggesting that slings, or specifically
wraps, are not infant carriers, or are single-use/single-user products
that are categorically used for short periods of time only, or are
otherwise intended to have a very short lifespan. Therefore, the
Commission concludes that wraps are infant carriers that meet the
definition of ``durable nursery products'' under CPSIA section 104.
Additional discussion of these issues is included in the FRFA.
H. Economic Burden
Comment: According to the SBA Office of Advocacy (Advocacy), ``the
CPSC's assumptions [regarding] the number [of firms affected by the
proposed rule] and impact [of the proposed rule] on affected small
carrier manufacturers is based on inadequate data and analyses.''
According to Advocacy, the CPSC provides ``the public with some data on
the sling carrier market, but it is an inadequate basis for the CPSC's
analyses as described in the IRFA.'' Advocacy's comment concluded:
``Advocacy recommends the CPSC gather more information on small sling
carrier manufacturer's market share as well as the number of accidents
that can be attributed to them. If the CPSC is unable to obtain this
information because of the uncertainty inherent in its analysis,
Advocacy recommends the CPSC present a range of potential costs instead
of one point estimate.''
Response: For the NPR, CPSC staff prepared an initial regulatory
flexibility analysis (IRFA) examining the impact the NPR could have on
small business. The IRFA identified 47 suppliers of slings to the U.S.
market, but noted that there might be hundreds more suppliers that
produce small quantities. For the FRFA, staff expanded the discussion
of firms to include 324 firms identified by the BCIA, an industry trade
association. According to the BCIA, about 250 of the 324 identified
firms had total annual sales revenues of less than $10,000, and an
additional 45 had revenues of greater than $10,000, but less than
$50,000. These identified firms with revenues less than $50,000
annually were characterized in our analysis as ``very small firms.''
The expanded discussion in the FRFA includes: (1) Additional
information on the characteristics of the firms, (2) estimates of
annual industry-wide sales, (3) estimates of the numbers of slings in
use, and (4) estimates of the market share of the very small firms.
The FRFA also includes an expanded discussion of sling injuries and
injury rates, and what we know about the injuries involving slings
produced by small and very small firms. This discussion is included in
the section of the FRFA titled, ``Sling Injuries and Risk Estimates.''
Finally, the FRFA substantially expanded the discussion of the
likely impacts of the rule on small and very small sling producers.
Based largely on the information from the BCIA, as well as some
information provided in the comments from Advocacy, staff developed
four hypothetical ``representative'' producers: (1) A hand weaver, (2)
a ring sling producer, (3) a machine weaver, and (4) a mass producer.
For each of these producers, staff developed estimates of annual sales,
average unit sales prices, and the number of style/fabric combinations
likely to be produced by the firms, all of which will affect the
estimated costs of the rule. For the very small representative firms
(i.e., the hand weaver and ring sling producer), the estimated annual
testing costs that would be triggered by the rule amounted to about 16
percent to 36 percent of total revenues. For the machine weaver, the
annual testing costs amounted to an estimated 2.4 percent to 4.7
percent of revenues. Only the mass producer (with annual revenues of
about $2.7 million) had annual expected costs of less than 1 percent.
The FRFA concludes that the final rule would have a significant adverse
impact on a substantial number of small businesses and could cause
numerous small producers to exit (or not to enter) the market. In
addition, there may be significant additional impacts on small
manufacturers, including the need to provide instructional materials.
We cannot rule out the potential for compliance costs to be high enough
that they could lead to significant economic impacts, especially for
very small manufacturers.
Comment: Advocacy recommended that the CPSC expand and improve its
discussion of alternatives that may reduce the costs of the rule on
small businesses.
Response: As recommended, the FRFA substantially expanded the
discussion of alternatives the Commission could choose that would
reduce the impact of the rule on small businesses. These alternatives
are discussed in detail in the FRFA (Tab D of the staff's briefing
package) and under Analysis of Alternatives in this briefing
memorandum. The options include:
[ssquf] Determining that slings are not durable infant or toddler
products and terminate rulemaking;
[ssquf] Delaying the effective date of the requirements;
[ssquf] Exempting wraps (a specific type of sling made entirely of
fabric) from the requirements of standard;
[ssquf] Allowing a small batch exemption for small manufacturers
(this alternative
[[Page 8677]]
would require a change in a federal statute);
[ssquf] Amending the existing CPSC regulation at 16 CFR part 1107
to reduce the frequency of periodic testing required for small or home-
based sling producers; or
[ssquf] Adopting ASTM F2907-15 with no changes, and directing staff
to work with ASTM to address the staff-recommended change.
Comment: More than 100 of the 188 comments received in response to
the NPR focused on the economic burden that the rule and testing
requirements would impose on very small producers of slings. Some of
these commenters said that they recognized the need for some product
safety regulation for slings, but they also expressed concern about the
impact of the rule on very small businesses. Many of the comments said
that the costs resulting from the testing requirements would drive
small producers out of business. Some of the commenters, who are very
small sling producers, suggested that the rule would be cost
prohibitive and would probably result in their exit from the sling
market. Several users expressed concern that the proposed rule would
reduce the availability of slings in the marketplace.
Response: The Commission agrees that the rule and associated
testing requirements will pose a significant economic burden on many
small producers and has discussed these possible impacts in the FRFA.
The FRFA discussion of alternatives has been expanded to include
additional alternatives that were not discussed in the IRFA and could
reduce the negative impact of the rule on small businesses. Despite the
expected impact, the Commission is promulgating the final rule for
sling carriers in order to comply with Congressional direction
regarding durable infant and toddler products and the Commission
designation in the product registration card rule of infant carriers as
such products. The Commission also believes that a mandatory standard
is necessary despite the costs to small business because the standard
would address mechanical or fabric failure hazards and impose warning
and instruction requirements that would address suffocation hazards.
The staff's briefing package notes that, of the six sling recalls since
2001, four involved small manufacturers, of which two may have been
very small with sales revenue of less than $50,000 annually. One recall
initiated after a death (a 10-day old-boy) appears to have involved a
very small manufacturer. The recall was for 40 slings sold over an 8-
month period, or five slings per month. Another recall, for a
potentially hazardous defect in the stitching (fall hazard), involved
165 slings sold over a 4-month period, or 41 slings per month. A third
recall involved defective aluminum rings, also a potential fall hazard,
with 1,200 ring slings sold over a 9-month period, or about 133 slings
per month. The largest recall involving a small business concerned
5,000 slings with defective rings sold over a 7-month period, roughly
700 per month. The remaining two recalls involved the same large firm.
Additionally, staff's briefing package includes information regarding
production test plans that could reduce the frequency of testing for
manufacturers that implement a product test plan, which could reduce
the testing costs.
Comment: Three commenters reported that information in the IRFA did
not reflect the true number of small businesses that would be affected
by the rule or the significant financial impact that would be imposed
on small producers. These commenters provided additional information on
the number and size of the very small producers and the likely
financial impact of the rule.
Response: The Commission agrees that the discussion of the market
and market impact of the sling proposed rule was not fully descriptive
of the very small manufacturers in the marketplace or of the full
economic burden that would be imposed by the rule. The information
provided by the commenters was used to develop estimates of annual
sales, average unit sales prices, and the number of style/fabric
combinations likely to be produced by the firms; all of this
information will affect the estimated testing costs of the rule. The
information has been incorporated into the FRFA's description of the
sling market and in the discussion of cost impacts on small and very
small businesses.
I. Existing Rules: Product Registration Card and Soft Infant and
Toddler Carriers (16 CFR Part 1126)
Comment: Three commenters requested reconsideration of the product
registration card requirement or specific aspects of it (e.g.,
``*perforated* registration cards is silly in my opinion''). Three
other commenters specifically mentioned that they agreed that the
product registration card requirement was necessary to conduct product
recalls. One commenter specifically suggested ``an online registration
system so that the carrier's owner can be continuously updated.''
Response: The requirements of the product registration rule (which
are set out at 16 CFR part 1130) are outside the scope of this
rulemaking on sling carriers. We note that the rule does provide for
online registration; however, ``electronic/email registration does not
replace the mandatory requirement stated in section 104(d)(1)(A) of the
CPSIA that each manufacturer of a durable infant or toddler product
must provide consumers with a postage-paid consumer registration form
with each such product.''
J. Incident Data
Comment: Thirty-two commenters raised issues relating to incident
data. In general, most of these comments expressed one or two opinions.
First, a majority of the comments regarding incidents claim that most
injuries and deaths cited in the NPR briefing package result from
positioning errors and caregiver missteps. Second, many commenters
claimed that no injury or death in the incident data presented was
related to the issue of fabric strength.
Response: For the incidents in which sufficient information was
available, caregiver missteps were often cited in the reports; however,
there were many incidents with insufficient information. The lack of
information is not evidence that product-related defects (for example,
fabric weakness) were absent in the incidents.
Comment: A number of commenters suggested that the injuries are not
``the result of manufacturer defects'' (e.g., -0011) or not related to
structural integrity (e.g., -0063, -0070).
Response: The Commission disagrees with this comment. Of the 54
injuries, nine were product-related (three buckle-related and six
miscellaneous product-related) incidents. Of the 52 non-injury
incidents, 12 were product-related (nine buckle-related and three
miscellaneous product-related) incidents. An additional 25 reported
incidents, including seven fatalities and 15 injuries (including two
hospitalizations) under the undetermined or unspecified category, did
not provide enough information for staff to make a determination on the
cause(s) leading to the incident. This lack of information is not the
same as conclusive evidence that no manufacturer issues were involved
in these incidents. In addition, although voluntary recalls are not
necessarily associated with findings of a defect, the NPR discussed
three recalls between 2005 and 2007, for structural integrity issues,
one associated with four injuries, including a skull fracture. Finally,
the updated data provided in Tab A of the staff's briefing package
discuss four new incident reports related to fabrics, rings, and
stitching,
[[Page 8678]]
including a minor injury that occurred when fabric ripped.
Comment: Several comments (-0011) raised issues related to risk and
relative risk of slings. One specific question was: ``How does the rate
of injury/death for sling carriers compare to other modes of carrying
children?'' In addition, comments (e.g., -0011, -0079) suggested that,
compared to carrying a child in the caregiver's arms, the risk of
carrying a child in a sling carrier was the same or lower.
Response: CPSC has not compared the rate of injury/death for sling
carriers with the rates for similar modes of infant carriers. Such a
comparative analysis is not relevant for the purposes of this
rulemaking. The Commission does not state that sling carriers are more
or less dangerous than other infant carriers, and regulation mandated
under section 104 of the CPSIA does not require such a comparison.
Comment: ``[The] non-incident, non-injury comments helped to
inflate the perceived danger of both sling carriers and SITCs.''
Response: For briefing packages on section 104 rules, staff reports
on all relevant data reported to CPSC. Because the non-injury comments
were not used as the basis for any new requirements for a standard,
including them in the briefing package does not affect the issuance of
a Section 104 rule.
Comment: Several commenters suggested that ``there was an overall
lack of information associating injuries with specific makes and models
of sling carriers,'' (-0011) or that all deaths were due to one type of
carrier (e.g., ``deaths due to improper use (of what I would imagine
were bag style slings) . . .'' -0087). One commenter's point, that
several other commenters copied and included in their comments, also
suggested that ``. . . bag style sling carriers are notoriously
(anecdotally?) more dangerous than ring slings or woven wraps . . .''
and that staff should attempt to correlate data ``with a specific brand
or general type of sling carrier.''
Response: CPSC staff intentionally omitted make and model
information in the NPR briefing package because many of the products
involved in incidents were not identifiable in that manner. Providing
the information for only the known manufacturers would unfairly
identify those entities. The purpose of the rulemaking is to encompass
the product class, not specific makes and models of slings of which
CPSC staff is aware. When staff observes a pattern of deaths or
injuries involving ``a specific brand,'' that data is investigated by
the CPSC's Office of Compliance. Regarding the request to correlate
data with a general type of carrier, staff reviewed the 17 deaths
reported in the two briefing packages associated with this rulemaking
(16 in the NPR, plus one additional death noted in this final rule
package) to identify the type of sling involved in each death. Six
deaths were associated with bag-type slings, four with wrap or wrap-
like slings, three with ring slings, and one with a pouch sling. There
was not enough information to identify the sling type involving the
three remaining deaths.
Comment: One comment (-0179) suggested that ``suffocation-related
incidents are understated. In addition, the commenter suggested that
staff ``mischaracterizes incidents . . .'' by categorizing some
incidents as ``undetermined'' or ``unspecified cause,'' instead of
identifying the incidents as involving positional asphyxia, and
excluding SIDS cases on the basis that they are position-related
incidents.
Response: The Commission disagrees. For each ruleamaking, CPSC
staff, as a team, makes a deliberate decision on the most relevant
period to gather data. Usually this period starts from when the latest
major version of the relevant ASTM standard occurred. For sling
carriers, the very first ASTM standard, F2907-12, was developed using
CPSC data from 2003 forward. The NPR covered the period from 2003
forward. Moreover, consistent with other durable product briefing
packages, certain incidents (e.g., those with an official cause of
death of SIDS, with no additional definitive information) were
considered out-of-scope cases. In addition, the commenter cites sling-
related data and analysis from CPSC from prior years. The data
extraction criteria for those earlier years were different because the
data were analyzed for a different purpose (e.g., it may have been a
search for all fatalities in sling carriers that have been reported to
CPSC). The discrepancy is not an attempt to understate the dangers of
suffocation associated with the use of sling carriers.
K. Instructions and Labeling
Comment: One commenter requested on-product labeling for products
that are manufactured after the effective date, so that consumers can
clearly identify products that meet the mandatory standard. An
additional comment (-0172) requested that the product include a marking
that clearly indicates that a compliant product meets the mandatory
standard.
Response: The Commission is not making any changes to the proposed
rule based on this comment because manufacturers are already allowed to
label compliant products under section 14 of the CPSA and 16 CFR part
1107. In addition, section 8.1.3 of ASTM F2907-15 and the product
registration card rule (16 CFR 1130.4) already include requirements
that slings bear a code mark or other means to identify the date of
manufacture. Additionally, manufacturers or importers may voluntarily
label compliant products with the words: ``Meets CPSC Safety
Requirements,'' under section 14 of the CPSA and 16 CFR part 1107.
Thus, adding a requirement in the final rule for sling carrier
manufacturers to mark their products would be redundant.
Comment: Nineteen comments generally discussed the effectiveness of
warnings and instructions in addressing the hazards. The most common
argument advanced by commenters is that, in the context of sling
carriers, labeling, instructions, and similar approaches are superior
to performance requirements or to the proposed material testing
requirements because the hazards with slings result from user error,
infant positioning, or similar behavioral issues. Some comments (e.g.,
-0043,-0063, -0095) assert that warnings and instructions are all that
are needed or that warnings and instructions are the only requirements
that are likely to avoid injuries. In contrast, one comment (-0179)
argues that warnings are not likely to address the hazard effectively,
as demonstrated by recent deaths, and that instructing consumers to
``check often'' is an unreasonable expectation.
Response: Improper infant positioning accounts for the majority of
fatalities associated with these products. The Commission generally
recommends designing the hazard out of a product or guarding the
consumer from the hazard, rather than employing warnings, because a
warning's effectiveness depends on persuading consumers to alter their
behavior to avoid the hazard. Nevertheless, as discussed in the NPR
briefing package, staff was unable to develop performance tests or
requirements that could address the infant positioning hazard; and
therefore, staff concluded that the ``last resort'' measure of warning
about proper and improper infant positioning was the only feasible
hazard-mitigation strategy (see Smith, 2014). Staff continues to
believe that this is the only viable way of addressing the infant
positioning hazard, short of a ban on slings. However, staff does not
agree that warnings and instructions are all that is needed to address
injuries with sling carriers. Consequently, the Commission
[[Page 8679]]
incorporates by reference ASTM F2907-15, which includes performance
requirements that are intended to address hazards other than infant
positioning.
Comment: Sixteen comments address the content of the warning label
and instructions, generally in terms of consumer comprehension of the
information. These include comments about the importance of the labels
and instructions to be understood easily, clear, accurate, pertinent,
and to include all necessary information, including information about
what to avoid.
Response: The warnings and instructions must be accurate,
comprehensive, and easy to understand, and the Commission believes that
the requirements for sling carriers accomplish these goals. Staff
worked extensively with the ASTM Subcommittee on Sling Carriers to
improve the requirements for warnings and instructions from the
original 2012 version of the voluntary standard to address more
effectively the sling hazards that cannot be addressed by performance
requirements. The current requirements for warning and instructional
content adequately address key information about the nature of the
hazards, the consequences of exposure to the hazards, and appropriate
behaviors in which consumers can and should engage--or not engage--to
avoid these hazards. Thus, no revisions to the content requirements are
necessary.
Comment: Seven comments suggested specific items that should be
included in the warnings. Specifically:
[ssquf] Two comments (-0016 & -0058) proposed warning against the
use of slings with infants younger than a certain age (i.e., 4 months
or 6 months).
[ssquf] Two comments (-0031 & -0118) stated that the warning should
include or highlight images of proper positioning, including the
acronym TICKS.
[ssquf] One comment (-0079) stated that consumers should be aware
of the recommendation to check stitching and fabric for wear.
[ssquf] Two comments (-0038 & -0041) argued that some companies
currently include dangerous instructions or positioning information.
[ssquf] One comment (-0172) stated that the current warning does
not sufficiently describe the suddenness with which suffocation can
occur and the need for constant mindfulness and monitoring. The comment
also stated that the fall hazard is not described sufficiently.
Response: The Commission agrees that the items proposed by the
commenters should be included on sling warning labels and concludes
that each item is already sufficiently addressed by the warning
currently required in ASTM F2907-15. The warning label requirements in
ASTM F2907-15, which are incorporated by reference into the final rule,
address most issues pertaining to unsafe positioning, by specifying
both proper and improper infant positioning in the warning and
instructional language and in the warning pictogram.
Comment: One comment (-0179) states that the warning's direction to
keep the ``face uncovered'' is weaker than previous warnings by CPSC,
and does not address concerns that sling-type carriers can cause
infants whose heads are below the rim of the sling to assume a curled
posture.
[GRAPHIC] [TIFF OMITTED] TR30JA17.004
Response: The Commission disagrees with the assertion that the
directive to keep the face uncovered is weaker than an instruction to
keep the head above the rim of the sling. CPSC staff and the ASTM
Subcommittee considered a reference about keeping the baby's head above
the rim of the sling, but concluded that consumers might have
difficulty assessing when an infant's head would be considered ``above
the rim.'' Furthermore, young infants may need head support when
carried in a sling, and this would require the sling to pass around the
back of the baby's head. This scenario is illustrated in Figure 1.
Although this graphic, which appears in the ``example pictogram'' of
the ASTM standard, is intended to show a proper position, consumers may
consider the infant's head to be ``below the rim,'' and therefore,
conclude incorrectly that such a position is improper. Given that the
warnings already instruct consumers to make sure the infant's body does
not curl into a chin-to-chest position, the Subcommittee and CPSC staff
agree that warning language instructing consumers to make sure that the
infant's face is uncovered and fully visible is sufficient to address
the risk of positional asphyxia, and would minimize confusion.
Comment: Fifteen comments specifically discuss the size or length
of the warning label and instructions. Many of the comments argued that
smaller, shorter, or more ``concise'' labels and instructions are
superior to larger or longer ones, but they provided no particular
evidence or rationale to support their arguments. One comment (-0179)
stated that manufacturers are producing ``unreasonably long''
instructions. Two comments (0003 & 0008) stated that large warning
labels hurt the aesthetics of the product; and some comments simply
expressed dislike of the idea of a ``huge'' label (e.g., --0070) or
thought that some of the information in the label seemed ``a tad much''
(-0132). Two comments (-0025 & -0096) claimed that shorter labels and
instructions are more effective because they are more likely to be
read, understood, noticed, or followed. Two comments (-0019, -0057)
argued that large labels are more likely to be removed by the consumer;
and one of these comments (-0019) specifically identified ``free-
hanging'' labels as labels that are likely to be accidentally torn or
ripped off, intentionally cut off or removed, or rolled and sewn
against a hem to keep it out of the way.
Response: Warnings generally should be physically large, but brief.
However, a concise warning is unlikely to be effective if it does not
convey all key information pertaining to the hazards--namely, a
description of the nature of the hazard, consequences of exposure to
the hazard, and how to avoid the hazard. Brevity is only one factor
that must be considered by a warning designer, and CPSC staff worked
with the ASTM Subcommittee to develop effective warning language that
is comprehensive, yet reasonably concise. Staff recognizes that a large
label may detract from the aesthetics of the product and that some
consumers may feel compelled to remove such a label from the product.
However, the alternative would be to create a warning that blends into
the product or goes unnoticed by consumers, which would likely offer
little-to-no safety benefit. Although the standard requires that
warning labels be permanent, CPSC
[[Page 8680]]
agrees that so-called ``free-hanging'' labels--that is, labels that are
affixed to the product at only one end of the label--are more likely to
be torn or ripped off, or otherwise altered by the consumer, and that
this would eliminate the potential safety benefit of the label.
Additionally, the standard proposed in the NPR does not prohibit such
labels or prevent manufacturers from affixing labels to the products in
this way. Thus, the final rule includes a requirement that prevents
label attachment along a single edge of the label.
The ASTM F2907-15 requirements that are most relevant to this issue
are those pertaining to warning label permanency. Section 8.3 of ASTM
F2907-15 states that warning labels shall be permanent, and section 5.7
specifies that warning label permanence is determined by testing in
accordance with section 7.3, which includes requirements for labels
attached with a seam. Section 5.7 includes two subsections that address
permanency requirements for labels that are applied directly to the
surface of the sling (5.7.1; e.g., via hot stamping or heat transfer)
and a requirement that non-paper labels shall not liberate small parts
(5.7.2). The Commission concludes that the following additional
subsection (which is included in the final rule) would appropriately
address the ``free-hanging'' label issue:
``5.7.3 Warning labels that are attached to the fabric with seams
shall remain in contact with the fabric around the entire perimeter of
the label, when the sling is in all manufacturer-recommended use
positions.''
On December 14, 2016, staff received a letter from the chair of the
ASTM subcommittee indicating the group would be considering this
requirement as quickly as possible.
Comment: Five comments addressed issues related to the medium
through which the warnings and instructions are to be delivered to
consumers. Some comments (-0003, -0095, -0172) suggested that the
Internet (e.g., the manufacturer's Web site) should be used to
communicate warning and instructional information. One of these (-0003)
stated that this approach, combined with providing this information in
materials that are supplied with the product, is sufficient, adding
that warnings do not need to be on the product at all. Another one of
these (-0172) specifically suggested requiring video instructions,
available both online and on a CD from the manufacturer, and that the
label should include a Web site address that refers the reader to
online instructions. Another (-0058) suggested instructional DVDs and
pamphlets as options. One comment (-0016) suggested that the
instructions could be a ``simple printable card.''
Response: The Internet or other media, such as CDs or DVDs, can be
a useful means of communicating safe baby-wearing information to
consumers. However, the Commission believes it is preferable to
communicate this information on the product itself, through warning
labels, so that such information would be available to consumers
throughout the product's full lifecycle, regardless of their access to
these other media forms of information. Furthermore, the instructional
requirements in ASTM F2907-15 do not specify the media form that the
instructions must take; they only specify: ``Instructions shall be
provided with the sling'' (Section 9.1). Thus, instructions may be
provided in other than a traditional paper form. Because not all
manufacturers maintain an online presence, the rule does not include a
mandatory label that requires online instructions; however, there is
nothing to prevent a manufacturer from including this information on
their label.
Comment: Three comments (-0005, -0177, & -0188) stated that there
should be a standard instruction manual or set of guidelines, perhaps
ASTM-approved, for all manufacturers. One of these (-0005) seemed to
suggest that the current standard already required this.
Response: Sling carriers vary substantially in design, and certain
products offer an enormous degree of adjustability. ``Wraps,'' for
example, are a type of sling that consists solely of a long length of
material that must be tied or knotted, and these products can be
wrapped and tied around the caregiver's body in myriad ways. Thus, the
Commission does not believe that a standard, universal instruction
manual could be developed and applied to all sling carriers. However,
section 9 of ASTM F2907-15 (which the rule incorporates by reference)
does require instructions to be provided with each sling and for these
instructions to include some standard content, including information on
assembly, adjustment, restraint systems (if applicable), maintenance,
cleaning, storage, and use. The final rule also requires instructions
to contain images of each manufacturer's recommended carrying position,
all warnings that are required to be on the product, and additional
safety-related instructions and information, such as the minimum and
maximum weight of the child for which the sling is intended, the
importance of checking for damaged seams and hardware, and a warning
never to use the sling when balance or mobility is impaired.
Comment: One comment (-0175) stated that section 8.1.1 of ASTM
F2907--15, for clarity and consistency, should match the corresponding
requirement in ASTM F2236--14, Standard Consumer Safety Specification
for Soft Infant and Toddler Carriers.
Response: CPSC agrees that consistency among the various juvenile
product standards is beneficial to manufacturers and consumers. Staff
has worked with the ASTM Ad Hoc Wording Task Group (Ad Hoc task group),
consisting of members of the various subcommittees affected by the
durable nursery products rules, whose stated mission is to develop
uniform and consistent language to be applied to similar portions of
various ASTM juvenile product standards. The Ad Hoc task group recently
completed draft recommended language for portions of the ``Marking and
Labeling'' section for ASTM juvenile product standards, and the final
recommendations are now posted on the ASTM Web site for consideration
by the individual subcommittees.
For uniformity, and to avoid confusion, CPSC staff ordinarily would
recommend that the final rule include a provision that differs from
section 8.1.1 of ASTM F2907-15 so that it is consistent with the Ad Hoc
task group recommendation. However, the current voluntary standard
includes a requirement that the product be marked with the Web site, if
applicable. The analogous Ad Hoc task group requirement includes no
such mandate. One possible resolution would be to use the Ad Hoc task
group recommendation, but add the Web site as an additional required
element. However, this change would result in a requirement whose
content is identical to the current voluntary standard requirement.
Given this finding and staff's belief that retaining the Web site
marking requirement is important, staff did not recommend that the
mandatory rule differ from this section of ASTM F2907. Staff believes
that it would be more appropriate to refrain from incorporating the Ad
Hoc task group recommendations until the ASTM subcommittee considers
future revisions to the standard. The final rule follows this approach.
L. Periodic Testing: Costs, Frequency, and Necessity
Comment: Because of the large economic burden of the testing
[[Page 8681]]
requirements for low-volume producers, several commenters (e.g., -0099,
-0177, -0166, -0178, -0175) suggested that the Commission consider a
testing schedule based on production interval (e.g., every 500 slings),
rather than on an annual timeline (e.g., every year). These commenters
suggested that because of the low volumes of the very small producers,
safety did not require annual testing.
Response: As described in the FRFA, small manufacturers that
establish production testing plans, which need not be complicated,
would be required to conduct periodic testing every 2 years, rather
than every year. The FRFA also discusses other regulatory alternatives
for Commission consideration that could further limit periodic testing
for low-volume manufacturers, and that could substantially reduce
periodic testing costs. One alternative discussed in the FRFA would
require, for manufacturers with established production testing plans,
would require third party periodic testing only after a certain number
of units of a product had been produced, even if it meant that periodic
third party tests would be conducted less often than every 2 years.
However, although this regulatory alternative could substantially
reduce the costs of periodic testing, it would require a modification
in the testing and certification rule (16 CFR part 1107) before it
could be implemented.
Comment: Three comments requested that the government provide
financial assistance to small businesses to cover third party testing
costs or for ``taxpayer-funded'' testing.
Response: Congress has not provided CPSC with the authority to
conduct premarket testing or to provide government assistance for
manufacturers' test programs.
Comment: Two comments suggested that small businesses should be
allowed, as a group, to submit fabric for testing. This means that the
group could ``submit a SINGLE testing piece for each category and have
the approval apply to each business so that the cost of testing can be
shared.'' (-0189)
Response: Commenters, such as the ones above, may be confusing the
testing that would be required by ASTM F2907 with other CPSC testing
requirements for children's products. In the case of lead and
phthalates, component testing and certification are allowed. However,
ASTM F2907 establishes performance test requirements for the product as
a whole because it is more than a simple fabric strength test. Other
factors that may contribute to a sling passing or failing the
performance tests include: The size and shape of the sling, any
hardware, and the instructions that accompany the sling (because the
tests are ``per manufacturer instructions'').
Comment: One comment suggested ``pricing [the 3rd party testing]
according to output would make sure out [sic] pieces follow regulations
while keeping big and small manufacturers running.'' (-0149)
Response: The price charged by third party testing laboratories is
not set or regulated by CPSC.
Comment: Eleven comments requested specific changes to the periodic
testing requirements. Four commenters specifically requested testing
bi-annually (e.g., ``allowing for testing every 2 years or only when
there is a material change,'' noting: ``It's possible to tweak the
testing requirements in ways that would not be overly onerous to small
business owners (testing every other year, only when there is a change
of materials, etc.)'')
Six commenters, including the four previous commenters, suggested
testing should be required only when a material change occurs. One
commenter requested testing every 3 years (``testing should be limited
to a manufacturing level achieved by a large manufacturer, or every
three years, whichever comes sooner.''); and four commenters suggested
a period less frequent than annually, but with no specific timeframe
suggested (e.g., ``Third party testing should not need to occur
yearly''; ``require testing either every year OR every 500 wraps . . .
''; ``modifying the testing schedule so that testing does not need to
be re-done annually for established manufacturers who don't have a
material change in the supply chain'').
One commenter suggested bulk testing of fibers and woven fabric.
One commenter suggested: ``basic licensure or proof of competency per
manufacturer/weaver,'' in lieu of periodic testing. Two commenters
stated that they were unsure what would constitute a material change.
Response: CPSC agrees that testing every other year (instead of
annual testing) represents a potentially meaningful reduction in the
burden of third party testing costs. Such an approach is already
permitted under an existing CPSC regulation, if certain basic
conditions are satisfied. Subpart C of 16 CFR part 1107 requires
periodic testing of children's products, including the third party
certification testing for durable nursery products. This testing must
be conducted at a minimum of 1-, 2-, or 3-year intervals, depending
upon whether the manufacturer has a periodic testing plan (1 year), a
production testing plan (2 years), or plans to conduct continued
testing using an accredited ISO/IEC 17025:2005 laboratory (3 years).
Periodic testing is required even if no material changes have occurred
in the children's product. Regarding the suggestion to conduct third
party testing after a fixed production volume (i.e., 500 units), third
party testing is required on a 1-, 2-, or 3-year period, irrespective
of the production volume.
The commenter suggesting bulk testing of fibers and woven fabric is
referring to component part testing, which is allowed and described in
16 CFR part 1109, Conditions and Requirements for Relying on Component
Part Testing or Certification, or Another Party's Finished Product
Testing or Certification, to Meet Testing and Certification
Requirements. Third party test results of bulk component material may
be used for certification purposes for all products using the bulk
material to which the tests apply.
Additionally, 16 CFR 1107.23 requires that the certification
testing be repeated whenever the manufacturer makes a material change
in the product. A material change is defined in 16 CFR 1107.2 as:
`` . . . any change in the product's design, manufacturing
process, or sourcing of component parts that a manufacturer
exercising due care knows, or should know, could affect the
product's ability to comply with the applicable rules, bans,
standards, or regulations.''
As described in 16 C FR1107.21(c)(2), a production testing plan is
a written plan describing actions taken by a manufacturer, other than
third party testing, to help ensure continued compliance of a
children's product. This written plan would include a description of
the actions, (e.g., incoming inspection of raw materials, first party
testing, in-factory quality assurance/quality control (QA/QC) systems)
that a manufacturer uses to control for potential variability in its
production process that could affect the product's compliance. Although
some testing is still required in a production testing plan, the test
methods employed are not required to be CPSC-accepted test methods, nor
must the testing be completed by a CPSC-accepted laboratory. 16 CFR
1107(a)(2). Additionally, 16 CFR part 1107 does not require
manufacturers necessarily to use destructive tests and permits
manufacturers to ``tailor'' the tests to the needs of the product. For
commenters who specifically requested biannual testing, or who
suggested testing yarns and fabrics, rather than whole products,
[[Page 8682]]
annually, the application of a production test plan is an option
currently available provided they establish a production test plan that
meets the requirements of 16 CFR part 1107(c)(2).
All product changes are not necessarily material changes. Only
changes that a manufacturer, exercising due care, knows, or should
know, could affect the product's ability to comply with the
requirements are material changes. Therefore, for a hand weaver, this
requirement may mean that a change in yarn alone is not necessarily a
material change, unless the new yarn could affect the compliance of the
finished product. For example, sourcing yarn from a different supplier
is considered a material change because the hand weaver cannot assume
that the new yarn has the same mechanical properties as previously used
yarns. Furthermore, only the rules affected by a material change
require third party testing. For example, if a hand weaver changes the
color of a yarn, unless the coloring process affects the mechanical
strength of the yarn, material change testing to ASTM F2907 section
7.1, Static Load Test, is not required.
Periodic testing frequency is determined outside this particular
rule by 16 CFR part 1107, which is outside the current rulemaking
effort.
Regarding the comment requesting ``basic licensure or proof of
competency per manufacturer/weaver,'' this is not an option available
to the Commission because it is not within the jurisdiction of the CPSC
to conduct pre-market testing or certify manufacturers for any
industry. Consequently, the final rule does not make such a change.
Comment: One commenter proposed, and several others referenced or
quoted the comment, that CPSC should: ``Require specific recordkeeping.
Manufacturers would need to keep a record of these compliant materials
for review'' as a ``quicker [sic], less costly, and less destructive
way to maintain compliance.''
Response: Record keeping related to the testing and certification
of children's products is already required under 16 CFR 1107.26.
Comment: Eleven commenters requested that the Commission consider
exemptions for certain types of fabrics or provide a guideline for
fiber content, yarn weights, thread count, weave structures and fabric
weights to be used for slings.
Specifically, one comment (CPSC-2014-0018-0070) stated: ``There are
already weight standards in place that determine whether a textile
shall be tested for flammability. This is because previous tests have
determined that a fabric over a certain weight does not pose a
flammability risk. I believe a similar standard could be determined to
provide a guideline for what characteristics of cloth (sett, ppi, fiber
content) make for a suitable textile to be used as an infant sling.
Anything produced outside these tested and approved parameters could be
tested to insure [sic] compliance with the standard.''
Response: Although the Standard for the Flammability of Clothing
Textiles (16 CFR part 1610) provides exemptions from flammability
testing for certain types of fabrics, such as ``plain surface fabrics,
regardless of fiber content, weighing 2.6 ounces per square yard or
more,'' the exemptions in 16 CFR part 1610 are based on years of test
experience and data. CPSC staff tested approximately 40 slings, to
date. However, at this time, these tests do not provide sufficient data
to determine guidelines or exemptions regarding fabric integrity for
the fabrics to be used for slings. CPSC could consider this issue in
the future, when more test experience and sufficient data are gathered.
Comment: We received one comment regarding flammability testing.
This comment (-0014) stated: ``I question the need for the flammability
testing. None of the injuries or fatalities was related to fire. In any
event, we are just talking about woven pieces of cloth here, no
different than other, less regulated, fabrics used for ordinary
clothing.''
Response: ASTM F2907-15 states:
(a) Flammability--There shall be no Class 2 or 3 fabrics used in
the construction of a sling carrier when the product is evaluated
against the requirements of 16 CFR part 1610.
The regulation at 16 CFR part 1610 is the standard that regulates
clothing textile flammability, Standard for the Flammability of
Clothing Textiles. Woven fabrics used for slings are in the same
category of clothing textiles. Accordingly, they also need to pass the
clothing flammability standard. Part 1610 provides exemptions for
certain types of fabrics, and the majority of fabrics used for slings
are heavier and of the type already exempted from flammability testing.
Therefore, a sling that uses plain-surface fabric weighing 2.6 oz./sq.
yard or more, or fabrics derived from any of the following fibers or
created entirely from a combination of these fibers: Acrylic,
modacrylic, nylon, olefin, polyester, and wool, will meet the
requirements of the standard without flammability testing. Only
products that are ``incapable of being evaluated to the requirements of
16 CFR 1610'' are required to undergo flammability tests under 16 CFR
1500.3(c)(6)(vi).
M. Miscellaneous Other
Comment: One comment questioned the estimate that staff determined
under the Paperwork Reduction Act. The commenter stated: ``It may not
be accurate to call the time and costs associated with preparing
instructional literature usual and customary. To date baby sling
manufacturers have not be [sic] required to supply instructional
literature. Many BCIA Members provide BCIA babywearing safety
information with their products in lieu of instructional literature, so
it may be fair to say that this literature will need to be developed
due to the implementation of this standard.''
Response: The rule requires manufacturers to provide instructional
material. Sling manufacturers that already provide such information,
estimated by the BCIA to be about one-third of the industry (about 135
manufacturers), may have to modify their existing instructions to make
sure that the instructions have all the content required by ASTM. The
additional effort would probably be modest, an estimated 5 hours, if
estimates for revisions to instructions for other children's products
are comparable. Using an hourly rate of $33.29 to calculate these
costs, the total compensation for sales and office workers in private
industry in goods-producing industries would amount to about $166
($33.29 x 5) per firm.
The BCIA estimated that firms that had not previously prepared
instructions would require 30 to 60 hours of labor, and/or paid
consultants, as well. If the remaining 265 firms require 45 hours, on
average, then the impact per-firm would be about $1,500 ($33.29 x 45).
Thus, the cost could average $166 for firms that already provide the
literature and $1,500 for those that do not. Once the literature has
been created, it would not need to be modified, unless the manufacturer
makes changes to a model that renders portions of the literature
obsolete. However, the cost of subsequent modifications to the
literature is likely to be less than the cost of its initial design.
Comment: Seven comments requested variations of a ban.
Specifically:
[ssquf] Two comments requested a ban of all sling carriers;
[ssquf] Four comments requested bans of certain types of sling
carriers. Three of these mentioned ``bag style'' sling carriers),
urging: ``[i]t would make the most sense to ban the manufacture of all
[[Page 8683]]
bag slings (as in the type of sling involved in the Infantino recall)
rather than punish those making perfectly safe wraps and ring slings
with unnecessary regulation'' (-0085) and ``[a]pprove specific bans on
dangerous types of carriers. As stated previously, bag style sling
carriers are notoriously (anecdotally?) more dangerous than ring slings
or woven wraps,'' (-0131).
[ssquf] One comments requested a ban on buckles used in sling
carriers, specifically: ``[b]an buckles in this class of carrier, as
well as the bag style slings.''(-0087).
Response: Section 104 of CPSIA does not permit the Commission to
ban products. In addition, although there was a recall related to
deaths in one certain type of ``bag-style'' sling, this is not the only
type of sling for which fatal incidents have been reported. Fatal
incidents have also been reported in wrap and ring slings. Regarding
the request specifically to ban buckles ``in this class of carriers,''
the test methods in the standard are designed to test any hardware for
slings, including buckles. Some designs use buckles for adjustment, and
the standard is designed to identify buckles that are not strong
enough.
VII. Final Rule
A. Final Rule for Part 1228 and Incorporation by Reference
Section 1228.2(a) of the final rule provides that sling carriers
must comply with ASTM F2907-15. The rule incorporates the ASTM standard
by reference with one modification. The rule modifies the ASTM standard
to address concerns about the ease with which required warning labels
can be removed if attached by only one seam. The Commission determines
that this modification to ASTM F2907-15 is more stringent than the
voluntary standard and would further reduce the risk of injury
associated with sling carriers.
The Office of the Federal Register (OFR) has regulations concerning
incorporation by reference. 1 CFR part 51. These regulations require
that, for a final rule, agencies must discuss in the preamble of the
rule the way that the materials the agency incorporates by reference
are reasonably available to interested persons and how interested
parties can obtain the materials. In addition, the preamble of the rule
must summarize the material. 1 CFR 51.5(b).
In accordance with the OFR's requirements, the discussion in this
section summarizes the provisions of ASTM F2907-15. Interested persons
may purchase a copy of ASTM F2907-15 from ASTM, either through ASTM's
Web site, or by mail at the address provided in the rule. A copy of the
standard may also be inspected at the CPSC's Office of the Secretary,
U.S. Consumer Product Safety Commission, or at NARA, as discussed
below. We note that the Commission and ASTM arranged for commenters to
have ``read-only'' access to ASTM F2907-15 during the NPR's comment
period.
ASTM F2907-15 contains requirements covering:
[ssquf] Laundering;
[ssquf] Hazardous sharp points or edges;
[ssquf] Small parts;
[ssquf] Lead in paint;
[ssquf] Wood parts;
[ssquf] Locking and latching mechanisms;
[ssquf] Warning labelling;
[ssquf] Openings;
[ssquf] Scissoring, shearing, and pinching;
[ssquf] Monofilament threads; and
[ssquf] Flammability.
The standard additionally contains test methods that must be used to
assess conformity with these requirements, as were discussed in detail
in section IV.B.1. of the sling carrier NPR.
B. Amendment to 16 CFR part 1112 to Include NOR for Sling Carriers
The final rule amends part 1112 to add a new section
1112.15(b)(39), which lists 16 CFR part 1228, Safety Consumer Safety
Specification for Sling Carriers, as a children's product safety rule,
for which the Commission has issued an NOR. Section XIII of this
preamble provides additional background information regarding
certification of sling carriers and issuance of an NOR.
VIII. 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). Without evidence to the contrary, CPSC
generally considers 6 months to be sufficient time for suppliers to
come into compliance with a new standard; and a 6-month effective date
is typical for other CPSIA section 104 rules. Six months is also the
period that JPMA typically allows for products in the JPMA
certification program to transition to a new standard once that
standard is published.
However, given the large number of very small suppliers who will
potentially experience significant economic impacts, in addition to the
lack of established history of compliance with the voluntary standard,
the rule provides a 12-month effective date. The Commission proposed a
12-month effective date in the NPR, and received six comments on the
proposed effective date; all but one agreed that 12 months was an
appropriate effective date for this product. Notably, comments
supporting the proposed 12-month effective date included comments from
the SBA's Office of Advocacy.
The safety standard for sling carriers and the corresponding
changes to part 1112 regarding requirements for third party conformity
assessment bodies will become effective 12 months after publication of
the final rule in the Federal Register.
IX. Regulatory Flexibility Act
A. Introduction
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612, requires
that agencies review a proposed rule and a final rule for the rule's
potential economic impact on small entities, including small
businesses, and identify alternatives that may reduce such impact.
Section 604 of the RFA generally requires that agencies prepare a final
regulatory flexibility analysis (FRFA) when promulgating final rules,
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 NPR included an initial regulatory flexibility analysis (IRFA),
describing the possible impacts of the proposed rule on small entities.
Specifically, the FRFA must contain:
[ssquf] A statement of the need for, and objectives of, the rule.
[ssquf] A statement of the significant issues raised by the public
comments in response to the IRFA. A statement 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.
[ssquf] The response of the agency to any comments filed by the
Chief Counsel for Advocacy of the Small Business Administration in
response to the proposed rule and a detailed statement of any change
made to the proposed rule in the final rule as a result of the
comments.
[ssquf] A description of and an estimate of the number of small
entities to which the rule will apply or an explanation of why no such
estimate is available.
[ssquf] A description of the projected reporting, recordkeeping,
and other compliance requirements of the rule, including an estimate of
the classes of small entities necessary for preparation of the report
or record.
[ssquf] A description of the steps the agency has taken to minimize
the significant economic impact on small entities consistent with the
stated objectives of applicable statutes,
[[Page 8684]]
including a statement of the factual, policy, and legal reasons for
selecting the alternative adopted in the final rule and why each of the
other significant alternatives to the rule considered by the agency
which affect the impact on small entities was rejected.
B. Reason for Agency Action and Legal Basis for the Final Rule
The Danny Keysar Child Product Safety Notification Act, section 104
of the CPSIA, requires the CPSC to promulgate mandatory standards for
nursery products that are substantially the same as, or more stringent
than, the voluntary standard. The Commission worked closely with ASTM
to develop the new requirements and test procedures that have been
incorporated into ASTM F2907-15, which the Commission incorporates by
reference.
C. Compliance Requirements of the Rule
The Commission is incorporating by reference the current voluntary
standard, with one modification regarding label attachment, to form the
final rule. Some of the more significant requirements of the current
voluntary standard for sling carriers (ASTM F2907-15) include static
and dynamic load testing to check structural integrity of the sling
carriers, and occupant-retention testing to check that the child is not
ejected from the sling carrier. The standard requires that the buckles,
fasteners, and knots that secure the sling carrier remain in position
before and after these three performance tests. There is also a
separate restraint-system test to help ensure that any restraints used
by the sling do not release while in use.
The voluntary standard also includes requirements to address the
following issues:
[ssquf] Sharp points and edges,
[ssquf] small parts,
[ssquf] marking and labeling requirements,
[ssquf] flammability requirements,
[ssquf] requirements for the permanency and adhesion of labels, and
[ssquf] requirements for instructional literature.
The rule requires warning labels with specific language in the
warnings and specifications for the size and color of the labels. The
updated warning statements are intended to provide additional details
of the fall and suffocation hazards in an effort to address those
hazards. The rule requires manufacturers to provide with their slings
instructional literature containing additional warnings not required on
labels; the rule does not specify the format of the instructions.
D. Other Federal Rules
CPSC has not identified any federal or state rule that either
overlaps or conflicts with the final rule.
E. Impact on Small Businesses
In the NPR, CPSC reported that it had identified 47 suppliers of
sling carriers to the U.S. market, including 33 companies based in the
United States and 14 foreign companies that exported directly to the
U.S. customers via Internet sales or sales to U.S. retailers. The 33
U.S.-based firms included 25 manufacturers, four importers, and four
firms for which the supply source was not identified. The NPR also
noted that ``there may be hundreds more suppliers that produce small
quantities of slings.'' Since the NPR, information provided by the BCIA
confirms the role of numerous small and very small artisanal
manufacturers in the sling market. The BCIA has identified more than
324 U.S. manufacturers of slings, wraps, and pouches, including both
members and non-members of BCIA. The firms identified by BCIA overlap
only partially with the 47 suppliers identified by CPSC staff. The BCIA
has also identified some additional hand weavers. Thus, the total
number of manufacturers may be about 400.
Because SBA guidelines pertain to U.S.-based entities, this
analysis is limited to domestic firms. Under SBA guidelines, a
manufacturer of sling carriers is ``small'' if it has 500 or fewer
employees; and importers and wholesalers are ``small'' if they have 100
or fewer employees. Based on these guidelines, all of the
manufacturers, except one (with a large parent corporation), appear to
be small businesses. These small businesses consist of approximately
400 U.S. based manufacturers and an unknown number of importers. In
addition, there is a subset of these small businesses that we describe
as ``very small businesses,'' which are manufacturers with a single
person or a couple working out of the home, with annual revenues of
less than $50,000. For analysis, we refer to these suppliers as ``very
small manufacturers'' to distinguish them from the more established
manufacturers; however, this is not an official SBA designation.
The Juvenile Products Manufacturers Association (JPMA) and the BCIA
have offered assistance to member manufacturers on testing and
compliance with the ASTM sling carrier standards. However, the ASTM
F2907 sling carrier standards are relatively new, and therefore, there
is no established history of conformance to the standard among
manufacturers. An email from the head of the BCIA on October 27, 2015
confirms the irregular nature of conformance with various provisions of
the F2907 standard.
As of October 2016, only one manufacturer is listed on the JPMA Web
site as certified compliant. Some manufacturers claim to be ``CPSIA
compliant,'' but that may refer only to requirements for lead,
flammability, labeling, small parts, and sharp edges and not
necessarily the ASTM standard. Based on our review of small firm Web
sites, a conversation with a small ring sling manufacturer, and a draft
magazine article by a small nursing wrap producer, we have identified
three additional firms that have conducted testing to some version of
the ASTM standard, for a total of four firms. If these four firms
already comply fully with the ASTM standard, they should not need to
make any additional product changes due to the rule.
For manufacturers that do not already conform, it is difficult to
assess the cost impact of the physical changes required for compliance
with the standard; this will vary with different product designs and
materials. Some of the fabrics currently used in slings include cotton,
linen, polyester, modal (a cellulosic-like rayon), silk, bamboo, and
various blends of fibers. There are a variety of different designs,
some patented. At least one firm has redesigned its products to be
subject to the soft carrier standard, rather than the sling standard.
Currently, the precise cost of product changes necessary to satisfy
testing under the ASTM standard is unknown. Additionally, according to
the SBA, stakeholders that contacted the SBA do not agree that the
costs to meet the requirements of the ASTM standard will necessarily be
minimal. Consequently, we cannot rule out the potential for costs
associated with the physical changes to lead to significant economic
impacts, especially for very small manufacturers.
In addition to complying with the mechanical requirements of the
rule, under section 14 of the CPSA, sling carriers will be subject to
third party testing and certification. Once the new requirements become
effective, all manufacturers will be subject to the additional costs
associated with third party testing and certification requirements
under the testing rule, Testing and Labeling Pertaining to Product
Certification (16 CFR part 1107). These costs will include any physical
and mechanical tests required by the final rule. Lead and phthalates
testing, if applicable, are already required; hence, lead and
phthalates testing are not part of this analysis.
[[Page 8685]]
The majority of the costs associated with the rule will likely be
related to testing. Few of the sling carrier manufacturers have the
technical capability or the equipment in-house to conduct many of the
tests required by the standard, especially the dynamic-load, occupant-
retention, and restraint-system tests. Therefore, most small and very
small manufacturers will likely have to rely on third party testing
during product development and could incur significant testing costs by
simply pre-testing to determine initially whether their products comply
with the standard and then retesting their products if the designs have
to be modified to comply.
According to a BCIA representative, third party testing to the ASTM
sling carrier voluntary standard, under the requirements of the Testing
and Certification Rule, could cost around $510-$1,050 per model sample.
Third party testing costs consists of two parts: (1) The testing costs
unique to F2907 associated with the dynamic-load test, the static-load
test, the occupant-retention test, and the restraints test; and (2) the
general testing costs associated with testing for flammability, small
parts, sharp edges, instructions, and labels. The testing costs unique
to sling carriers vary widely, from $210 to $650, depending on whether
the testing is done in China or in the United States, and on whether a
discount, such as those negotiated by the BCIA for its members, is
applied. The general testing costs may amount to $300 to $400 per test.
The very small firms that manufacture in the United States will likely
also test in the United States to avoid logistical difficulties, thus
incurring higher costs.
Because very small firms likely will have their products tested in
the United States, their costs will be higher than the minimum testing
cost of $510 per model sample. Therefore, we use a testing fee of $700
per sample to conduct our analysis of impacts. The $700 would cover all
elements of the required testing, including flammability, small parts,
sharp edges, instructions, and labels. However, the cumulative effect
of the various physical tests, which will be done on a single sample in
the order specified in the standard, will render the tested sling
unsellable, which adds to the impact of the rule. One commenter
estimated that there are 100 domestic hand weavers and 50 foreign hand
weavers of slings. For hand-woven slings, for example, the hand weaver
will lose the revenue from a $200 to $800 sling, due to the destructive
nature of testing. The loss of revenue represents a direct cost of
testing and must be considered when evaluating impacts.
Section 9 of ASTM F2907 requires instructions to be provided with
each sling and for these instructions to include some standard content,
including information on contacting the manufacturer, assembly,
adjustment, restraint systems (if applicable), maintenance, cleaning,
storage, and use. The final rule also requires instructions to contain
images of each manufacturer's recommended carrying position, all
warnings that are required to be on the product, and additional safety-
related instructions and information, such as the minimum and maximum
weight of the child for which the sling is intended, the importance of
checking for damaged seams and hardware, and never using the sling when
balance or mobility is impaired.
Sling carrier manufacturers that already provide such information,
estimated by the BCIA to be at about one-third of the industry, or
approximately 135 manufacturers, may have to modify their existing
instructions to make sure the instructions have all the content
required by ASTM. The additional effort would probably be modest,
estimated at 5 hours, if estimates for revisions to instructions for
other children's products are comparable. Using an hourly rate of
$33.29 to calculate these costs, the total compensation for sales and
office workers in private industry in goods-producing industries would
amount to about $166 ($33.29 per hour x 5 hours) per firm.
The BCIA estimated that firms that had not previously prepared
instructions would require 30 to 60 hours of labor, and possibly
outside advice, as well. If the remaining 265 firms require 45 hours,
on average, then the impact per firm would be about $1,500 ($33.29 per
hour x 45 hours). Thus the cost could average $166 for firms that
already provide the literature and $1,500 for those that do not. Once
the literature has been created, it would not have to be modified,
unless the manufacturer makes changes to a model that render portions
of the literature obsolete. The cost of subsequent modifications to the
literature is likely to be less than the cost of its initial design.
Based upon our analysis of data provided by the BCIA, the initial
certification tests, the periodic tests (individually and in
combination), and the cost of instructional material are likely to have
a significant impact on all but mass producers of slings, and could
cause numerous very small producers to exit the market. Similarly,
small importers will also be subject to third party testing and
certification requirements. Consequently, these importers will
experience the associated costs of compliance. The resulting costs
could have a significant impact on these small importers. Additionally,
according to the SBA, stakeholders that contacted the SBA do not agree
(as suggested in the initial regulatory flexibility analysis) that the
costs to meet the requirements of the ASTM standard will necessarily be
minimal. Accordingly, we conclude that the final rule will likely have
a significant impact on a substantial number of small entities.
F. Alternatives
The Commission has considered several alternatives that may
potentially reduce the impact of the final rule on small businesses.
These alternatives are:
[ssquf] Adopting the voluntary standard without change and working
with ASTM to improve durability/attachment of warning labels in a
future revision of the voluntary standard. This alternative could
marginally reduce the impact of the rule on small businesses. Section
104 of the CPSIA requires that the Commission promulgate a standard
that is either substantially the same as the voluntary standard, or
more stringent if the Commission determines that a more stringent
standard would further reduce injuries associated with the product.
Therefore, adopting ASTM F2907-15, with no modifications, would be the
least stringent rule allowable; however, the modification to the
standard regarding label attachment would further reduce the risk of
injury associated with sling carriers.
[ssquf] Delaying the effective date of the requirements beyond 12
months. Typically, the Commission provides a 6-month effective date for
durable nursery product rules. For this rule, the Commission proposed a
12-month effective date, and provides that period in the final rule.
One alternative that could reduce the impact on small firms would be to
set an effective date later than 12 months. Implementing a later
effective date could mitigate the effects of the rule on small
businesses by delaying the need to conduct third party certification
tests and allowing the businesses to spread the costs of bringing their
slings into conformance over a longer period. This alternative,
however, would only delay, not alleviate the effects of the rule.
Moreover, commenters generally favored the 12-month effective date.
[ssquf] Exempting wraps from the standard. Although the testing
conducted by Laboratory Sciences has
[[Page 8686]]
been very limited, laboratory staff found no wraps (i.e., simple
rectangular pieces of woven or knitted fabric) that fail tests for
static- and dynamic-load testing, which check for structural integrity,
nor did staff find any wraps that failed the tests for occupant
retention, which are used to check that the child is not ejected from
the sling carrier. No injuries involving wraps have been identified
that involve structural fabric weaknesses. Given that improper infant
positioning is the primary hazard associated with sling carriers and
that this hazard is addressed in the rule exclusively through the use
of warnings, staff concludes that excluding wraps from education,
instruction, and labeling may be ill-advised.
[ssquf] Providing an exemption for small batch manufacturers from
the testing requirements proposed under the rule, if permissible, this
approach would exempt from the rules testing requirements for the large
number of very small businesses in the sling market. Under Section
14(d)(4)(C)(ii) of the CPSA, however, the Commission cannot ``provide
any alternative requirements or exemption'' from third party testing
for ``durable infant or toddler products,'' as defined in section
104(f) of the Consumer Product Safety Improvement Act of 2008.
[ssquf] Amending 16 part 1107 to reduce the frequency of periodic
testing for small or home based sling producers. Currently, under the
requirements of 16 CFR 1107.21, small home-based businesses that
produce sling carriers must conduct periodic third party tests every
year, or, if they have a formal production testing plan, every two
years. The testing costs associated with third party periodic testing
could be substantially reduced if the Commission amended existing
regulations to allow small home based sling producers to conduct
periodic testing less frequently. The details of this option that the
Commission could consider at a later date would need to be determined
by the Commission separately; it might apply to all nursery products,
or it might be limited to sling carriers. However, all home-based firms
would still be required to: (1) Produce conforming products; (2)
conduct the initial certification tests (16 CFR 1107.20); (3) re-
certify whenever there is a material change to the product (16 CFR
1107.23); and (4) implement a production testing plan and conduct on
going production tests (16 CFR 1107.21(c)). This is not an alternative
to the rule, but a possible additional action.
[ssquf] Determining that Slings are not Durable Products. The
Commission could determine that sling carriers, or some subset of sling
carriers such as wraps, do not constitute a durable infant or toddler
product. The definition of what constitutes a durable product, and the
degree to which empirical and anecdotal evidence on sling carriers
conforms to these definitions was discussed in the 2014 NPR briefing
package. Because the Commission has previously issued a regulation
defining ``durable infant or toddler product'' to include sling
carriers, this alternative would require additional Commission
regulatory action. Under this alternative, while there would be no
mandatory standard, the voluntary standard would still exist and
enforcement actions, such as recalls under Section 15 of the CPSA,
would still be available. Notwithstanding, for the reasons stated in
the 2014 NPR briefing package and reiterated herein, because the
Commission has previously issued a regulation defining ``durable infant
or toddler product'' to include ``infant slings,'' and staff conducted
a lengthy analysis at the notice of proposed rulemaking staged which
concluded that sling carriers are durable infant carriers, the
Commission believes that not regulating would not meet the requirements
under Section 104 to promulgate a standard that is substantially the
same or more stringent than the current voluntary standard.
X. Environmental Considerations
The Commission's regulations address whether the agency is required
to prepare an environmental assessment or an environmental impact
statement. Under these regulations, a rule that has ``little or no
potential for affecting the human environment,'' is categorically
exempt from this requirement. 16 CFR 1021.5(c)(1). The final rule falls
within the categorical exemption.
XI. Paperwork Reduction Act
This rule contains information collection requirements under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The preamble to
the proposed rule discussed the information collection burden of the
proposed rule and specifically requested comments on our estimates.
Sections 8 and 9 of ASTM F2907-15 contain requirements for marking,
labeling, and instruction literature. These requirements fall within
the definition of ``collection of information,'' as defined in 44
U.S.C. 3502(3).
The Commission received one comment on regarding the information
collection of this rule, discussed in section VI.M of this document.
OMB has not yet assigned a control number to this information
collection. We will publish a notice in the Federal Register providing
the number when we receive approval from OMB. This final rule makes
modifications regarding the information collection burden because the
number of estimated suppliers subject to the information collection
burden has increased since publication of the NPR. Accordingly, the
estimated burden of this collection of information is modified as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Frequency of Total annual
16 CFR section respondents responses responses Hours per response Total burden hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1228................................................ 400 3 1,200 11.5 13,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
XII. Preemption
Section 26(a) of the CPSA provides that when a consumer product
safety standard is in effect and applies to a risk of injury associated
with a consumer product, no state (or political subdivision) may
establish or continue a provision of a standard or regulation that
prescribes requirements for the performance, composition, contents,
design, finish, construction, packaging, or labeling of the product
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.''
Therefore, the preemption provision of section 26(a) of the CPSA would
apply to a rule issued under section 104.
[[Page 8687]]
XIII. Amendment to 16 CFR Part 1112 To Include Notice of Requirements
(NOR) for Sling Carriers
Section 14(a) of the CPSA imposes the requirement 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 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 Standard Consumer Safety Specification for
Sling Carriers, to be codified at 16 CFR 1228, is a children's product
safety rule that requires the issuance of an NOR.
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 section 14(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 standard for sling
carriers, require the Commission to amend part 1112. Accordingly, the
Commission is now amending part 1112 to include the standard for sling
carriers in the list of 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 sling
carriers would be required to meet the third-party conformity
assessment body accreditation requirements in 16 CFR part 1112,
Requirements Pertaining to Third-Party Conformity Assessment Bodies.
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 1228, Standard Consumer Safety Specification for Sling
Carriers, included in its scope of accreditation of CPSC safety rules
listed for the laboratory on the CPSC Web site at: www.cpsc.gov/labsearch.
As required by the RFA, staff conducted a FRFA when the Commission
issued the part 1112 rule (78 FR 15836, 15855-58). Briefly, the FRFA
concluded that the accreditation requirements would not have a
significant adverse impact on a substantial number of small test
laboratories because no requirements were imposed on test laboratories
that did not intend to provide third-party testing services. The only
test laboratories that were expected to provide such services were
those that anticipated receiving sufficient revenue from the mandated
testing to justify accepting the requirements as a business decision.
Moreover, a test laboratory would only choose to provide such services
if it anticipated receiving revenues sufficient to cover the costs of
the requirements.
Based on similar reasoning, amending 16 CFR part 1112 to include
the NOR for the sling carriers standard will not have a significant
adverse impact on small test laboratories. Moreover, based upon the
number of test laboratories in the United States that have applied for
CPSC acceptance of accreditation to test for conformance to other
mandatory juvenile product standards, we expect that only a few test
laboratories will seek CPSC acceptance of their accreditation to test
for conformance with the sling carrier standard. Most of these test
laboratories will have already been accredited to test for conformity
to other mandatory juvenile product standards, and the only costs to
them would be the cost of adding the sling carrier standard to their
scope of accreditation. For these reasons, the Commission certifies
that the NOR amending 16 CFR part 1112 to include the sling carriers
standard will not have a significant impact on a substantial number of
small entities.
List of Subjects
16 CFR Part 1112
Administrative practice and procedure, Audit, Consumer protection,
Reporting and recordkeeping requirements, Third-party conformity
assessment body.
16 CFR Part 1228
Consumer protection, Imports, Incorporation by reference, Infants
and children, Labeling, Law enforcement, and Toys.
For the reasons discussed in the preamble, the Commission amends
Title 16 of the Code of Federal Regulations as follows:
PART 1112--REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY
ASSESSMENT BODIES
0
1. The authority citation for part 1112 continues to read as follows:
Authority: 15 U.S.C. 2063; Pub. L. 110-314, section 3, 122 Stat.
3016, 3017 (2008).
0
2. Amend Sec. 1112.15 by adding paragraph (b)(39) 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?
* * * * *
(b) * * *
(39) 16 CFR part 1228, Safety Standard for Sling Carriers.
* * * * *
0
3. Add part 1228 to read, as follows:
PART 1228--SAFETY STANDARD FOR SLING CARRIERS
Sec.
1228.1 Scope.
1228.2 Requirements for sling 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. 1228.1 Scope.
This part establishes a consumer product safety standard for sling
carriers.
Sec. 1228.2 Requirements for sling carriers.
(a) Except as provided in paragraph (b) of this section, each sling
carrier must comply with all applicable provisions of ASTM F2907-15,
Standard Consumer Safety Specification for Sling Carriers, approved on
October 15, 2015. 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_federalregulations/ibr_locations.html.
[[Page 8688]]
(b) In addition to complying with section 5.7.2 of ASTM F2907-15,
comply with the following:
(1) 5.7.3 Warning labels that are attached to the fabric with seams
shall remain in contact with the fabric around the entire perimeter of
the label, when the sling is in all manufacturer recommended use
positions.
(2) [Reserved]
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2017-01285 Filed 1-27-17; 8:45 am]
BILLING CODE 6355-01-P