Safety Standard for Sling Carriers
This Proposed Rule document was issued by the Consumer Product Safety Commission (CPSC)
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Parts 1112 and 1228
[Docket No. CPSC-2014-0018]
Safety Standard for Sling Carriers
Consumer Product Safety Commission.
Notice of proposed rulemaking.
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 proposing a safety standard for sling carriers in response to the direction under Section 104(b) of the CPSIA.
Submit comments by October 6, 2014.
You may submit comments related to the Paperwork Reduction Act (PRA) aspects of the marking, labeling, and instructional literature of the proposed rule to the Office of Information and Regulatory Affairs, OMB, Attn: CPSC Desk Officer, FAX: 202-395-6974, or emailed to: email@example.com.
You may submit other comments, identified by Docket No. CPSC-2014-0018, by any of the following methods:
Electronic Submissions: Submit electronic comments to the Federal eRulemaking Portal at: http://www.regulations.gov. Follow the instructions for submitting comments. The Commission does not accept comments submitted by electronic mail (email), except through www.regulations.gov. The Commission encourages you to submit electronic comments by using the Federal eRulemaking Portal, as described above.
Written Submissions: Submit written submissions by mail/hand delivery/courier to: Office of the Secretary, Consumer Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814; telephone (301) 504-7923.
Instructions: All submissions received must include the agency name and docket number for this notice. All comments received may be posted without change, including any personal identifiers, contact information, or other personal information provided, to: http://www.regulations.gov. Do not submit confidential business information, trade secret information, or other sensitive or protected information that you do not want to be available to the public. If furnished at all, such information should be submitted in writing.
Docket: For access to the docket to read background documents or comments received, go to: http://www.regulations.gov, and insert the docket number CPSC-2014-0018, into the “Search” box, and follow the prompts.
For Further Information Contact
Hope E J. Nesteruk, Project Manager, Division of Human Factors, Directorate for Engineering Sciences, Consumer Product Safety Commission, 5 Research Place, Rockville, MD 20850; telephone: 301-987-2579; email: firstname.lastname@example.org.
I. Background and Statutory Authority
The Consumer Product Safety Improvement Act of 2008 (CPSIA, Pub. L. 110-314) was enacted on August 14, 2008. Section 104(b) of the CPSIA, part of the Danny Keysar Child Product Safety Notification Act, requires the Commission to: (1) Examine and assess the effectiveness of voluntary consumer product safety standards for durable infant or toddler products, in consultation with representatives of consumer groups, juvenile product manufacturers, and independent child product engineers and experts; and (2) promulgate consumer product safety standards for durable infant and toddler products. These standards are to be “substantially the same as” applicablevoluntary 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. Section 104(f)(1) of the CPSIA defines the term “durable infant or toddler product” 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.”
Section 104 also requires manufacturers of durable infant or toddler products to comply with a registration program that the Commission establishes. Section 104(d).
In this document, the Commission is proposing a safety standard for sling carriers. Section 104(f)(2)(H) of the CPSIA lists “infant carriers” as one of the categories of durable infant or toddler products identified for purposes of section 104. 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 hand-held infant carriers (78 FR 73415 (December 6, 2013)) and soft infant carriers (78 FR 20511 (April 5, 2013)) and a proposed rule on frame backpack carriers (79 FR 28458 (May 16, 2014)). In the Commission's product registration card rule identifying additional products that the Commission considered 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). The durability of infant slings is discussed in section II.B. of this document.
Because the voluntary standard on infant slings, ASTM 2907-14a, “Standard Consumer Safety Specification for Sling Carriers,” refers to “infant slings” as “sling carriers,” the notice of proposed rulemaking refers to infant slings as “sling carriers.” The terms are intended to be interchangeable and have the same meaning.
Pursuant to Section 104(b)(1)(A), the Commission consulted with manufacturers, retailers, trade organizations, laboratories, consumer advocacy groups, consultants, and members of the public in the development of this proposed standard, largely through the ASTM process. CPSC staff participated in the ASTM sling carrier subcommittee meetings and task group meetings and worked with the ASTM sling carrier task groups to develop ballot language for revisions to the sling carrier voluntary standard. The proposed rule is based on the voluntary standard developed by ASTM International (formerly the American Society for Testing and Materials), ASTM F2907-14a, “Standard Consumer Safety Specification for Sling Carriers” (ASTM F2907-14a), without change.
The ASTM standard is copyrighted, but the standard is available as a read-only document during the comment period on this proposal only, at: http://www.astm.org/cpsc, by permission of ASTM.
II. Product Description
A. Definition of Sling Carrier
ASTM F2907-14a “Standard Consumer Safety Specification for Sling Carriers” 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 generally 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 identified three broad classes of sling carrier products available in the United States:
Ring slings, modifications of wraps and pouch slings, and other products that meet the definition of a sling carrier contain parts that are also considered durable from an engineering perspective and suggest they were selected for long-term use. In addition, the test methods in ASTM F2907-14a combine to ensure that slings meet a minimum level of durability.
ASTM F2907 does not distinguish among the type of slings. The voluntary standard's requirements apply equally to all slings.
B. Sling Carrier Use
ASTM F2907-14a states that sling carriers generally are intended for children starting at full-term birth, until a weight of about 35 pounds (15.9 kg). According to the data tables used to produce the 2000 Centers for Disease Control and Prevention (CDC) U.S. growth charts, the median (50th percentile) weight of a child does not exceed 35 pounds until about 46 months for boys and 49 months for girls (CDC, 2000). Moreover, the 5th percentile bodyweight of a child does not exceed 35 pounds until about 65 months for boys and 69 months for girls. This means that more than half of all 3-year-olds are likely to be at or below the maximum weight of 35 pounds, and that even some 5-year-olds are likely to be at or below this upper weight limit. Although the Commission believes that sling carriers are most likely to be used with infants, it seems reasonably foreseeable that some portion of the user population will use these carriers with preschool-aged children.
Evidence suggests that sling carriers are often reused for multiple children. For example, according to a 2005 survey conducted by the American Baby Group (2006 Baby Products Tracking Study), nearly one-third (31 percent) of mothers who own slings had a sling that was handed down or purchased secondhand. Preliminary data from CPSC's Durable Nursery Products Exposure Survey found that 21 percent of sling owners acquired the sling used. The Survey also found that after the owner discontinued use of the sling,only 4 percent threw away the sling; 96 percent of owners stored the sling for future use, sold the sling, gave the sling away, or returned the sling to the original owner. These results suggest that most sling owners at least perceive sling carriers to have a future useful life, even if the sling had been used previously.
The Commission is aware of several online Web sites, forums, and “babywearing” groups dedicated to buying, selling, and trading previously used sling carriers. (“Babywearing” is commonly used to describe the wearing or carrying of a baby in a sling or similar carrier.) For example, a simple search of sold listings for a used “baby sling” on eBay resulted in more than 1,700 listings during a roughly 3-month period. Although some of the products in these ads do not meet the definition of a “sling carrier,” a brief examination of the most recent 200 sales suggests that a very large percentage of these products would be considered a sling carrier. Thus, many consumers appear to be purchasing slings secondhand.
C. Market Description
The Commission has identified 47 suppliers to the U.S. market, but there may be hundreds more suppliers that produce small quantities of slings. (The Commission made these determinations using information from Dun & Bradstreet and Reference USAGov, as well as firm Web sites.) Web sites such as Etsy show thousands of listings for artisans producing slings and wraps (although each firm may have multiple listings), which accounts for additional suppliers who are not among the 47 suppliers identified. Sling carriers are distributed by a variety of methods, such as mass merchandisers, small specialty juvenile products stores, and Internet-only distributors.
Of the 47 sling carrier suppliers identified, 33 companies are based in the United States: 25 are manufacturers, and four are importers. Available information does not identify the supply source for four firms. There are also 14 foreign companies that export directly to the United States via Internet sales or directly to U.S. retailers.
A sling carrier is an uncomplicated product to produce, typically requiring only fabric, thread, rings (and in some cases, fasteners), and a sewing machine. A common scenario for a 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. However, the newer home businesses may be relatively unsophisticated and may not be aware of the sling carrier voluntary standard effort or know that sling carriers may be subject to existing federal regulations on children's products.
According to a the 2006 Baby Products Tracking Study, 17 percent of new mothers own sling carriers. As noted previously, approximately 31 percent of sling carriers were handed down or purchased secondhand. Thus, about 69 percent of sling carriers were acquired new. (The data collected for the Baby Products Tracking Study do not represent an unbiased statistical sample. American Baby Products surveyed potential respondents from its mailing lists to generate a sample of 3,600 new and expectant mothers. Additionally, because the most recent survey information is from 2005, the data may not reflect the current market.) This information suggests annual sales of about 471,000 sling carriers (.17 × .69 × 4 million births per year), with prices ranging from $30 to around $150. (U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC), National Center for Health Statistics, National Vital Statistics System, “Births: Final Data for 2009,”National Vital Statistics Reports Volume 61, Number 1 (August 28, 2012): Table I. Number of births in 2010 is rounded from 3,999,386.)
However, this sales estimate may be a substantial underestimate for two reasons: (1) Industry sources state that slings have increased in popularity since the survey was done in 2005; and (2) other products like wraps, pouches, and some soft carriers, which fall under the standard, may not have been included in the Baby Products Tracking study. Based on discussions with an industry representative, sales of these other products that fall under the proposed rule for sling carriers could increase the Commission's sales estimate to about 600,000 to 1 million units annually.
III. Incident Data
The Commission is aware of a total of 122 incidents (16 fatal and 106 nonfatal) related to sling carriers, which were reported to have occurred from January 1, 2003 through October 27, 2013. Because reporting is ongoing, the number of reported fatalities, nonfatal injuries, and non-injury incidents may change in the future. Given that reporting is incomplete, the Commission strongly discourages drawing inferences based on the year-to-year increase or decrease shown in the reported data. (The CPSC databases searched were the In-Depth Investigation (INDP) file, the Injury or Potential Injury Incident (IPII) file, the Death Certificate (DTHS) file, and the National Electronic Injury Surveillance System (NEISS). These reported deaths and incidents do not provide a complete count of all deaths and incidents that occurred during that time period. However, they do provide a minimum number of deaths and incidents occurring during this time period and illustrate the circumstances involved in the incidents related to sling carriers.)
Among the incidents in which age was reported, all but one of the children were 12 months old or younger; the age of the oldest child was reported to be 3 years. Some incident reports did not indicate the age because there was no injury involved or age was unknown. Table 1 provides the age breakdown as reported in the 122 incidents.
CPSC received reports of 16 fatalities associated with the use of a sling carrier that occurred during the period from January 1, 2003 through October 27, 2013. Eleven of the 16 decedents were 1-month olds; the remaining five were between 3- and 5-months old. Nine of the decedents were described as having died of smothering, (also known as “suffocation,” or “positional asphyxia.”) Suffocation can occur when babies are contained entirely within the pouch of a sling. Infants who are placed with their heads below the rim of the sling are likely to stay in the same position because they are surrounded by unyielding fabric under the tension of their weight, and are tightly confined within the product, typically with their faces directed towards or held against the parent's body. The highest risk of suffocation occurs when the infant's face (nose and mouth) is pressed against the mother's body, blocking the infant's breathing, and rapidly suffocating the baby within a few minutes. The cause of death was undetermined for the remaining decedents.
One fatal victim was 5 months old. The age range of the remaining 15 fatal victims was from birth to 3 months; 11 infants were ages 1 month and younger, and the remaining four were 3 months old. Infants younger than 4 months old are at a high risk for suffocation because they have relatively immature physiological systems controlling breathing and arousal.
Of the 106 sling carrier-related nonfatal incidents that were reported to have occurred from January 1, 2003 through October 27, 2013, 54 reports reflected an injury to the infant during use of the product. Age was unreported for one of the injured, and one report stated that a 3-year-old was injured. For the rest of the incidents, the child's age ranged from 1 month to 11 months.
Among the 54 reported nonfatal injuries, nine were reported as involving hospitalizations. Among the hospitalizations, one injury was described as a permanent brain injury due to breathing difficulties suffered by the infant. The rest of the hospitalizations were serious head injuries, such as a fracture and/or brain hemorrhage, which resulted from infants falling from the carrier. Eleven additional skull/face/wrist fracture injuries were reported, but none of these incidents was reported to involve hospitalizations. The remaining non-hospitalized injuries included closed-head injuries, contusions/abrasions, lacerations/scratches, among others. (A closed head injury is a head injury where the skull remained intact. A closed head injury can range from a minor bump to the head to a severe life threatening traumatic brain injury.) A majority of the injuries resulted from falls from the carrier; most of these falls resulted from the caregiver slipping, tripping, or bending over while carrying the infant in the sling. The remaining injuries were due to miscellaneous product-related issues or other caregiver missteps, such as the caregiver not allowing enough safety clearance for the child in the sling carrier while the caregiver performed daily activities.
The remaining 52 incident reports stated that no injury had occurred or provided no information about any injury.
C. Hazard Pattern Identification
The Commission considered all 122 reported incidents (16 fatal and 106 nonfatal) to identify hazard patterns associated with sling carriers. In order of frequency of incident reports, the Commission grouped the hazard patterns into the following categories:
1. Problems with the positioning of the infant in the sling carrier: Thirty-one of the 122 reported incidents (25 percent) were in this category. Among them were nine deaths due to smothering, one permanent brain impairment injury due to breathing difficulty, and two other injuries—one related to breathing difficulty and the other related to blood-circulation in the infant's leg. The rest of the incidents reported that the infant suffered breathing problems while in the carrier or that the caregiver had difficulty safely positioning the infant in the sling carrier to avoid the potential for suffocation.
2. Caregiver missteps: Twenty of the 28 incidents (23 percent) in this category were reported to have occurred when the caregiver slipped, tripped, or bent over, causing the infant in the sling to either fall with the caregiver or fall out of the carrier. Eight additional incidents among the 28 reported in this category occurred when caregivers dropped the infant during placement into/removal out of the carrier or failed to provide enough safety clearance for the infant in the carrier as the caregivers conducted their daily activities. Examples of the latter scenario include an infant getting struck by a door or a falling object, or an infant hitting a wall. Although these 28 incidents did not involve any fatalities, all but one incident resulted in an injury to the infant. These incidents included 11 reports of skull fractures and one report of bleeding in the brain. Other injuries included closed-head injuries, contusions of the head/leg/back, and a finger laceration.
3. Undetermined or unspecified cause: Twenty five reported incidents (20 percent) included seven fatalities, two hospitalized injuries, and 13 non-hospitalized injuries, with very little information available on the circumstances leading to the incidents. The official reports did not indicate a specific cause of death. Among the injuries, which included fractures of the skull/wrist, as well as other serious head injuries, most were reported through hospital emergency departments with very little scenario-specific information.
4. Problems with buckles: Twelve of the 122 incidents (10 percent) reported buckles releasing, slipping, or breaking, causing infants to fall or nearly fall. There was one hospitalization for a skull fracture and two non-hospitalized injuries. There were no fatalities in this category.
5. Miscellaneous product-related issues: There were nine incident reports (seven percent) in which consumers complained of a design flaw posing a possible strangulation hazard, a brokencomponent, rough fabric, or a sharp surface; or consumers indicated an unspecified product failure. Although these reports did not include any fatalities, there were six injuries reported in this category, including one skull fracture.
6. Consumer comments: There were 17 non-event reports (14 percent) of consumer comments or observations of perceived safety hazards. In most of these cases, the consumer did not own the sling carrier in question. None of these reports indicates that any event actually occurred.
D. Product Recalls
Since January 1, 2003, the CPSC has issued five consumer-level recalls involving sling carriers. All five recalls were for product defects that created a substantial product hazard and resulted in the recall of about 1.1 million sling carriers. Two of the recalled products posed a suffocation hazard, while three recalls were related to structural integrity and fall or potential fall hazards.
IV. Other Standards
A. International Standards
The Commission identified one European standard that covers fabric carriers without rigid structure. In addition, a guideline for sling carriers is under development in Europe.
1. British Standard EN13209-2:2005, Child Use and Care Articles—Baby Carriers—Safety Requirements and Test Methods—Part 2: Soft Carriers (27 September 2005), is the European standard for soft, fabric carriers. However, EN13209 specifically states that the scope is intended for a “product [that] has holes designed to accommodate the child's legs.” Sling carriers do not have holes through which a child's legs pass. Although some individual requirements in the EN13209 standard may be more stringent than those in F2907-14a, the reported incidents do not suggest that these are prevalent hazard patterns associated with sling carriers. Therefore, the Commission does not believe that incorporating these more stringent requirements would further reduce the risk of injury associated with sling carriers.
2. CEN/TR 16512, Child use and care articles—Guidelines for the safety of children's slings, is a guideline that is under development in Europe. However, because this guideline, once completed would not be a standard, CEN/TR 16512 is not an option for consideration. The Commission expects that this guideline, when published, will contain recommendations similar to EN13209, but with recommendations adapted for the unique attributes of sling carriers.
The Commission notes that the ASTM F15.21 subcommittee has worked to make F2907 the most appropriate standard for the unique nature of sling carriers by harmonizing with other standards (e.g., EN13209 and ASTM F2236), when appropriate, but also addressing the uniqueness of sling carriers, when needed. The Commission believes that ASTM F2907-14a is the most comprehensive standard that addresses the incident hazard patterns and that F2907-14a adequately addresses the hazards identified to date.
Voluntary Standard—ASTM F2907
1. Description of Standard
ASTM F2907, “Standard Consumer Safety Performance Specification for Sling Carriers,” establishes safety performance requirements, test methods, and labeling requirements to minimize the hazards to children presented by sling carriers. ASTM first published a consumer product safety standard for sling carriers in 2012. ASTM has revised the voluntary standard five times since then. The current version, ASTM F2907-14a, was approved on February 15, 2014, and published in March 2014. ASTM F15.21 subcommittee issued a ballot on May 16, 2014, that proposed a modification in the occupant retention test pass/fail criteria. According to the ballot, “the current Occupant Retention test criteria (section 6.3) are not accurately separating good ring slings from poorly-constructed ring slings.” The modification ASTM has proposed would increase from 1 inch to 3 inches the amount the ring sling attachment system may slip while still passing the standard. At the time of writing, the Commission does not have sufficient information to assess this change. Staff welcomes comments on the issue.
The current version of the sling carrier standard, ASTM F2907-14a, contains requirements to address the following issues:
In addition, F2907-14a includes construction, quality, and durability test methods that are specific to sling carriers in the static, dynamic, occupant retention, and restraint system tests. These test methods combine to ensure that slings meet a minimum level of durability.
2. Adequacy of Requirements in Addressing Identifiable Hazard Patterns
Positioning. The Commission identified positioning as the primary hazard pattern in 31 cases. This includes nine deaths due to smothering, one permanent brain impairment injury due to breathing difficulty, and two other injuries—one related to breathing difficulty and the other related to blood circulation in the infant's leg.
As noted previously, the Commission identified suffocation/asphyxia related to positioning as a risk associated with sling carriers. Suffocation can occur when babies are contained entirely within the pouch of a sling. The highest risk of suffocation occurs when the infant's face (nose and mouth) is pressed against the mother's body, blocking the infant's breathing and rapidly suffocating a baby within a few minutes. Furthermore, because of its shape and lack of support, a sling carrier can facilitate an infant being positionedwithin the confines of the sling in a manner that causes acute neck hyper-flexion (chin touching the chest). Infants found in this compromised position are likely to stay in the position because infant neck muscles are too weak to support the weight of their head. Infants who stay for prolonged periods of time in this position can experience compromised airflow to the lungs, resulting in an inadequate supply of oxygen to the brain. Oxygen deprivation to the brain can lead to loss of consciousness and death.
Although there is no performance test for positioning in ASTM F2907-14a, ASTM F2907-14a requires statements in the warnings and instructions for sling carriers to caution against the hazards identified by the Commission through examination of the sling carrier incidents. Section 8.3.3 of F2907-14a specifies the warnings that must appear on each sling and addresses each of the hazard patterns the Commission found in the suffocation data. In short, all sling carriers must: (1) Include a safety alert symbol
and the signal word “WARNING,” (2) warn that failure to follow the manufacturer's instructions can result in “death or serious injury,” (3) state the minimum and maximum recommended weights for the sling, and (4) warn about the potential suffocation and fall hazards associated with sling carriers.
More specifically, according to ASTM F2097-14a, the warnings that pertain to suffocation and positioning must address:
Lastly, the warning label prescribed by ASTM F2907-14a must include a pictogram that illustrates proper and improper infant positioning within the sling. ASTM F2907-14a includes an example of the type of pictogram sought but does not specify a particular design.
Section 9 of ASTM F2907-14a specifies what instructional literature must be provided with the sling. This section requires that the instructions contain an image of each manufacturer's recommended carrying position, include all of the warning statements that are required to appear on the sling, and provide several additional instructions.
ASTM subcommittees for other durable nursery product standards have also tried to address positioning hazards related to a C-shaped curl in an infant's head, neck, and torso area; however, there has been no repeatable performance test identified. The Commission attempted to address the positioning hazard associated with sling carriers in a new manner, based on the recognition that a sling carrier is worn by the caregiver and involves direct contact with the caregiver, thereby allowing for the possibility of the caregiver seeing a child who is in distress. Specifically, the Commission explored a “face exposure” test that, at a minimum, could keep a sling from preventing the caregiver from observing the infant's face. The Commission pursued this possible test with the ASTM task group but found that the available anthropomorphic mannequins, e.g., CAMI dummies, do not accurately represent the manner in which a child sits in a sling, and that the variable nature of sling products makes the repeatability of a test questionable. Together with the ASTM task group, the Commission concluded that a test to address positioning hazards is technically infeasible at this point.
Ultimately, the Commission concluded that warning requirements about proper and improper infant positioning present in ASTM F2907-14a is the only feasible hazard-mitigation strategy at this time. The Commission will continue to consider possible performance requirements pertaining to this issue and will pursue such an approach with the ASTM Subcommittee in the future, if an approach becomes feasible. Because there is no feasible performance test and because the warning statements in ASTM F2907 were developed considering both known hazard patterns for sling carriers and established practices for warning labels, the Commission believes that the warnings and instructions published in ASTM F2907-14a are adequate to inform caregivers about how to reduce the likelihood of positioning incidents.
Caregiver Missteps. Incidents involving caregiver missteps included 11 reports of skull fractures and one episode of bleeding in the brain. Other injuries included closed head injuries, contusions of the head/leg/back, and a finger laceration. The Commission determined that these incidents were related directly to the actions, often accidental, of the caregiver. Examples include a caregiver slipping or tripping while wearing the sling carrier with the child inside, or incidental contact occurring between the child and an object, such as a door or wall. Although these types of incidents cannot be addressed directly through a performance test, the standard addresses these incidents by alerting caregivers of the hazard and making sure that the sling contains the infant. ASTM F2907-14a requires the following statement to appear on the on-product label to address the fall hazard to infants associated with “caregiver missteps,” such as tripping or bending over:
FALL HAZARD—Leaning, bending over, or tripping can cause baby to fall. Keep one hand on baby while moving.
In addition, the occupant retention test in ASTM F2907-14a is intended to reduce the likelihood that the child will fall out of the sling due to a caregiver misstep. ASTM F2907-14a requires the test mass to be contained within the sling for the duration of the test.
Buckles. Twelve of the incidents involved buckles releasing, slipping, or breaking, and included a hospitalization for a skull fracture and two non-hospitalized injuries. ASTM F2907-14a addresses this hazard in several ways, using the static, dynamic, occupant retention, and restraint system tests. For the reasons described previously, the Commission believes that the performance tests in F2907-14a adequately address hazards associated with buckle failure.
V. Effective Date
The Administrative Procedure Act (APA) requires that the effective date of the rule be at least 30 days after publication of the final rule, 5 U.S.C. 553(d). The Commission generally considers 6 months sufficient time for suppliers to come into compliance with a proposed durable infant and toddler product rule. Six months is the period the Juvenile Products Manufacturers Association (JPMA) typically allows for products in JPMA's certification program to shift to a new voluntary standard once that new voluntary standard is published. Therefore,juvenile product manufacturers are accustomed to adjusting to new standards with this time frame. However, in this instance, a large number of very small suppliers potentially will experience significant economic impacts complying with the rule. In addition, because ASTM F2907 has only been in existence for approximately 2 years, there is relatively little information regarding compliance with the voluntary standard. Thus, the Commission is proposing a 12-month effective date. The Commission invites comment on whether 12 months is an appropriate length of time for sling carrier manufacturers to come into compliance with the rule.
VI. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) requires agencies to review proposed rules for a rule's potential economic impact on small entities, including small businesses. Section 603 of the RFA generally requires that agencies prepare an initial regulatory flexibility analysis (IRFA) and make the analysis available to the public for comment when the agency publishes a general notice of proposed rulemaking. The IRFA must describe the impact of the proposed rule on small entities and identify any alternatives that may reduce the impact. Specifically, the IRFA must contain:
1. Reason for Agency Action and Legal Basis for the Proposed 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 F2907-14a, which the Commission proposes to incorporate by reference.
2. Compliance Requirements of the Proposed Rule
The Commission is incorporating by reference the current voluntary standard, with no revision, to form the proposed rule. Some of the more significant requirements of the current voluntary standard for sling carriers (ASTM F2907-14a) include static and dynamic load testing to verify the structural integrity of the sling carriers and occupant retention testing to help ensure that the child is not ejected from the sling carrier. The ASTM 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:
The updated warning statements provide additional details of the fall and suffocation hazards and are intended to address the primary fatality risk associated with infant slings, suffocation.
3. Other Federal Rules
Section 14(a)(2) of the Consumer Product Safety Act (CPSA) requires every manufacturer and private labeler of a children's product that is subject to a children's product safety rule to certify, based on third party testing conducted by a CPSC-accepted laboratory, that the product complies with all applicable children's product safety rules. Section 14(i)(2) of the CPSA requires the Commission to establish protocols and standards by rule for, among other things, making sure that a children's product is tested periodically and when there has been a material change in the product, and safeguarding against the exercise of undue influence by a manufacturer or private labeler against a conformity assessment body. A final rule implementing sections 14(a)(2) and 14(i)(2) of CPSA, Testing and Labeling Pertaining to Product Certification (16 CFR part 1107), became effective on February 13, 2013 (the 1107 rule). When the sling carrier rule is finalized, sling carriers will be subject to a mandatory children's product safety rule. Accordingly, sling carriers will also be subject to the third party testing requirements of section 14 of the CPSA and the 1107 rule. Slings are already subject to lead and phthalates testing under the 1107 Rule. This rule adds certain mechanical tests and other requirements to the third party testing requirement.
In addition, the 1107 rule requires certifiers to use CPSC-accredited laboratories to conduct the third party testing of children's products. Section 14(a)(3) of the CPSA required the Commission to publish a notice of requirements (NOR) for the accreditation of third party conformance assessment bodies (i.e., testing laboratories) to test for conformance with each children's product safety rule. The NORs for existing rules are set forth in 16 CFR part 1112. Consequently the Commission is proposing an amendment to 16 CFR part 1112 that would establish the requirements for the accreditation of testing laboratories to test for compliance with the sling carrier final rule.
4. Impact on Small Businesses
Of the 47 identified suppliers of sling carriers to the U.S. market, 33 are domestic firms. (We limit our analysis to domestic firms because U.S. Small Business Administration (SBA) guidelines pertain to U.S.-based entities.) Under SBA guidelines, a manufacturer of sling carriers is small if it has 500 or fewer employees, and importers and wholesalers are small if the importers or wholesalers have 100 or fewer employees. Based on these guidelines, 31 of the domestic firms supplying sling carriers to the U.S. market appear to be small businesses. These businesses consist of 23 manufacturers, four importers, and four firms with unknown supply sources.
Additionally, as noted previously, an unquantified number of producers supply baby slings to the U.S. market via Web sites such as Etsy. Although we have no information on these suppliers, based on the general nature of suppliers selling products on Etsy and similar markets, we assume that these suppliers are well within SBA criteria for small business. For purposes of analysis, we refer to these suppliers as “very small manufacturers” to distinguish them from the more established manufacturers, but this is not an official SBA designation.
Before preparation of a regulatory flexibility analysis, the Commission conducts a screening analysis to determine whether a regulatory flexibility analysis or a certification statement of no significant impact on a substantial number of small entities is appropriate for a proposed rule. The SBA gives considerable flexibility in defining the threshold for “no significant economic impact.” However, the Commission typically uses 1 percent of gross revenue as a threshold; unless the impact is expected to fall below the 1 percent threshold for the small businesses evaluated, the Commission prepares a regulatory flexibility analysis.
Because we were unable to demonstrate that the draft proposed rule would impose an economic impact less than 1 percent of gross revenue for the affected firms, the Commission did not prepare a certification statement, but conducted an IRFA.
JPMA and the Baby Carrier Industry Alliance (BCIA) have advised some manufacturers of F2907-12, F2907-13a, F2907-13b, and F2907-14. These organizations are offering assistance to member manufacturers on testing and compliance with the ASTM sling carrier standards. However, the ASTM sling carrier standards are relatively new, and there is no established history of compliance among manufacturers.
As of January 2014, only two of the 23 known small manufacturers of sling carriers are listed on the JPMA Web site as certified compliant. Based on our review of small firm Web sites and a conversation with a small ring sling manufacturer, we have identified three additional firms (not JPMA certified) that have conducted testing to some version of the ASTM standard, for a total of five firms that have conducted testing to some version of the ASTM standard. These firms may have already experienced the impacts of the proposed rule and may not experience any additional impacts. The remaining firms are likely to incur some cost associated with the proposed rule.
Due to the nature of the product and the relative ease of production, the Commission believes that most of the physical changes needed to meet the standard, such as changing fabrics, changing stitching, adding reinforcements, changing buckles, changing rings, changing labels, and changing instructions, are unlikely to be costly. Because sling carriers are largely made of fabric, tooling costs are not usually a large factor.
Some manufacturers of ring slings are having difficulties with their products passing the occupant retention tests consistently. The problem appears to be variation in testing results based on how the sling is positioned on the test fixture. At this time, the precise cost of changes necessary to satisfy testing under the ASTM standard is unknown; and we cannot rule out the potential for costs high enough to lead to significant economic impacts, especially for the very small manufacturers.
According to one manufacturer, changes to warning labels required under the proposed rule may have an impact on very small suppliers. We do not have sufficient data to determine whether this impact is expected to be economically significant. For example, if the cost of printing and sewing in the labels is 30 cents per sling, then the impact would be 1 percent of the sales price for a $30 sling. CPSC staff contacted a representative from the BCIA to obtain label prices but has no independent estimate at this time. An additional consideration is that the labels are relatively large and may reduce the appeal of the product if they cannot be readily concealed. However, this impact will apply to all sling manufacturers.
Another manufacturer also expressed concerns that minor deviations from the font sizes required by the standard on the labels could force manufacturers to redo portions of the testing. This phenomenon may diminish as businesses become familiar with the requirements. Testing costs are discussed below.
The majority of the costs associated with the proposed standard will probably be related to testing. Few of the sling carrier manufacturers have the technical capability or the equipment to conduct any testing in house; and most small and very small manufacturers probably will have to rely on third party testing during product development. Some small and very small manufacturers could experience significant costs simply testing to find out initially whether their products comply with the proposed standard and with any additional testing necessary to develop complying products.
In addition, under section 14 of the CPSA, sling carriers are subject to third party testing and certification. Once the new requirements become effective, all manufacturers will be subject to the additional costs associated with the third party testing and certification requirements under the testing rule, Testing and Labeling Pertaining to Product Certification (16 CFR part 1107). This will include any physical and mechanical test requirements specified in the final rule; lead and phthalates testing, if applicable, are already required; hence, lead and phthalates testing are not included in this discussion.
According to a BCIA representative, third party testing to the ASTM sling carrier voluntary standard could cost around $500−$1,050 per model sample, with $700 as an average cost. Third party testing consists of two costs: 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 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 the United States and whether a discount, such as the discount negotiated by the BCIA for its members, is applied. The general testing costs may amount to $300 to $400. The very small firms that manufacture in the United States will probably also test in the United States to avoid logistical difficulties, thus incurring higher costs.
The $700 estimate for average testing costs includes all the required testing, such as flammability, sharp edges, etc. If a very small manufacturer with one model only needed to conduct one third party test annually, the costs of testing would amount to $700. A very small manufacturer producing 20 to 30 low-priced slings a month might have annual revenues of $10,800 (30 slings per month × 12 months × $30 per sling). Testing one sample at $700 would amount to 6.5 percent ($700/$10,800) of annual revenue for this hypothetical very small manufacturer, which we would clearly classify as a significant economic impact. Even if this manufacturer could sell its slings for $150, testing one sample at $700 would amount to 1.3 percent of annual revenue of $54,000 (360 slings*$150 per sling).
As a comparison, third party testing costs for soft infant and toddler carriers (SITCs) were estimated at $500−$600 per sample for the SITC standard, ASTM F2236-14. However, the higher testing costs for slings could reflect additional testing for occupant retention, which is not part of the SITC standard.
Based upon the previous example, even in the unlikely case that very small sling manufacturers are able to develop a complying product without incurring significant economic impacts, very small sling manufacturers are still likely to incur significant economic impacts complying with section 14 of the CPSA.These types of impacts would apply to the very small producers marketing their products primarily via Etsy and other Web sites.
Although information on sales revenue is limited to half of all manufacturers, we estimate that most of the 23 small domestic manufacturers have substantially larger sales volumes than the example above, with annual sales ranging between $200,000 and $16 million. Thus, product development and testing costs would be a lower percentage of sales revenue than the example above. At the lower range of $200,000 in revenues, significant economic impacts would occur if the producer had to test three models per year. Firms with revenues closer to the upper end of the range, $16 million, would need to test more than 200 models per year to experience significant economic impacts from testing. The number of tests needed for product development purposes or to meet the “high degree of assurance” criteria under section 14 of the CPSA is not known.
About a third of firms (8 of 23) also have other product lines, which may cushion the impact of design changes and increased testing costs for sling carriers. These other products may be similar products, such as mei tais (a traditional Asian unstructured soft carrier falling under the SITC standard) or SITCs, or these other products may be completely unrelated juvenile products.
At this time, only one of the four importers identified is in compliance with F2907-12, F2907-13a or F2907-13b. Depending upon the costs of coming into compliance incurred by the importers' suppliers and whether the importers' suppliers are able to pass on the costs, the other three importers could experience a significant economic impact. Three of the four importers are owned by foreign parent companies that supply the importers' slings. These parent companies must make the business decision to comply or to discontinue U.S. operations. Two of the four importers could respond by simply discontinuing their sling product line altogether because these importers have varied product lines.
As is the case with manufacturers, all importers will 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.
As mentioned previously, four of the small domestic firms have unknown supply sources, and none of these supply sources has claimed compliance with any version of F2907. However, two firms have varied product lines and may be in a better position to comply without incurring significant economic impacts. The other two appear to be small firms specializing in slings, and therefore, these small firms may be impacted more heavily by compliance and testing costs.
Under the Danny Keysar Child Product Safety Notification Act, section 104 of the CPSIA, one alternative would be to set an effective date later than 12 months. Setting a later effective date would reduce the economic impact on firms in two ways. First, firms would be less likely to experience a lapse in production, which could result if firms are unable to comply within the required timeframe. Second, firms could spread costs over a longer time period, thereby reducing their annual costs and the present value of their total costs. Given the large number of very small suppliers who potentially will experience significant economic impacts, a later effective date may warrant consideration. The Commission welcomes comments regarding an appropriate effective date.
VII. Environmental Considerations
The Commission's regulations address whether we are required to prepare an environmental assessment or an environmental impact statement. If our rule has “little or no potential for affecting the human environment,” our rule will be categorically exempted from this requirement. 16 CFR 1021.5(c)(1). The proposed rule falls within the categorical exemption.
VIII. Paperwork Reduction Act
This proposed rule contains information collection requirements that are subject to public comment and review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). In this document, pursuant to 44 U.S.C. 3507(a)(1)(D), we set forth:
Title: Safety Standard for Sling Carriers.
Description: The proposed rule would require each sling carrier to comply with ASTM F2907-14a, Standard Consumer Safety Specification for Sling Carriers. Sections 8 and 9 of ASTM F2907-14a contain requirements for marking, labeling, and instructional literature. These requirements fall within the definition of “collection of information,” as defined in 44 U.S.C. 3502(3).
Description of Respondents: Persons who manufacture or import sling carriers.
Estimated Burden: We estimate the burden of this collection of information as follows:
Our estimates are based on the following:
Section 8.1.1 of ASTM F2907-14a requires that the name and the place of business (city, state, mailing address, including zip code, or telephone number) and Web site, if applicable, of the manufacturer, distributor, or seller be marked clearly and legibly on each product and its retail package. Section 8.1.2 of ASTM F2907-14a requires a code mark or other means that identifies the date (month and year, as a minimum) of manufacture.
There are 47 known entities supplying sling carriers to the U.S. market. All 47 firms are assumed to use labels already on both their productsand their packaging, but the firms might need to make some modifications to their existing labels. The estimated time required to make these modifications is about 1 hour per model. Each entity supplies an average of three different models of sling carrier; therefore, the estimated burden associated with labels is 1 hour per model × 47 entities × 3 models per entity = 141 hours. We estimate the hourly compensation for the time required to create and update labels is $27.71 (U.S. Bureau of Labor Statistics, “Employer Costs for Employee Compensation,” September 2013, Table 9, total compensation for all sales and office workers in goods-producing private industries: http://www.bls.gov/ncs/). Therefore, the estimated annual cost to industry associated with the labeling requirements is $3,907.11 ($27.71 per hour × 141 hours = $3,907.11). There are no operating, maintenance, or capital costs associated with the collection.
Section 9.1 of ASTM F2907-14a requires instructions to be supplied with the product. Sling carriers do not generally require assembly, but require instructions for proper use, fit, and adjustment on a caregiver's body, as well as maintenance, cleaning, and storage. Under the OMB's regulations (5 CFR 1320.3(b)(2)), the time, effort, and financial resources necessary to comply with a collection of information that would be incurred by persons in the “normal course of their activities” are excluded from a burden estimate, where an agency demonstrates that the disclosure activities required to comply are “usual and customary.” Therefore, because we are unaware of sling carriers that generally require some instructions for use, but lack any instructions to the user, we estimate tentatively that there are no burden hours associated with section 9.1 of ASTM F803-13 because any burden associated with supplying instructions with sling carriers would be “usual and customary” and would not within the definition of “burden” under the OMB's regulations.
Based on this analysis, the proposed standard for sling carriers would impose a burden to industry of 141 hours, at an estimated cost of $3,907.11 annually.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), we have submitted the information collection requirements of this rule to the OMB for review. Interested persons are requested to submit comments regarding information collection by August 22, 2014, to the Office of Information and Regulatory Affairs, OMB (see the ADDRESSES section at the beginning of this notice).
Pursuant to 44 U.S.C. 3506(c)(2)(A), we invite comments on:
Section 26(a) of the CPSA, 15 U.S.C. 2075(a), provides that where a consumer product safety standard is in effect and applies to a product, no state or political subdivision of a state may either establish or continue in effect a requirement dealing with the same risk of injury, unless the state requirement is identical to the federal standard. Section 26(c) of the CPSA also provides that states or political subdivisions of states may apply to the Commission for an exemption from this preemption under certain circumstances. Section 104(b) of the CPSIA refers to the rules to be issued under that section as “consumer product safety rules.” Therefore, the preemption provision of section 26(a) of the CPSA would apply to a rule issued under section 104.
X. Certification and Notice of Requirements (NOR)
The CPSA establishes certain requirements for product certification and testing. 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). Certification of children's products subject to a children's product safety rule must be based on testing conducted by a CPSC-accepted third party conformity assessment body. Id. 2063(a)(2). The Commission must publish a notice of requirements (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. Id. 2063(a)(3). Thus, the proposed rule for 16 CFR part 1228, “Safety Standard for Sling Carriers,” when issued as a final rule, will be a children's product safety rule that requires the issuance of an NOR.
To meet the requirement that the Commission issue an NOR for the sling carrier standard, the Commission proposes to amend an existing rule. 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 took effect 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 Section14(a)(2) of the CPSA. The final rule also codifies all of the NORs that the CPSC had published to date. All new NORs, such as the sling carrier standard, require an amendment to part 1112. Accordingly, the proposed rule would amend part 1112 to include the sling carrier standard, along with the 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 part 1112. 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, Safety Standard for Sling Carriers, included in the laboratory's 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 final regulatory flexibility analysis (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 laboratories because no requirements were imposed on laboratories that did not intend to provide third party testing services. The only 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.
Based on similar reasoning, amending the part 1112 rule to include the NOR for the sling carrier standard will not have a significant adverse impact onsmall laboratories. Moreover, based upon the number of laboratories in the United States that have applied for CPSC acceptance of the accreditation to test for conformance to other juvenile product standards, we expect that only a few laboratories will seek CPSC acceptance of their accreditation to test for conformance with the sling carrier standard. Most of these laboratories will have already been accredited to test for conformance to other juvenile product standards, and the only costs to them would be the cost of adding the sling carrier standard to their scope of accreditation. As a consequence, the Commission certifies that the NOR for the sling carrier standard will not have a significant impact on a substantial number of small entities.
XI. Request for Comments
This proposed rule begins a rulemaking proceeding under section 104(b) of the CPSIA to issue a consumer product safety standard for sling carriers. We invite all interested persons to submit comments on any aspect of the proposed rule.
Comments should be submitted in accordance with the instructions in theADDRESSESsection at the beginning of this notice.
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, Toys.
For the reasons discussed in the preamble, the Commission proposes to amend Title 16 of the Code of Federal Regulations as follows:
Part 1112 Requirements Pertaining to Third Party Conformity Assessment Bodies
1. The authority citation for part 1112 continues to read as follows:
Pub. L. 110-314, section 3, 122 Stat. 3016, 3017 (2008); 15 U.S.C. 2063.
2. Amend § 1112.15, by adding paragraph (b)(39) to read as follows:
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.
* * * * *
3. Add part 1228 to read as follows:
Part 1228 Safety Standard for Sling CarriersSec.
Requirements for sling carriers.
Pub. L. 110-314, sec. 104, 122 Stat. 3016 (August 14, 2008); Pub. L. 112-28, 125 Stat. 273 (August 12, 2011).
This part establishes a consumer product safety standard for sling carriers.
Requirements for sling carriers.
(a) Each sling carrier must comply with all applicable provisions of ASTM F2907-14a, Standard Consumer Safety Specification for Sling Carriers, approved on February 15, 2014. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from ASTM International, 100 Bar Harbor Drive, P.O. Box 0700, West Conshohocken, PA 19428; http://www.astm.org/cpsc.htm. You may inspect a copy at the Office of the Secretary, U.S. Consumer Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814, telephone 301-504-7923, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federalregulations/ibr_locations.html.
Dated: July 10, 2014.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2014-16792 Filed 7-22-14; 8:45 am]
BILLING CODE 6355-01-P
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Comment Period Closed
Oct 6 2014, at 11:59 PM ET
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Date Posted: Jul 23, 2014
RIN: Not Assigned
CFR: 16 CFR Parts 1112 and 1228
Federal Register Number: 2014-16792
In my opinion, the proposed regulations will do nothing to prevent future deaths since that is caused by user error, rather than unsafe equipment. I think the...
These regulations will put so many small and home businesses out of business. The costs of testing are too high and too stringent for a small company to be...
Like many of the other commentators I too worry that this would hurt small business owners who would not be able to cover the cost of expensive testing. By your...
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