CPSC Issues Final Rule Safety Standard Soft Infant Toddler Carriers

The CPSC has issued a Final Rule on the Safety Standard for Soft Infant and Toddler Carriers, 16 CFR 1226 on March 28, 2014. This final rule will become effective on September 29, 2014 and apply to products manufactured or imported on or after that date. The ASTM standard for Soft Infant and Toddler Carriers, ASTM F2236-14, which was released on January 1, 2014, incorporates all the new mandatory requirements of the Final Rule.Front Soft Carriers

ASTM F2236-14’s definition of a “soft infant and toddler carrier” distinguishes soft infant and toddler carriers from other types of infant carriers that are also worn by a caregiver but that are not covered under ASTM F-2236-14, specifically slings (including wraps), and framed backpack carriers.

Soft infant and toddler carriers are designed to carry a child in an upright position. Slings are designed to carry a child in a reclined position. However, some slings may also be used to carry a child upright. The primary distinction between a sling and a soft infant and toddler carrier is that a sling allows for carrying a child in a reclined position. Different hazard patterns arise from carrying a child in a reclined position. Accordingly, slings are not covered by the standard for soft infant and toddler carriers.

Like soft infant and toddler carriers, framed backpack carriers are intended to carry a child in an upright position. However, framed backpack carriers are distinguishable from soft infant and toddler carriers because typically, backpack carriers are constructed of sewn fabric over a rigid frame and are intended solely for carrying a child on the caregiver’s back.

ASTM F2236-14 includes the following key provisions: scope, terminology, general requirements, performance requirements, test methods, marking and labeling, and instructional literature.

Scope

The scope of the voluntary standard was broadened in December 2012 to include soft infant and toddler carriers with an upper weight limit of up to 45 pounds. Previously, it was unclear whether carriers with upper weight limits over 25 pounds fell within the standard. Expanding the scope of the standard clarifies that all soft infant and toddler carrier products currently on the market fall within the standard.

Terminology

Section 3.1 of the standard includes 14 definitions to help explain general requirements and performance requirements. Section 3.1.7 of the standard explains that a “leg opening” is the “opening in the soft carrier through which the occupant’s legs extend when the product is used in the manufacturer’s recommended use position.” Sections 3.1.4 and 3.1.13 of ASTM F2236-14, respectively, explain that a “dynamic load” is the “application of impulsive force through free fall of a weight,” and that a “static load” is a “vertically downward force applied by a calibrated force gage or by dead weights.” Beginning in 2012, the standard included a new definition for “carrying position” to clarify methods for dynamic and static load testing in section 7 of the standard. Finally, in 2013, the standard was updated to include a new definition for “fastener” to aid in a new test for fastener strength and strap retention.

General Requirements

ASTM F2236-14 includes general requirements that the products must meet, as well as specified test methods to ensure compliance with the general requirements, which include:

  • restrictions on sharp points or edges, as defined by 16 CFR §§ 1500.48 and .49;
  • restrictions on small parts, as defined by 16 CFR part 1501;
  • restrictions on lead in paint, as set forth in 16 CFR part 1303;
  • requirements for locking and latching devices;
  • requirements for permanent warning labels;
  • restrictions on flammability, as set forth in 16 CFR part 1610;
  • requirements for toy accessories, as set forth in ASTM F 963.

The flammability requirement in section 5.7 of the standard was changed, beginning with ASTM F2236-13, from a flammable solids requirement (16 CFR 1500.3(c)(6)(vi)), to meet the more stringent flammability requirement for wearing apparel (16 CFR part 1610). Adopting the wearing apparel flammability requirement in the soft infant and toddler standard makes it consistent with other wearable infant carriers made of sewn fabric, such as slings, to prevent a foreseeable fire hazard in all wearable infant carriers.

Performance Requirements and Test Methods

ASTM F2236-14 provides performance requirements and test methods that are designed to protect against falls from the carrier due to large leg openings, breaking fasteners or seams, and straps that slip, including:

Leg Openings

Tested leg openings must not permit passage of a test sphere weighing 5 pounds that is 14.75 inches in circumference.

Dynamic and Static Load

Beginning with the 2012 version of ASTM F2236, the dynamic load test was strengthened from requiring a 25-pound shot bag to be dropped, free fall, from 1 inch above the seat area onto the carrier seat 1,000 times, to requiring testing with a 25-pound shot bag, or a shot bag equal to the manufacturer’s maximum occupant weight limit, whichever is heavier. Additionally, the static load test was revised—from requiring a 75-pound weight for testing—to requiring a 75-pound weight, or a weight equal to three times the manufacturer’s recommended maximum occupant weight, whichever is greater, to be placed in the seat area of the carrier for 1 minute. Such revisions to the dynamic and static load tests strengthen the test requirements, by requiring that products with a maximum recommended weight of 45 pounds be tested to a 135-pound weight instead of 75 pounds, which represents an 80 percent increase in the severity of the requirement.

ASTM F2236-14 requires that testing conducted with the new required loads must not result in a “hazardous condition,” as defined in the general requirements, or result in a structural failure, such as fasteners breaking or disengaging, or seams separating when tested in accordance with the dynamic and static load testing methods. Additionally, the standard provides that dynamic and static load testing must not result in adjustable sections of support/shoulder straps slipping more than 1 inch per strap from their original adjusted position after testing.

Section 6.2.2 of the standard on Support/Shoulder Strap Slippage was modified beginning with ASTM F2236-13a. The modification clarifies what constitutes passing or failing the strap slippage test. Section 6.2.2 was amended to state: “Adjustable sections of support/shoulder straps shall not slip, in a manner that loosens the strap, more than 1 in. (25 mm) per strap from their original adjusted position after dynamic and static load testing is performed in accordance with 7.2.1 and 7.2.2, respectively.” The amendment allows straps to tighten during testing but not loosen more than 1 inch, which is the intent of the testing.

Fastener Strength and Strap Retention

ASTM F2236-14 includes a new component-level performance requirement that was added to the standard in 2013 to evaluate the strength of fasteners and strap retention to help prevent falls from a carrier. Previously, soft infant and toddler carriers were recalled due to an occupant fall hazard caused by broken fasteners that passed the static and dynamic performance requirements in the then existing standard, ASTM F2236-10. Accordingly, the performance requirement in section 6.4 of ASTM F2236-14 states that load-bearing fasteners at the shoulder and waist of soft infant and toddler carriers, such as buckles, loops, and snaps, may not break or disengage; nor may their straps slip more than 1 inch when subjected to an 80-pound pull force. Adjustable leg opening fasteners must also be tested but are subjected to lower loads, a 45-pound pull force, because these fasteners do not carry the same load as fasteners at the shoulders and waist. ASTM F2236-14 requires that when tested, fasteners must not break or disengage, and adjustable elements must not slip more than 1 inch.

Similar to the strap slip requirement in the static and dynamic load testing section of the standard, ASTM also clarified the strap slip section of the fastener strength test section in ASTM F2236-13a. Sections 6.4.1 and 6.4.2 were amended to state: “Each unique fastener, except for leg opening adjustment fasteners as tested per 6.4.2, shall not break or disengage, and adjustable elements in straps shall not slip , in a manner that loosens the strap, more than 1 in. (2.5 cm) . . . .” This amendment allows straps to tighten during testing but not to loosen more than 1 inch, which is the intent of the testing.

Additionally, Note 1 to section 6.4 of the standard provides that the fastener strength and strap retention testing apply only to load-bearing fasteners. ASTM F2236-13 stated: “Fasteners intended to retain items such as, but not limited to, hoods, bibs and toy rings, are exempt from these requirements.” ASTM approved two changes to the language in Note 1 to clarify that several non-load-bearing features, “sleeping hoods” and “head adjustment fasteners,” are included in the list of examples exempted from fastener strength testing when such features are non-load-bearing. Note 1 in section 6.4 of ASTM F2236-14 now provides that: “Fasteners intended to retain items such as, but not limited to, sleeping hoods, head adjustment fasteners, bibs and toy rings, are exempt from these requirements.”

Unbounded Leg Opening

The voluntary standard was updated in 2013 to clarify the unbounded leg opening test procedure to improve test repeatability. ASTM F2236-14 requires that an unbounded leg opening must not allow complete passage of a truncated test cone that is 4.7 inches long, with a major diameter of 4.7 inches and a minor diameter of 3 inches. The standard requires a test cone to be pulled through the leg opening with a 5-pound force for 1 minute.

Marking, Labeling, and Instructional Literature

ASTM F2236-14 requires that each product and its retail package be marked or labeled with certain information and warnings. The warning label requirement was updated in 2013 to address fall and suffocation hazards. ASTM F2236-14 requires that the warning label provide a fall hazard statement addressing that infants can fall through wide leg openings or out of the carrier. The standard requires the following fall-related precautionary statements be addressed on the warning label: Adjust leg openings to fit baby’s legs snugly; before each use, make sure all [fasteners/knots] are secure; take special care when leaning or walking; never bend at waist, bend at knees; only use this carrier for children between _ lbs. and _ lbs. Additionally, ASTM F2236-14 requires that a suffocation hazard statement must address the fact that infants under 4 months old can suffocate in the carrier if the child’s face is pressed tightly against the caregiver’s body. The standard requires that the warning label must also address the following suffocation-related precautionary statements: Do not strap infant too tightly against your body; allow room for head movement; keep infant’s face free from obstructions at all times. Products must also contain an informational statement that a child must face toward the caregiver until heor she can hold his or her head upright. All products are required to come with instructional literature on assembly, use, maintenance, cleaning, and required warnings.

ASTM F2236-14 includes an example warning label that identifies more clearly the hazards, the consequences of ignoring the warning, and how to avoid the hazards. The label format was designed to communicate more effectively these warnings to the caregiver (Fig. 1). Manufacturers may alter the rectangular shape of the label to fit on shoulder straps, if the manufacturer chooses not to place label in the occupant space. However, the standard requires that the label be placed in a prominent and conspicuous location, where the caregiver will see the label when placing the soft infant and toddler carrier on their body.

Unsure how this might impact your product or future product development? Contact us today to see how we can help. info@jacobysolutions.com or 866-873-7335 ext. 101

 

The initial list of Priority Products released for Safer Consumer Products Regulations

The initial list of Priority Products released for Safer Consumer Products Regulations were issued on by the California CA-DTSC_Children-Padded-ProductsDepartment of Toxic Substances Control (DTSC) on March 13, 2014. The three categories of products that DTSC selected for inclusion in the initial proposed list are:

  • Spray Polyurethane Foam Systems containing unreacted diisocyanates;
  • Children’s Foam Padded Sleeping Products containing Tris(1,3-dichloro-2-propyl)phosphate or TDCPP; and
  • Paint and Varnish Strippers, and Surface Cleaners with methylene chloride.

The Priority Products listed will not be final until they are adopted into regulation. This process will be done in conformance with California’s rulemaking law – the Administrative Procedure Act (APA). The APA process includes a 45-day public notice and comment period. It allows DTSC up to one year from the public notice date to finalize the regulations. The March 2014 announcement is not the start of formal rulemaking. DTSC anticipates initiation of the rulemaking process for the Priority Products within 12 months. Each Priority Product may have a separate set of regulations.

Children’s foam-padded sleeping products that contain the flame retardant TDCPP have been proposed as an Initial Priority Product. These polyurethane foam-padded sleeping products include:

  • Nap mats and cots
  • Sleep positioners
  • Travel Beds
  • Bassinet foam
  • Portable crib mattresses
  • Play pens
  • Car bed pads

 
TDCPP is also known as chlorinated tris or tris(1,3-dichloro-2-propyl) phosphate. It is a high production volume chemical that is considered a carcinogen by California’s Office of Environmental Health Hazard Assessment.

NEXT STEPS

IF I MAKE A “PRIORITY PRODUCT,” WHAT DO I HAVE TO DO?

If you are a “responsible entity” [a business that manufactures, imports, distributes, sells, or assemble consumer products placed into the stream of commerce in California], you must submit a Priority Product notification to DTSC within 60 days after the effective date of the regulation establishing a product-chemical combination as a final Priority Product. Subsequently, you may be required to perform an Alternatives Analysis—a process that evaluates toxicity and other information concerning the Chemicals of Concern in the product, and compares those data to alternative chemicals or product redesigns that may make that product safer.

DTSC will review Alternative Analysis reports and determine a regulatory course of action, if needed. Responsible entities must comply with the requirements of the Department’s regulatory response. Manufacturers have the principal duty to comply with the regulations. Other responsible entities may include importers, assemblers, or retailers of a Priority Product.

If the manufacturer does not comply, responsibility for compliance falls to the importer. An importer, retailer, or assembler must comply with the requirements applicable to a responsible entity only if the manufacturer has failed to comply and DTSC has notified the importer, retailer, or assembler by posting the information on the Failure to Comply List.

If the manufacturer of a Priority Product fails to comply with the requirements to submit a notification or complete an Alternatives Analysis, the importers must cease to place the product in the stream of commerce in California, and retailers or assemblers must cease ordering the Priority Product and submit a Cease Ordering Notification to the Department.

HOW AND WHEN DO I NOTIFY DTSC IF MY PRODUCT IS A PRIORITY PRODUCT?

The clock will start when the regulations establishing a Priority Product take effect (after rulemaking per the APA is complete). Notify DTSC within 60 days if your product-chemical combination has been adopted as a Priority Product. If a product-chemical combination is introduced into the stream of commerce in California after it has been listed as a Priority Product, the responsible entity must submit a Priority Product notification to DTSC within 60 days of the product’s introduction.

WHAT DOES THE PRIORITY PRODUCT NOTIFICATION INCLUDE? WHAT IS THE FORMAT?

DTSC is developing an online system for electronic submittals of Priority Product Notifications. The Priority Product Notification includes:

  1. Name and contact information of the responsible entity and whether the responsible entity is the product manufacturer, importer, assembler, or retailer.
  2. The type, brand name, and product name of the Priority Product. This includes a description of known products where the Priority Product is used as a component of one or more assembled products.
  3. If applicable, the name of and contact information for the entity that will be complying with the Safer Consumer Product requirements on behalf of or instead of the responsible entity.
  4. If applicable, an indication that a notification is being submitted stating either that the Chemical(s) of Concern is present in the manufacturer’s Priority Product only as contaminants or at very low concentrations; that the manufacturer intends to remove the Chemical of Concern from the product; or that the manufacturer no longer intends to sell the product in California.

Proposed Reforms to Proposition 65 Warnings

Proposed reforms to Proposition 65 warnings are on the agenda for discussion in an upcoming public workshop scheduled by California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) on April 14, 2014. The purpose of the proposed reform is to “reduce unnecessary litigation and require more useful information to the public on what they are being exposed to and how they can protect themselves.” The proposal would “improve the quality of Proposition 65 warnings while providing both flexibility and certainty for businesses”. The proposal would establish three (3) to five (5) minimum elements required for warnings;

  1. Use of the signal word “WARNING”
  2. Use of the word “expose” to be consistent with language in the statute
  3. The standard (Globally Harmonized System) pictogram for toxic hazards (only for consumer products other than foods, occupational and environmental warnings)
  4. Disclosure of the names of up to 12 commonly-known chemicals that require warnings; Acrylamide, Arsenic, Benzene, Cadmium, Chlorinated Tris, 1,4-Dioxane, Formaldehyde, Lead, Mercury, Phthalates, Tobacco Smoke and Toluene.
  5. A link to a new OEHHA website to allow the public to access more information relating to the warning, including additional chemicals, routes of exposure, and if applicable, any actions that individuals could take to reduce or avoid the exposure.

The proposal outlines additional points which it says would “provide the public with better information and businesses with more regulatory certainty, clarity and additional warning options”;

  • Provides an opportunity for small retailers (25 or fewer employees) to cure certain minor warning violations within 14 days and avoid any private enforcement whatsoever.
  • Incorporates alternatives such as email (for environmental exposures) as well as automated processes that may be developed in the future, while maintaining existing options such as on-product warnings and signs.
  • Includes tailored language for specific warning contexts (e.g. alcohol, drugs, medical devices, parking garages, hotels, apartments, and theme parks)
  • Businesses may propose tailored warning methods and content for specific chemicals or exposure scenarios for adoption into regulations
  • Recognizes warnings covered by existing court-approved settlements

The next steps outlined by the OEHHA are;

  • Hold pre-regulatory public workshop on April 14, 2014
  • Propose formal regulation in early summer of 2014
  • Adopt final regulation in early summer 2015
  • Develop website concurrent with regulatory process

An example of the proposed warning labels is shown below For consumer products OTHER than foods, prescription drugs, prescription medical devices or dental services shall at a minimum include the following;

For exposures to listed carcinogens
P65Warning-Lead-New
For exposure to reproductive toxins
P65Warning-Phthalates-New
For exposure to listed carcinogens AND reproductive toxins
P65Warning-Lead_Phthalates-New

Need help in better understanding Prop 65? Jacoby Solutions consultants can brief you on this issue and answer any questions related to your products. Contact us today and someone will get back to you promptly. email us at  info@jacobysolutions.com or call 866-873-7335.

The CPSC issues Final Rule for Carriages and Strollers

The CPSC issued a Final Rule for Carriages and Strollers on March 10, 2014, which will become effective on September 10, 2015. On May 20, 2013 the CPSC issued a notice of proposed rulemaking (NPR) for carriages and strollers which proposed to incorporate by reference the voluntary standard, ASTM F833-13, “Standard Consumer Safety Performance Specification for Carriages and Strollers”, with certain changes to strengthen the voluntary ASTM standard.

The Final Rule incorporates by reference most of the recent voluntary standard, ASTM F833-13b, with a modification to address head entrapment hazards associated with multi-positional adjustable grab bars. In the NPR, the CPSC proposed a performance requirement and test method to address scissoring, shearing and pinching hazards associated with 2D fold strollers, which were already required for 3D fold strollers. For the testing of a 2D fold stroller and convertible carriage/strollers, the CPSC proposed a test within an access zone based on the incident data and the anthropocentric dimensions of the child occupant. The CPSC also proposed a test method to test the frame folding action of a stroller while the stroller is moved from the completely folded to the completely erect position and from the partially folded position to the fully erect and locked position (travel distance calculation).

The definition of a “2D fold stroller” that is found within ASTM F833-13b is a stroller that folds the handlebars and leg tubes only in front-to-back (or back-to-front) direction. To address the 2D fold stroller hazards, ASTM F833-13b requires the frame folding action of a 2D fold stroller and convertible carriage/stroller to be designed and constructed to prevent injury from scissoring, shearing, or pinching. Units with a removable seat that prevents the complete folding of the unit while still attached are exempt from this requirement.

The CPSC is requiring an additional modification to the passive containment/foot opening test method in ASTM F833-13b, to address head entrapment hazards associated with multi-positional adjustable grab bars. Specifically, the test method for passive containment/foot opening is revised as follows:

(a) 7.12.1 Secure the front wheels of the unit in their normal standing position so that the unit cannot move forward. Attach the tray(s) or grab bar(s) in the position that creates the bounded opening(s). Position any adjustable features (that is, grab bar, calf supports, foot rests, etc.) that may affect the bounded opening(s) to create an opening(s) size that is most likely to cause failure; and

(b) 7.12.3 If necessary, reattach/re-position tray(s) grab bar(s), then perform the torso probe test per 7.12.4. Position any adjustable features (that is, grab bar, calf supports, foot rests, etc.) that may affect the bounded opening(s), to create the opening(s) size that is most likely to cause failure.

The Administrative Procedure Act (APA) generally requires that the effective date of the rule be at least 30 days after publication of the final rule [ 5 U.S.C. 553(d)].  The safety standard for carriages and strollers will become effective 18 months after publication of a final rule in the Federal Register.

CPSC Issues Final Rule for the Safety Standard of Bedside Sleepers

Co-SleeperThe CPSC issued a Final Rule for the Safety Standard of Bedside Sleepers on January 15, 2014 with an effective date of July 15, 2014. The rule incorporates the voluntary standard developed by ASTM International (formerly the American Society for Testing and Materials), ASTM F2906-13, “Standard Consumer Safety Specification for Bedside Sleepers” (ASTM F2906-13), by reference, and requires bedside sleepers to be tested to 16 CFR part 1218, the Safety Standard for Bassinets and Cradles (bassinet standard). ASTM F2906-13 defines “bedside sleeper” as “a rigid frame assembly that may be combined with a fabric or mesh assembly, or both, used to function as sides, ends, or floor or a combination thereof, and that is intended to provide a sleeping environment for infants and is secured to an adult bed.” A “multi-mode product” is “a unit that is designed and intended to be used in more than one mode (for example, a play yard, bassinet, changing table, hand held carrier, or bedside sleeper).” A bedside sleeper is intended to be secured to an adult bed to permit newborns and infants to sleep close by an adult without being in the adult bed. Bedside sleepers currently on the market have a horizontal sleep surface that typically is 1 inch to 4 inches below the level of the adult bed’s mattress. The side of the bedside sleeper that is adjacent to the adult bed can usually be adjusted to a lower position, a feature that differentiates bedside sleepers from bassinets, where all four sides of a bassinet are the same height. Current bedside sleepers range in size from about 35″ x 20″ to 40″ x 30.″ Bedside sleepers may have rigid sides, but they are most commonly constructed with a tube frame covered by mesh or fabric. Bedside sleepers are intended for use with children up to the developmental stage where they can push up on hands and knees (about 5 months). This is the same developmental range for the intended users of bassinets. Several manufacturers produce multiuse (or multimode) bedside sleeper products that can convert into bassinets and/or play yards. Most bedside sleeper products can be converted into a bassinet by raising the lowered side to create four equal-height sides, and a few also convert into both a bassinet and play yard. Some play yards include bedside sleeper accessories, which when attached, convert the play yard into a bedside sleeper; and some bassinets convert into bedside sleepers. All of the tube-framed products that CPSC staff has evaluated may be collapsed for storage and transport. A bedside sleeper that can be used in additional modes would need to meet each applicable standard. For example, a bedside sleeper that converts to a bassinet must meet the bedside sleeper standard and the bassinet standard. The CPSC has proposed to adopt by reference, ASTM International’s voluntary standard, ASTM F2906-12, Standard Consumer Safety Specification for Bedside Sleepers, with a few additions to strengthen the standard.

  • § 5.1Prior to or immediately after testing to this consumer safety specification, the bedside sleeper must be tested to 16 CFR part 1218. Multimode products must also be tested to each applicable standard. When testing to 16 CFR part 1218, the unit shall be freestanding, and not be secured to the test platform, as dictated elsewhere in this standard.
  • § 5.1.1The bassinet minimum side height shall be as required in 16 CFR part 1218, with the exception of a lowered side rail as permitted in § 5.4.Show citation box
  • § 7.1All bedside sleeper products shall comply with the marking and labeling requirements of 16 CFR part 1218.
  • § 8.1All bedside sleeper products shall comply with the instructional literature requirements of 16 CFR part 1218

CPSC Issues Direct Final Rule on the Safety Standards for Infant Bath Seats, Toddler Beds, and Full-Size Baby Cribs

CPSC_logo_redblue_QR The Consumer Product Safety Commission (CPSC) on Monday, December 9, 2013, issued a direct final rule on the Safety Standards for Infant Bath Seats, Toddler Beds, and Full-Size Cribs. Under the authority of section 104(b) of the CPSIA, the CPSC is publishing this direct final rule, revising the CPSC’s standards for infant bath seats, toddler beds, and full-size cribs, to incorporate by reference more recent versions of the applicable ASTM standards.

The rule is effective on March 24, 2014, unless the CPSC receives significant adverse comment by January 8, 2014. If the CPSC receives timely significant adverse comments, they will publish notification in the Federal Register, withdrawing this direct final rule before its effective date.

Infant Bath Seats

On September 25, 2013 the ASTM revised the safety standard for infant bath seats to the current ASTM standard, ASTM F1967-13. The differences between the previous version, ASTM F1967-11a and the current version, ASTM F1967-13 is outlined below.

Attachment Components. The 2013 version of the ASTM standard contains a new definition and requirement for attachment components. The requirement specifies that all components needed to attach the bath seat to the bath tub (attachment components) must be permanently attached to the bath seat. The CPSC is aware of a bath seat design that provides some attachment components that are separate from the bath seat. With this design, consumers must install the attachment components, consisting of adhesive discs, on to the bath tub surface. If the consumer fails to install the adhesive discs or fails to install them properly, these bath seats pose a tip over hazard.

Test Surface Preparation. ASTM F1967-11a specifies that bath seats be tested for stability on two specific test surfaces and also provides specific directions for preparing the test surfaces. The CPSC is aware of third party testing laboratories that interpreted one step in the testing preparation directions differently than ASTM intended. Following this alternate interpretation, the testing laboratory provided passing test results for some bath seats that otherwise would not have passed the stability requirement. Therefore, ASTM changed this section of the standard to specify more clearly test surface preparation.

Definition of a Bath Seat/Restraints Systems. In 2011, ASTM changed the definition of a “bath seat” to specify better the type of support that a bath seat provides. Before the ASTM F1967-11a version, the definition of “bath seat” did not specify the type of support the product provided. The revised (and current) definition states that a bath seat provides, at a minimum, support to the front and back of a seated infant. Thus, a product with only back support is no longer considered a bath seat. ASTM F1967-13 removes a provision that applied to bath seats with only back support because the provision is no longer relevant, given the current definition of “bath seat” as a product with front and back support.

Suction Cup Requirements. ASTM clarified two requirements for testing bath seats that use suction cups. The standard provides two suction cup test requirements: One provision evaluates the attachment between the suction cups and the test surface; the other evaluates the attachment of the suction cups to the bath seat itself. The first difference between the two versions clarifies the test requirement to emphasize that the bath seat must actually attach to the test surfaces as part of the test. The second difference specifies that this particular test only needs to be performed on one of the two test surfaces.

Markings and Labeling. ASTM made two minor changes to labeling requirements. One revision changed the test for label permanency to the relative humidity (RH) to be a range rather than a specific RH. The CPSC considers this a practical change that was needed because producing an exact RH for the test is difficult. The second change to the labeling requirements removes the word “adult” before the term “caregiver” in a provision that requires a warning to “be located on the product so that it is visible to the [adult] caregiver.”

Toddler Beds

On September 25, 2013, ASTM notified the CPSC that ASTM has revised ASTM F1821 again and has published a new version, ASTM F1821-13. This version contains 12 significant changes from ASTM F1821-09. These changes bring the ASTM standard into accord with the CPSC’s mandatory standard for toddler beds at 16 CFR part 1217.

Full-Size Cribs

The revised standard, ASTM F1169-13, differs from ASTM F1169-11 (the current CPSC standard) in one aspect that is reflected in two sections of the revised standard. ASTM F1169-11 requires that before and after testing a crib, the crib must comply with all general requirements of the standard. These general requirements address the distance between slats. However, the specific testing procedure for slats allows for one slat to fail during testing if the load at failure is at least 60 pounds and an additional 25 percent of the slats are tested and meet the 80-pound force requirement. Thus, a tested crib potentially could comply with the specific testing procedures for slats even if a slat failed during testing, but not meet the general slat spacing requirements because of the failed slat. In that situation, the crib would not comply with the requirements in the current standard because the crib would not meet all of the general requirements after the crib had been tested.

The revised standard, ASTM F1169-13, provides an exception for this specific situation so that a crib’s failure to meet the slat spacing requirement under the testing circumstances described above would not cause the crib to be considered noncompliant.

CPSC Issues Final Rule for Hand-Held Infant Carriers

Hand-Held Infant Carrier

The Consumer Product Safety Commission (CPSC) has issued a Final Rule for Hand-Held Infant Carriers on Friday, December 6, 2013. The rule will become effective on June 6, 2014.

On December 10, 2012, the CPSC issued a notice of proposed rulemaking (NPR) for hand-held infant carriers. 77 FR 73354. The NPR proposed to incorporate by reference the then current voluntary standard, ASTM F2050-12, Standard Consumer Safety Specification for Hand-Held Infant Carriers, with certain modifications to strengthen the ASTM standard.

One proposed modification provided for a change in the warning label to better address suffocation and restraint-related hazards. The other proposed modification addressed the testing procedures for the carry handle auto-locking requirement and specified using an aluminum cylinder as the surrogate for the occupant of the carrier rather than a CAMI Mark II 6-month infant dummy (CAMI dummy).

Since the CPSC published the NPR, ASTM has revised ASTM F2050 twice. On July 1, 2013, ASTM approved an updated version of the voluntary standard, ASTM F2050-13, which includes the warning label modification proposed in the NPR.

On September 1, 2013, ASTM approved another revision of the voluntary standard, ASTM F2050-13a, which includes a carry handle auto-locking performance requirement that is different than the requirement proposed in the NPR.

The draft final rule incorporates by reference the most recent version of the ASTM standard, ASTM F2050-13a, with one modification—a clarification of the definition of “hand-held infant carrier,” to include a specific reference to both “rigid-sided” and “semi-rigid-sided” products.

Changes to Requirements of ASTM F2050-13a

The final rule modifies the definition of “hand-held infant carrier” to clarify that the definition includes products with semi rigid sides, as well as products that are rigid-sided. ASTM revised the hand-held infant carrier standard in 2012, to include a separate definition for “hand-held bassinets/cradles.”

A Moses basket meets the definition of a “hand-held bassinet” because a Moses basket is a freestanding product with a rest/support surface that is no more than 10° from horizontal, that sits directly on the floor, without legs or a stand, and has handles or hand-holds intended to allow carrying an occupant whose torso is completely supported by the product. However, because hand-held infant carriers (of which hand-held bassinets/cradles are a subset) are defined in part as “a rigid-sided product” and many Moses baskets have flexible sides, some manufacturers and importers may have interpreted the standard as excluding semi-rigid-sided products such as Moses baskets.

Because Moses baskets meet the definition of “hand-held bassinet/cradle,” and Moses baskets are not subject to any other durable children’s product standard (specifically ASTM F2194-13, Standard Consumer Safety Specification for Bassinets and Cradles), the CPSC has determined that Moses baskets are within the scope of the rule. The modification of the definition of “hand-held infant carrier” to include semi rigid-sided products clarifies that Moses baskets are covered by the rule.

Warning Label: The NPR proposed requiring a strangulation warning label to be affixed to the outer surface of the cushion or padding of a hand-held carrier seat in or adjacent to the area where the child’s head would rest. Under the proposal, the warning label for hand-held carrier seats that are intended to be used as restraints in motor vehicles would include a pictogram, while the warning label for hand-held carrier seats not intended to be used as restraints in motor vehicles would not include the pictogram because these seats do not have the chest clips depicted in the pictogram.

Handle Auto-Lock Test: The NPR proposed a modification of the test method for preventing the carrier from rotating and spilling an unrestrained infant when a caregiver picks up the carrier and the handle is not locked in the carry position. The test method in ASTM F2050-12 required the tester to use a standard CAMI dummy as an infant surrogate. The NPR proposed a change that would require the tester to use an aluminum cylinder designed as a surrogate for a 6-month-old infant, in lieu of the CAMI dummy, because testing had revealed that the CAMI dummy could be wedged into the seat padding or otherwise manipulated, so that the CAMI dummy did not fall out during the lift test when the CAMI dummy otherwise should fall. Furthermore, the Commission was concerned that the ability to pass or fail the test based on friction or placement of the CAMI would affect the consistency and repeatability of the test results.

CPSC Voluntary Remedial Actions and Guidelines Final Rule

CPSC Voluntary Recall The Consumer Product Safety Commission (CPSC) has proposed amendments to its Voluntary Remedial Actions and Guidelines that would make corrective action plans for product recalls legally binding, which is a departure from over forty years of working with manufacturers on recalls and could impact liability risks for companies.

Previously if a manufacturer, distributor or retailer reported to the CPSC a consumer product that had violated a standard or created a substantial risk of injury or death to the public, they were allowed to negotiate and create a voluntary “corrective action plan” (CAP) that would “fast track” recall remediation measures and notify consumers.

Unlike mandatory CAP’s, voluntary CAP’s are not legally binding which allows companies to diverge from the CAP and in some cases not accomplish the CPSC’s desired results of the recall. In September of this year, the CPSC proposed a rulemaking to the standardized recall agreements based on studies which showed that product recalls seldom were totally successful.

In November of this year the Commission approved by a margin of 3 – 1, the proposed rulemaking to standardized recall provisions and make voluntary recall agreements legally binding. This means that the CPSC will have greater input into what will be required in the voluntary CAP’s which in some cases could include the creation of mandatory compliance systems within the company that would address issues arising out of the product recall.

For example, the CPSC could impose enhancements to the company’s existing compliance policies by ensuring that its ongoing program contains written standards and policies, a mechanism for confidential employee reporting of compliance related questions or concerns, and appropriate communication of company compliance policies to all employees through training programs.

The new rule would give the requirements within the voluntary CAP teeth by allowing the court system to get involved when violations occur. While Commissioner Robert Adler, who proposed the new rule, admitted that the violation of corrective action plans has not been a “big problem,” he explained that even if one corrective action plan is violated, “that [violation] may leave hundreds and hundreds and hundreds of thousands of consumers at risk of a defective product.”

Time for Small Batch Manufacturers to Reapply for Exemption for 2014

Small Batch Registration Deadline

 

NOTE that if you are a registered small batch manufacturer with the U.S. Consumer Product Safety Commission (CPSC) for calendar year 2013 and you wish to continue in this status, you must register again for calendar year 2014.  Registration must be submitted annually.  On or about December 1st, 2013, the CPSC will release instructions on how to renew your registration.

 

If you qualify and if you are a manufacturer of children’s products and produce in small batches, it is critical that you register for a small batch exemption if your sales are less than 1 million dollars from the previous calendar year or you have manufactured less than 7,500 qualifying (children’s products) units. See the CPSC website for details relating to your product.

If you are a new company  and new to this subject matter, you may have this question. Are small batch manufacturers currently required to third party test their children’s products in order to certify compliance to applicable regulations?

 It depends on the children’s product and the materials used to manufacture that children’s product.

Small batch manufacturers must always third party test for the following children’s product safety rules (Group A):

Qualifying small batch manufacturers are NOT required to third party test for compliance with certain other children’s product safety rules. Note, however, that all manufacturers, even those that are small batch manufacturers, must ensure that their children’s products are in compliance with the underlying children’s product safety rules in Group B and issue a general certificate of conformity (GCC)

Qualifying small batch manufacturers registered with the Commission are NOT required to third party test for the following children’s product safety rules (Group B):

With respect to Group B, qualifying small batch manufacturers will need to ensure that the products comply with those regulations and issue a general certificate of conformity (GCC).

As a qualifying small batch manufacturer, you will need to register with the CPSC on an annual basis.  You can visit the CPSC page for more information. Ignorance of the law is no excuse so please register today.

New California Proposition 65 Settlements

A number of California Proposition 65 settlements have been reached involving a wide variety of products including vinyl flooring, air compressors, cosmetic bags, bandages, eyewear, kitchen and door mats, bathroom accessories, and small novelty items. These settlements establish requirements for these products that the defendants have agreed to meet.

These requirements apply to accessible materials of the following adult and children items.Proposition 65 Settlements

PHTHALATES

Bandages

Dashboard Accessories

Bathroom Accessories

Temporary Tattoos

Place Mats and Shower Curtains

Watches and Clocks

Bathroom, Kitchen, and Door Mats

Stationary

Plastic Figures, Charms and Small Novelty Items

Requirement:

  • No more than 1000 ppm DEHP, BBP and DBP each
  • Warning labels cannot be used as an alternative to meeting the 1000 ppm limit

Eyewear

Requirement:

  • No more than 1000 ppm total DEHP
  • Warning labels cannot be used as an alternative to meeting the 1000 ppm limit

Vinyl Flooring

Requirement:

  • No more than 1000 ppm DEHP, BBP, DBP, DIDP and DnHP each
  • Or provide specified warning label

LEAD

Holiday Lights

Cosmetics Bags

Luggage Tags

Requirement:

  • No more than 50 ppm total lead
  • No more than 1.0 μg in wipe test

Note: Both requirements must be met

  • Warning labels cannot be used as an alternative to meeting both requirements

Air Compressors

Requirement:

  • No more than 100 ppm total lead
  • Warning labels cannot be used as an alternative to meeting the 100 ppm limit

Brass Pencil Sharpeners

Requirement:

  • No more than 100 ppm total lead
  • No more than 1.0 μg in wipe test

Note: Both requirements must be met

  • Or provide specified warning label