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;
Use of the signal word “WARNING”
Use of the word “expose” to be consistent with language in the statute
The standard (Globally Harmonized System) pictogram for toxic hazards (only for consumer products other than foods, occupational and environmental warnings)
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.
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
For exposure to reproductive toxins
For exposure to listed carcinogens AND reproductive toxins
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.
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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.
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The 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
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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.
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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.
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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.”
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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):
Lead-in-paint and other surface coatings, 16 CFR §1303;
Other durable infant or toddler products, as additional children’s product safety rules are enacted, 15 U.S.C. 2056a(f), Sec. 104 of the CPSIA.
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.
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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.
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
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The new ASTM Standard for Sling Carriers has a revised scope which further defines which infant carriers fall within the scope of F2236 (Soft Infant and Toddler Carriers) and which fall within F2907 (Sling Carriers). The CPSIA requires all baby carriers to belong to one or the other.
The standard 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. In general, the child will be between full term birth and 35 lb (15.9 kg).”
Further definition includes; “Slings consist of a variety of unstructured designs ranging from a hammock-shaped product suspended on the caregiver’s upper torso to a long length of material wrapped around the caregiver’s body.”
Additionally the standard says, “The sling carrier is normally “worn” by the caregiver, and thus the child is supported from one or both shoulders of the caregiver. These products are worn on the front, hip or back of the caregiver, with the child either facing towards or away from the caregiver or reclined on the front only of the caregiver.”
No sling carrier produced after the approval date of new standard shall either by label or other means, indicate compliance with the specification unless it complies with all of the requirements of the new standard.
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A marketer of iPhone accessories, bottle holders, lens cleaners, dog collars, leashes, and other outdoor accessories has agreed to settle Federal Trade Commission charges that it falsely claimed certain of its products were “Made in the USA,” or “Truly Made in the USA” even though the products contained substantial foreign content.
The proposed settlement prohibits the company from deceiving consumers about the degree to which its products are made in the United States.
Based in Logan Utah, E.K. Ekcessories, Inc. sells merchandise directly to consumers on its website, ekusa.com, and through online sellers such as Amazon and REI.
The company claimed on its website that “For 28 years E.K. Ekcessories has been producing superior quality made accessories in our 60,000 sq. ft. facility in Logan, Utah;” and “Our source of pride and satisfaction abounds from a true ‘Made in USA’ product.” In fact, the company imports many of its products and components, according to the complaint. The FTC also alleged that the company distributed deceptive promotional materials for its products to third-party retailers such as Amazon and REI.
The FTC alleged that E.K. Ekcessories, Inc. violated the Federal Trade Commission Act by making false and unsupported statements that its products were all or virtually all made in the United States.
Under the proposed order, the company is prohibited from claiming that any product is made in the United States unless that product is all or virtually all made in the United States. The company also is prohibited from making any misleading claims about a product’s country of origin and from providing deceptive promotional material to third-party retailers, or otherwise providing the “means or instrumentalities” for others to make deceptive U.S.-origin claims. The company also is required to contact all distributors who bought or received products between January 1, 2010 and May 1, 2013, and provide them with a notice and a copy of the order.
According to the Commission’s 1997 U.S. Origin Claims Enforcement Policy Statement, for a product to be advertised or labeled as “Made in the U.S.A,” the product must be “all or virtually all” made in the United States – that is, all significant parts and processing must be of U.S. origin, and the product should contain no (or negligible) foreign content.
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Proposed Reforms to Proposition 65 Warnings
/in California Prop 65/by BillJProposed 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;
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”;
The next steps outlined by the OEHHA are;
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
For exposure to reproductive toxins
For exposure to listed carcinogens AND reproductive toxins
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
/in Uncategorized/by BillJThe 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
/in ASTM, CPSC/by BillJCPSC Issues Direct Final Rule on the Safety Standards for Infant Bath Seats, Toddler Beds, and Full-Size Baby Cribs
/in ASTM, CPSC, News/by BillJThe 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
/in CPSC, News/by BillJThe 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
/in Uncategorized/by BillJPreviously 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
/in CPSC, Posts/by BillJNOTE 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
/in California Prop 65, News/by BillJA 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.
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:
Eyewear
Requirement:
Vinyl Flooring
Requirement:
LEAD
Holiday Lights
Cosmetics Bags
Luggage Tags
Requirement:
Note: Both requirements must be met
Air Compressors
Requirement:
Brass Pencil Sharpeners
Requirement:
Note: Both requirements must be met
New ASTM Standard for Sling Carriers Released (ASTM F2907-13b)
/in ASTM, News/by BillJThe new ASTM Standard for Sling Carriers has a revised scope which further defines
which infant carriers fall within the scope of F2236 (Soft Infant and Toddler Carriers) and which fall within F2907 (Sling Carriers). The CPSIA requires all baby carriers to belong to one or the other.
The standard 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. In general, the child will be between full term birth and 35 lb (15.9 kg).”
Further definition includes; “Slings consist of a variety of unstructured designs ranging from a hammock-shaped product suspended on the caregiver’s upper torso to a long length of material wrapped around the caregiver’s body.”
Additionally the standard says, “The sling carrier is normally “worn” by the caregiver, and thus the child is supported from one or both shoulders of the caregiver. These products are worn on the front, hip or back of the caregiver, with the child either facing towards or away from the caregiver or reclined on the front only of the caregiver.”
No sling carrier produced after the approval date of new standard shall either by label or other means, indicate compliance with the specification unless it complies with all of the requirements of the new standard.
Marketer of Outdoor Accessories Agrees to Drop Made in the USA Claims
/in FTC, News/by BillJA marketer of iPhone accessories, bottle holders, lens cleaners, dog collars, leashes, and other outdoor
accessories has agreed to settle Federal Trade Commission charges that it falsely claimed certain of its products were “Made in the USA,” or “Truly Made in the USA” even though the products contained substantial foreign content.
The proposed settlement prohibits the company from deceiving consumers about the degree to which its products are made in the United States.
Based in Logan Utah, E.K. Ekcessories, Inc. sells merchandise directly to consumers on its website, ekusa.com, and through online sellers such as Amazon and REI.
The company claimed on its website that “For 28 years E.K. Ekcessories has been producing superior quality made accessories in our 60,000 sq. ft. facility in Logan, Utah;” and “Our source of pride and satisfaction abounds from a true ‘Made in USA’ product.” In fact, the company imports many of its products and components, according to the complaint. The FTC also alleged that the company distributed deceptive promotional materials for its products to third-party retailers such as Amazon and REI.
The FTC alleged that E.K. Ekcessories, Inc. violated the Federal Trade Commission Act by making false and unsupported statements that its products were all or virtually all made in the United States.
Under the proposed order, the company is prohibited from claiming that any product is made in the United States unless that product is all or virtually all made in the United States. The company also is prohibited from making any misleading claims about a product’s country of origin and from providing deceptive promotional material to third-party retailers, or otherwise providing the “means or instrumentalities” for others to make deceptive U.S.-origin claims. The company also is required to contact all distributors who bought or received products between January 1, 2010 and May 1, 2013, and provide them with a notice and a copy of the order.
According to the Commission’s 1997 U.S. Origin Claims Enforcement Policy Statement, for a product to be advertised or labeled as “Made in the U.S.A,” the product must be “all or virtually all” made in the United States – that is, all significant parts and processing must be of U.S. origin, and the product should contain no (or negligible) foreign content.