Maine proposes four chemicals for priority designation

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Maine proposes four chemicals for priority designation. The Maine Department of Environmental Protection (DEP) Maine Priority Chemicalshas proposed four rules that would designate cadmium, formaldehyde, mercury and arsenic as priority chemicals. Manufacturers, importers or distributors of certain children’s products which are in the stream of commerce in Maine will have to report the use of these four chemicals in their products if they are above a certain “minimum amount”.

The proposed rule states that, “No later than 180 days after the effective date of this chapter, the manufacturer [this would include an importer as well] of any of the following: bedding, childcare articles, clothing, cosmetics, craft supplies, footwear, games, jewelry and embellishments, safety seat, occasion supplies, personal accessories, personal care products, school supplies, or toys which are intended for use by a child under the age of 12 years, that contain intentionally-add [chemicals] shall report to the department the following information:

  1. The name and address of the manufacturer [including importers]
  2. The name, address and phone number of a contact person for the manufacturer [including importers]
  3. Description of the product or products containing [the chemical], including the overall size of the product and/or component of the product that contains [the chemical] and whether the product or chemical-containing component of the product, can be placed in the mouth (typically if the item is smaller than 5 cm in one dimension, it is regarded as mouthable)
  4. The number of items sold or distributed in Maine or nationally
  5. The amount of [the chemical] in the product reported
  6. The function of [the chemical] in the product reported
  7. Any other information the manufacturer deems relevant to the reporting of the chemical, such as relevant independent scientific study on exposure specific to the amount of chemical present in the finished product reported or product of similar functionality.

A public comment period on the proposed rules expired on January 31, 2014. The proposed rules would implement Maine’s Toxic Chemicals in Children’s Products law, which aims to protect the health, safety and welfare of children by reducing their exposure to chemicals of high concern by providing substitutes when feasible. Maine has already listed bisphenol A (BPA) and nonylphenol/nonylphenol Ethoxylates (NP/NPE) as priority chemicals.

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

 

FTC Announces Changes to Textile Labeling Rules

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The FTC Announces Changes to Textile Labeling Rules, addressing fiber content and country-of-origin disclosures.FTC Label Changes

The Rules implement the Textile Fiber Products Identification Act, which requires that certain textiles sold in the United States carry labels disclosing the generic names and percentages by weight of the fibers in the product, the manufacturer or marketer name, and the country where the product was processed or manufactured.

In May 2013, the FTC proposed changes to the Rules and sought public comment. Based on comments received, the agency proposed amendments to the Rules and sought public comments. After weighing the comments it received, the Commission approved the changes announced today, including amendments that would:

  • incorporate the updated International Organization for Standardization standard establishing generic fiber names for manufactured fibers;
  • allow certain hang-tags disclosing fiber names and trademarks, and performance information, without the need to disclose the product’s full fiber content;
  • clarify that an imported product’s country of origin is the country where it was processed or manufactured, as determined under laws and regulations enforced by U.S. Customs and Border Protection;
  • better address electronic commerce with revised definitions of “invoice” and “invoice or other paper,”
  • replace the requirement that guarantors sign continuing guarantees under penalty of perjury with a requirement that they acknowledge that providing a false guaranty is unlawful, and certify that they will actively monitor and ensure compliance with the applicable law; and
  • clarify the provision identifying textile fiber product categories and products that are exempt from the Act’s requirements.

Based on the comments received, the Commission decided not to adopt its proposal to make continuing guaranties effective for one year unless revoked earlier. Thus, continuing guaranties filed with the Commission will remain effective until revoked.

The Commission vote to publish the Federal Register Notice amending the Rules and Regulations under the Textile Fiber Products Identification Act was 4-0. It will be published in the Federal Register soon. The amended Rules will become effective 30 days after the Federal Register Notice is posted.

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

CPSC Issues Final Rule Safety Standard Soft Infant Toddler Carriers

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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

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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

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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

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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.