Source: https://www.federalregister.gov/documents/2015/07/17/2015-17413/toys-determination-regarding-heavy-elements-limits-for-unfinished-and-untreated-wood
Timestamp: 2019-04-19 22:17:35
Document Index: 659793063

Matched Legal Cases: ['art 1109', '§\u20093', 'art 1251', 'art 1107', '§\u20091251', 'art 1107']

A Rule by the Consumer Product Safety Commission on 07/17/2015
The rule is effective on September 15, 2015, unless we receive a significant adverse comment by August 17, 2015. If we receive a timely significant adverse comment, we will publish notification in the Federal Register, withdrawing this direct final rule before its effective date.
42376-42381 (6 pages)
C. Determination for Unfinished and Untreated Wood for ASTM F963 Limits for Heavy Elements
https://www.federalregister.gov/d/2015-17413 https://www.federalregister.gov/d/2015-17413
The Consumer Product Safety Commission (“Commission,” or “CPSC”) is issuing a direct final rule determining that unfinished and untreated trunk wood does not contain heavy elements that would exceed the limits specified in the Commission's toy standard, ASTM F963-11. Based on this determination, unfinished and untreated wood in toys does not require third party testing for the heavy element limits in ASTM F963.
Section 14(a) of the Consumer Product Safety Act, (“CPSA”), as amended by the Consumer Product Safety Improvement Act of 2008 (“CPSIA”), requires that manufacturers of products subject to a consumer product safety rule or similar rule, ban, standard or regulation enforced by the CPSC must certify that the product complies with all applicable CPSC-enforced requirements. 15 U.S.C. 2063(a). For children's products, certification must be based on testing conducted by a CPSC-accepted third party conformity assessment body. Id. Pub. L. 112-28 (August 12, 2011), directed the CPSC to seek comment on “opportunities to reduce the cost of third party testing requirements consistent with assuring compliance with any applicable consumer product safety rule, ban, standard, or regulation.” In response to Pub. L. 112-28, the Commission published in the Federal Register a Request for Comment (“RFC”). See http://www.cpsc.gov/​/PageFiles/​103251/​3ptreduce.pdf. As directed by the Commission, staff submitted a briefing package to the Commission that described opportunities that the Commission Start Printed Page 42377could pursue to potentially reduce the third party testing costs consistent with assuring compliance. See http://www.cpsc.gov/​PageFiles/​129398/​reduce3pt.pdf.
In addition to soliciting and reviewing comments as required by Pub. L. 112-28, the Commission published in the Federal Register on April 16, 2013 a Request for Information (“RFI”) on four potential opportunities to reduce testing burdens. See http://www.gpo.gov/​fdsys/​pkg/​FR-2013-04-16/​pdf/​2013-08858.pdf. In February 2014, the Commission also published a notice in the Federal Register of a CPSC workshop on potential ways to reduce third party testing costs through determinations consistent with assuring compliance. See http://www.gpo.gov/​fdsys/​pkg/​FR-2014-02-27/​pdf/​2014-04265.pdf. The workshop was held on April 3, 2014.
Section 106 of the CPSIA states that the provisions of ASTM International (“ASTM”), Consumer Safety Specifications for Toy Safety (“ASTM F963” or “toy standard”), “shall be considered to be consumer product safety standards issued by the Commission under section 9 of the CPSA (15 U.S.C. 2058).” [1] Thus, toys subject to ASTM F963-11, the current mandatory version of the standard, must be tested by a CPSC-accepted third party conformity assessment body and demonstrate compliance with all applicable CPSC requirements for the manufacturer to issue a Children's Product Certificate (“CPC”) before the toys can be entered into commerce.
The toy standard has numerous requirements. Among them, section 4.3.5 requires that surface coating materials and accessible substrates of toys [2] that can be sucked, mouthed, or ingested, comply with the solubility limits on eight heavy elements. (We refer to these elements as the “ASTM heavy elements.”) One of the eight ASTM heavy elements is lead. The Commission previously determined that certain materials do not exceed lead content limits, and therefore, those materials do not require third party testing when used in children's products (including toys). 16 CFR 1500.91. Thus, CPSC staff focused its work on the remaining seven ASTM heavy elements. The eight ASTM heavy elements and their solubility limits are shown below.
For some materials, the concentrations of all the listed heavy elements might always be below their respective solubility limits due to biological, manufacturing, or other constraints. For example, one of the specified elements may be sequestered in a portion of a plant, such as the roots, that is not used in textile manufacturing. Additionally, a manufacturing process step may remove a specified element, if the element is present, from the material being processed. For these materials, compliance with the limits stated in section 4.3.5 of ASTM F963-11 is assured without requiring third party testing because the material is intrinsically compliant.
Uncoated or coated paper (wood or other cellulosic fiber).
Staff chose these materials for research because they met two criteria:
The contractor's report is available on the Commission's Web site at: http://www.cpsc.gov/​/Global/​Research-and-Statistics/​Technical-Reports/​Toys/​TERAReportASTMElements.pdf. CPSC staff reviewed the contractor's report and prepared a briefing package providing recommendations to the Commission. The staff's briefing package is also available on the Commission's Web site. http://www.cpsc.gov/​/Global/​Newsroom/​FOIA/​CommissionBriefingPackages/​2015/​DFRandNPRDeterminationsontheASTMElementsUnfinishedWoods%20June302015.pdf.
The presence and concentrations of the elements in the environmental Start Printed Page 42378media (e.g., soil, water, air), and in the base materials for the textiles and paper;
The contractor examined secondary sources and reviewed articles to identify the available data regarding the elements' concentrations in the materials listed above. The contractor summarized the relevant data on bioavailability and presence/concentrations in environmental media (i.e., soil, air, and water) from the most recent Agency for Toxic Substances and Disease Registry (“ATSDR”) [4] toxicological profile, supplemented with more recent authoritative reviews. The contractor conducted a literature search for data on concentrations of the chemical elements in each of the specific materials. Potentially relevant papers for information on concentrations of chemical elements in each product were identified and reviewed. The contractor used the references from reviewed articles to identify other articles to examine and used the references in those articles to find other sources recursively, to uncover relevant cited references.[5] The literature screening was to examine whether there is a potential for an ASTM heavy element to be present in the natural material at levels above its solubility limit. When the contractor determined there was sufficient information to indicate the potential for an ASTM heavy element to be present, the contractor stopped that particular line of inquiry and reported the results.
As discussed in the staff's briefing package, the contractor's report does not support a Commission determination for any material other than unfinished and untreated wood. The literature reviewed by the contractor did not provide sufficient information to determine that any of the reviewed materials, other than unfinished and untreated wood, do not contain the heavy elements in concentrations above the limits stated in the toy standard.
Of the materials reviewed, the contractor identified the most studies for wood. Although the contractor could not examine every study concerning wood, the contractor reported that the studies examined constitute a representative sample of studies. The contractor studied measurements taken from trees in natural settings, samples from trees grown on contaminated soils, hydroponically grown [6] seedlings, experimental studies with seedlings grown in pots in which the soil had some of the elements intentionally added, and seedlings soaked in solutions containing one or more of the ASTM heavy elements.
Conclusions. The contractor's report provides sufficient information for the Commission to determine that unfinished and untreated wood from tree trunks does not contain the ASTM heavy elements in concentrations above Start Printed Page 42379their respective solubility limits, and are, therefore, not required to be third party tested to assure compliance with the ASTM F963-11 solubility test. The studies examined multiple species of trees grown on several continents. No study examined by the contractor found any of the ASTM heavy elements in tree trunks at concentrations beyond the element's solubility limit.
The contractor's report indicates that heavy elements could be present in wood from other portions of the tree: The roots, bark, leaves, or fruit. The studies examined by the contractor showed high levels of one or more of the ASTM heavy elements in portions of trees other than trunks. However, commercial timber harvesting involves the process of “delimbing” The tree to create logs that can be transported and cut at a sawmill or lumberyard.[7] Often, the sawmill creates uniform-length planks from the delivered logs. These planks are sold to wood wholesalers or retailers, and are bought by wooden toy and other manufacturers. Because commercial practice creates logs from only the trunks of harvested trees, the wood available for use in toys and other wooden objects is sourced from these logs, or trunks of trees, and not the other parts of trees that could contain the ASTM elements above the limits in the toy standard.[8]
CPSC staff assessed the burden reduction that could result from a determination that unfinished and untreated trunk wood does not require third party testing for compliance with the limits on heavy elements in the toy standards. Testing the soluble concentration of the ASTM heavy elements requires placing the toy (or component part of the toy) in a solution of hydrochloric acid for 2 hours. After 2 hours, the solids are separated from the solution, and the solution is analyzed for the presence of any of the ASTM F963-11 heavy elements using atomic spectroscopy. The cost of this testing can vary by factors such as geography and the volume of testing that a manufacturer obtains from a testing laboratory. Based on published invoices and price lists, the cost of a third party test for the ASTM heavy elements ranges from around $60 in China, up to around $190 in the United States.
Staff cannot estimate with any certainty what the total potential burden reduction would be from a determination that unfinished and untreated wood will not contain concentrations of antimony, arsenic, barium, cadmium, mercury, and selenium in excess of the limits in ASTM F963-11. Most of the approximately 80,000 kinds of toys on the market [9] probably do not contain any wood components. If we assume that 10 percent of the approximately 80,000 different kinds of toys on the market have at least one wood component that requires third party testing, and we also assume that the average cost of a third party test is about $125 (representing the approximate midpoint of the range for the test's cost), then the potential total burden reduction from a determination for unfinished and untreated wood from tree trunks would be about $1 million annually. This estimate assumes that only one type of wood was used in a product so that the manufacturer would not have to test each individual unfinished and untreated wood component part in a product, as allowed by the component part testing rule (16 CFR part 1109). The estimated benefits could be lower if some manufacturers certify that their wood components comply with the ASTM F963-11 heavy elements requirements, based on third party tests of their raw materials instead of the finished product, as allowed by the component part testing rule. Moreover, the assumption that 10 percent of the toys have wood components is intended only to illustrate the potential benefits; the Start Printed Page 42380assumption is not based on any formal study of the toy market.
Section 3 of the CPSIA grants the Commission general rulemaking authority to issue regulations, as necessary, to implement the CPSIA. Public Law 110-314, § 3, Aug. 14, 2008. As noted previously, section 14 of the CPSA, which was amended by the CPSIA, requires third party testing for children's products that are subject to a children's product safety rule. 15 U.S.C. 2063(a)(2). Section 14(d)(3)(B) of the CPSA, as amended by Public Law 112-28, gives the Commission the authority to “prescribe new or revised third party testing regulations if it determines that such regulations will reduce third party testing costs consistent with assuring compliance with the applicable consumer product safety rules, bans, standards, and regulations.” Id. 2063(d)(3)(B). These statutory provisions authorize the Commission to issue this rule determining that unfinished and untreated trunk wood will not exceed the limits for heavy elements stated in the toy standard, and therefore, unfinished and untreated trunk wood does not require third party conformity assessment body testing to assure compliance with the heavy elements limits stated in the toy standard.
This determination relieves unfinished and untreated trunk wood from the third party testing requirement of section 14 of the CPSA for purposes of supporting the required certification. However, if the unfinished and untreated wood is altered so that the material exceeds the heavy elements limits of ASTM F963, the determination is not applicable to that material. The changed or altered material or product must then be tested and meet the heavy element requirements of ASTM F963.
This rule creates a new Part 1251 for “Toys; Determination Regarding Heavy Elements Limits for Unfinished and Untreated Wood.” Section 1251.1 of the rule explains the statutorily-created requirements for toys under ASTM F963 and the third party testing requirements for children's products.
Section 1251.2(a) of the rule establishes the Commission's determination that unfinished and untreated trunk wood does not exceed the limits for the heavy elements established in section 4.3.5 of the toy standard with a high degree of assurance as that term is defined in 16 CFR part 1107. The determination only applies if the material has not been treated or adulterated with the addition of any materials that could result in the addition of any of the heavy elements listed in the toy standard at levels above their respective solubility limits. In section 1251.2(b) of the rule, unfinished and untreated trunk wood means wood harvested from trees with no added surface coatings (e.g., varnish, paint, shellac, polyurethane) and no materials added to the wood substrate (e.g., stains, dyes, preservatives, antifungals, insecticides). Because commercial practice creates wood from only the trunks of harvested trees, unfinished and untreated wood as used in the rule means wood that is generally commercially available. Unfinished and untreated wood does not include manufactured or engineered woods such as pressed wood, plywood, particle board, or fiberboard.
The Commission is issuing this rule as a direct final rule (“DFR”). The Administrative Procedure Act (“APA”) generally requires notice and comment rulemaking 5 U.S.C. 553(b). In Recommendation 95-4, the Administrative Conference of the United States (“ACUS”) endorsed direct final rulemaking as an appropriate procedure to expedite promulgation of rules that are noncontroversial and that are not expected to generate significant adverse comment. See 60 FR 43108 (August 18, 1995). Consistent with the ACUS recommendation, the Commission is publishing this rule as a direct final rule because we believe the determination will not be controversial. The rule will not impose any new obligations, but will relieve companies from the requirement of having toys (or materials that are component parts of toys) tested by a third party conformity assessment body if the toys or materials are made of unfinished and untreated wood. We expect that the determination will be supported by stakeholders. The determination responds to the desire expressed by numerous stakeholders and Congress that the Commission provide relief from the burdens of third party testing while also ensuring that products will comply with all applicable children's product safety rules. The rule establishes a discrete determination that a specific material (unfinished and untreated wood) in a particular type of product (toys) will always comply with the toy standard's limits on heavy elements. We expect that this focused action will not engender any significant adverse comments.
Unless we receive a significant adverse comment within 30 days, the rule will become effective on September 15, 2015. In accordance with ACUS's recommendation, the Commission considers a significant adverse comment to be one where the commenter explains why the rule would be inappropriate, including an assertion challenging the rule's underlying premise or approach, or a claim that the rule would be ineffective or unacceptable without change.
Should the Commission receive a significant adverse comment, the Commission will withdraw this direct final rule. A notice of proposed rulemaking (“NPR”), providing an opportunity for public comment, is also being published in this same issue of the Federal Register.
The APA generally requires that a substantive rule must be published not less than 30 days before its effective date. 5 U.S.C. 553(d)(1). Because the final rule provides relief from existing testing requirements under the CPSIA, the effective date is September 15, 2015. However, as discussed in section D of the preamble, if the Commission receives a significant adverse comment the Commission will withdraw the DFR and proceed with the NPR published in this same issue of the Federal Register.
The Regulatory Flexibility Act (“RFA”) generally requires that agencies review proposed and final rules for the rules' potential economic impact on small entities, including small businesses, and prepare regulatory flexibility analyses. 5 U.S.C. 603 and 604.
The rule would relieve toy manufacturers and importers of the responsibility of obtaining third party tests for compliance with the limits on the ASTM elements for components of toys consisting of unfinished and untreated wood. Although the impact will be to reduce testing costs, we expect that the rule would have only limited impact on toy manufacturers and importers for two reasons. First, the rule will affect only those companies that manufacture or import toys that contain unfinished and untreated wood components. We expect that relatively few of the approximately 80,000 toys on the market contain any unfinished and Start Printed Page 42381untreated wood components. Therefore this rule would be expected to impact only a small number of manufacturers and importers or at most, a small portion of the toys in the market.
Second, manufacturers of toys containing unfinished and untreated wood components still would be required to test to other aspects of the ASTM toy standard, so the impact of this rule relative to production costs for most firms should be small. Due to the small number of entities affected and the limited scope of the impact, the Commission certifies that this rule will not have a significant impact on a substantial number of small entities pursuant to section 605(b) of the RFA, 5 U.S.C. 605(b).
The Consumer Product Safety Improvement Act of 2008 (“CPSIA”) made provisions of ASTM F963, Consumer Product Safety Specifications for Toy Safety (“toy standard”), a mandatory consumer product safety standard. Among the mandated provisions is section 4.3.5 of ASTM F963 which requires that surface coating materials and accessible substrates of toys that can be sucked, mouthed, or ingested, must comply with solubility limits that the toy standard establishes for eight heavy elements. Materials used in toys subject to section 4.3.5 of the toy standard must comply with the third party testing requirements of section 14(a)(2) of the Consumer Product Safety Act (“CPSA”), unless listed in § 1251.2.
(a) Unfinished and untreated wood does not exceed the limits for the heavy elements established in section 4.3.5 of the toy standard with a high degree of assurance as that term is defined in 16 CFR part 1107, provided that the material has been neither treated nor adulterated with materials that could result in the addition of any of the heavy elements listed in the toy standard at levels above their respective solubility limits.
2. ASTM F963-11 contains the following note regarding the scope of the solubility requirement: NOTE 3—For the purposes of this requirement, the following criteria are considered reasonably appropriate for the classification of toys or parts likely to be sucked, mouthed or ingested: (1) All toy parts intended to be mouthed or contact food or drink, components of toys which are cosmetics, and components of writing instruments categorized as toys; (2) Toys intended for children less than 6 years of age, that is, all accessible parts and components where there is a probability that those parts and components may come into contact with the mouth.
5. This method is often referred to as “tree searching.”
[FR Doc. 2015-17413 Filed 7-16-15; 8:45 am]