Third Party Testing for Certain Children's Products; Notice of Requirements for Accreditation of Third Party Conformity Assessment Bodies To Assess Conformity With the Limits on Phthalates in Children's Toys and Child Care Articles, 49286-49291 [2011-19678]

Download as PDF 49286 Federal Register / Vol. 76, No. 154 / Wednesday, August 10, 2011 / Rules and Regulations amending Class D airspace at Cabaniss Navy Outlying Field (NOLF), Corpus Christi, TX. CONSUMER PRODUCT SAFETY COMMISSION Effective date: 0901 UTC August 25, 2011. [CPSC Docket No. CPSC–2011–0052] DATES: 16 Chapter II FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center, Operations Support Group, Federal Aviation Administration, Southwest Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone (817) 321– 7716. Third Party Testing for Certain Children’s Products; Notice of Requirements for Accreditation of Third Party Conformity Assessment Bodies To Assess Conformity With the Limits on Phthalates in Children’s Toys and Child Care Articles SUPPLEMENTARY INFORMATION: AGENCY: Consumer Product Safety Commission. ACTION: Notice of Requirements. History On June 2, 2011, the FAA published in the Federal Register a final rule amending Class D airspace at Cabaniss NOLF, Corpus Christi, TX (76 FR 31821, Docket No. FAA–2010–1171). Subsequent to publication, an error was discovered in the latitude coordinates listed in the regulatory text. This action corrects that error. Class D airspace designations are published in paragraph 5000 of FAA Order 7400.9U dated August 18, 2010, and effective September 15, 2010, which is incorporated by reference in 14 CFR Part 71.1. The Class D airspace designations listed in this document will be published subsequently in the Order. Correction to Final Rule Accordingly, pursuant to the authority delegated to me, the latitude coordinates listed in the regulatory text for the Class D airspace area at Cabaniss NOLF, Corpus Christi, TX, as published in the Federal Register June 2, 2010 (76 FR 31821), (FR Doc. 2011–13559), are corrected as follows: ASW TX D Corpus Christi, TX [Corrected] Cabaniss NOLF, TX mstockstill on DSK4VPTVN1PROD with RULES On page 31822, column 1, line 49 of the regulatory text, remove ‘lat. 27°38′15″ N.,’ and insert ‘lat. 27°38′16″ N.’; and on line 50 remove ‘lat. 27°41′30″ N.,’ and insert ‘lat. 27°41′22″ N.’ Issued in Fort Worth, Texas, on August 2, 2011. Walter L. Tweedy, Acting Manager, Operations Support Group, ATO Central Service Center. [FR Doc. 2011–20303 Filed 8–9–11; 8:45 am] BILLING CODE 4910–13–P VerDate Mar<15>2010 16:51 Aug 09, 2011 Jkt 223001 SUMMARY: The Consumer Product Safety Commission (CPSC, Commission, or we) is issuing a notice of requirements that provides the criteria and process for Commission acceptance of accreditation of third party conformity assessment bodies for testing pursuant to the phthalates limits in section 108 of the Consumer Product Safety Improvement Act of 2008 (CPSIA). The Commission is issuing this notice of requirements pursuant to section 14(a)(3)(B)(vi) of the Consumer Product Safety Act (CPSA). DATES: Effective Date: The requirements for accreditation of third party conformity assessment bodies to assess conformity with phthalates limits when tested in accordance with CPSC–CH– C1001–09.3, Standard Operating Procedure for Determination of Phthalates, and GB/T 22048–2008, Toys and Children’s Products— Determination of Phthalate Plasticizers in Polyvinyl Chloride Plastic are effective August 10, 2011. Submit comment by September 9, 2011. Comments on this notice should be captioned ‘‘Third Party Testing for Certain Children’s Products; Notice of Requirements for Accreditation of Third Party Conformity Assessment Bodies to Assess Conformity with the Limits on Phthalates in Children’s Toys and Child Care Articles.’’ ADDRESSES: You may submit comments, identified by Docket No. CPSC–2011– 0052, by any of the following methods: Electronic Submissions: Submit electronic comments in the following way: Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. To ensure timely processing of comments, the Commission is no longer accepting comments submitted by electronic mail (e-mail) except through https://www.regulations.gov. Written Submissions: Submit written submissions in the following ways: PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 Mail/Hand delivery/Courier (for paper, disk, or CD–ROM submissions) preferably in five copies, to: Office of the Secretary, Consumer Product Safety Commission, Room 502, 4330 East West Highway, Bethesda, MD 20814; telephone (301) 504–7923. Instructions: All submissions received must include the agency name and docket number for this notice. All comments received may be posted without change to https:// www.regulations.gov, including any personal information provided. Do not submit confidential business information, trade secret information, or other sensitive or protected information (such as a Social Security Number) electronically; if furnished at all, such information should be submitted in writing. Docket: For access to the docket to read background documents or comments received, go to https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Carol Afflerbach, Compliance Officer, Office of Compliance and Field Investigations, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, Maryland 20814; email cafflerbach@cpsc.gov. SUPPLEMENTARY INFORMATION: I. Introduction Section 14(a)(3)(B)(vi) of the CPSA, as added by section 102(a)(2) of the Consumer Product Safety Improvement Act of 2008 (CPSIA), Public Law 110– 314, directs the CPSC to publish a notice of requirements for accreditation of third party conformity assessment bodies (also known as ‘‘testing laboratories’’ or ‘‘laboratories’’) to assess children’s products for conformity with ‘‘other children’s product safety rules.’’ 1 Section 14(f)(1) of the CPSA defines ‘‘children’s product safety rule’’ as ‘‘a consumer product safety rule under [the CPSA] or similar rule, regulation, standard, or ban under any other Act enforced by the Commission, including a rule declaring a consumer product to be a banned hazardous product or substance.’’ Under section 14(a)(3)(A) of the CPSA, each manufacturer (including the importer) or private labeler of products subject to those regulations must have products that are manufactured more than 90 days after 1 The Commission voted 5–0 to publish this notice of requirements, with amendments, in the Federal Register. Chairman Inez M. Tenenbaum and Commissioners Thomas H. Moore and Robert S. Adler filed a joint statement regarding the vote. Commissioners Nancy A. Nord and Anne M. Northup filed individual statements. The statements may be viewed at https://www.cpsc.gov/ pr/statements/html. E:\FR\FM\10AUR1.SGM 10AUR1 mstockstill on DSK4VPTVN1PROD with RULES Federal Register / Vol. 76, No. 154 / Wednesday, August 10, 2011 / Rules and Regulations the Federal Register publication date of a notice of the requirements for accreditation, tested by a third party conformity assessment body accredited to do so, and must issue a certificate of compliance with the applicable regulations based on that testing. Section 14(a)(2) of the CPSA, as added by section 102(a)(2) of the CPSIA, requires that certification be based on testing of sufficient samples of the product, or samples that are identical in all material respects to the product. The Commission also emphasizes that, irrespective of certification, the product in question must comply with the applicable CPSC requirements (see, e.g., section 14(h) of the CPSA, as added by section 102(b) of the CPSIA). This notice provides the criteria and process for Commission acceptance of accreditation of third party conformity assessment bodies for testing pursuant to the following test methods: • CPSC–CH–C1001–09.3, Standard Operating Procedure for Determination of Phthalates, issued on April 1, 2010 (‘‘CPSC Test Method’’). This is the most recent version of the test method, and it can be downloaded from the CPSC Web site at https://www.cpsc.gov/about/cpsia/ CPSC-CH-C1001-09.3.pdf; and/or • GB/T 22048–2008, Toys and Children’s Products—Determination of Phthalate Plasticizers in Polyvinyl Chloride Plastic, issued on June 16, 2008 (‘‘Chinese Test Method’’). The Commission is recognizing limited circumstances in which it will accept certifications based on product testing conducted before the publication of this notice of requirements. The details regarding those limited circumstances can be found in part VI of this document below. Although section 14(a)(3)(B)(vi) of the CPSA directs the CPSC to publish a notice of requirements for accreditation of third party conformity assessment bodies to assess conformity with ‘‘all other children’s product safety rules,’’ this notice of requirements is limited to test methods CPSC–CH–C1001–09.3, Standard Operating Procedure for Determination of Phthalates, and GB/T 22048–2008, Toys and Children’s Products—Determination of Phthalate Plasticizers in Polyvinyl Chloride Plastic. The CPSC acknowledges that the test methods for determining phthalates content are not, by themselves, rules that are codified in the Code of Federal Regulations. However, section 108(d) of the CPSIA considers the phthalates content limits to be ‘‘consumer product safety standards’’ under the Consumer Product Safety Act. Section 14(a)(3)(B)(vi) of the CPSA directs the Commission to publish VerDate Mar<15>2010 18:09 Aug 09, 2011 Jkt 223001 notices of requirements for the accreditation of third party conformity assessment bodies to assess conformity with ‘‘other children’s product safety rules,’’ and section 14(f)(1) of the CPSA defines a ‘‘children’s product safety rule,’’ in part, as ‘‘a consumer product safety rule under [the CPSA].’’ Section 3(a)(6) of the CPSA, in turn, defines a ‘‘consumer product safety rule’’ as ‘‘a consumer products safety standard described in section 7(a) [of the CPSA] * * * or a rule under this Chapter declaring a consumer product a banned hazardous product.’’ Accordingly, because the phthalates content limits are ‘‘consumer product safety standards’’ under the CPSA, it follows that they are also ‘‘consumer product safety rules’’ under section 3(a)(6) of the CPSA and, in turn, ‘‘children’s product safety rules’’ under section 14(f)(1) of the CPSA. Thus, the phthalates content limits are ‘‘children’s product safety rules’’ for which a notice of requirements for accreditation of third party conformity assessment bodies must be published. In addition, because the test methods would be used to assess conformity with the phthalates limits, it is appropriate for the notice of requirements to apply to the CPSC Test Method and the Chinese Test Method. The CPSC also recognizes that section 14(a)(3)(B)(vi) of the CPSA is captioned: ‘‘All Other Children’s Product Safety Rules,’’ but the body of the statutory requirement refers only to ‘‘other children’s product safety rules.’’ Nevertheless, section 14(a)(3)(B)(vi) of the CPSA could be construed to require a notice of requirements for ‘‘all’’ other children’s product safety rules, rather than a notice of requirements for ‘‘some’’ or ‘‘certain’’ children’s product safety rules. However, whether a particular rule represents a ‘‘children’s product safety rule’’ may be subject to interpretation. Commission staff is continuing to evaluate which rules, regulations, standards, or bans are ‘‘children’s product safety rules.’’ The CPSC intends to issue additional notices of requirements for other rules which the Commission determines to be ‘‘children’s product safety rules.’’ This notice of requirements applies to all third party conformity assessment bodies, as described in section 14(f)(2) of the CPSA. Generally speaking, such third party conformity assessment bodies are: (1) Third party conformity assessment bodies that are not owned, managed, or controlled by a manufacturer or private labeler of a children’s product to be tested by the third party conformity assessment body for certification purposes; (2) ‘‘firewalled’’ conformity assessment PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 49287 bodies (those that are owned, managed, or controlled by a manufacturer or private labeler of a children’s product to be tested by the third party conformity assessment body for certification purposes and that seek accreditation under the additional statutory criteria for ‘‘firewalled’’ conformity assessment bodies); and (3) third party conformity assessment bodies owned or controlled, in whole or in part, by a government. The Commission requires baseline accreditation of each category of third party conformity assessment body to the International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) Standard 17025:2005, ‘‘General Requirements for the Competence of Testing and Calibration Laboratories.’’ The accreditation must be by an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation-Mutual Recognition Arrangement (ILAC–MRA), and the scope of the accreditation must include testing for any of the test methods identified earlier in this document for which the third party conformity assessment body seeks to be accredited. (A description of the history and content of the ILAC–MRA approach and of the requirements of the ISO/IEC 17025:2005 laboratory accreditation standard is provided in the CPSC staff briefing memorandum, ‘‘Third Party Conformity Assessment Body Accreditation Requirements for Testing Compliance with 16 CFR part 1501 (Small Parts Regulations),’’ dated November 2008, and available on the CPSC’s Web site at: https://www.cpsc. gov/library/foia/foia09/brief/ smallparts.pdf). The Commission has established an electronic accreditation registration and listing system that can be accessed via its Web site at: https://www.cpsc.gov/ about/cpsia/labaccred.html. The Commission stayed the enforcement of certain provisions of section 14(a) of the CPSA in a notice published in the Federal Register on February 9, 2009 (74 FR 6396); the stay applied to testing and certification of various products, including the phthalates limits of section 108 of the CPSIA. On December 28, 2009, the Commission published a notice in the Federal Register (74 FR 68588), revising the terms of the stay. One section of the December 28, 2009, notice addressed: ‘‘Consumer Products or Children’s Products Where the Commission Is Continuing the Stay of Enforcement Until Further Notice,’’ due to factors such as pending rulemaking proceedings affecting the product or the E:\FR\FM\10AUR1.SGM 10AUR1 49288 Federal Register / Vol. 76, No. 154 / Wednesday, August 10, 2011 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES absence of a notice of requirements. The phthalates content testing and certification requirements for children’s toys and child care articles were included in that section of the December 28, 2009 notice. The absence of a notice of requirements prevented the lifting of the stay in the December 28, 2009 notice with regard to testing and certifications of children’s toys and child care articles for phthalates content. On February 8, 2011, the Commission published a notice in the Federal Register (76 FR 6765), continuing the stay of enforcement for testing and certification of children’s products for which a notice of requirements for accreditation of laboratories had not yet been published. The phthalates content testing and certification requirements for children’s toys and child care articles were mentioned specifically as an example of a provision for which the stay would continue, pending publication of the notice of requirements. Thus, publication of this notice of requirements would have had the effect of lifting the stay on testing and certification requirements for phthalates content in children’s toys and child care articles; however, on July 27, 2011, the Commission voted to stay enforcement of the testing and certification requirements of section 14 of the CPSA with respect to toys and child care articles subject to the phthalates content limits until December 31, 2011. Accordingly, the Commission will enforce third party testing and certification requirements for products subject to the phthalates content limits if such products are manufactured on or after January 1, 2012. (Under the CPSA, the term ‘‘manufacturer’’ includes anyone who manufactures or imports a product.) This notice of requirements is exempt from the notice and comment rulemaking requirements of the Administrative Procedure Act, 5 U.S.C. 553 (see section 14(a)(3)(G) of the CPSA, as added by section 102(a)(2) of the CPSIA (15 U.S.C. 2063(a)(3)(G))). II. Testing & Certification to Phthalates Limits—Prior Guidance Remains in Effect The Commission approved a ‘‘Statement of Policy: Testing of Component Parts with Respect to Section 108 of the Consumer Product Safety Improvement Act’’ on August 7, 2009. On August 17, 2009, a Notice of Availability regarding the Statement of Policy was published in the Federal Register (74 FR 41400). The Statement of Policy can be viewed and downloaded from the CPSC Web site at: VerDate Mar<15>2010 16:51 Aug 09, 2011 Jkt 223001 https://www.cpsc.gov/about/cpsia/ componenttestingpolicy.pdf. In brief, we believe that only those plastic parts or other product parts which could conceivably contain phthalates (‘‘plasticized component parts’’) should be tested for phthalates. We consider it to be unnecessary to test and certify materials that are known not to contain phthalates or to certify that phthalates are absent from materials that are known not to contain phthalates.2 In addition, we believe that when testing covered products, the assessment of the concentration of phthalates is to be based on testing of the plasticized component parts, rather than testing of the entire product, to avoid dilution of the concentrations of phthalates that can occur when the entire product is considered. The Statement of Policy remains in effect until further notice (except that the CPSC Test Method referenced in the Statement of Policy, CPSC–CH–C1001–09.2, has been superseded by CPSC–CH–C1001–09.3 as outlined in part VI of this document below). The Commission voted to publish a ‘‘Draft Guidance Regarding Which Children’s Products are Subject to the Requirements of CPSIA Section 108’’ on February 13, 2009. On February 23, 2009, the staff guidance was published in the Federal Register (74 FR 8058). This staff guidance can be viewed and downloaded from the CPSC Web site at: https://www.cpsc.gov/businfo/frnotices/ fr09/draftphthalatesguidance.pdf. The Commission may choose to update this staff guidance or initiate a formal rulemaking concerning the topics addressed by the guidance after receipt of the Chronic Hazard Advisory Panel report required by section 108(b)(2)(C) of the CPSIA. Until such time, this staff guidance remains in effect (except that the CPSC Test Method referenced in the guidance, CPSC–CH–C1001–09.1, has been superseded by CPSC–CH–C1001– 09.3 as outlined in part VI of this document below). Answers to frequently asked questions that provide guidance concerning the requirements of section 108 of the CPSIA can be viewed on the CPSC Web site at: https://www.cpsc.gov/ about/cpsia/sect108.html#faqs. The Commission intends for this guidance to be useful and therefore the materials on this Web page may be modified 2 Untreated/unfinished wood, metal, natural fibers, natural latex and mineral products are not expected to inherently contain phthalates and need not be tested or certified provided that these materials have neither been treated or adulterated with the addition of materials that could result in the addition of phthalates into the product or material. PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 periodically in the future. In order to receive automatic notification of any such updates, interested parties may sign up for the CPSIA email subscription list at: https:// www.cpsc.gov/about/cpsia/ cpsialist.aspx. The Commission notes that the phthalate content limits in section 108 of the CPSIA are statutory requirements and we may always take action with regard to products defined in this section of the statute that exceed those limits. III. Responses to Comments Received on the CPSC Testing Method The Commission requested comments regarding the Statement in the Notice of Availability published in the Federal Register (74 FR 41400). We received several comments on the CPSC Test Method. We describe and respond to the comments in this section of the document. To make it easier to identify the comments and our responses, the word ‘‘Comment,’’ in parentheses, will appear before the comment’s description, and the word ‘‘Response,’’ in parentheses, will appear before our response. We also have numbered each comment to help distinguish between different topics. The number assigned to each comment is for organizational purposes only and does not signify the comment’s value, or importance, or the order in which it was received. (Comment 1)—Some commenters questioned the necessity to run the test in triplicate. Other test multiples from two to five were suggested. Some commenters asked whether the sample to be tested always needed to be ground to a powder. A commenter asked about the proper cleaning protocol of the cryogenic mill. (Response 1)—We have examined all suggestions and comments pertaining to the CPSC Test Method and have updated our test method to address these issues (CPSC–CH–C1001–09.3). We adjusted the method to allow the third party conformity assessment body to choose an appropriate quality assurance program; thus, the third party conformity assessment body will determine the number of replicates to be tested. The CPSC Test Method allows, but does not require, third party conformity assessment bodies to pulverize the sample. Cryogenic mill equipment should be cleaned as thoroughly as any other laboratory equipment that comes into contact with a sample. (Comment 2)—One commenter suggested that the official Chinese test method, GB/T 22048–2008, Toys and Children’s Products—Determination of Phthalate Plasticizers in Polyvinyl E:\FR\FM\10AUR1.SGM 10AUR1 mstockstill on DSK4VPTVN1PROD with RULES Federal Register / Vol. 76, No. 154 / Wednesday, August 10, 2011 / Rules and Regulations Chloride Plastic, should be added to the lists of acceptable extraction and analysis methods. The commenter also suggested that each plasticized component part should be cut into pieces no larger than 2 mm prior to the extraction step. (Response 2)—We have reviewed the test method GB/T 22048–2008 and determined that it is an acceptable test method for inclusion in this notice of requirements. With regard to the 2 mm maximum size of pieces, we agree with this comment and have incorporated the dimension into the current edition of the CPSC Test Method (CPSC–CH– C1001–09.3). (Comment 3)—Another commenter suggested that the CPSC Test Method include a description of the limit of detection (LOD) and limit of quantitation (LOQ). The commenter added that, on the last page of CPSC– CH–C1001–09.2, there appears to be an error in the DEHP calculation. Under column C, measured DEHP concentration by GC–MSW is 200 μg/ ml. In the final calculation column, 200 μg/ml is mistakenly cited as 20 μg/ml. (Response 3)—Detection and quantitation limits have not been outlined specifically at this point. Third party conformity assessment bodies should follow their own internal quality assurance program. These limits may be introduced in the future, following further validation and round robin studies. The DEHP calculation included a typographical error that was corrected for the current edition of the test method (CPSC–CH–C1001–09.3). (Comment 4)—One commenter stated that grinding the sample into a powder is time-consuming, adds additional expense to the testing methods, and could introduce the possibility of significant interlaboratory variability. (Response 4)—Grinding the sample into a powder is no longer required in the CPSC Test Method; however, third party conformity assessment bodies may continue to do so, if they wish. (Comment 5)—One commenter asked how the CPSC Test Method prevents interferences that can lead to a false positive for the phthalates of interest. The commenter also asked if the detection method could be revised. (Response 5)—We have updated the CPSC Test Method (to CPSC–CH– C1001–09.3) to include a vigorous qualitative assessment by trained staff to avoid false positives. Such steps include: Retention time matching with known standards and full-scan mass spectrum analysis. We will continue to consider new methods that could simplify or improve the analysis. VerDate Mar<15>2010 16:51 Aug 09, 2011 Jkt 223001 (Comment 6)—One commenter pointed out typographical inconsistencies found within the text of the method. Additionally, the commenter asked: What is the minimum signal-to-noise ratio required, and what are the reproducibility and detection limits of the method? (Response 6)—We have corrected the typographical errors that might have caused confusion. Signal-to-noise, detection limits, and reproducibility requirements have not been outlined specifically at this point. Third party conformity assessment bodies should follow their own internal quality assurance program. Testing requirements may be adjusted following further validation and round robin studies. (Comment 7)—One commenter asked if the chromatography was optimized. (Response 7)—The gas chromatography parameters outlined have been successful at providing adequate separation while minimizing sampling time. However, due to the nature of DINP and DIDP, they will not completely separate chromatographically. DINP and DIDP are actually a mixture of compounds; DINP and DIDP contain some of the same phthalate species, leading to an overlap. We recommend following the selection monitoring analysis scheme outlined in the CPSC Test Method to quantify these compounds for instances when they are both present. (Comment 8)—One commenter suggested that we create a flexible correlative policy that permits use of several methods suitable for the routine identification and measurement of total phthalate concentration, such as ASTM D7083–04, the Canada Product Safety Bureau method, the European Toy Safety Directive method, and GB/T 22048–2008, Toys and Children’s Products—Determination of Phthalate Plasticizers in Polyvinyl Chloride Plastic. (Response 8)—The current edition of the CPSC Test Method (CPSC–CH– C1001–09.3) allows alternative test methods. Additionally, any combination of the approved extraction and analysis methods listed may be used. We have included GB/T 22048–2008, Toys and Children’s Products—Determination of Phthalate Plasticizers in Polyvinyl Chloride Plastic, as an additional test method in this notice of requirements. We have not included ASTM D7083–04 as an alternative detection method due to the lack of selectivity from using a flame ionization detector; this method may lead to false positives. We will review other suggested methods and PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 49289 may include them as alternatives in future revisions of the test method. IV. Accreditation Requirements A. Baseline Third Party Conformity Assessment Body Accreditation Requirements For a third party conformity assessment body to be accredited to test children’s products for conformity with the test methods identified earlier in part I of this document, it must be accredited by an ILAC–MRA signatory accrediting body, and the accreditation must be registered with, and accepted by, the Commission. A listing of ILAC– MRA signatory accrediting bodies is available on the Internet at: https:// ilac.org/membersbycategory.html. The accreditation must be to ISO Standard ISO/IEC 17025:2005, ‘‘General Requirements for the Competence of Testing and Calibration Laboratories,’’ and the scope of the accreditation must expressly include testing to the test method CPSC–CH–C1001–09.3, Standard Operating Procedure for Determination of Phthalates, and/or to the test method GB/T 22048–2008, Toys and Children’s Products— Determination of Phthalate Plasticizers in Polyvinyl Chloride Plastic. A true copy, in English, of the accreditation and scope documents demonstrating compliance with these requirements must be registered with the Commission electronically. The additional requirements for accreditation of firewalled and governmental conformity assessment bodies are described in parts IV.B and IV.C of this document below. The Commission will maintain on its Web site an up-to-date listing of third party conformity assessment bodies whose accreditations it has accepted and the scope of each accreditation. Once the Commission adds a third party conformity assessment body to that list, the third party conformity assessment body may commence testing children’s toys and child care articles for phthalates content to support certification by the manufacturer or private labeler of compliance with the test method(s) identified earlier in part I of this document. B. Additional Accreditation Requirements for Firewalled Conformity Assessment Bodies In addition to the baseline accreditation requirements in part IV.A of this document above, firewalled conformity assessment bodies seeking accredited status must submit to the Commission copies, in English, of their training documents, showing how employees are trained to notify the E:\FR\FM\10AUR1.SGM 10AUR1 49290 Federal Register / Vol. 76, No. 154 / Wednesday, August 10, 2011 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES Commission immediately and confidentially of any attempt by the manufacturer, private labeler, or other interested party to hide or exert undue influence over the third party conformity assessment body’s test results. This additional requirement applies to any third party conformity assessment body in which a manufacturer or private labeler of a children’s product to be tested by the third party conformity assessment body owns an interest of 10 percent or more. While the Commission is not addressing common parentage of a third party conformity assessment body and a children’s product manufacturer at this time, it will be vigilant to see if this issue needs to be addressed in the future. As required by section 14(f)(2)(D) of the CPSA, the Commission must formally accept, by order, the accreditation application of a third party conformity assessment body before the third party conformity assessment body can become an accredited firewalled conformity assessment body. The Commission’s order must also find that accrediting the firewalled conformity assessment body would provide equal or greater consumer safety protection than the manufacturer’s or private labeler’s use of an independent conformity assessment body. C. Additional Accreditation Requirements for Governmental Conformity Assessment Bodies In addition to the baseline accreditation requirements of part IV.A of this document above, the CPSIA permits accreditation of a third party conformity assessment body owned or controlled, in whole or in part, by a government if: • To the extent practicable, manufacturers or private labelers located in any nation are permitted to choose conformity assessment bodies that are not owned or controlled by the government of that nation; • The third party conformity assessment body’s testing results are not subject to undue influence by any other person, including another governmental entity; • The third party conformity assessment body is not accorded more favorable treatment than other third party conformity assessment bodies in the same nation who have been accredited; • The third party conformity assessment body’s testing results are accorded no greater weight by other governmental authorities than those of other accredited third party conformity assessment bodies; and VerDate Mar<15>2010 16:51 Aug 09, 2011 Jkt 223001 • The third party conformity assessment body does not exercise undue influence over other governmental authorities on matters affecting its operations or on decisions by other governmental authorities controlling distribution of products based on outcomes of the third party conformity assessment body’s conformity assessments. The Commission will accept the accreditation of a governmental third party conformity assessment body if it meets the baseline accreditation requirements of part IV.A of this document above and meets the additional conditions stated here. To obtain this assurance, CPSC staff will engage the governmental entities relevant to the accreditation request. V. How does a third party conformity assessment body apply for acceptance of its accreditation? The Commission has established an electronic accreditation acceptance and registration system accessed via the Commission’s Internet site at: https:// www.cpsc.gov/about/cpsia/ labaccred.html. The applicant provides, in English, basic identifying information concerning its location, the type of accreditation it is seeking, and electronic copies of its ILAC–MRA accreditation certificate and scope statement, and firewalled third party conformity assessment body training document(s), if relevant. CPSC staff will review the submission for accuracy and completeness. In the case of baseline third party conformity assessment bodies and governmentowned or government-operated conformity assessment bodies, when that review and any necessary discussions with the applicant are completed satisfactorily, the third party conformity assessment body in question is added to the CPSC’s list of accredited third party conformity assessment bodies at https://www.cpsc.gov/about/ cpsia/labaccred.html. In the case of a firewalled conformity assessment body seeking accredited status, when staff’s review is complete, staff transmits its recommendation on accreditation to the Commission for consideration. (A third party conformity assessment body that may ultimately seek acceptance as a firewalled third party conformity assessment body also can initially request acceptance as a third party conformity assessment body accredited for testing of children’s products other than those of its owners.) If the Commission accepts a staff recommendation to accredit a firewalled conformity assessment body, the firewalled conformity assessment body PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 will be added to the CPSC’s list of accredited third party conformity assessment bodies. In each case, the Commission will notify the third party conformity assessment body electronically of acceptance of its accreditation. All information to support an accreditation acceptance request must be provided in the English language. Once the Commission adds a third party conformity assessment body to the list, the third party conformity assessment body may begin testing children’s products to support certification of compliance with the phthalates content limits for which it has been accredited. VI. Acceptance of Children’s Product Certifications Based on Third Party Conformity Assessment Body Testing to CPSC–CH–C1001–09, Standard Operating Procedure for Determination of Phthalates, and/or GB/T 22048–2008, Toys and Children’s Products— Determination of Phthalate Plasticizers in Polyvinyl Chloride Plastic, Prior to the Effective Date For certifications of children’s toy or child care articles subject to the phthalates content limits in section 108 of the CPSIA, the Commission will allow certifications to be based on prior testing under certain conditions. Firms that elect to voluntarily have the phthalates content of children’s toys and child care articles tested by a third party conformity assessment body, using either the CPSC Test Method or the Chinese Test Method, before January 1, 2012, will not need to have those products retested. The Commission’s acceptance of certifications based on prior testing under certain conditions should prevent testing backlogs at accredited third party conformity assessment bodies, making it less likely that the Commission will have to postpone the effective date for certification. The Commission will accept a certificate of compliance to the phthalates limits in section 108 of the CPSIA based on testing performed by an accredited third party conformity assessment body (including a government-owned or -controlled conformity assessment body, and a firewalled conformity assessment body) if: • At the time of product testing, the product was tested by a third party conformity assessment body that was ISO/IEC 17025 accredited by an ILAC– MRA member at the time of the test. For firewalled conformity assessment bodies, the firewalled conformity assessment body must be one that the E:\FR\FM\10AUR1.SGM 10AUR1 mstockstill on DSK4VPTVN1PROD with RULES Federal Register / Vol. 76, No. 154 / Wednesday, August 10, 2011 / Rules and Regulations Commission has accredited by order at or before the time the product was tested, even if the order did not include the test methods specified in this notice. If the third party conformity assessment body has not been accredited by a Commission order as a firewalled conformity assessment body, the Commission will not accept a certificate of compliance based on testing performed by the third party conformity assessment body before it is accredited, by Commission order, as a firewalled conformity assessment body; • For tests conducted using the CPSC Test Method, the test was conducted on or after July 27, 2009. The Commission has chosen July 27, 2009, because it is the date the Commission posted a test method for testing component parts for phthalates on the Commission Web site: (https://www.cpsc.gov/about/cpsia/ CPSC-CH-C1001-09.2.pdf). The test method was updated on April 1, 2010, to the current method (https:// www.cpsc.gov/about/cpsia/CPSC-CHC1001-09.3.pdf.). The Commission will accept phthalates content certifications for products tested before January 1, 2012, if the product was tested using either CPSC–CH–C1001–09.2 or CPSC– CH–C1001–09.3. The Commission acknowledges that, on March 3, 2009, it released a test method that involved testing the entire product (https:// www.cpsc.gov/about/cpsia/CPSC-CHC1001-09.1.pdf) (‘‘March 2009 test method’’). The Commission will not accept phthalates content certifications for products tested using the March 2009 test method (CPSC–CH–C1001– 09.1). The Commission considers testing the entire product to be less protective of children because mouthable component parts with high concentrations of phthalates in products with large quantities of nonplasticized parts would be able to pass the test because the total mass of the product would dilute the overall phthalate measure. • For tests conducted using the Chinese Test Method, the test was conducted on or after June 18, 2008. The Commission has chosen June 18, 2008, because that is the date that the Chinese Test Method was issued. • The third party conformity assessment body’s application for accreditation is accepted by CPSC by the mandatory effective date, as established by the Commission; • The accreditation scope in the application for accreditation expressly includes one or both of the acceptable test methods identified earlier in part I of this document; VerDate Mar<15>2010 16:51 Aug 09, 2011 Jkt 223001 • The test results show compliance with the applicable current standards; and • The third party conformity assessment body’s accreditation and inclusion of one or both of the test methods (identified earlier in part I of this document) in its scope remain in effect through the effective date for mandatory third party testing and manufacturer certification for the subject products’ respective standards. Dated: July 29, 2011. Alberta E. Mills, Acting Secretary, Consumer Product Safety Commission. [FR Doc. 2011–19678 Filed 8–9–11; 8:45 am] BILLING CODE 6355–01–P COMMODITY FUTURES TRADING COMMISSION 17 CFR Part 35 RIN 3038–AD21 Agricultural Swaps AGENCY: Commodity Futures Trading Commission. ACTION: Final rule. SUMMARY: The Commodity Futures Trading Commission (‘‘Commission’’ or ‘‘CFTC’’) is charged with proposing rules to implement new statutory provisions enacted by Title VII of the Dodd-Frank Wall Street Reform and Consumer Protection Act (‘‘Dodd-Frank Act’’). The Dodd-Frank Act provides that swaps in an agricultural commodity (as defined by the Commission) are prohibited unless entered into pursuant to a rule, regulation or order of the Commission adopted pursuant to certain provisions of the Commodity Exchange Act (‘‘CEA’’ or ‘‘Act’’). On February 3, 2011, the Commission requested comment on a set of proposed rules that would, among other things, implement regulations whereby swaps in agricultural commodities may transact subject to the same rules as all other swaps. The proposed rules for swaps in an agricultural commodity would repeal and replace the Commission’s current regulations concerning the exemption of swap agreements. After reviewing the comments submitted in response to the proposed rules, the Commission has determined to issue these final rules for swaps in an agricultural commodity in the form as originally proposed. The February 3, 2011, proposed rules also included provisions that would substantially amend the Commission’s regulations regarding commodity option PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 49291 transactions. However, in this final rule the Commission is only issuing the rules for swaps in an agricultural commodity. The proposed rules for commodity option transactions will be addressed at a later date. DATES: Effective Date—December 31, 2011. FOR FURTHER INFORMATION CONTACT: Donald Heitman, Senior Special Counsel, (202) 418–5041, dheitman@cftc.gov, or Ryne Miller, Attorney Advisor, (202) 418–5921, rmiller@cftc.gov, Division of Market Oversight, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street, NW., Washington, DC 20581. SUPPLEMENTARY INFORMATION: I. Introduction A. Dodd-Frank Act On July 21, 2010, President Obama signed the Dodd-Frank Wall Street Reform and Consumer Protection Act.1 Title VII of the Dodd-Frank Act 2 amended the CEA 3 to establish a comprehensive new regulatory framework for swaps and security-based swaps. The legislation was enacted to reduce risk, increase transparency, and promote market integrity within the financial system by, among other things: (1) Providing for the registration and comprehensive regulation of swap dealers and major swap participants; (2) imposing clearing and trade execution requirements on standardized derivative products; (3) creating robust recordkeeping and real-time reporting regimes; and (4) enhancing the Commission’s rulemaking and enforcement authorities with respect to, among others, all registered entities and intermediaries subject to the Commission’s oversight. B. Proposed Agricultural Swaps Rules Section 723(c)(3) of the Dodd-Frank Act provides that swaps in an agricultural commodity (as defined by the Commission) 4 are prohibited unless entered into pursuant to a rule, regulation or order of the Commission adopted pursuant to CEA section 4(c). 1 See Dodd-Frank Wall Street Reform and Consumer Protection Act, Public Law 111–203, 124 Stat. 1376 (2010). The text of the Dodd-Frank Act may be accessed at https://www.cftc.gov./ LawRegulation/OTCDERIVATIVES/index.htm. 2 Pursuant to section 701 of the Dodd-Frank Act, Title VII may be cited as the ‘‘Wall Street Transparency and Accountability Act of 2010.’’ 3 7 U.S.C. 1 et seq. 4 As discussed below, in accordance with the mandate of the Dodd-Frank Act, the Commission recently promulgated a final rule defining the term ‘‘agricultural commodity.’’ See 76 FR 41048, July 13, 2011. E:\FR\FM\10AUR1.SGM 10AUR1

Agencies

Consumer Product Safety Commission

[Federal Register Volume 76, Number 154 (Wednesday, August 10, 2011)]
[Rules and Regulations]
[Pages 49286-49291]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19678]


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CONSUMER PRODUCT SAFETY COMMISSION

16 Chapter II

[CPSC Docket No. CPSC-2011-0052]


Third Party Testing for Certain Children's Products; Notice of 
Requirements for Accreditation of Third Party Conformity Assessment 
Bodies To Assess Conformity With the Limits on Phthalates in Children's 
Toys and Child Care Articles

AGENCY: Consumer Product Safety Commission.

ACTION: Notice of Requirements.

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SUMMARY: The Consumer Product Safety Commission (CPSC, Commission, or 
we) is issuing a notice of requirements that provides the criteria and 
process for Commission acceptance of accreditation of third party 
conformity assessment bodies for testing pursuant to the phthalates 
limits in section 108 of the Consumer Product Safety Improvement Act of 
2008 (CPSIA). The Commission is issuing this notice of requirements 
pursuant to section 14(a)(3)(B)(vi) of the Consumer Product Safety Act 
(CPSA).

DATES: Effective Date: The requirements for accreditation of third 
party conformity assessment bodies to assess conformity with phthalates 
limits when tested in accordance with CPSC-CH-C1001-09.3, Standard 
Operating Procedure for Determination of Phthalates, and GB/T 22048-
2008, Toys and Children's Products--Determination of Phthalate 
Plasticizers in Polyvinyl Chloride Plastic are effective August 10, 
2011.
    Submit comment by September 9, 2011. Comments on this notice should 
be captioned ``Third Party Testing for Certain Children's Products; 
Notice of Requirements for Accreditation of Third Party Conformity 
Assessment Bodies to Assess Conformity with the Limits on Phthalates in 
Children's Toys and Child Care Articles.''

ADDRESSES: You may submit comments, identified by Docket No. CPSC-2011-
0052, by any of the following methods:
    Electronic Submissions: Submit electronic comments in the following 
way:
    Federal eRulemaking Portal: https://www.regulations.gov. Follow the 
instructions for submitting comments. To ensure timely processing of 
comments, the Commission is no longer accepting comments submitted by 
electronic mail (e-mail) except through https://www.regulations.gov.
    Written Submissions: Submit written submissions in the following 
ways: Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions) preferably in five copies, to: Office of the Secretary, 
Consumer Product Safety Commission, Room 502, 4330 East West Highway, 
Bethesda, MD 20814; telephone (301) 504-7923.
    Instructions: All submissions received must include the agency name 
and docket number for this notice. All comments received may be posted 
without change to https://www.regulations.gov, including any personal 
information provided. Do not submit confidential business information, 
trade secret information, or other sensitive or protected information 
(such as a Social Security Number) electronically; if furnished at all, 
such information should be submitted in writing.
    Docket: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Carol Afflerbach, Compliance Officer, 
Office of Compliance and Field Investigations, U.S. Consumer Product 
Safety Commission, 4330 East West Highway, Bethesda, Maryland 20814; e-
mail cafflerbach@cpsc.gov.

SUPPLEMENTARY INFORMATION:

I. Introduction

    Section 14(a)(3)(B)(vi) of the CPSA, as added by section 102(a)(2) 
of the Consumer Product Safety Improvement Act of 2008 (CPSIA), Public 
Law 110-314, directs the CPSC to publish a notice of requirements for 
accreditation of third party conformity assessment bodies (also known 
as ``testing laboratories'' or ``laboratories'') to assess children's 
products for conformity with ``other children's product safety rules.'' 
\1\ Section 14(f)(1) of the CPSA defines ``children's product safety 
rule'' as ``a consumer product safety rule under [the CPSA] or similar 
rule, regulation, standard, or ban under any other Act enforced by the 
Commission, including a rule declaring a consumer product to be a 
banned hazardous product or substance.'' Under section 14(a)(3)(A) of 
the CPSA, each manufacturer (including the importer) or private labeler 
of products subject to those regulations must have products that are 
manufactured more than 90 days after

[[Page 49287]]

the Federal Register publication date of a notice of the requirements 
for accreditation, tested by a third party conformity assessment body 
accredited to do so, and must issue a certificate of compliance with 
the applicable regulations based on that testing. Section 14(a)(2) of 
the CPSA, as added by section 102(a)(2) of the CPSIA, requires that 
certification be based on testing of sufficient samples of the product, 
or samples that are identical in all material respects to the product. 
The Commission also emphasizes that, irrespective of certification, the 
product in question must comply with the applicable CPSC requirements 
(see, e.g., section 14(h) of the CPSA, as added by section 102(b) of 
the CPSIA).
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    \1\ The Commission voted 5-0 to publish this notice of 
requirements, with amendments, in the Federal Register. Chairman 
Inez M. Tenenbaum and Commissioners Thomas H. Moore and Robert S. 
Adler filed a joint statement regarding the vote. Commissioners 
Nancy A. Nord and Anne M. Northup filed individual statements. The 
statements may be viewed at https://www.cpsc.gov/pr/statements/html.
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    This notice provides the criteria and process for Commission 
acceptance of accreditation of third party conformity assessment bodies 
for testing pursuant to the following test methods:
     CPSC-CH-C1001-09.3, Standard Operating Procedure for 
Determination of Phthalates, issued on April 1, 2010 (``CPSC Test 
Method''). This is the most recent version of the test method, and it 
can be downloaded from the CPSC Web site at https://www.cpsc.gov/about/cpsia/CPSC-CH-C1001-09.3.pdf; and/or
     GB/T 22048-2008, Toys and Children's Products--
Determination of Phthalate Plasticizers in Polyvinyl Chloride Plastic, 
issued on June 16, 2008 (``Chinese Test Method'').
    The Commission is recognizing limited circumstances in which it 
will accept certifications based on product testing conducted before 
the publication of this notice of requirements. The details regarding 
those limited circumstances can be found in part VI of this document 
below.
    Although section 14(a)(3)(B)(vi) of the CPSA directs the CPSC to 
publish a notice of requirements for accreditation of third party 
conformity assessment bodies to assess conformity with ``all other 
children's product safety rules,'' this notice of requirements is 
limited to test methods CPSC-CH-C1001-09.3, Standard Operating 
Procedure for Determination of Phthalates, and GB/T 22048-2008, Toys 
and Children's Products--Determination of Phthalate Plasticizers in 
Polyvinyl Chloride Plastic. The CPSC acknowledges that the test methods 
for determining phthalates content are not, by themselves, rules that 
are codified in the Code of Federal Regulations. However, section 
108(d) of the CPSIA considers the phthalates content limits to be 
``consumer product safety standards'' under the Consumer Product Safety 
Act. Section 14(a)(3)(B)(vi) of the CPSA directs the Commission to 
publish notices of requirements for the accreditation of third party 
conformity assessment bodies to assess conformity with ``other 
children's product safety rules,'' and section 14(f)(1) of the CPSA 
defines a ``children's product safety rule,'' in part, as ``a consumer 
product safety rule under [the CPSA].'' Section 3(a)(6) of the CPSA, in 
turn, defines a ``consumer product safety rule'' as ``a consumer 
products safety standard described in section 7(a) [of the CPSA] * * * 
or a rule under this Chapter declaring a consumer product a banned 
hazardous product.'' Accordingly, because the phthalates content limits 
are ``consumer product safety standards'' under the CPSA, it follows 
that they are also ``consumer product safety rules'' under section 
3(a)(6) of the CPSA and, in turn, ``children's product safety rules'' 
under section 14(f)(1) of the CPSA. Thus, the phthalates content limits 
are ``children's product safety rules'' for which a notice of 
requirements for accreditation of third party conformity assessment 
bodies must be published. In addition, because the test methods would 
be used to assess conformity with the phthalates limits, it is 
appropriate for the notice of requirements to apply to the CPSC Test 
Method and the Chinese Test Method.
    The CPSC also recognizes that section 14(a)(3)(B)(vi) of the CPSA 
is captioned: ``All Other Children's Product Safety Rules,'' but the 
body of the statutory requirement refers only to ``other children's 
product safety rules.'' Nevertheless, section 14(a)(3)(B)(vi) of the 
CPSA could be construed to require a notice of requirements for ``all'' 
other children's product safety rules, rather than a notice of 
requirements for ``some'' or ``certain'' children's product safety 
rules. However, whether a particular rule represents a ``children's 
product safety rule'' may be subject to interpretation. Commission 
staff is continuing to evaluate which rules, regulations, standards, or 
bans are ``children's product safety rules.'' The CPSC intends to issue 
additional notices of requirements for other rules which the Commission 
determines to be ``children's product safety rules.''
    This notice of requirements applies to all third party conformity 
assessment bodies, as described in section 14(f)(2) of the CPSA. 
Generally speaking, such third party conformity assessment bodies are: 
(1) Third party conformity assessment bodies that are not owned, 
managed, or controlled by a manufacturer or private labeler of a 
children's product to be tested by the third party conformity 
assessment body for certification purposes; (2) ``firewalled'' 
conformity assessment bodies (those that are owned, managed, or 
controlled by a manufacturer or private labeler of a children's product 
to be tested by the third party conformity assessment body for 
certification purposes and that seek accreditation under the additional 
statutory criteria for ``firewalled'' conformity assessment bodies); 
and (3) third party conformity assessment bodies owned or controlled, 
in whole or in part, by a government.
    The Commission requires baseline accreditation of each category of 
third party conformity assessment body to the International 
Organization for Standardization (ISO)/International Electrotechnical 
Commission (IEC) Standard 17025:2005, ``General Requirements for the 
Competence of Testing and Calibration Laboratories.'' The accreditation 
must be by an accreditation body that is a signatory to the 
International Laboratory Accreditation Cooperation-Mutual Recognition 
Arrangement (ILAC-MRA), and the scope of the accreditation must include 
testing for any of the test methods identified earlier in this document 
for which the third party conformity assessment body seeks to be 
accredited.
    (A description of the history and content of the ILAC-MRA approach 
and of the requirements of the ISO/IEC 17025:2005 laboratory 
accreditation standard is provided in the CPSC staff briefing 
memorandum, ``Third Party Conformity Assessment Body Accreditation 
Requirements for Testing Compliance with 16 CFR part 1501 (Small Parts 
Regulations),'' dated November 2008, and available on the CPSC's Web 
site at: https://www.cpsc.gov/library/foia/foia09/brief/smallparts.pdf).
    The Commission has established an electronic accreditation 
registration and listing system that can be accessed via its Web site 
at: https://www.cpsc.gov/about/cpsia/labaccred.html.
    The Commission stayed the enforcement of certain provisions of 
section 14(a) of the CPSA in a notice published in the Federal Register 
on February 9, 2009 (74 FR 6396); the stay applied to testing and 
certification of various products, including the phthalates limits of 
section 108 of the CPSIA. On December 28, 2009, the Commission 
published a notice in the Federal Register (74 FR 68588), revising the 
terms of the stay. One section of the December 28, 2009, notice 
addressed: ``Consumer Products or Children's Products Where the 
Commission Is Continuing the Stay of Enforcement Until Further 
Notice,'' due to factors such as pending rulemaking proceedings 
affecting the product or the

[[Page 49288]]

absence of a notice of requirements. The phthalates content testing and 
certification requirements for children's toys and child care articles 
were included in that section of the December 28, 2009 notice. The 
absence of a notice of requirements prevented the lifting of the stay 
in the December 28, 2009 notice with regard to testing and 
certifications of children's toys and child care articles for 
phthalates content. On February 8, 2011, the Commission published a 
notice in the Federal Register (76 FR 6765), continuing the stay of 
enforcement for testing and certification of children's products for 
which a notice of requirements for accreditation of laboratories had 
not yet been published.
    The phthalates content testing and certification requirements for 
children's toys and child care articles were mentioned specifically as 
an example of a provision for which the stay would continue, pending 
publication of the notice of requirements. Thus, publication of this 
notice of requirements would have had the effect of lifting the stay on 
testing and certification requirements for phthalates content in 
children's toys and child care articles; however, on July 27, 2011, the 
Commission voted to stay enforcement of the testing and certification 
requirements of section 14 of the CPSA with respect to toys and child 
care articles subject to the phthalates content limits until December 
31, 2011.
    Accordingly, the Commission will enforce third party testing and 
certification requirements for products subject to the phthalates 
content limits if such products are manufactured on or after January 1, 
2012. (Under the CPSA, the term ``manufacturer'' includes anyone who 
manufactures or imports a product.)
    This notice of requirements is exempt from the notice and comment 
rulemaking requirements of the Administrative Procedure Act, 5 U.S.C. 
553 (see section 14(a)(3)(G) of the CPSA, as added by section 102(a)(2) 
of the CPSIA (15 U.S.C. 2063(a)(3)(G))).

II. Testing & Certification to Phthalates Limits--Prior Guidance 
Remains in Effect

    The Commission approved a ``Statement of Policy: Testing of 
Component Parts with Respect to Section 108 of the Consumer Product 
Safety Improvement Act'' on August 7, 2009. On August 17, 2009, a 
Notice of Availability regarding the Statement of Policy was published 
in the Federal Register (74 FR 41400). The Statement of Policy can be 
viewed and downloaded from the CPSC Web site at: https://www.cpsc.gov/about/cpsia/componenttestingpolicy.pdf. In brief, we believe that only 
those plastic parts or other product parts which could conceivably 
contain phthalates (``plasticized component parts'') should be tested 
for phthalates. We consider it to be unnecessary to test and certify 
materials that are known not to contain phthalates or to certify that 
phthalates are absent from materials that are known not to contain 
phthalates.\2\ In addition, we believe that when testing covered 
products, the assessment of the concentration of phthalates is to be 
based on testing of the plasticized component parts, rather than 
testing of the entire product, to avoid dilution of the concentrations 
of phthalates that can occur when the entire product is considered. The 
Statement of Policy remains in effect until further notice (except that 
the CPSC Test Method referenced in the Statement of Policy, CPSC-CH-
C1001-09.2, has been superseded by CPSC-CH-C1001-09.3 as outlined in 
part VI of this document below).
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    \2\ Untreated/unfinished wood, metal, natural fibers, natural 
latex and mineral products are not expected to inherently contain 
phthalates and need not be tested or certified provided that these 
materials have neither been treated or adulterated with the addition 
of materials that could result in the addition of phthalates into 
the product or material.
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    The Commission voted to publish a ``Draft Guidance Regarding Which 
Children's Products are Subject to the Requirements of CPSIA Section 
108'' on February 13, 2009. On February 23, 2009, the staff guidance 
was published in the Federal Register (74 FR 8058). This staff guidance 
can be viewed and downloaded from the CPSC Web site at: https://www.cpsc.gov/businfo/frnotices/fr09/draftphthalatesguidance.pdf. The 
Commission may choose to update this staff guidance or initiate a 
formal rulemaking concerning the topics addressed by the guidance after 
receipt of the Chronic Hazard Advisory Panel report required by section 
108(b)(2)(C) of the CPSIA. Until such time, this staff guidance remains 
in effect (except that the CPSC Test Method referenced in the guidance, 
CPSC-CH-C1001-09.1, has been superseded by CPSC-CH-C1001-09.3 as 
outlined in part VI of this document below).
    Answers to frequently asked questions that provide guidance 
concerning the requirements of section 108 of the CPSIA can be viewed 
on the CPSC Web site at: https://www.cpsc.gov/about/cpsia/sect108.html#faqs. The Commission intends for this guidance to be 
useful and therefore the materials on this Web page may be modified 
periodically in the future. In order to receive automatic notification 
of any such updates, interested parties may sign up for the CPSIA email 
subscription list at: https://www.cpsc.gov/about/cpsia/cpsialist.aspx. 
The Commission notes that the phthalate content limits in section 108 
of the CPSIA are statutory requirements and we may always take action 
with regard to products defined in this section of the statute that 
exceed those limits.

III. Responses to Comments Received on the CPSC Testing Method

    The Commission requested comments regarding the Statement in the 
Notice of Availability published in the Federal Register (74 FR 41400). 
We received several comments on the CPSC Test Method. We describe and 
respond to the comments in this section of the document. To make it 
easier to identify the comments and our responses, the word 
``Comment,'' in parentheses, will appear before the comment's 
description, and the word ``Response,'' in parentheses, will appear 
before our response. We also have numbered each comment to help 
distinguish between different topics. The number assigned to each 
comment is for organizational purposes only and does not signify the 
comment's value, or importance, or the order in which it was received.
    (Comment 1)--Some commenters questioned the necessity to run the 
test in triplicate. Other test multiples from two to five were 
suggested. Some commenters asked whether the sample to be tested always 
needed to be ground to a powder. A commenter asked about the proper 
cleaning protocol of the cryogenic mill.
    (Response 1)--We have examined all suggestions and comments 
pertaining to the CPSC Test Method and have updated our test method to 
address these issues (CPSC-CH-C1001-09.3). We adjusted the method to 
allow the third party conformity assessment body to choose an 
appropriate quality assurance program; thus, the third party conformity 
assessment body will determine the number of replicates to be tested. 
The CPSC Test Method allows, but does not require, third party 
conformity assessment bodies to pulverize the sample. Cryogenic mill 
equipment should be cleaned as thoroughly as any other laboratory 
equipment that comes into contact with a sample.
    (Comment 2)--One commenter suggested that the official Chinese test 
method, GB/T 22048-2008, Toys and Children's Products--Determination of 
Phthalate Plasticizers in Polyvinyl

[[Page 49289]]

Chloride Plastic, should be added to the lists of acceptable extraction 
and analysis methods. The commenter also suggested that each 
plasticized component part should be cut into pieces no larger than 2 
mm prior to the extraction step.
    (Response 2)--We have reviewed the test method GB/T 22048-2008 and 
determined that it is an acceptable test method for inclusion in this 
notice of requirements. With regard to the 2 mm maximum size of pieces, 
we agree with this comment and have incorporated the dimension into the 
current edition of the CPSC Test Method (CPSC-CH-C1001-09.3).
    (Comment 3)--Another commenter suggested that the CPSC Test Method 
include a description of the limit of detection (LOD) and limit of 
quantitation (LOQ). The commenter added that, on the last page of CPSC-
CH-C1001-09.2, there appears to be an error in the DEHP calculation. 
Under column C, measured DEHP concentration by GC-MSW is 200 [micro]g/
ml. In the final calculation column, 200 [micro]g/ml is mistakenly 
cited as 20 [micro]g/ml.
    (Response 3)--Detection and quantitation limits have not been 
outlined specifically at this point. Third party conformity assessment 
bodies should follow their own internal quality assurance program. 
These limits may be introduced in the future, following further 
validation and round robin studies. The DEHP calculation included a 
typographical error that was corrected for the current edition of the 
test method (CPSC-CH-C1001-09.3).
    (Comment 4)--One commenter stated that grinding the sample into a 
powder is time-consuming, adds additional expense to the testing 
methods, and could introduce the possibility of significant 
interlaboratory variability.
    (Response 4)--Grinding the sample into a powder is no longer 
required in the CPSC Test Method; however, third party conformity 
assessment bodies may continue to do so, if they wish.
    (Comment 5)--One commenter asked how the CPSC Test Method prevents 
interferences that can lead to a false positive for the phthalates of 
interest. The commenter also asked if the detection method could be 
revised.
    (Response 5)--We have updated the CPSC Test Method (to CPSC-CH-
C1001-09.3) to include a vigorous qualitative assessment by trained 
staff to avoid false positives. Such steps include: Retention time 
matching with known standards and full-scan mass spectrum analysis. We 
will continue to consider new methods that could simplify or improve 
the analysis.
    (Comment 6)--One commenter pointed out typographical 
inconsistencies found within the text of the method. Additionally, the 
commenter asked: What is the minimum signal-to-noise ratio required, 
and what are the reproducibility and detection limits of the method?
    (Response 6)--We have corrected the typographical errors that might 
have caused confusion. Signal-to-noise, detection limits, and 
reproducibility requirements have not been outlined specifically at 
this point. Third party conformity assessment bodies should follow 
their own internal quality assurance program. Testing requirements may 
be adjusted following further validation and round robin studies.
    (Comment 7)--One commenter asked if the chromatography was 
optimized.
    (Response 7)--The gas chromatography parameters outlined have been 
successful at providing adequate separation while minimizing sampling 
time. However, due to the nature of DINP and DIDP, they will not 
completely separate chromatographically. DINP and DIDP are actually a 
mixture of compounds; DINP and DIDP contain some of the same phthalate 
species, leading to an overlap. We recommend following the selection 
monitoring analysis scheme outlined in the CPSC Test Method to quantify 
these compounds for instances when they are both present.
    (Comment 8)--One commenter suggested that we create a flexible 
correlative policy that permits use of several methods suitable for the 
routine identification and measurement of total phthalate 
concentration, such as ASTM D7083-04, the Canada Product Safety Bureau 
method, the European Toy Safety Directive method, and GB/T 22048-2008, 
Toys and Children's Products--Determination of Phthalate Plasticizers 
in Polyvinyl Chloride Plastic.
    (Response 8)--The current edition of the CPSC Test Method (CPSC-CH-
C1001-09.3) allows alternative test methods. Additionally, any 
combination of the approved extraction and analysis methods listed may 
be used. We have included GB/T 22048-2008, Toys and Children's 
Products--Determination of Phthalate Plasticizers in Polyvinyl Chloride 
Plastic, as an additional test method in this notice of requirements. 
We have not included ASTM D7083-04 as an alternative detection method 
due to the lack of selectivity from using a flame ionization detector; 
this method may lead to false positives. We will review other suggested 
methods and may include them as alternatives in future revisions of the 
test method.

IV. Accreditation Requirements

A. Baseline Third Party Conformity Assessment Body Accreditation 
Requirements

    For a third party conformity assessment body to be accredited to 
test children's products for conformity with the test methods 
identified earlier in part I of this document, it must be accredited by 
an ILAC-MRA signatory accrediting body, and the accreditation must be 
registered with, and accepted by, the Commission. A listing of ILAC-MRA 
signatory accrediting bodies is available on the Internet at: https://ilac.org/membersbycategory.html. The accreditation must be to ISO 
Standard ISO/IEC 17025:2005, ``General Requirements for the Competence 
of Testing and Calibration Laboratories,'' and the scope of the 
accreditation must expressly include testing to the test method CPSC-
CH-C1001-09.3, Standard Operating Procedure for Determination of 
Phthalates, and/or to the test method GB/T 22048-2008, Toys and 
Children's Products--Determination of Phthalate Plasticizers in 
Polyvinyl Chloride Plastic. A true copy, in English, of the 
accreditation and scope documents demonstrating compliance with these 
requirements must be registered with the Commission electronically. The 
additional requirements for accreditation of firewalled and 
governmental conformity assessment bodies are described in parts IV.B 
and IV.C of this document below.
    The Commission will maintain on its Web site an up-to-date listing 
of third party conformity assessment bodies whose accreditations it has 
accepted and the scope of each accreditation. Once the Commission adds 
a third party conformity assessment body to that list, the third party 
conformity assessment body may commence testing children's toys and 
child care articles for phthalates content to support certification by 
the manufacturer or private labeler of compliance with the test 
method(s) identified earlier in part I of this document.

B. Additional Accreditation Requirements for Firewalled Conformity 
Assessment Bodies

    In addition to the baseline accreditation requirements in part IV.A 
of this document above, firewalled conformity assessment bodies seeking 
accredited status must submit to the Commission copies, in English, of 
their training documents, showing how employees are trained to notify 
the

[[Page 49290]]

Commission immediately and confidentially of any attempt by the 
manufacturer, private labeler, or other interested party to hide or 
exert undue influence over the third party conformity assessment body's 
test results. This additional requirement applies to any third party 
conformity assessment body in which a manufacturer or private labeler 
of a children's product to be tested by the third party conformity 
assessment body owns an interest of 10 percent or more. While the 
Commission is not addressing common parentage of a third party 
conformity assessment body and a children's product manufacturer at 
this time, it will be vigilant to see if this issue needs to be 
addressed in the future.
    As required by section 14(f)(2)(D) of the CPSA, the Commission must 
formally accept, by order, the accreditation application of a third 
party conformity assessment body before the third party conformity 
assessment body can become an accredited firewalled conformity 
assessment body. The Commission's order must also find that accrediting 
the firewalled conformity assessment body would provide equal or 
greater consumer safety protection than the manufacturer's or private 
labeler's use of an independent conformity assessment body.

C. Additional Accreditation Requirements for Governmental Conformity 
Assessment Bodies

    In addition to the baseline accreditation requirements of part IV.A 
of this document above, the CPSIA permits accreditation of a third 
party conformity assessment body owned or controlled, in whole or in 
part, by a government if:
     To the extent practicable, manufacturers or private 
labelers located in any nation are permitted to choose conformity 
assessment bodies that are not owned or controlled by the government of 
that nation;
     The third party conformity assessment body's testing 
results are not subject to undue influence by any other person, 
including another governmental entity;
     The third party conformity assessment body is not accorded 
more favorable treatment than other third party conformity assessment 
bodies in the same nation who have been accredited;
     The third party conformity assessment body's testing 
results are accorded no greater weight by other governmental 
authorities than those of other accredited third party conformity 
assessment bodies; and
     The third party conformity assessment body does not 
exercise undue influence over other governmental authorities on matters 
affecting its operations or on decisions by other governmental 
authorities controlling distribution of products based on outcomes of 
the third party conformity assessment body's conformity assessments.
    The Commission will accept the accreditation of a governmental 
third party conformity assessment body if it meets the baseline 
accreditation requirements of part IV.A of this document above and 
meets the additional conditions stated here. To obtain this assurance, 
CPSC staff will engage the governmental entities relevant to the 
accreditation request.

V. How does a third party conformity assessment body apply for 
acceptance of its accreditation?

    The Commission has established an electronic accreditation 
acceptance and registration system accessed via the Commission's 
Internet site at: https://www.cpsc.gov/about/cpsia/labaccred.html. The 
applicant provides, in English, basic identifying information 
concerning its location, the type of accreditation it is seeking, and 
electronic copies of its ILAC-MRA accreditation certificate and scope 
statement, and firewalled third party conformity assessment body 
training document(s), if relevant.
    CPSC staff will review the submission for accuracy and 
completeness. In the case of baseline third party conformity assessment 
bodies and government-owned or government-operated conformity 
assessment bodies, when that review and any necessary discussions with 
the applicant are completed satisfactorily, the third party conformity 
assessment body in question is added to the CPSC's list of accredited 
third party conformity assessment bodies at https://www.cpsc.gov/about/cpsia/labaccred.html. In the case of a firewalled conformity assessment 
body seeking accredited status, when staff's review is complete, staff 
transmits its recommendation on accreditation to the Commission for 
consideration. (A third party conformity assessment body that may 
ultimately seek acceptance as a firewalled third party conformity 
assessment body also can initially request acceptance as a third party 
conformity assessment body accredited for testing of children's 
products other than those of its owners.) If the Commission accepts a 
staff recommendation to accredit a firewalled conformity assessment 
body, the firewalled conformity assessment body will be added to the 
CPSC's list of accredited third party conformity assessment bodies. In 
each case, the Commission will notify the third party conformity 
assessment body electronically of acceptance of its accreditation. All 
information to support an accreditation acceptance request must be 
provided in the English language.
    Once the Commission adds a third party conformity assessment body 
to the list, the third party conformity assessment body may begin 
testing children's products to support certification of compliance with 
the phthalates content limits for which it has been accredited.

VI. Acceptance of Children's Product Certifications Based on Third 
Party Conformity Assessment Body Testing to CPSC-CH-C1001-09, Standard 
Operating Procedure for Determination of Phthalates, and/or GB/T 22048-
2008, Toys and Children's Products--Determination of Phthalate 
Plasticizers in Polyvinyl Chloride Plastic, Prior to the Effective Date

    For certifications of children's toy or child care articles subject 
to the phthalates content limits in section 108 of the CPSIA, the 
Commission will allow certifications to be based on prior testing under 
certain conditions. Firms that elect to voluntarily have the phthalates 
content of children's toys and child care articles tested by a third 
party conformity assessment body, using either the CPSC Test Method or 
the Chinese Test Method, before January 1, 2012, will not need to have 
those products retested. The Commission's acceptance of certifications 
based on prior testing under certain conditions should prevent testing 
backlogs at accredited third party conformity assessment bodies, making 
it less likely that the Commission will have to postpone the effective 
date for certification.
    The Commission will accept a certificate of compliance to the 
phthalates limits in section 108 of the CPSIA based on testing 
performed by an accredited third party conformity assessment body 
(including a government-owned or -controlled conformity assessment 
body, and a firewalled conformity assessment body) if:
     At the time of product testing, the product was tested by 
a third party conformity assessment body that was ISO/IEC 17025 
accredited by an ILAC-MRA member at the time of the test. For 
firewalled conformity assessment bodies, the firewalled conformity 
assessment body must be one that the

[[Page 49291]]

Commission has accredited by order at or before the time the product 
was tested, even if the order did not include the test methods 
specified in this notice. If the third party conformity assessment body 
has not been accredited by a Commission order as a firewalled 
conformity assessment body, the Commission will not accept a 
certificate of compliance based on testing performed by the third party 
conformity assessment body before it is accredited, by Commission 
order, as a firewalled conformity assessment body;
     For tests conducted using the CPSC Test Method, the test 
was conducted on or after July 27, 2009. The Commission has chosen July 
27, 2009, because it is the date the Commission posted a test method 
for testing component parts for phthalates on the Commission Web site: 
(https://www.cpsc.gov/about/cpsia/CPSC-CH-C1001-09.2.pdf). The test 
method was updated on April 1, 2010, to the current method (https://www.cpsc.gov/about/cpsia/CPSC-CH-C1001-09.3.pdf.). The Commission will 
accept phthalates content certifications for products tested before 
January 1, 2012, if the product was tested using either CPSC-CH-C1001-
09.2 or CPSC-CH-C1001-09.3. The Commission acknowledges that, on March 
3, 2009, it released a test method that involved testing the entire 
product (https://www.cpsc.gov/about/cpsia/CPSC-CH-C1001-09.1.pdf) 
(``March 2009 test method''). The Commission will not accept phthalates 
content certifications for products tested using the March 2009 test 
method (CPSC-CH-C1001-09.1). The Commission considers testing the 
entire product to be less protective of children because mouthable 
component parts with high concentrations of phthalates in products with 
large quantities of nonplasticized parts would be able to pass the test 
because the total mass of the product would dilute the overall 
phthalate measure.
     For tests conducted using the Chinese Test Method, the 
test was conducted on or after June 18, 2008. The Commission has chosen 
June 18, 2008, because that is the date that the Chinese Test Method 
was issued.
     The third party conformity assessment body's application 
for accreditation is accepted by CPSC by the mandatory effective date, 
as established by the Commission;
     The accreditation scope in the application for 
accreditation expressly includes one or both of the acceptable test 
methods identified earlier in part I of this document;
     The test results show compliance with the applicable 
current standards; and
     The third party conformity assessment body's accreditation 
and inclusion of one or both of the test methods (identified earlier in 
part I of this document) in its scope remain in effect through the 
effective date for mandatory third party testing and manufacturer 
certification for the subject products' respective standards.

    Dated: July 29, 2011.
Alberta E. Mills,
Acting Secretary, Consumer Product Safety Commission.
[FR Doc. 2011-19678 Filed 8-9-11; 8:45 am]
BILLING CODE 6355-01-P

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