Testing and Labeling Pertaining to Product Certification Regarding Representative Samples for Periodic Testing of Children's Products, 69586-69594 [2011-27686]

Download as PDF 69586 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Proposed Rules CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1107 [CPSC Docket No. CPSC–2011–0082] Testing and Labeling Pertaining to Product Certification Regarding Representative Samples for Periodic Testing of Children’s Products Consumer Product Safety Commission. ACTION: Notice of proposed rulemaking. AGENCY: The Consumer Product Safety Commission (‘‘CPSC,’’ ‘‘Commission,’’ or ‘‘we’’) is proposing to amend its regulations on testing and labeling pertaining to product certification. The proposed rule would address the testing of representative samples to ensure continued compliance of children’s products with all applicable rules, bans, standards, and regulations. The proposed rule also would establish a recordkeeping requirement associated with the testing of representative samples. We are taking this action to implement part of H.R. 2715 (Pub. L. 112–28).1 DATES: Written comments must be received by January 23, 2012. ADDRESSES: You may submit comments, identified by Docket No. CPSC–2011– 0082, 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 (email), except through: https://www.regulations.gov. Written Submissions: Submit written submissions in the following way: 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 820, 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 proposed collection of information. All comments received may be posted without change, mstockstill on DSK4VPTVN1PROD with PROPOSALS2 SUMMARY: 1 The Commission voted 5–0 to publish this notice of proposed rulemaking, with changes, in the Federal Register. Chairman Inez M. Tenenbaum, Commissioner Robert S. Adler, and Commissioner Thomas H. Moore issued a joint statement. Commissioner Nancy A. Nord issued a statement. The statements can be found at https:// www.cpsc.gov/pr/statements.html. VerDate Mar<15>2010 17:31 Nov 07, 2011 Jkt 226001 including any personal identifiers, contact information, or other personal information provided to: https:// www.regulations.gov. Do not submit confidential business information, trade secret information, or other sensitive or protected information electronically. Such information should be submitted in writing, with the sensitive portions clearly identified. Docket: For access to the docket to read background documents or comments received, go to: https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Randy Butturini, Project Manager, Office of Hazard Identification and Reduction, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; telephone (301) 504–7562; email rbutturini@cpsc.gov. SUPPLEMENTARY INFORMATION: I. Introduction and Statutory Authority Section 14(a)(2) of the Consumer Product Safety Act (CPSA), 15 U.S.C. 2063(a)(2), requires manufacturers and private labelers of any children’s product that is subject to a children’s product safety rule to submit samples of the product, or samples that are identical in all material respects to the product, to a third party conformity assessment body whose accreditation has been accepted by the CPSC to be tested for compliance with such children’s product safety rule. Based on that testing, the manufacturer or private labeler must issue a certificate that certifies that such children’s product complies with the children’s product safety rule. 15 U.S.C. 2063(a)(2)(B). CPSC regulations, at 16 CFR part 1110, limit the certificate requirement to importers and domestic manufacturers. The manufacturer or importer of the children’s product must issue a separate certificate for each applicable children’s product safety rule or a combined certificate that certifies compliance with all applicable children’s product safety rules and specifies each such rule. This certificate is called a Children’s Product Certificate (‘‘CPC’’). Further, former section 14(d)(2)(B) of the CPSA, 15 U.S.C. 2063(d)(2)(B), as originally provided in section 102 of the Consumer Product Safety Improvement Act of 2008 (‘‘CPSIA’’), requires that we establish protocols and standards for: • Ensuring that a children’s product tested for compliance with a children’s product safety rule is subject to testing periodically and when there has been a material change in the product’s design or manufacturing process, including the sourcing of component parts; PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 • Testing of random samples to ensure continued compliance; • Verifying that a children’s product tested by a conformity assessment body complies with applicable children’s product safety rules; and • Safeguarding against the exercise of undue influence on a third party conformity assessment body by a manufacturer or private labeler. In the Federal Register of May 20, 2010 (75 FR 28336), we published a proposed rule on ‘‘Testing and Labeling Pertaining to Product Certification.’’ The proposed rule was intended to implement what was then known as section 14(d)(2)(B) of the CPSA and to implement parts of section 14(a) of the CPSA. Proposed § 1107.22, ‘‘Random Samples,’’ would implement the testing of random samples requirement in the CPSA, by requiring each manufacturer of a children’s product to select samples for periodic testing by using a process that assigns each sample in the production population an equal probability of being selected (75 FR at 28349 through 28350, 28365). On August 12, 2011, the President signed H.R. 2715 into law. Among other things, H.R. 2715 replaced the CPSA’s requirement for the testing of ‘‘random samples’’ with a requirement for the testing of ‘‘representative samples.’’ Additionally, H.R. 2715 corrected an editorial error in section 14 of the CPSA, by renumbering section 14(d) of the CPSA, ‘‘Additional Regulations for Third Party Testing,’’ as section 14(i) of the CPSA. Elsewhere in this Federal Register, we are publishing a final rule for part 1107 on those aspects of the rule left unchanged by H.R. 2715. However, because H.R. 2715 amended the CPSA to require the testing of ‘‘representative samples,’’ we deleted § 1107.22 from the final rule, and we are issuing this proposed rule to implement the new statutory requirement for the testing of representative samples. Additionally, § 1107.26 of the final rule establishes requirements pertaining to recordkeeping. We have reserved § 1107.26(a)(4) in anticipation of a recordkeeping requirement related to representative samples. This proposed rule, therefore, would establish a new recordkeeping requirement for representative samples. We are issuing this proposed rule pursuant to section 14(i)(2)(B) of the CPSA, as well as its implementing authority pursuant to section 3 of the CPSIA. II. Description of the Proposed Rule The proposal would amend Title 16 of the Code of Federal Regulations: Part E:\FR\FM\08NOP2.SGM 08NOP2 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 1107, titled ‘‘Testing and Labeling Pertaining to Product Certification.’’ The amendment would implement section 14(i)(2)(B)(ii) of the CPSA, by amending § 1107.21, ‘‘Periodic Testing.’’ The proposal would require that periodic testing be conducted using representative samples. Additionally, the proposal would amend § 1107.26 to include a recordkeeping provision related to testing representative samples. A. Proposed § 1107.21(f)—Testing Representative Samples The proposal would create a new § 1107.21(f), which would state that a manufacturer must select representative product samples to be submitted to the third party conformity assessment body for periodic testing. We recognize that the proposed rule on ‘‘Testing and Labeling Pertaining to Product Certification’’ (75 FR 28336 (May 20, 2010)) would have treated ‘‘Random Samples’’ as a distinct section, rather than as a subparagraph within § 1107.21, ‘‘Periodic Testing.’’ However, because we have treated the requirement in section 14(i)(2)(B)(ii) of the CPSA as part of the periodic testing process, the proposed rule would place a requirement for the testing of representative samples in § 1107.21, rather than create a separate section. The procedure used to select representative product samples for periodic testing must provide a basis for inferring compliance about the population of untested products produced during the applicable periodic testing interval. The number of samples selected for the sampling procedure must be sufficient to ensure continuing compliance with all of the applicable children’s product safety rules. Manufacturers must document the procedure used to select the product samples for periodic testing and document the basis for inferring the compliance of the product manufactured during the periodic testing interval from the results of the tested samples. Proposed § 1107.21(f) would implement the requirement to test representative samples, by requiring each manufacturer of a children’s product to select samples for periodic testing known to be representative of the population of products manufactured since the last periodic test occurred (or since certification for the first periodic tests). In order for the test results of the samples submitted to a third party conformity assessment body to infer compliance of the untested units of the children’s product, the manufacturer must have knowledge that the tested VerDate Mar<15>2010 17:31 Nov 07, 2011 Jkt 226001 samples are, indeed, representative of the product produced. Haphazard methods of sample selection cannot provide a basis for inferring the compliance of the untested units without additional information indicating that the samples are representative. 1. Representative Samples Representative samples of a children’s product selected for testing are comparable to the unselected portion of the children’s product population with respect to compliance to the applicable children’s product safety rule(s). To be representative, the manufacturer must have a basis for inferring that, had other samples been chosen for testing, test results from those samples would have indicated the same compliance or noncompliance to the applicable children’s product safety rule as the representative samples. Determining that the selected samples are representative may be achieved in many ways, depending upon on the rule, ban, standard, or regulation being evaluated. For example, for the chemical tests, a sample selected from a homogeneous material, such as a wellmixed container of paint, could be considered representative of the entire container. For discretely produced products, information indicating uniform materials and dimensional control could be used to indicate that a sample is representative of the product for mechanical tests. For example, if a bicycle handlebar sample is manufactured from the same grade of steel and with the same dimensions (e.g., wall thickness, length, shape, placement of holes for attaching brake levers) as other handlebars produced, that handlebar sample can be considered representative of the population of handlebars for the purpose of the complying with the handlebar stem test in 16 CFR 1512.18(g). Other methods that may be used to establish that samples selected for periodic testing are representative— with respect to compliance—of the population of products manufactured since the last periodic test. Examples of such methods include: Incoming inspection of raw materials or component parts; process control data generated during product manufacture; and use of manufacturing techniques with intrinsic manufacturing uniformity, such as die casting. Random sampling is another means of selecting representative samples that provide a basis for inferring the compliance of untested product units PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 69587 from the tested product units. The conditions that allow for the inference of compliance concerning untested units versus tested units may be met by a range of probability-based sampling designs, including, but not limited to, simple random sampling, cluster sampling, systematic sampling, stratified sampling, and multistage sampling. These methods allow the manufacturer the flexibility to select a random sampling procedure that is most appropriate for the manufacturer’s product production setting but still allow for the inference about the compliance of the population of product units. For example, alternative sampling procedures—like systematic sampling (where a starting unit is randomly selected and then every kth unit after that is selected) or multistage sampling (where units are grouped in clusters such as pallets, the clusters are randomly selected and then units within the selected clusters are randomly drawn)—can be employed for products for which such sampling procedures would be beneficial. Even though every unit produced does not have the same probability of selection for testing in these examples, these techniques can be used to infer the compliance of the untested units. It should be noted, however, that just because random sampling can be used as one method of conducting representative testing, it is by no means the only method to meet the new broader ‘‘representative’’ sampling in H.R. 2715. With evidence that the samples submitted to a third party conformity assessment body are representative of the children’s product produced since the last periodic test (or since product certification for the first periodic test interval), the manufacturer can infer the compliance of the untested units. 2. Testing To Ensure Compliance For the purposes of periodic testing, passing test results means the samples tested are in compliance with the applicable children’s product safety rule. Most children’s product safety rules require each product sample submitted to pass the prescribed tests. For example, each pacifier subjected to the guard and shield testing specified in 16 CFR 1511.3 must pass the test. In a similar manner, each infant walker submitted for testing must pass the tests prescribed in 16 CFR part 1216. However, for some children’s product standards, compliance with the standard can include individual test results that exceed a specified maximum. For example, for children’s products tested for compliance to 16 E:\FR\FM\08NOP2.SGM 08NOP2 69588 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Proposed Rules CFR part 1611, Standard for the flammability of vinyl plastic film, 10 samples are averaged to determine if the maximum burn rate exceeds 1.2 inches per second, as specified in 16 CFR 1611.3. Because the maximum burn rate applies to the average, it is possible for one or more of the tested samples to exceed that burn rate when tested. In this circumstance, the samples are considered to be in conformance with the standard and have passed the test. As another example, small carpets and rugs that are children’s products are subject to the requirements for periodic testing. For small carpets and rugs, at least seven of the eight samples tested for compliance to 16 CFR part 1631, Standard for the surface flammability of small carpets and rugs (FF 2–70), must meet the test criterion specified in § 1631.3(b). Alternatively, a small carpet or rug that does not meet the test criterion must be permanently labeled prior to its introduction into commerce. Small carpets and rugs that meet either condition would be considered to be in compliance with 16 CFR part 1631 and deemed to have passed the periodic tests. B. Proposed § 1107.26(a)(4)— Recordkeeping Proposed § 1107.26(a)(4) would require a manufacturer of a children’s product subject to an applicable children’s product safety rule to maintain records documenting the testing of representative samples, as set forth in proposed § 1107.21(f) on periodic testing, including the number of representative samples selected and the procedure used to select representative samples. Records also must include the basis for inferring compliance of the product manufactured during the periodic testing interval from the results of the tested samples. The recordkeeping requirement for the testing of representative samples is intended to allow manufacturers to demonstrate continued compliance by establishing how the samples selected are representative of the population of products manufactured during the periodic testing interval and how the manufacturer can infer compliance of all products produced during this interval based on such testing. III. Environmental Considerations This proposed rule falls within the scope of the Commission’s environmental review regulations at 16 CFR 1021.5(c)(2), which provide a categorical exclusion from any requirement for the agency to prepare an environmental assessment or environmental impact statement for product certification rules. IV. Regulatory Flexibility Analysis The Regulatory Flexibility Act (‘‘RFA’’), 5 U.S.C. 601–612, generally requires that agencies review proposed rules for their potential economic impact on small entities, including small businesses. The RFA calls for agencies to prepare and make available for public comment an initial regulatory flexibility analysis describing the impact of the proposed rule on small entities and identifying impact-reducing alternatives. 5 U.S.C. 603. The Commission is proposing this rule in order to implement Section 14(i)(2)(B)(ii) of the CPSA. As originally enacted in 2008, this provision required the Commission to promulgate a regulation to establish protocols and standards for the testing of ‘‘random samples’’ to ensure that children’s products continue to comply with all applicable children’s product safety rules. H.R. 2715, which was enacted on August 12, 2011, amended the provision by substituting the term ‘‘representative’’ for the term ‘‘random,’’ in describing the samples that must be tested. A. Objectives of the Rule The objective of the rule is to reduce the risk of death and injury from consumer products, especially from products intended for children aged 12 years and younger. The proposed rule would accomplish this objective by requiring that manufacturers select the samples of children’s products for periodic testing (which will be required by 16 CFR 1107.21), using a procedure that results in the selection of samples from a population that is representative of the unselected products and provides a basis for inferring that if the selected samples comply with the applicable children’s product safety rules, then the units not selected will also comply. (The term ‘‘manufacturer,’’ for purposes of this proposed rule, includes private labelers and importers of products manufacturer by foreign manufacturers.) Being able to infer the compliance of the untested units is how the continued compliance of the product is ensured. B. Small Entities to Which the Rule Will Apply By regulation (16 CFR part 1110), the domestic manufacturer or importer is responsible for ensuring that a consumer product is properly tested, and, based upon the testing results, certifying that the product conforms to all applicable consumer product safety rules. Therefore, the domestic manufacturer or importer will be responsible for ensuring that representative samples of children’s products that are subject to one or more children’s product safety rules are tested to ensure continued compliance. The definition of a ‘‘children’s product’’ is broad and includes bicycles, furniture, apparel, jewelry, televisions, electronic games, toys, and so on, if designed or intended primarily for a child 12 years of age or younger. Virtually all children’s products are subject to one or more children’s product safety rules. A full list of the children’s product safety rules for which third party testing and certification will be required is given in Table 1. TABLE 1—PRODUCT SAFETY RULES APPLICABLE TO CHILDREN’S PRODUCTS mstockstill on DSK4VPTVN1PROD with PROPOSALS2 16 CFR part No. (or test method or standard) Description 1420 .......................................................................................................... 1203 .......................................................................................................... 1512 .......................................................................................................... 1513 .......................................................................................................... 1500.86(a)(5) ............................................................................................ 1500.86(a)(7) and (8) ............................................................................... 1505 .......................................................................................................... 1615 .......................................................................................................... 1616 .......................................................................................................... 1610 .......................................................................................................... 1632 .......................................................................................................... 1633 .......................................................................................................... 1611 .......................................................................................................... VerDate Mar<15>2010 17:31 Nov 07, 2011 Jkt 226001 PO 00000 Frm 00004 Fmt 4701 All-Terrain Vehicles. Bicycle Helmets. Bicycles. Bunk Beds. Clacker Balls. Dive Sticks and Other Similar Articles. Electrically Operated Toys or Articles. Flammability of Children’s Sleepwear, Sizes 0 through 6X. Flammability of Children’s Sleepwear, Sizes 7 through 14. Flammability of Clothing Textiles. Flammability of Mattresses and Mattress Pads. Flammability (Open-Flame) of Mattress Sets. Flammability of Vinyl Plastic Film. Sfmt 4702 E:\FR\FM\08NOP2.SGM 08NOP2 69589 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Proposed Rules TABLE 1—PRODUCT SAFETY RULES APPLICABLE TO CHILDREN’S PRODUCTS—Continued 16 CFR part No. (or test method or standard) Description 1219 .......................................................................................................... 1215 .......................................................................................................... 1216 .......................................................................................................... Sec. 101 of CPSIA (Test Method CPSC–CH–E1001–08, CPSC–CH– E1001–08.1 or 2005 CPSC Laboratory SOP). Sec. 101 of CPSIA (Test Method CPSC–CH–E1001–08 or CPSC–CH– E1001–08.1). Sec. 101 of CPSIA (Test Method CPSC–CH–E1002–08 and/or CPSC– CH–E1002–08.1). 1303 .......................................................................................................... 1220 .......................................................................................................... 1511 .......................................................................................................... Sec. 108 of CPSIA (Test Method CPSC–CH–C1001–09.3 ) .................. 1510 .......................................................................................................... 1501 .......................................................................................................... 1630 .......................................................................................................... 1631 .......................................................................................................... 1217 .......................................................................................................... (ASTM F963) ............................................................................................ The number of firms that could be impacted was estimated by reviewing every industry in the North American Industrial Classification System (NAICS) and selecting industries whose firms could manufacture or sell any children’s product that could be covered by a consumer product safety rule. Firms are classified in the NAICS category that describes their primary activity. Therefore, firms that might manufacture or import consumer products covered by a safety rule as a secondary or tertiary activity may not have been counted. There is no separate Full-Size Cribs. Infant Bath Seats. Infant Walkers. Lead Content in Children’s Metal Jewelry. Lead Content in Children’s Metal Products. Lead Content in Children’s Non-Metal Products. Lead Paint. Non-Full-Size Cribs. Pacifiers. Phthalate Content of Children’s Toys and Child Care Articles. Rattles. Small Parts Rule. Surface Flammability of Carpets and Rugs. Surface Flammability of Small Carpets and Rugs. Toddler Beds. Toys. NAICS category for importers. Firms that import products might be classified as manufacturers, wholesalers, or retailers. C. Manufacturers According to the criteria established by the U.S. Small Business Administration (‘‘SBA), manufacturers are generally considered to be small entities if they have fewer than 500 employees. Table 2 shows the number of manufacturing firms by the NAICS categories that cover most children’s products that are subject to a product safety rule. Although there are more than 26,000 manufacturers that would be considered small in these categories, not all of these firms are engaged in manufacturing children’s products that are subject to a children’s product safety rule. It would be expected that most of the firms engaged in Doll, Toy, and Game manufacturing produce some products that are intended for children age 12 and younger. On the other hand, the Surgical Appliance and Supplies Manufacturing category includes crash helmets, but most of the other products in this category are not under the CPSC’s jurisdiction. TABLE 2—MANUFACTURERS Description 31411 ........................ 315 ............................ 316211 ...................... 316212 ...................... 316219 ...................... 326299 ...................... 336991 ...................... 33712 ........................ 33791 ........................ 339113 ...................... 33991 ........................ 33992 ........................ 33993 ........................ 339942 ...................... 339999 ...................... Carpet and Rug Mills ........................................................................................................ Apparel Manufacturing ...................................................................................................... Rubber and Plastic Footwear Manufacturing ................................................................... House Slipper Manufacturing ........................................................................................... Other Footwear Manufacturing ......................................................................................... All Other Rubber Product Manufacturing ......................................................................... Motorcycle, Bicycle, and Parts Manufacturing ................................................................. Household and Institutional Furniture Manufacturing ....................................................... Mattress Manufacturing .................................................................................................... Surgical Appliance and Supplies Manufacturing .............................................................. Jewelry and Silverware Manufacturing ............................................................................. Sporting and Athletic Goods Manufacturing ..................................................................... Doll, Toy and Game Manufacturing ................................................................................. Lead Pencil and Art Good Manufacturing ........................................................................ All Other Miscellaneous Manufacturing ............................................................................ 244 7,126 43 1 53 622 447 6,058 427 1,817 2,470 1,707 694 124 4,646 262 7,195 45 1 54 666 452 6,154 441 1,916 2,484 1,748 705 129 4,695 Total Manufacturers ................................................................................................... mstockstill on DSK4VPTVN1PROD with PROPOSALS2 NAICS Code Small firms Total firms 26,479 26,947 Source: U.S. Department of Commerce, Bureau of the Census, 2008 County Business Patterns, Number of Firms, Number of Establishments, Employment, and Annual Payroll by Small Enterprise Employment Sizes for the United States, NAICS Sectors: 2008. Available at: https:// www2.census.gov/econ/susb/data/2008/us_naicssector_small_emplsize_2008.xls, last accessed on 16 August 2011. In addition to the manufacturers in Table 3, there were 25,184 nonemployer businesses classified in NAICS 315 (Apparel Manufacturing) and 61,180 VerDate Mar<15>2010 17:31 Nov 07, 2011 Jkt 226001 classified in NAICS 3399 (Other Miscellaneous Manufacturers) in 2008. Nonemployer businesses are generally very small businesses with no PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 employees. They are typically sole proprietorships, and they may or may not constitute the owner’s principal source of income. The average receipts E:\FR\FM\08NOP2.SGM 08NOP2 69590 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Proposed Rules for the nonemployer businesses classified in Apparel Manufacturing was about $31,000, and the average receipts for the nonemployer businesses classified as Other Miscellaneous Manufacturers was about $41,000.2 D. Wholesalers Wholesalers would be impacted by the rule if they import any children’s product that is subject to a product safety rule. Wholesalers who obtain their products strictly from domestic manufacturers or from other wholesalers would not be impacted by the rule because the manufacturer or importer would be responsible for certifying the products. Table 3 shows the number of wholesalers by NAICS code that would cover most children’s products that are subject to a product safety rule. According to SBA criteria, wholesalers are generally considered to be small entities if they have fewer than 100 employees. Although there are more than 78,000 wholesalers that would be considered small in these categories, not all of these firms are engaged in importing children’s products that are subject to a children’s product safety rule. A significant proportion of the firms classified as Toy and Hobby Goods and Supplies Merchant Wholesalers probably import at least some children’s products. However, the only firms classified as Motor Vehicle and Motor Vehicle Parts and Suppliers that would be impacted by the final rule are those that import all-terrain vehicles that are intended for children 12 year old or younger. TABLE 3—WHOLESALERS NAICS Code Description Small firms Total firms 4231 .......................... 4232 .......................... 42362 ........................ 42391 ........................ 42392 ........................ 42394 ........................ 42399 ........................ 42432 ........................ 42433 ........................ 42434 ........................ 42499 ........................ Motor Vehicle and Motor Vehicle Parts and Suppliers .................................................... Furniture and Home Furnishing Merchant Wholesalers .................................................. Electrical and Electronic Appliance, Television, and Radio Set Merchant Wholesalers Sporting and Recreational Goods and Supplies Merchant Wholesalers ......................... Toy and Hobby Goods and Supplies Merchant Wholesalers .......................................... Jewelry, Watch, Precious Stone, and Precious Metal Merchant Wholesalers ................ Other Miscellaneous Durable Goods Merchant Wholesalers .......................................... Men’s and Boy’s Clothing and Furnishings Merchant Wholesalers ................................. Women’s, Children’s, and Infant’s Clothing, and Accessories Merchant Wholesalers ... Footwear Merchant Wholesalers ...................................................................................... Other Miscellaneous Nondurable Goods Merchant Wholesalers .................................... 17,734 11,353 2,444 5,019 2,227 7,363 9,040 3,557 6,797 1,521 11,203 18,769 11,844 2,591 5,196 2,302 7,447 9,302 3,722 7,029 1,593 11,490 Total Wholesalers ...................................................................................................... 78,258 81,285 Source: U.S. Department of Commerce, Bureau of the Census, 2008 County Business Patterns, Number of Firms, Number of Establishments, Employment, and Annual Payroll by Small Enterprise Employment Sizes for the United States, NAICS Sectors: 2008. (Available at: https://www2. census.gov/econ/susb/data/2008/us_naicssector_small_emplsize_2008.xls, last accessed on 16 August 2011. In addition to the wholesalers tabulated in Table 3, the U.S. Census Bureau estimated that there were 206,072 nonemployer businesses classified in NAICS categories that could include wholesalers of children’s products. Nonemployer businesses are generally very small sole proprietorships. The average receipts for the nonemployer business wholesalers were about $86,000.3 An unknown number of nonemployer wholesalers could import children’s products. E. Retailers Retailers that obtain all of their products from domestic manufacturers or wholesalers will not be directly impacted by the rule because the manufacturers or wholesalers would be responsible for the testing and certification of the children’s products. However, there are some retailers that manufacture or directly import some products and, therefore, will be responsible for ensuring that these products are properly tested and certified. The number of such retailers is not known. Table 4 shows the number of retailers by NAICS code that would cover most children’s products. According to SBA size standards, retailers are generally considered to be small entities if their annual sales are less than $7 million to $30 million, depending on the specific NAICS category. Because of the way in which the data were reported by the Bureau of the Census, the estimates of the number of small firms in each category in Table 4 are based on similar, but different criteria. Although there are more than 100,000 firms that would be considered to be small businesses in these categories, it is not known how many of these firms are engaged in importing or manufacturing children’s products. Many of these firms probably obtain all of their products from domestic wholesalers or manufacturers and would not be directly impacted by the rule. TABLE 4—RETAILERS SBA size standard (millions of dollars of annual sales) mstockstill on DSK4VPTVN1PROD with PROPOSALS2 NAICS Code Description 441221 .......................... Motorcycle, ATV, and Personal Watercraft Dealers. 2 U.S. Department of Commerce, Bureau of the Census, ‘‘Revised 2008 Nonemployer Statistics Table.’’ Available at: https://www.census.gov/econ/ nonemployer/Revised%202008%20 VerDate Mar<15>2010 17:31 Nov 07, 2011 Jkt 226001 < 30 Data%20With%202009%20Methodology %20Applied.xls (last accessed 16 August 2011). 3 U.S. Department of Commerce, Bureau of the Census, ‘‘Revised 2008 Nonemployer Statistics PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 Criteria used for estimate of small firms (millions of dollars of annual sales) < 25 Small firms 4,794 Total firms 4,879 Table.’’ available at https://www.census.gov/econ/ nonemployer/Revised%202008%20Data%20With %202009%20Methodology%20Applied.xls (last accessed 16 August 2011). E:\FR\FM\08NOP2.SGM 08NOP2 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Proposed Rules 69591 TABLE 4—RETAILERS—Continued Criteria used for estimate of small firms (millions of dollars of annual sales) SBA size standard (millions of dollars of annual sales) NAICS Code Description Small firms Total firms 4421 .............................. 44813 ............................ 44814 ............................ 44815 ............................ 44819 ............................ 4482103 ........................ 4482104 ........................ 45111 ............................ 45112 ............................ 452 ................................ 45322 ............................ 454111 .......................... 454113 .......................... 4542 .............................. Furniture Stores ................................................... Children’s and Infant’s Clothing Stores ............... Family Clothing Stores ......................................... Clothing Accessories Stores ................................ Other Clothing Stores .......................................... Children’s & Juveniles’ Shoe Stores ................... Family Shoe Stores ............................................. Sporting Goods Stores ........................................ Hobby, Toy, & Game Stores ............................... General Merchandise Stores ............................... Gift, Novelty, and Souvenir Store ........................ Electronic Shopping ............................................. Mail Order Houses ............................................... Vending Machine Operators ................................ < 19 < 30 < 25.5 < 14 < 19 < 25.5 < 25.5 < 14 < 25.5 < 30 < 30 < 30 < 35.5 < 10 < 10 < 25 < 25 < 10 < 10 < 25 < 25 < 10 < 25 < 25 < 25 < 25 < 25 < 10 16,033 2,057 6,588 2,757 6,331 227 2,905 14,388 4,612 6,873 19,297 11,374 5,281 3,796 16,611 2,074 6,684 2,774 6,393 230 2,941 14,545 4,629 6,971 19,339 11,646 5,645 3,887 Total Retailers ............................................... ........................ ........................ 107.313 124,700 Source: U.S. Census Bureau, 2007 Economic Census, Release date 11/02/2010. In addition to the retailers tabulated in Table 4, the U.S. Census Bureau estimated that there were 324,918 nonemployer businesses classified in NAICS categories that could include retailers of children’s products. Nonemployer businesses are generally very small sole proprietorships. The average receipts for the nonemployer business wholesalers were about $40,000.4 An unknown number of nonemployer wholesalers could import children’s products. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 F. Compliance, Reporting, and Recordkeeping Requirements of Proposed Rule The proposed rule would require that children’s product manufacturers select representative samples required for the third party periodic testing (required by 16 CFR 1107.21) to be selected using a procedure that provides a basis for inferring compliance about the population of untested products produced during the applicable periodic testing interval. The proposed rule would further require that the number of samples selected must be sufficient to ensure continuing compliance with all the applicable children’s product safety rules. In order to be able to infer the compliance of the untested products, the samples selected must be representative of the untested or unselected units in the population of 4 U.S. Department of Commerce, Bureau of the Census, ‘‘Revised 2008 Nonemployer Statistics Table.’’ Available at: https://www.census.gov/econ/ nonemployer/Revised%202008%20Data%20With% 202009%20Methodology%20Applied.xls (last accessed 16 August 2011). VerDate Mar<15>2010 17:31 Nov 07, 2011 Jkt 226001 products produced during the periodic testing interval. In other words, children’s product manufacturers must have a basis for believing that if the samples selected for periodic testing show compliance with the applicable children’s product safety rules, then one can infer the compliance of the untested units in the population. Haphazard or nonpurposive methods of sample selection cannot provide a basis for believing that the samples are representative without additional information. In many cases, a manufacturer’s knowledge of the manufacturing processes or materials used in the process may provide such information. For example, if the manufacturer knows that a product or component is manufactured using the same grade of material as all of the other units, and if the production processes are controlled such that the all dimensions are the same as all other units, then that product or component could be considered representative of all other units produced during the interval. Information that can be used to establish that a sample is representative can come from a variety of sources, including inspection of, or tests on, incoming materials or components, as well as inspection, tests, and processcontrol data generated during production. Other methods of selecting representative samples include various probability-based sampling methods. These methods include simple random sampling, cluster sampling, systematic sampling, stratified sampling, and multistage sampling. Probability-based sampling methods allow one to make PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 statistical inferences about the population of the products, based upon results of tests on the selected samples. The proposed rule would require that manufacturers document the procedures used to select the product samples for periodic testing and document the basis for that belief that the samples are representative of the untested product produced during the periodic testing interval. The records must be maintained for five years. The records can be maintained electronically or in hardcopy. The manufacturer must make the records available for inspection by the CPSC upon request. The records may be maintained in languages other than English—if they can be provided immediately to the CPSC upon request, and provided that the manufacturer can translate them accurately into English within 48 hours—or any longer period negotiated with CPSC staff, upon a request by the CPSC to translate the records. There will be some costs associated with developing and implementing sampling procedures that will result in the selection of representative samples. Some knowledge of subjects such as statistics and quality control techniques may be necessary to develop the procedure even though the Commission has not mandated the use of statistical sampling techniques. Some manufacturers may have these skills inhouse; others may need to hire outside consultants with these skills. There also may be some ongoing costs associated with selecting the representative samples once the procedures have been developed. There also would be some costs associated with documenting the E:\FR\FM\08NOP2.SGM 08NOP2 69592 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 procedure and maintaining the records that would be required by the proposed rule. We invite comment on these costs and other impacts that the proposed rule could have on manufacturers. G. Alternatives for Reducing the Adverse Impact on Small Businesses The Regulatory Flexibility Act requires agencies to consider alternatives to proposed rules that would accomplish the stated objectives of the applicable statutes and that would reduce the economic impact on small entities. At a minimum, agencies must consider: 1. The establishment of differing compliance or reporting requirements that take into account the resources available to small businesses; 2. The clarification, consolidation, or simplification of compliance and reporting requirements for small entities; 3. The use of performance rather than design standards; and 4. An exemption from coverage of the rule, or any part of the rule thereof, for small entities. One alternative we considered was to propose less stringent alternatives for selecting representative samples. One alternative would be to allow manufacturers to select the samples using any method, provided that the method used would not purposively lead to the selection of samples that the manufacturers knows are more likely to comply with a standard or requirement than other samples, or select samples that are manufactured and chosen specifically to comply with a standard or requirement (often referred to as ‘‘golden samples’’). For example, manufacturers could pull randomly or nonpurposively the samples for periodic testing from their finished goods inventory or from the next lot or batch when the periodic testing needs to be completed. This alternative was not incorporated in the proposed rule because we think that it is necessary for the manufacturer to have a positive basis for their belief that the samples selected for periodic testing are, in fact, representative of the entire population of units produced during the periodic testing interval. If the manufacturer does not have a basis for believing that the samples selected are representative, then the ability to make inferences regarding the compliance of the untested units produced during the interval is limited, and the continued compliance, as stated in § 14(i)(2)(B)(ii) of the CPSA, cannot be ensured. We invite comments on these or any other alternatives to the proposed rule VerDate Mar<15>2010 17:31 Nov 07, 2011 Jkt 226001 that could reduce the impact on small businesses. In providing such comments, we request that the comments provide specific suggestions and well-developed justifications for the suggestions. V. Paperwork Reduction Act This proposed rule contains information collection requirements that are subject to public comment and review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). We describe the provisions in this section of the document with an estimate of the annual reporting burden. Our estimate includes the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information. We invite comments on: (1) Whether the collection of information is necessary for the proper performance of the CPSC’s functions, including whether the information will have practical utility; (2) the accuracy of the CPSC’s estimate of the burden of the proposed collection of information, including the validity of the method and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Title: Amendment to Regulation on Testing and Labeling Pertaining to Product Certification Regarding Representative Samples for Periodic Testing of Children’s Products Description: The proposed rule would require records that describe how the samples for periodic testing are selected, the number of samples that will be selected, and an explanation of why the procedure described will result in the selection of representative samples, such that one can infer that the untested units produced during the periodic testing interval comply with the applicable children’s product safety rules if the samples selected comply. Description of Respondents: Manufacturers of children’s products. We estimate the burden of this collection of information as follows: Although it might take a manufacturer several hours, perhaps several days to analyze its products and manufacturing processes to determine its options for selecting representative samples (and some might need to hire consultants for this purpose), the actual documentation PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 of the procedure and basis for inferring compliance will probably take less time. On the assumption that, because this document would be required by regulation, manufacturers will make sure that the document is reviewed and edited properly, it could take an average of 4 hours to prepare this document, once the procedure that will be used is decided and the number of samples has been determined. Developing the sampling procedure and documenting it are managerial or professional functions. According to the Bureau of Labor Statistics, as of March 2011, total compensation for management, professional, and related occupations for all workers in private industry was $50.08 an hour. Therefore, the cost of creating the record documenting a procedure for selecting representative samples could be estimated to be about $200 ($50.08 × 4 hours).5 In developing the estimates of the recordkeeping burden associated with the testing and labeling pertaining to the certification of a children’s products rule, we estimated that there were about 1.6 million children’s products. However, manufacturers probably will not need to develop and document a separate sampling procedure for each product. It might be more reasonable to believe that manufacturers will be able to use the same sampling plan for similar or closely related products or product lines. Therefore, manufacturers may need to develop and document separate sampling procedures for each set of closely related children’s products or children’s product lines rather than each individual product. For example, a manufacturer of die-cast toy cars might offer 50 different models, but if each one is manufactured using the same manufacturing processes and the same materials, one sampling plan for all diecast cars might be sufficient. We do not have information on the number of closely related products or product lines that manufacturers offer or the average number of individual models within each set of closely related products or product lines. In some cases, a manufacturer might have only one product in a particular product line. Some large manufacturers may offer several hundred models or styles within some product lines. A starting point to estimate the recordkeeping burden of the proposed rule is to assume that each product line averages 10 to 50 individual product models or styles. If each product line averages 50 individual models or styles, 5 Bureau of Labor Statistics, Employer Costs for Employee Compensation, Table 9 (March 2011). Available at: https://www.bls.gov/ncs. E:\FR\FM\08NOP2.SGM 08NOP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Proposed Rules then a total of 32,000 individual sampling plans (1.6 million children’s products ÷ 50 models or styles) would need to be developed and documented. This would require 128,000 hours (32,000 plans × 4 hours per plan) at a total cost of approximately $6.4 million (128,000 hours × $50.08 per hour). If each product line averages 10 individual models or styles, then a total of 160,000 different sampling plans (1.6 million children’s products ÷ 10 models or styles) would need to be documented. This would require 640,000 hours (160,000 plans × 4 hours per plan), at a total cost of approximately $32 million (640,000 hours × $50.08 per hour). Once a sampling plan is developed and documented, manufacturers will probably not incur the full cost of documenting their sampling plans in subsequent years because the same plan and documentation should be valid. However, each year, it is expected that manufacturers will retire some product lines and introduce new ones. Moreover, some manufacturers will leave the market, and other manufacturers will enter the market. Therefore, there will be some ongoing costs associated with documenting sampling plans. We do not have data on the number of new product lines introduced annually, whether from existing manufacturers or from new manufacturers entering a market. For purposes of this analysis, we will assume that about 20 percent of the children’s product lines are new each year, either because an existing manufacturer has changed an existing product line to the extent that a new sampling plan is required, introduced a new product line, or because a new manufacturer has entered the market. If this is the case, then the ongoing recordkeeping costs associated with the draft proposed rule would be 25,600 hours (128,000 hours × 0.2) to 128,000 hours (640,000 hours × 0.2) annually or approximately $1.3 million (25,600 hours × $50.08 per hour) to approximately $6.4 million (128,000 hours × $50.08 per hour) annually. Another potential ongoing recordkeeping cost might result if manufacturers make adjustments or revisions to their sampling plans or procedures for their existing product lines. This might occur if manufacturers find that their initial procedures are difficult to implement or if they come up with more efficient methods of selecting representative samples. We do not have any information that could be used to estimate how often manufacturers will revise these plans. For purposes of this analysis, we will VerDate Mar<15>2010 17:31 Nov 07, 2011 Jkt 226001 assume that this, too, would amount to about 20 percent of the burden estimated for the initial year, or approximately $1.3 million to $6.4 million annually. As noted above, we do not have empirical data for most of the numbers used in the examples above. We invite comments from manufacturers and others to gather better insight on the potential recordkeeping burden of the draft proposed rule. In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), we have submitted the information collection requirements of this rule to OMB for review. Interested persons are requested to fax comments regarding information collection by December 8, 2011, to the Office of Information and Regulatory Affairs, OMB (see ADDRESSES). VI. Executive Order 12988 (Preemption) Executive Order 12988 (February 5, 1996), requires agencies to state in clear language the preemptive effect, if any, of new regulations. The proposed rule would be issued under the authority of the CPSA and the CPSIA. The CPSA provision on preemption appears at section 26 of the CPSA. The CPSIA provision on preemption appears at section 231 of the CPSIA. The preemptive effect of this rule would be determined in an appropriate proceeding by a court of competent jurisdiction. VII. Effective Date The Administrative Procedure Act (APA) generally requires that the effective date of a rule be at least 30 days after publication of a final rule. 5 U.S.C. 553(d). The Commission intends that any final rule based on this proposal would become effective on the same date as the rule on ‘‘Testing and Labeling Pertaining to Certification,’’ published elsewhere in this Federal Register, which is February 8, 2013. VIII. Request for Comments The issuance of this proposed rule begins a rulemaking proceeding under sections 3 and 102 of the CPSIA that will establish performance and recordkeeping requirements for the testing of representative samples for periodic testing of children’s products. We invite interested persons to submit comments on any aspect of the proposed rule. Comments should be submitted in accordance with the instructions in the ADDRESSES section at the beginning of this notice. PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 69593 List of Subjects in 16 CFR Part 1107 Business and industry, Children, Consumer protection, Imports, Product testing and certification, Records, Record retention, Toys. Accordingly, the Commission proposes to amend 16 CFR part 1107, as proposed to be added elsewhere in this issue of the Federal Register, to read as follows: PART 1107—TESTING AND LABELING PERTAINING TO PRODUCT CERTIFICATION 1. The authority citation for part 1107 continues to read as follows: Authority: 15 U.S.C. 2063, Sec. 3, 102 Pub. L. 110–314, 122 Stat. 3016, 3017, 3022. Subpart C—Certification of Children’s Products 2. Add paragraph (f) to § 1107.21 to read as follows: § 1107.21 Periodic testing. * * * * * (f) A manufacturer must select representative product samples to be submitted to the third party conformity assessment body for periodic testing. The procedure used to select representative product samples for periodic testing must provide a basis for inferring compliance about the population of untested products produced during the applicable periodic testing interval. The number of samples selected for the sampling procedure must be sufficient to ensure continuing compliance with all applicable children’s product safety rules. The manufacturer must document the procedure used to select the product samples for periodic testing and the basis for inferring the compliance of the product manufactured during the periodic testing interval from the results of the tested samples. * * * * * 3. Add paragraph (a)(4) to § 1107.26 to read as follows: § 1107.26 Recordkeeping. (a) * * * (4) Records documenting the testing of representative samples, as set forth in § 1107.21(f), including the number of representative samples selected and the procedure used to select representative samples. Records also must include the basis for inferring compliance of the product manufactured during the periodic testing interval from the results of the tested samples; * * * * * E:\FR\FM\08NOP2.SGM 08NOP2 69594 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Proposed Rules Dated: October 21, 2011. Todd A. Stevenson, Secretary, Consumer Product Safety Commission. [FR Doc. 2011–27686 Filed 11–7–11; 8:45 am] mstockstill on DSK4VPTVN1PROD with PROPOSALS2 BILLING CODE 6355–01–P VerDate Mar<15>2010 17:31 Nov 07, 2011 Jkt 226001 PO 00000 Frm 00010 Fmt 4701 Sfmt 9990 E:\FR\FM\08NOP2.SGM 08NOP2

Agencies

Consumer Product Safety Commission

[Federal Register Volume 76, Number 216 (Tuesday, November 8, 2011)]
[Proposed Rules]
[Pages 69586-69594]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27686]

[[Page 69585]]

Vol. 76

Tuesday,

No. 216

November 8, 2011

Part V

Consumer Product Safety Commission

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16 CFR Part 1107

Testing and Labeling Pertaining to Product Certification Regarding
Representative Samples for Periodic Testing of Children's Products;
Proposed Rule

Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 /
Proposed Rules

[[Page 69586]]

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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1107

[CPSC Docket No. CPSC-2011-0082]

Testing and Labeling Pertaining to Product Certification
Regarding Representative Samples for Periodic Testing of Children's
Products

AGENCY: Consumer Product Safety Commission.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Consumer Product Safety Commission (``CPSC,''
``Commission,'' or ``we'') is proposing to amend its regulations on
testing and labeling pertaining to product certification. The proposed
rule would address the testing of representative samples to ensure
continued compliance of children's products with all applicable rules,
bans, standards, and regulations. The proposed rule also would
establish a recordkeeping requirement associated with the testing of
representative samples. We are taking this action to implement part of
H.R. 2715 (Pub. L. 112-28).\1\
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\1\ The Commission voted 5-0 to publish this notice of proposed
rulemaking, with changes, in the Federal Register. Chairman Inez M.
Tenenbaum, Commissioner Robert S. Adler, and Commissioner Thomas H.
Moore issued a joint statement. Commissioner Nancy A. Nord issued a
statement. The statements can be found at https://www.cpsc.gov/pr/statements.html.

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DATES: Written comments must be received by January 23, 2012.

ADDRESSES: You may submit comments, identified by Docket No. CPSC-2011-
0082, 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 (email), except through: https://www.regulations.gov.
Written Submissions: Submit written submissions in the following
way:
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 820, 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 proposed collection of information. All
comments received may be posted without change, including any personal
identifiers, contact information, or other personal information
provided to: https://www.regulations.gov. Do not submit confidential
business information, trade secret information, or other sensitive or
protected information electronically. Such information should be
submitted in writing, with the sensitive portions clearly identified.
Docket: For access to the docket to read background documents or
comments received, go to: https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Randy Butturini, Project Manager,
Office of Hazard Identification and Reduction, Consumer Product Safety
Commission, 4330 East West Highway, Bethesda, MD 20814; telephone (301)
504-7562; email rbutturini@cpsc.gov.

SUPPLEMENTARY INFORMATION:

I. Introduction and Statutory Authority

Section 14(a)(2) of the Consumer Product Safety Act (CPSA), 15
U.S.C. 2063(a)(2), requires manufacturers and private labelers of any
children's product that is subject to a children's product safety rule
to submit samples of the product, or samples that are identical in all
material respects to the product, to a third party conformity
assessment body whose accreditation has been accepted by the CPSC to be
tested for compliance with such children's product safety rule. Based
on that testing, the manufacturer or private labeler must issue a
certificate that certifies that such children's product complies with
the children's product safety rule. 15 U.S.C. 2063(a)(2)(B). CPSC
regulations, at 16 CFR part 1110, limit the certificate requirement to
importers and domestic manufacturers. The manufacturer or importer of
the children's product must issue a separate certificate for each
applicable children's product safety rule or a combined certificate
that certifies compliance with all applicable children's product safety
rules and specifies each such rule. This certificate is called a
Children's Product Certificate (``CPC'').
Further, former section 14(d)(2)(B) of the CPSA, 15 U.S.C.
2063(d)(2)(B), as originally provided in section 102 of the Consumer
Product Safety Improvement Act of 2008 (``CPSIA''), requires that we
establish protocols and standards for:
Ensuring that a children's product tested for compliance
with a children's product safety rule is subject to testing
periodically and when there has been a material change in the product's
design or manufacturing process, including the sourcing of component
parts;
Testing of random samples to ensure continued compliance;
Verifying that a children's product tested by a conformity
assessment body complies with applicable children's product safety
rules; and
Safeguarding against the exercise of undue influence on a
third party conformity assessment body by a manufacturer or private
labeler.
In the Federal Register of May 20, 2010 (75 FR 28336), we published
a proposed rule on ``Testing and Labeling Pertaining to Product
Certification.'' The proposed rule was intended to implement what was
then known as section 14(d)(2)(B) of the CPSA and to implement parts of
section 14(a) of the CPSA. Proposed Sec. 1107.22, ``Random Samples,''
would implement the testing of random samples requirement in the CPSA,
by requiring each manufacturer of a children's product to select
samples for periodic testing by using a process that assigns each
sample in the production population an equal probability of being
selected (75 FR at 28349 through 28350, 28365).
On August 12, 2011, the President signed H.R. 2715 into law. Among
other things, H.R. 2715 replaced the CPSA's requirement for the testing
of ``random samples'' with a requirement for the testing of
``representative samples.'' Additionally, H.R. 2715 corrected an
editorial error in section 14 of the CPSA, by renumbering section 14(d)
of the CPSA, ``Additional Regulations for Third Party Testing,'' as
section 14(i) of the CPSA.
Elsewhere in this Federal Register, we are publishing a final rule
for part 1107 on those aspects of the rule left unchanged by H.R. 2715.
However, because H.R. 2715 amended the CPSA to require the testing of
``representative samples,'' we deleted Sec. 1107.22 from the final
rule, and we are issuing this proposed rule to implement the new
statutory requirement for the testing of representative samples.
Additionally, Sec. 1107.26 of the final rule establishes requirements
pertaining to recordkeeping. We have reserved Sec. 1107.26(a)(4) in
anticipation of a recordkeeping requirement related to representative
samples. This proposed rule, therefore, would establish a new
recordkeeping requirement for representative samples.
We are issuing this proposed rule pursuant to section 14(i)(2)(B)
of the CPSA, as well as its implementing authority pursuant to section
3 of the CPSIA.

II. Description of the Proposed Rule

The proposal would amend Title 16 of the Code of Federal
Regulations: Part

[[Page 69587]]

1107, titled ``Testing and Labeling Pertaining to Product
Certification.'' The amendment would implement section 14(i)(2)(B)(ii)
of the CPSA, by amending Sec. 1107.21, ``Periodic Testing.'' The
proposal would require that periodic testing be conducted using
representative samples. Additionally, the proposal would amend Sec.
1107.26 to include a recordkeeping provision related to testing
representative samples.

A. Proposed Sec. 1107.21(f)--Testing Representative Samples

The proposal would create a new Sec. 1107.21(f), which would state
that a manufacturer must select representative product samples to be
submitted to the third party conformity assessment body for periodic
testing. We recognize that the proposed rule on ``Testing and Labeling
Pertaining to Product Certification'' (75 FR 28336 (May 20, 2010))
would have treated ``Random Samples'' as a distinct section, rather
than as a subparagraph within Sec. 1107.21, ``Periodic Testing.''
However, because we have treated the requirement in section
14(i)(2)(B)(ii) of the CPSA as part of the periodic testing process,
the proposed rule would place a requirement for the testing of
representative samples in Sec. 1107.21, rather than create a separate
section.
The procedure used to select representative product samples for
periodic testing must provide a basis for inferring compliance about
the population of untested products produced during the applicable
periodic testing interval. The number of samples selected for the
sampling procedure must be sufficient to ensure continuing compliance
with all of the applicable children's product safety rules.
Manufacturers must document the procedure used to select the product
samples for periodic testing and document the basis for inferring the
compliance of the product manufactured during the periodic testing
interval from the results of the tested samples.
Proposed Sec. 1107.21(f) would implement the requirement to test
representative samples, by requiring each manufacturer of a children's
product to select samples for periodic testing known to be
representative of the population of products manufactured since the
last periodic test occurred (or since certification for the first
periodic tests). In order for the test results of the samples submitted
to a third party conformity assessment body to infer compliance of the
untested units of the children's product, the manufacturer must have
knowledge that the tested samples are, indeed, representative of the
product produced. Haphazard methods of sample selection cannot provide
a basis for inferring the compliance of the untested units without
additional information indicating that the samples are representative.
1. Representative Samples
Representative samples of a children's product selected for testing
are comparable to the unselected portion of the children's product
population with respect to compliance to the applicable children's
product safety rule(s). To be representative, the manufacturer must
have a basis for inferring that, had other samples been chosen for
testing, test results from those samples would have indicated the same
compliance or noncompliance to the applicable children's product safety
rule as the representative samples.
Determining that the selected samples are representative may be
achieved in many ways, depending upon on the rule, ban, standard, or
regulation being evaluated. For example, for the chemical tests, a
sample selected from a homogeneous material, such as a well-mixed
container of paint, could be considered representative of the entire
container.
For discretely produced products, information indicating uniform
materials and dimensional control could be used to indicate that a
sample is representative of the product for mechanical tests. For
example, if a bicycle handlebar sample is manufactured from the same
grade of steel and with the same dimensions (e.g., wall thickness,
length, shape, placement of holes for attaching brake levers) as other
handlebars produced, that handlebar sample can be considered
representative of the population of handlebars for the purpose of the
complying with the handlebar stem test in 16 CFR 1512.18(g).
Other methods that may be used to establish that samples selected
for periodic testing are representative--with respect to compliance--of
the population of products manufactured since the last periodic test.
Examples of such methods include: Incoming inspection of raw materials
or component parts; process control data generated during product
manufacture; and use of manufacturing techniques with intrinsic
manufacturing uniformity, such as die casting.
Random sampling is another means of selecting representative
samples that provide a basis for inferring the compliance of untested
product units from the tested product units. The conditions that allow
for the inference of compliance concerning untested units versus tested
units may be met by a range of probability-based sampling designs,
including, but not limited to, simple random sampling, cluster
sampling, systematic sampling, stratified sampling, and multistage
sampling. These methods allow the manufacturer the flexibility to
select a random sampling procedure that is most appropriate for the
manufacturer's product production setting but still allow for the
inference about the compliance of the population of product units. For
example, alternative sampling procedures--like systematic sampling
(where a starting unit is randomly selected and then every kth unit
after that is selected) or multistage sampling (where units are grouped
in clusters such as pallets, the clusters are randomly selected and
then units within the selected clusters are randomly drawn)--can be
employed for products for which such sampling procedures would be
beneficial. Even though every unit produced does not have the same
probability of selection for testing in these examples, these
techniques can be used to infer the compliance of the untested units.
It should be noted, however, that just because random sampling can be
used as one method of conducting representative testing, it is by no
means the only method to meet the new broader ``representative''
sampling in H.R. 2715.
With evidence that the samples submitted to a third party
conformity assessment body are representative of the children's product
produced since the last periodic test (or since product certification
for the first periodic test interval), the manufacturer can infer the
compliance of the untested units.
2. Testing To Ensure Compliance
For the purposes of periodic testing, passing test results means
the samples tested are in compliance with the applicable children's
product safety rule. Most children's product safety rules require each
product sample submitted to pass the prescribed tests. For example,
each pacifier subjected to the guard and shield testing specified in 16
CFR 1511.3 must pass the test. In a similar manner, each infant walker
submitted for testing must pass the tests prescribed in 16 CFR part
1216.
However, for some children's product standards, compliance with the
standard can include individual test results that exceed a specified
maximum. For example, for children's products tested for compliance to
16

[[Page 69588]]

CFR part 1611, Standard for the flammability of vinyl plastic film, 10
samples are averaged to determine if the maximum burn rate exceeds 1.2
inches per second, as specified in 16 CFR 1611.3. Because the maximum
burn rate applies to the average, it is possible for one or more of the
tested samples to exceed that burn rate when tested. In this
circumstance, the samples are considered to be in conformance with the
standard and have passed the test.
As another example, small carpets and rugs that are children's
products are subject to the requirements for periodic testing. For
small carpets and rugs, at least seven of the eight samples tested for
compliance to 16 CFR part 1631, Standard for the surface flammability
of small carpets and rugs (FF 2-70), must meet the test criterion
specified in Sec. 1631.3(b). Alternatively, a small carpet or rug that
does not meet the test criterion must be permanently labeled prior to
its introduction into commerce. Small carpets and rugs that meet either
condition would be considered to be in compliance with 16 CFR part 1631
and deemed to have passed the periodic tests.

B. Proposed Sec. 1107.26(a)(4)--Recordkeeping

Proposed Sec. 1107.26(a)(4) would require a manufacturer of a
children's product subject to an applicable children's product safety
rule to maintain records documenting the testing of representative
samples, as set forth in proposed Sec. 1107.21(f) on periodic testing,
including the number of representative samples selected and the
procedure used to select representative samples. Records also must
include the basis for inferring compliance of the product manufactured
during the periodic testing interval from the results of the tested
samples.
The recordkeeping requirement for the testing of representative
samples is intended to allow manufacturers to demonstrate continued
compliance by establishing how the samples selected are representative
of the population of products manufactured during the periodic testing
interval and how the manufacturer can infer compliance of all products
produced during this interval based on such testing.

III. Environmental Considerations

This proposed rule falls within the scope of the Commission's
environmental review regulations at 16 CFR 1021.5(c)(2), which provide
a categorical exclusion from any requirement for the agency to prepare
an environmental assessment or environmental impact statement for
product certification rules.

IV. Regulatory Flexibility Analysis

The Regulatory Flexibility Act (``RFA''), 5 U.S.C. 601-612,
generally requires that agencies review proposed rules for their
potential economic impact on small entities, including small
businesses. The RFA calls for agencies to prepare and make available
for public comment an initial regulatory flexibility analysis
describing the impact of the proposed rule on small entities and
identifying impact-reducing alternatives. 5 U.S.C. 603.
The Commission is proposing this rule in order to implement Section
14(i)(2)(B)(ii) of the CPSA. As originally enacted in 2008, this
provision required the Commission to promulgate a regulation to
establish protocols and standards for the testing of ``random samples''
to ensure that children's products continue to comply with all
applicable children's product safety rules. H.R. 2715, which was
enacted on August 12, 2011, amended the provision by substituting the
term ``representative'' for the term ``random,'' in describing the
samples that must be tested.

A. Objectives of the Rule

The objective of the rule is to reduce the risk of death and injury
from consumer products, especially from products intended for children
aged 12 years and younger. The proposed rule would accomplish this
objective by requiring that manufacturers select the samples of
children's products for periodic testing (which will be required by 16
CFR 1107.21), using a procedure that results in the selection of
samples from a population that is representative of the unselected
products and provides a basis for inferring that if the selected
samples comply with the applicable children's product safety rules,
then the units not selected will also comply. (The term
``manufacturer,'' for purposes of this proposed rule, includes private
labelers and importers of products manufacturer by foreign
manufacturers.) Being able to infer the compliance of the untested
units is how the continued compliance of the product is ensured.

B. Small Entities to Which the Rule Will Apply

By regulation (16 CFR part 1110), the domestic manufacturer or
importer is responsible for ensuring that a consumer product is
properly tested, and, based upon the testing results, certifying that
the product conforms to all applicable consumer product safety rules.
Therefore, the domestic manufacturer or importer will be responsible
for ensuring that representative samples of children's products that
are subject to one or more children's product safety rules are tested
to ensure continued compliance. The definition of a ``children's
product'' is broad and includes bicycles, furniture, apparel, jewelry,
televisions, electronic games, toys, and so on, if designed or intended
primarily for a child 12 years of age or younger. Virtually all
children's products are subject to one or more children's product
safety rules. A full list of the children's product safety rules for
which third party testing and certification will be required is given
in Table 1.

Table 1--Product Safety Rules Applicable to Children's Products
------------------------------------------------------------------------
16 CFR part No. (or test method or
standard) Description
------------------------------------------------------------------------
1420................................... All-Terrain Vehicles.
1203................................... Bicycle Helmets.
1512................................... Bicycles.
1513................................... Bunk Beds.
1500.86(a)(5).......................... Clacker Balls.
1500.86(a)(7) and (8).................. Dive Sticks and Other Similar
Articles.
1505................................... Electrically Operated Toys or
Articles.
1615................................... Flammability of Children's
Sleepwear, Sizes 0 through 6X.
1616................................... Flammability of Children's
Sleepwear, Sizes 7 through 14.
1610................................... Flammability of Clothing
Textiles.
1632................................... Flammability of Mattresses and
Mattress Pads.
1633................................... Flammability (Open-Flame) of
Mattress Sets.
1611................................... Flammability of Vinyl Plastic
Film.

[[Page 69589]]

1219................................... Full-Size Cribs.
1215................................... Infant Bath Seats.
1216................................... Infant Walkers.
Sec. 101 of CPSIA (Test Method CPSC-CH- Lead Content in Children's
E1001-08, CPSC-CH-E1001-08.1 or 2005 Metal Jewelry.
CPSC Laboratory SOP).
Sec. 101 of CPSIA (Test Method CPSC-CH- Lead Content in Children's
E1001-08 or CPSC-CH-E1001-08.1). Metal Products.
Sec. 101 of CPSIA (Test Method CPSC-CH- Lead Content in Children's Non-
E1002-08 and/or CPSC-CH-E1002-08.1). Metal Products.
1303................................... Lead Paint.
1220................................... Non-Full-Size Cribs.
1511................................... Pacifiers.
Sec. 108 of CPSIA (Test Method CPSC-CH- Phthalate Content of Children's
C1001-09.3 ). Toys and Child Care Articles.
1510................................... Rattles.
1501................................... Small Parts Rule.
1630................................... Surface Flammability of Carpets
and Rugs.
1631................................... Surface Flammability of Small
Carpets and Rugs.
1217................................... Toddler Beds.
(ASTM F963)............................ Toys.
------------------------------------------------------------------------

The number of firms that could be impacted was estimated by
reviewing every industry in the North American Industrial
Classification System (NAICS) and selecting industries whose firms
could manufacture or sell any children's product that could be covered
by a consumer product safety rule. Firms are classified in the NAICS
category that describes their primary activity. Therefore, firms that
might manufacture or import consumer products covered by a safety rule
as a secondary or tertiary activity may not have been counted. There is
no separate NAICS category for importers. Firms that import products
might be classified as manufacturers, wholesalers, or retailers.

C. Manufacturers

According to the criteria established by the U.S. Small Business
Administration (``SBA), manufacturers are generally considered to be
small entities if they have fewer than 500 employees. Table 2 shows the
number of manufacturing firms by the NAICS categories that cover most
children's products that are subject to a product safety rule. Although
there are more than 26,000 manufacturers that would be considered small
in these categories, not all of these firms are engaged in
manufacturing children's products that are subject to a children's
product safety rule. It would be expected that most of the firms
engaged in Doll, Toy, and Game manufacturing produce some products that
are intended for children age 12 and younger. On the other hand, the
Surgical Appliance and Supplies Manufacturing category includes crash
helmets, but most of the other products in this category are not under
the CPSC's jurisdiction.

Table 2--Manufacturers
----------------------------------------------------------------------------------------------------------------
NAICS Code Description Small firms Total firms
----------------------------------------------------------------------------------------------------------------
31411...................................... Carpet and Rug Mills............... 244 262
315........................................ Apparel Manufacturing.............. 7,126 7,195
316211..................................... Rubber and Plastic Footwear 43 45
Manufacturing.
316212..................................... House Slipper Manufacturing........ 1 1
316219..................................... Other Footwear Manufacturing....... 53 54
326299..................................... All Other Rubber Product 622 666
Manufacturing.
336991..................................... Motorcycle, Bicycle, and Parts 447 452
Manufacturing.
33712...................................... Household and Institutional 6,058 6,154
Furniture Manufacturing.
33791...................................... Mattress Manufacturing............. 427 441
339113..................................... Surgical Appliance and Supplies 1,817 1,916
Manufacturing.
33991...................................... Jewelry and Silverware 2,470 2,484
Manufacturing.
33992...................................... Sporting and Athletic Goods 1,707 1,748
Manufacturing.
33993...................................... Doll, Toy and Game Manufacturing... 694 705
339942..................................... Lead Pencil and Art Good 124 129
Manufacturing.
339999..................................... All Other Miscellaneous 4,646 4,695
Manufacturing.
-------------------------------
Total Manufacturers............. 26,479 26,947
----------------------------------------------------------------------------------------------------------------
Source: U.S. Department of Commerce, Bureau of the Census, 2008 County Business Patterns, Number of Firms,
Number of Establishments, Employment, and Annual Payroll by Small Enterprise Employment Sizes for the United
States, NAICS Sectors: 2008. Available at: https://www2.census.gov/econ/susb/data/2008/us_naicssector_small_emplsize_2008.xls, last accessed on 16 August 2011.

In addition to the manufacturers in Table 3, there were 25,184
nonemployer businesses classified in NAICS 315 (Apparel Manufacturing)
and 61,180 classified in NAICS 3399 (Other Miscellaneous Manufacturers)
in 2008. Nonemployer businesses are generally very small businesses
with no employees. They are typically sole proprietorships, and they
may or may not constitute the owner's principal source of income. The
average receipts

[[Page 69590]]

for the nonemployer businesses classified in Apparel Manufacturing was
about $31,000, and the average receipts for the nonemployer businesses
classified as Other Miscellaneous Manufacturers was about $41,000.\2\
---------------------------------------------------------------------------

\2\ U.S. Department of Commerce, Bureau of the Census, ``Revised
2008 Nonemployer Statistics Table.'' Available at: https://www.census.gov/econ/nonemployer/Revised%202008%20Data%20With%202009%20Methodology%20Applied.xls
(last accessed 16 August 2011).
---------------------------------------------------------------------------

D. Wholesalers

Wholesalers would be impacted by the rule if they import any
children's product that is subject to a product safety rule.
Wholesalers who obtain their products strictly from domestic
manufacturers or from other wholesalers would not be impacted by the
rule because the manufacturer or importer would be responsible for
certifying the products. Table 3 shows the number of wholesalers by
NAICS code that would cover most children's products that are subject
to a product safety rule. According to SBA criteria, wholesalers are
generally considered to be small entities if they have fewer than 100
employees. Although there are more than 78,000 wholesalers that would
be considered small in these categories, not all of these firms are
engaged in importing children's products that are subject to a
children's product safety rule. A significant proportion of the firms
classified as Toy and Hobby Goods and Supplies Merchant Wholesalers
probably import at least some children's products. However, the only
firms classified as Motor Vehicle and Motor Vehicle Parts and Suppliers
that would be impacted by the final rule are those that import all-
terrain vehicles that are intended for children 12 year old or younger.

Table 3--Wholesalers
----------------------------------------------------------------------------------------------------------------
NAICS Code Description Small firms Total firms
----------------------------------------------------------------------------------------------------------------
4231....................................... Motor Vehicle and Motor Vehicle 17,734 18,769
Parts and Suppliers.
4232....................................... Furniture and Home Furnishing 11,353 11,844
Merchant Wholesalers.
42362...................................... Electrical and Electronic 2,444 2,591
Appliance, Television, and Radio
Set Merchant Wholesalers.
42391...................................... Sporting and Recreational Goods and 5,019 5,196
Supplies Merchant Wholesalers.
42392...................................... Toy and Hobby Goods and Supplies 2,227 2,302
Merchant Wholesalers.
42394...................................... Jewelry, Watch, Precious Stone, and 7,363 7,447
Precious Metal Merchant
Wholesalers.
42399...................................... Other Miscellaneous Durable Goods 9,040 9,302
Merchant Wholesalers.
42432...................................... Men's and Boy's Clothing and 3,557 3,722
Furnishings Merchant Wholesalers.
42433...................................... Women's, Children's, and Infant's 6,797 7,029
Clothing, and Accessories Merchant
Wholesalers.
42434...................................... Footwear Merchant Wholesalers...... 1,521 1,593
42499...................................... Other Miscellaneous Nondurable 11,203 11,490
Goods Merchant Wholesalers.
--------------------------------------------------------------------
Total Wholesalers............... 78,258 81,285
----------------------------------------------------------------------------------------------------------------
Source: U.S. Department of Commerce, Bureau of the Census, 2008 County Business Patterns, Number of Firms,
Number of Establishments, Employment, and Annual Payroll by Small Enterprise Employment Sizes for the United
States, NAICS Sectors: 2008. (Available at: https://www2.census.gov/econ/susb/data/2008/us_naicssector_small_emplsize_2008.xls, last accessed on 16 August 2011.

In addition to the wholesalers tabulated in Table 3, the U.S.
Census Bureau estimated that there were 206,072 nonemployer businesses
classified in NAICS categories that could include wholesalers of
children's products. Nonemployer businesses are generally very small
sole proprietorships. The average receipts for the nonemployer business
wholesalers were about $86,000.\3\ An unknown number of nonemployer
wholesalers could import children's products.
---------------------------------------------------------------------------

\3\ U.S. Department of Commerce, Bureau of the Census, ``Revised
2008 Nonemployer Statistics Table.'' available at https://www.census.gov/econ/nonemployer/Revised%202008%20Data%20With%202009%20Methodology%20Applied.xls
(last accessed 16 August 2011).
---------------------------------------------------------------------------

E. Retailers

Retailers that obtain all of their products from domestic
manufacturers or wholesalers will not be directly impacted by the rule
because the manufacturers or wholesalers would be responsible for the
testing and certification of the children's products. However, there
are some retailers that manufacture or directly import some products
and, therefore, will be responsible for ensuring that these products
are properly tested and certified. The number of such retailers is not
known. Table 4 shows the number of retailers by NAICS code that would
cover most children's products. According to SBA size standards,
retailers are generally considered to be small entities if their annual
sales are less than $7 million to $30 million, depending on the
specific NAICS category. Because of the way in which the data were
reported by the Bureau of the Census, the estimates of the number of
small firms in each category in Table 4 are based on similar, but
different criteria. Although there are more than 100,000 firms that
would be considered to be small businesses in these categories, it is
not known how many of these firms are engaged in importing or
manufacturing children's products. Many of these firms probably obtain
all of their products from domestic wholesalers or manufacturers and
would not be directly impacted by the rule.

Table 4--Retailers
----------------------------------------------------------------------------------------------------------------
Criteria used
SBA size for estimate
standard of small firms
NAICS Code Description (millions of (millions of Small firms Total firms
dollars of dollars of
annual sales) annual sales)
----------------------------------------------------------------------------------------------------------------
441221........................ Motorcycle, ATV, < 30 < 25 4,794 4,879
and Personal
Watercraft
Dealers.

[[Page 69591]]

4421.......................... Furniture Stores < 19 < 10 16,033 16,611
44813......................... Children's and < 30 < 25 2,057 2,074
Infant's
Clothing Stores.
44814......................... Family Clothing < 25.5 < 25 6,588 6,684
Stores.
44815......................... Clothing < 14 < 10 2,757 2,774
Accessories
Stores.
44819......................... Other Clothing < 19 < 10 6,331 6,393
Stores.
4482103....................... Children's & < 25.5 < 25 227 230
Juveniles' Shoe
Stores.
4482104....................... Family Shoe < 25.5 < 25 2,905 2,941
Stores.
45111......................... Sporting Goods < 14 < 10 14,388 14,545
Stores.
45112......................... Hobby, Toy, & < 25.5 < 25 4,612 4,629
Game Stores.
452........................... General < 30 < 25 6,873 6,971
Merchandise
Stores.
45322......................... Gift, Novelty, < 30 < 25 19,297 19,339
and Souvenir
Store.
454111........................ Electronic < 30 < 25 11,374 11,646
Shopping.
454113........................ Mail Order < 35.5 < 25 5,281 5,645
Houses.
4542.......................... Vending Machine < 10 < 10 3,796 3,887
Operators.
---------------------------------------------------------------------------------
Total .............. .............. 107.313 124,700
Retailers.
----------------------------------------------------------------------------------------------------------------
Source: U.S. Census Bureau, 2007 Economic Census, Release date 11/02/2010.

In addition to the retailers tabulated in Table 4, the U.S. Census
Bureau estimated that there were 324,918 nonemployer businesses
classified in NAICS categories that could include retailers of
children's products. Nonemployer businesses are generally very small
sole proprietorships. The average receipts for the nonemployer business
wholesalers were about $40,000.\4\ An unknown number of nonemployer
wholesalers could import children's products.
---------------------------------------------------------------------------

\4\ U.S. Department of Commerce, Bureau of the Census, ``Revised
2008 Nonemployer Statistics Table.'' Available at: https://www.census.gov/econ/nonemployer/Revised%202008%20Data%20With%202009%20Methodology%20Applied.xls
(last accessed 16 August 2011).
---------------------------------------------------------------------------

F. Compliance, Reporting, and Recordkeeping Requirements of Proposed
Rule

The proposed rule would require that children's product
manufacturers select representative samples required for the third
party periodic testing (required by 16 CFR 1107.21) to be selected
using a procedure that provides a basis for inferring compliance about
the population of untested products produced during the applicable
periodic testing interval. The proposed rule would further require that
the number of samples selected must be sufficient to ensure continuing
compliance with all the applicable children's product safety rules.
In order to be able to infer the compliance of the untested
products, the samples selected must be representative of the untested
or unselected units in the population of products produced during the
periodic testing interval. In other words, children's product
manufacturers must have a basis for believing that if the samples
selected for periodic testing show compliance with the applicable
children's product safety rules, then one can infer the compliance of
the untested units in the population.
Haphazard or nonpurposive methods of sample selection cannot
provide a basis for believing that the samples are representative
without additional information. In many cases, a manufacturer's
knowledge of the manufacturing processes or materials used in the
process may provide such information. For example, if the manufacturer
knows that a product or component is manufactured using the same grade
of material as all of the other units, and if the production processes
are controlled such that the all dimensions are the same as all other
units, then that product or component could be considered
representative of all other units produced during the interval.
Information that can be used to establish that a sample is
representative can come from a variety of sources, including inspection
of, or tests on, incoming materials or components, as well as
inspection, tests, and process-control data generated during
production.
Other methods of selecting representative samples include various
probability-based sampling methods. These methods include simple random
sampling, cluster sampling, systematic sampling, stratified sampling,
and multistage sampling. Probability-based sampling methods allow one
to make statistical inferences about the population of the products,
based upon results of tests on the selected samples.
The proposed rule would require that manufacturers document the
procedures used to select the product samples for periodic testing and
document the basis for that belief that the samples are representative
of the untested product produced during the periodic testing interval.
The records must be maintained for five years. The records can be
maintained electronically or in hardcopy. The manufacturer must make
the records available for inspection by the CPSC upon request. The
records may be maintained in languages other than English--if they can
be provided immediately to the CPSC upon request, and provided that the
manufacturer can translate them accurately into English within 48
hours--or any longer period negotiated with CPSC staff, upon a request
by the CPSC to translate the records.
There will be some costs associated with developing and
implementing sampling procedures that will result in the selection of
representative samples. Some knowledge of subjects such as statistics
and quality control techniques may be necessary to develop the
procedure even though the Commission has not mandated the use of
statistical sampling techniques. Some manufacturers may have these
skills in-house; others may need to hire outside consultants with these
skills. There also may be some ongoing costs associated with selecting
the representative samples once the procedures have been developed.
There also would be some costs associated with documenting the

[[Page 69592]]

procedure and maintaining the records that would be required by the
proposed rule. We invite comment on these costs and other impacts that
the proposed rule could have on manufacturers.

G. Alternatives for Reducing the Adverse Impact on Small Businesses

The Regulatory Flexibility Act requires agencies to consider
alternatives to proposed rules that would accomplish the stated
objectives of the applicable statutes and that would reduce the
economic impact on small entities. At a minimum, agencies must
consider:
1. The establishment of differing compliance or reporting
requirements that take into account the resources available to small
businesses;
2. The clarification, consolidation, or simplification of
compliance and reporting requirements for small entities;
3. The use of performance rather than design standards; and
4. An exemption from coverage of the rule, or any part of the rule
thereof, for small entities.
One alternative we considered was to propose less stringent
alternatives for selecting representative samples. One alternative
would be to allow manufacturers to select the samples using any method,
provided that the method used would not purposively lead to the
selection of samples that the manufacturers knows are more likely to
comply with a standard or requirement than other samples, or select
samples that are manufactured and chosen specifically to comply with a
standard or requirement (often referred to as ``golden samples''). For
example, manufacturers could pull randomly or nonpurposively the
samples for periodic testing from their finished goods inventory or
from the next lot or batch when the periodic testing needs to be
completed.
This alternative was not incorporated in the proposed rule because
we think that it is necessary for the manufacturer to have a positive
basis for their belief that the samples selected for periodic testing
are, in fact, representative of the entire population of units produced
during the periodic testing interval. If the manufacturer does not have
a basis for believing that the samples selected are representative,
then the ability to make inferences regarding the compliance of the
untested units produced during the interval is limited, and the
continued compliance, as stated in Sec. 14(i)(2)(B)(ii) of the CPSA,
cannot be ensured.
We invite comments on these or any other alternatives to the
proposed rule that could reduce the impact on small businesses. In
providing such comments, we request that the comments provide specific
suggestions and well-developed justifications for the suggestions.

V. Paperwork Reduction Act

This proposed rule contains information collection requirements
that are subject to public comment and review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). We describe the provisions in this section of
the document with an estimate of the annual reporting burden. Our
estimate includes the time for reviewing instructions, searching
existing data sources, gathering and maintaining the data needed, and
completing and reviewing each collection of information.
We invite comments on: (1) Whether the collection of information is
necessary for the proper performance of the CPSC's functions, including
whether the information will have practical utility; (2) the accuracy
of the CPSC's estimate of the burden of the proposed collection of
information, including the validity of the method and assumptions used;
(3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Title: Amendment to Regulation on Testing and Labeling Pertaining
to Product Certification Regarding Representative Samples for Periodic
Testing of Children's Products
Description: The proposed rule would require records that describe
how the samples for periodic testing are selected, the number of
samples that will be selected, and an explanation of why the procedure
described will result in the selection of representative samples, such
that one can infer that the untested units produced during the periodic
testing interval comply with the applicable children's product safety
rules if the samples selected comply.
Description of Respondents: Manufacturers of children's products.
We estimate the burden of this collection of information as
follows: Although it might take a manufacturer several hours, perhaps
several days to analyze its products and manufacturing processes to
determine its options for selecting representative samples (and some
might need to hire consultants for this purpose), the actual
documentation of the procedure and basis for inferring compliance will
probably take less time.
On the assumption that, because this document would be required by
regulation, manufacturers will make sure that the document is reviewed
and edited properly, it could take an average of 4 hours to prepare
this document, once the procedure that will be used is decided and the
number of samples has been determined. Developing the sampling
procedure and documenting it are managerial or professional functions.
According to the Bureau of Labor Statistics, as of March 2011, total
compensation for management, professional, and related occupations for
all workers in private industry was $50.08 an hour. Therefore, the cost
of creating the record documenting a procedure for selecting
representative samples could be estimated to be about $200 ($50.08 x 4
hours).\5\
---------------------------------------------------------------------------

\5\ Bureau of Labor Statistics, Employer Costs for Employee
Compensation, Table 9 (March 2011). Available at: https://www.bls.gov/ncs.
---------------------------------------------------------------------------

In developing the estimates of the recordkeeping burden associated
with the testing and labeling pertaining to the certification of a
children's products rule, we estimated that there were about 1.6
million children's products. However, manufacturers probably will not
need to develop and document a separate sampling procedure for each
product. It might be more reasonable to believe that manufacturers will
be able to use the same sampling plan for similar or closely related
products or product lines. Therefore, manufacturers may need to develop
and document separate sampling procedures for each set of closely
related children's products or children's product lines rather than
each individual product. For example, a manufacturer of die-cast toy
cars might offer 50 different models, but if each one is manufactured
using the same manufacturing processes and the same materials, one
sampling plan for all die-cast cars might be sufficient. We do not have
information on the number of closely related products or product lines
that manufacturers offer or the average number of individual models
within each set of closely related products or product lines. In some
cases, a manufacturer might have only one product in a particular
product line. Some large manufacturers may offer several hundred models
or styles within some product lines.
A starting point to estimate the recordkeeping burden of the
proposed rule is to assume that each product line averages 10 to 50
individual product models or styles. If each product line averages 50
individual models or styles,

[[Page 69593]]

then a total of 32,000 individual sampling plans (1.6 million
children's products / 50 models or styles) would need to be developed
and documented. This would require 128,000 hours (32,000 plans x 4
hours per plan) at a total cost of approximately $6.4 million (128,000
hours x $50.08 per hour). If each product line averages 10 individual
models or styles, then a total of 160,000 different sampling plans (1.6
million children's products / 10 models or styles) would need to be
documented. This would require 640,000 hours (160,000 plans x 4 hours
per plan), at a total cost of approximately $32 million (640,000 hours
x $50.08 per hour).
Once a sampling plan is developed and documented, manufacturers
will probably not incur the full cost of documenting their sampling
plans in subsequent years because the same plan and documentation
should be valid. However, each year, it is expected that manufacturers
will retire some product lines and introduce new ones. Moreover, some
manufacturers will leave the market, and other manufacturers will enter
the market. Therefore, there will be some ongoing costs associated with
documenting sampling plans.
We do not have data on the number of new product lines introduced
annually, whether from existing manufacturers or from new manufacturers
entering a market. For purposes of this analysis, we will assume that
about 20 percent of the children's product lines are new each year,
either because an existing manufacturer has changed an existing product
line to the extent that a new sampling plan is required, introduced a
new product line, or because a new manufacturer has entered the market.
If this is the case, then the ongoing recordkeeping costs associated
with the draft proposed rule would be 25,600 hours (128,000 hours x
0.2) to 128,000 hours (640,000 hours x 0.2) annually or approximately
$1.3 million (25,600 hours x $50.08 per hour) to approximately $6.4
million (128,000 hours x $50.08 per hour) annually.
Another potential ongoing recordkeeping cost might result if
manufacturers make adjustments or revisions to their sampling plans or
procedures for their existing product lines. This might occur if
manufacturers find that their initial procedures are difficult to
implement or if they come up with more efficient methods of selecting
representative samples. We do not have any information that could be
used to estimate how often manufacturers will revise these plans. For
purposes of this analysis, we will assume that this, too, would amount
to about 20 percent of the burden estimated for the initial year, or
approximately $1.3 million to $6.4 million annually.
As noted above, we do not have empirical data for most of the
numbers used in the examples above. We invite comments from
manufacturers and others to gather better insight on the potential
recordkeeping burden of the draft proposed rule.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3507(d)), we have submitted the information collection requirements of
this rule to OMB for review. Interested persons are requested to fax
comments regarding information collection by December 8, 2011, to the
Office of Information and Regulatory Affairs, OMB (see ADDRESSES).

VI. Executive Order 12988 (Preemption)

Executive Order 12988 (February 5, 1996), requires agencies to
state in clear language the preemptive effect, if any, of new
regulations. The proposed rule would be issued under the authority of
the CPSA and the CPSIA. The CPSA provision on preemption appears at
section 26 of the CPSA. The CPSIA provision on preemption appears at
section 231 of the CPSIA. The preemptive effect of this rule would be
determined in an appropriate proceeding by a court of competent
jurisdiction.

VII. Effective Date

The Administrative Procedure Act (APA) generally requires that the
effective date of a rule be at least 30 days after publication of a
final rule. 5 U.S.C. 553(d). The Commission intends that any final rule
based on this proposal would become effective on the same date as the
rule on ``Testing and Labeling Pertaining to Certification,'' published
elsewhere in this Federal Register, which is February 8, 2013.

VIII. Request for Comments

The issuance of this proposed rule begins a rulemaking proceeding
under sections 3 and 102 of the CPSIA that will establish performance
and recordkeeping requirements for the testing of representative
samples for periodic testing of children's products. We invite
interested persons to submit comments on any aspect of the proposed
rule. Comments should be submitted in accordance with the instructions
in the ADDRESSES section at the beginning of this notice.

List of Subjects in 16 CFR Part 1107

Business and industry, Children, Consumer protection, Imports,
Product testing and certification, Records, Record retention, Toys.

Accordingly, the Commission proposes to amend 16 CFR part 1107, as
proposed to be added elsewhere in this issue of the Federal Register,
to read as follows:

PART 1107--TESTING AND LABELING PERTAINING TO PRODUCT CERTIFICATION

1. The authority citation for part 1107 continues to read as
follows:

Authority: 15 U.S.C. 2063, Sec. 3, 102 Pub. L. 110-314, 122
Stat. 3016, 3017, 3022.

Subpart C--Certification of Children's Products

2. Add paragraph (f) to Sec. 1107.21 to read as follows:

Sec. 1107.21 Periodic testing.

* * * * *
(f) A manufacturer must select representative product samples to be
submitted to the third party conformity assessment body for periodic
testing. The procedure used to select representative product samples
for periodic testing must provide a basis for inferring compliance
about the population of untested products produced during the
applicable periodic testing interval. The number of samples selected
for the sampling procedure must be sufficient to ensure continuing
compliance with all applicable children's product safety rules. The
manufacturer must document the procedure used to select the product
samples for periodic testing and the basis for inferring the compliance
of the product manufactured during the periodic testing interval from
the results of the tested samples.
* * * * *
3. Add paragraph (a)(4) to Sec. 1107.26 to read as follows:

Sec. 1107.26 Recordkeeping.

(a) * * *
(4) Records documenting the testing of representative samples, as
set forth in Sec. 1107.21(f), including the number of representative
samples selected and the procedure used to select representative
samples. Records also must include the basis for inferring compliance
of the product manufactured during the periodic testing interval from
the results of the tested samples;
* * * * *

[[Page 69594]]

Dated: October 21, 2011.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2011-27686 Filed 11-7-11; 8:45 am]
BILLING CODE 6355-01-P

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