[Federal Register Volume 75, Number 223 (Friday, November 19, 2010)]
[Notices]
[Pages 70911-70914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-29209]


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CONSUMER PRODUCT SAFETY COMMISSION


Third Party Testing for Certain Children's Products; Children's 
Sleepwear, Sizes 0 Through 6X and 7 Through 14: Requirements for 
Accreditation of Third Party Conformity Assessment Bodies

AGENCY: Consumer Product Safety Commission.

ACTION: Notice of Requirements.

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SUMMARY: The Consumer Product Safety Commission (CPSC or Commission) is 
issuing a notice of requirements that provides the criteria and process 
for Commission acceptance of accreditation of third party conformity 
assessment bodies for testing of children's sleepwear pursuant to 16 
CFR parts 1615 and 1616, the CPSC regulations under the Flammable 
Fabrics Act (FFA) relating to the flammability of children's sleepwear. 
The Commission is issuing this notice of requirements pursuant to 
section 14(a)(3)(B)(vi) of the CPSA, 15 U.S.C. 2063(a)(3)(B)(vi).

DATES: Effective Date: The requirements for accreditation of third 
party conformity assessment bodies to assess conformity with 16 CFR 
parts 1615 and 1616 are effective upon publication of this notice in 
the Federal Register.

FOR FURTHER INFORMATION CONTACT: Patricia K. Adair, Director, Division 
of Combustion and Fire Sciences, U.S. Consumer Product Safety 
Commission, 4330 East West Highway, Bethesda, MD 20814; telephone 301-
504-7536; e-mail <a href="/cdn-cgi/l/email-protection#d9a9b8bdb8b0ab99baa9aabaf7beb6af"><span class="__cf_email__" data-cfemail="98e8f9fcf9f1ead8fbe8ebfbb6fff7ee">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: 

I. Introduction

A. Statutory Authority

    Section 14(a)(3)(B)(vi) of the CPSA, as added by section 102(a)(2) 
of the Consumer Product Safety Improvement Act of 2008 (CPSIA), Public 
Law 110-314, directs the CPSC to establish and publish a notice of 
requirements for accreditation of third party conformity assessment 
bodies to assess children's products for conformity with ``other 
children's product safety rules.'' Section 14(f)(1) of the CPSA defines 
``children's product safety rule'' as ``a consumer product safety rule 
under [the CPSA] or similar rule, regulation, standard, or ban under 
any other Act enforced by the Commission, including a rule declaring a 
consumer product to be a banned hazardous product or substance.'' Under 
section 14(a)(3)(A) of the CPSA, each manufacturer (including an 
importer) or private labeler of products subject to those regulations 
must have products that are manufactured more than 90 days after the 
establishment and Federal Register publication of a notice of the 
requirements for accreditation tested by a third party conformity 
assessment body accredited to do so, and must issue a certificate of 
compliance with the applicable regulations based on that testing. The 
Commission may extend the 90-day period by not more than 60 days if the 
Commission determines that an insufficient number of third party 
conformity assessment bodies have been accredited to permit 
certification for a children's product safety rule. Any requests for an 
extension should contain detailed facts showing why an extension is 
necessary.
    Section 14(a)(2) of the CPSA, as added by section 102(a)(2) of the 
CPSIA, requires that certification be based on testing of sufficient 
samples of the product, or samples that are identical in all material 
respects to the product. The Commission also emphasizes that, 
irrespective of certification, the product in question must comply with 
applicable CPSC requirements (see, e.g.,

[[Page 70912]]

section 14(h) of the CPSA, added by section 102(b) of the CPSIA).
    Section 14(a)(3)(G) of the CPSA, 15 U.S.C. 2063(a)(3)(G), exempts 
notices of requirements from the notice and comment rulemaking 
requirements of the Administrative Procedure Act, 5 U.S.C. 553. 
Therefore, the Commission finds good cause that notice and public 
procedure thereon are unnecessary.

B. The Children's Sleepwear Standards

    The Standards applicable to children's sleepwear (the 
``Standards'') are 16 CFR part 1615, Standard for the Flammability of 
Children's Sleepwear: Sizes 0 Through 6X (FF3-71), and 16 CFR part 
1616, Standard for the Flammability of Children's Sleepwear: Sizes 7 
Through 14 (FF5-74). The Standards were issued in the early 1970s to 
reduce the unreasonable risk of burn injuries and deaths from fires 
associated with children's sleepwear. Most burn incidents involving 
children's sleepwear do not occur while children are sleeping; rather, 
the incidents occur while the children are awake, unsupervised, and 
wearing the sleepwear. The primary hazard is ignition of sleepwear by 
contact with hot surfaces and/or small open-flame ignition sources, 
such as stove elements, matches, and lighters. The Standards require 
that children's sleepwear, and fabric intended for such sleepwear, stop 
burning when the flame source is removed.
    The original children's sleepwear Standard for sizes 0 through 6X 
was revised in 1972, to include a statistical sampling plan for fabrics 
and garments. The sampling plan was devised to give assurance to 
manufacturers that sleepwear garments reaching the marketplace meet the 
flammability test, and that children wearing the sleepwear garments 
receive increased protection. The sampling plan also was intended to 
provide a framework for premarket testing, and thus, greatly assist in 
detecting noncomplying fabrics and garments before they are placed on 
the market. When the Standard for sizes 7 through 14 was issued in 
1975, it incorporated the same sampling plan as the one in the Standard 
for sizes 0 through 6X.
    The Standards require testing of the fabric to be used in 
children's sleepwear, of preproduction prototypes of the garment style 
or type which includes testing of the seams and the trim attached to 
the fabric, and of the seams of finished garments, by having fabric, 
seams, and trim exposed to a flame source under controlled conditions, 
as discussed below. To meet the criteria in Sec.  1615.3(b) and Sec.  
1616.3(b), three samples of five specimens each are tested, and the 
average char length of the sample must not exceed 17.8 centimeters (cm) 
(7.0 inches (in)) and no individual specimen may have a char length of 
25.4 cm (10.0 in).
    In 1996, the Commission published amendments to the Standards that 
except products of wearing apparel from the definition of children's 
sleepwear for the purpose of testing to the flammability requirements 
if they are:
    (1) Infant garments as defined in Sec.  1615.1(c) or;
    (2) Tight-fitting as defined in Sec.  1615.1(o) and Sec.  
1616.2(m), provided the garment is labeled with its size and provided 
with a specified warning statement on a hangtag attached to the garment 
and on a label on any package in which the garment is sold.

All wearing apparel excepted pursuant to Sec.  1615.1(c), Sec.  
1615.1(o) or Sec.  1616.2(m) must otherwise comply with all the 
applicable requirements of the Standard for the Flammbility of Clothing 
Textiles (16 CFR part 1610) and the Standard for the Flammability of 
Vinyl Plastic Film (16 CFR part 1611).
    Children's sleepwear garments subject to the Standards must follow 
specific sampling plans and be tested for flammability performance at 
several stages of production. The Standards have performance 
requirements for fabric, prototypes (seams and trims), and garment 
production units. There are recordkeeping requirements at each stage of 
testing. The following summarizes the three stages of testing:
    (1) Fabric testing. Fabrics that are promoted for use in children's 
sleepwear are tested in the finished state (either original state or 
after one laundering) and must meet the requirements after 50 
launderings (wash and dry) in either the fabric or finished garment 
state. Testing is of a Fabric Production Unit (FPU), which is a 
continuous length of fabric up to 5,000 linear yards, or 10,000 linear 
yards for reduced sampling, which has a specified identity that remains 
unchanged throughout the unit, except for color or print pattern, as 
specified in the Standards. Samples are taken from the beginning and 
end of the FPU.
    (2) Prototype testing. Once a garment design is proposed, the seams 
and trims are tested to assure that satisfactory garment specifications 
have been chosen prior to production. All seam types and all seams over 
10 inches are tested. Trims are tested in the orientation they will be 
used in the final garment; however, neckline, shoulder, and sleeve trim 
are only tested in the vertical configuration (the most severe 
scenario).
    (3) Production testing. Garment Production Unit (GPU) testing is 
carried out to assess the flammability of the garment as produced. The 
longest seam type is tested at this stage. Tests are conducted on each 
GPU, and each GPU is either accepted or rejected. The maximum number of 
garments in a GPU is 500 dozen (6,000 garments).

C. This Notice of Requirements

    This notice provides the criteria and process for the Commission's 
acceptance of accreditation of third party conformity assessment bodies 
for testing pursuant to 16 CFR part 1615, Standard for the Flammability 
of Children's Sleepwear: Sizes 0 Through 6X (FF3-71), and 16 CFR part 
1616, Standard for the Flammability of Children's Sleepwear: Sizes 7 
Through 14 (FF5-74). Section 3(a)(2) of the CPSA defines a ``children's 
product'' as ``a consumer product designed or intended primarily for 
children 12 years of age and younger.'' The sizes of sleepwear covered 
by the cited regulations are primarily intended for children age 12 
years and younger; these sizes of sleepwear are therefore ``children's 
products'' as that term is defined in the CPSA.
    This notice of requirements applies to all third party conformity 
assessment bodies as described in section 14(f)(2) of the CPSA that 
desire to test children's sleepwear to the requirements of 16 CFR parts 
1615 and/or 1616, where the test results will be used as the basis for 
a certification that the sleepwear complies with those requirements. 
Such third party conformity assessment bodies can be grouped into three 
general categories: (1) Third party conformity assessment bodies that 
are not owned, managed, or controlled by a manufacturer or private 
labeler of a children's product to be tested by the third party 
conformity assessment body for certification purposes; (2) 
``firewalled'' conformity assessment bodies (those that are owned, 
managed, or controlled by a manufacturer or private labeler of a 
children's product to be tested by the third party conformity 
assessment body for certification purposes and that seek accreditation 
under the additional statutory criteria for ``firewalled'' conformity 
assessment bodies); and (3) third party conformity assessment bodies 
owned or controlled, in whole or in part, by a government.
    This notice of requirements is effective on November 19, 2010. 
Further, the publication of this notice of requirements lifts the 
Commission's previous stay of enforcement with

[[Page 70913]]

regard to testing and certifications related to 16 CFR parts 1615 and 
1616. Therefore, each manufacturer of children's sleepwear subject to 
these regulations that is manufactured after February 17, 2011 must 
have samples of any such product, or samples that are identical in all 
material respects to such product, tested by a third party conformity 
assessment body accredited to do so and, based on such testing, issue a 
certificate that the sleepwear complies with the applicable Standard, 
before the sleepwear is imported for consumption or warehousing or 
distributed in commerce. (Under section 3(a)(11) of the CPSA, the term 
``manufacturer'' includes anyone who manufactures or imports a 
product.) The Commission also is recognizing limited circumstances in 
which it will accept certifications based on product testing conducted 
before the third party conformity assessment body is accepted as 
accredited by the CPSC. The details regarding those limited 
circumstances are in part IV of this document below.
    As noted above, these Standards require testing at three stages in 
the process of developing and producing the sleepwear (fabric, 
prototype seams and trim, and production seams). The tests at each of 
these stages are designed to detect risks that can be reflected in the 
production garments. In addition, the results of the tests cannot have 
meaning unless the sampling criteria in the Standards are followed. 
Therefore, in order for third party testing to serve as the basis for 
the required certificate that the garment complies with the applicable 
Standard, it is necessary for the tests by a third party conformity 
assessment body whose accreditation has been accepted by the Commission 
be performed as specified in the Standards, that is, tests at the three 
stages specified in the Standards according to the sampling criteria in 
the Standards. Of course, responsible parties must, in addition, comply 
with all recordkeeping requirements of the Standards. We do note, 
however, that 16 CFR 1615.35(b)(1) and 1616.35(c)(1) allow a firm to 
use another testing regime if the firm has proof that the other test is 
at least as stringent as the Standards.
    In addition, the Commission will not require third party testing to 
demonstrate that a product meets the exception for ``tight-fitting 
garments'' as defined by Sec. Sec.  1615.1(c) and 1616.2(m), as these 
garments are not subject to the Standards. However, all fabrics 
intended for sleepwear meeting the tight-fitting exception from 16 CFR 
parts 1615 and 1616 must meet the flammability requirements of 16 CFR 
part 1610, Standard for the Flammability of Clothing Textiles, and 16 
CFR part 1611, Standard for the Flammability of Vinyl Plastic Film. The 
Commission also will not require that the presence of the required 
labels and hangtags for tight-fitting garments be subject to third 
party testing. This is consistent with the exemption from testing 
accorded to labeling requirements under the Federal Hazardous 
Substances Act (see NEWS from CPSC, December 18, 2009 (Release No. 10-
083)).

D. Lifting the Stay of Enforcement of Section 14(a) of the CPSA as to 
Children's Sleepwear

    The Commission stayed the enforcement of certain provisions of 
section 14(a) of the CPSA in a notice published in the Federal Register 
on February 9, 2009 (74 FR 6396). The stay applied to testing and 
certification of various products, including children's sleepwear. On 
December 28, 2009, the Commission published a notice in the Federal 
Register (74 FR 68588) revising the terms of the stay. The December 28, 
2009 notice did not lift the stay with regard to testing and 
certification of children's sleepwear because no notice of requirements 
had been published applicable to the Standards for these products. 
Since this notice provides such a notice of requirements, it has the 
effect of lifting the stay with regard to 16 CFR parts 1615 and 1616.

II. Accreditation Requirements

A. Baseline Third Party Conformity Assessment Body Accreditation 
Requirements

    For a third party conformity assessment body to be accredited to 
test children's products for conformity with the test methods in the 
regulations identified earlier in part I of this document, it must be 
accredited by an ILAC-MRA signatory accrediting body, and the 
accreditation must be registered with, and accepted by, the Commission. 
A listing of ILAC-MRA signatory accrediting bodies is available on the 
Internet at http:[sol][sol]ilac.org[sol]membersbycategory.html. The 
accreditation must be to ISO Standard ISO/IEC 17025:2005, General 
Requirements for the Competence of Testing and Calibration 
Laboratories, and the scope of the accreditation must expressly include 
testing to the regulations in 16 CFR parts 1615 and/or 1616. (A 
description of the history and content of the ILAC-MRA approach and of 
the requirements of the ISO[sol]IEC 17025:2005 laboratory accreditation 
standard is provided in the CPSC staff briefing memorandum, ``Third 
Party Conformity Assessment Body Accreditation Requirements for Testing 
Compliance with 16 CFR part 1501 (Small Parts Regulations),'' dated 
November 2008, and available on the CPSC's Web site at 
http:[sol][sol]www.cpsc.gov[sol]ibrary[sol]foia[sol]foia09[sol]brief[sol
]smallparts.pdf. A true copy, in English, of the accreditation and 
scope documents demonstrating compliance with the requirements of this 
notice must be registered with the Commission electronically. The 
additional requirements for accreditation of firewalled and 
governmental conformity assessment bodies are described in parts II.B 
and II.C of this document below.
    The Commission will maintain on its Web site an up-to-date listing 
of the third party conformity assessment bodies whose accreditations it 
has accepted and the scope of each accreditation. Subject to the 
limited provisions for acceptance of ``retrospective'' testing noted in 
part IV below, once the Commission adds a third party conformity 
assessment body to that list, the third party conformity assessment 
body may commence testing of children's products to support the 
manufacturer's certification that the product complies with the 
regulations identified earlier in part I of this document.

B. Additional Accreditation Requirements for Firewalled Conformity 
Assessment Bodies

    In addition to the baseline accreditation requirements in part II.A 
of this document above, firewalled conformity assessment bodies seeking 
accredited status must submit to the Commission copies, in English, of 
their training documents showing how employees are trained to notify 
the Commission immediately and confidentially of any attempt by the 
manufacturer, private labeler, or other interested party to hide or 
exert undue influence over the third party conformity assessment body's 
test results. This additional requirement applies to any third party 
conformity assessment body in which a manufacturer or private labeler 
of a children's product to be tested by the third party conformity 
assessment body owns an interest of 10 percent or more. While the 
Commission is not addressing common parentage of a third party 
conformity assessment body and a children's product manufacturer at 
this time, it will be vigilant to see if this issue needs to be 
addressed in the future.
    As required by section 14(f)(2)(D) of the CPSA, the Commission must

[[Page 70914]]

formally accept, by order, the accreditation application of a third 
party conformity assessment body before the third party conformity 
assessment body can become an accredited firewalled conformity 
assessment body. The Commission's order must also find that accrediting 
the firewalled conformity assessment body would provide equal or 
greater consumer safety protection than the manufacturer's or private 
labeler's use of an independent conformity assessment body.

C. Additional Accreditation Requirements for Governmental Conformity 
Assessment Bodies

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

III. How Does a Third Party Conformity Assessment Body Apply for 
Acceptance of Its Accreditation?

    The Commission has established an electronic accreditation 
registration and acceptance system accessed via the Commission's 
Internet site at 
http:[sol][sol]www.cpsc.gov[sol]about[sol]cpsia[sol]labaccred.html. The 
applicant provides, in English, basic identifying information 
concerning its location and the type of accreditation it is seeking, as 
well as electronic copies of its ILAC-MRA accreditation certificate and 
scope statement and its firewalled third party conformity assessment 
body training document(s), if applicable.
    Commission staff will review the submission for accuracy and 
completeness. In the case of baseline third party conformity assessment 
bodies and government-owned or government-controlled conformity 
assessment bodies, when that review and any necessary discussions with 
the applicant are satisfactorily completed, the third party conformity 
assessment body in question is added to the CPSC's list of accredited 
third party conformity assessment bodies at 
http:[sol][sol]www.cpsc.gov[sol]about[sol]cpsia[sol]labaccred.html. In 
the case of a firewalled conformity assessment body seeking accredited 
status, when the staff's review is complete, the staff transmits its 
recommendation on accreditation to the Commission for consideration. (A 
third party conformity assessment body that ultimately may seek 
acceptance as a firewalled third party conformity assessment body also 
initially can request acceptance as a third party conformity assessment 
body accredited for testing of children's products other than those of 
its owners.) If the Commission accepts a staff recommendation to 
accredit a firewalled conformity assessment body, the Commission will 
issue an order making the required statutory findings, and the 
firewalled conformity assessment body then will be added to the CPSC's 
list of accredited third party conformity assessment bodies. In each 
case, the Commission will notify the third party conformity assessment 
body electronically of acceptance of its accreditation. All information 
to support an accreditation acceptance request must be provided in the 
English language.
    Subject to the limited provisions for acceptance of 
``retrospective'' testing noted in part IV of this document below, once 
the Commission adds a third party conformity assessment body to the 
list, the third party conformity assessment body may begin testing of 
children's products to support certification of compliance with the 
regulations for which it has been accredited.

IV. Limited Acceptance of Children's Product Certifications Based on 
Third Party Conformity Assessment Body Testing Prior to the 
Commission's Acceptance of Accreditation

    The Commission will accept a certificate of compliance with 16 CFR 
part 1615 and[sol]or 16 CFR part 1616 based on testing performed by an 
accredited third party conformity assessment body (including a 
government-owned or government-controlled conformity assessment body, 
or a firewalled conformity assessment body) prior to the Commission's 
acceptance of its accreditation if all the following conditions are 
met:
    <bullet> When the product was tested, the testing was done by a 
third party conformity assessment body that at that time was 
ISO[sol]IEC 17025 accredited by an ILAC-MRA signatory and the scope of 
the accreditation included the regulations specified in this notice. 
For firewalled conformity assessment bodies, the Commission will not 
accept a certificate of compliance based on testing performed by the 
third party conformity assessment body unless the firewalled conformity 
assessment body was accredited by order as a firewalled conformity 
assessment body before the product was tested, even though the order 
will not have included the test methods in the regulations specified in 
this notice.
    <bullet> The third party conformity assessment body's application 
for testing using the test methods in the regulations identified in 
this notice is accepted by the CPSC on or before January 18, 2011.
    <bullet> The product was tested on or after November 19, 2009, with 
respect to the regulations identified in this notice.
    <bullet> The test results show compliance with the applicable 
current standards and[sol]or regulations.
    <bullet> The third party conformity assessment body's accreditation 
remains in effect from the date of testing through the effective date 
for mandatory third party testing and manufacturer certification for 
conformity with 16 CFR parts 1615 and[sol]or 1616.

    Dated: November 15, 2010.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2010-29209 Filed 11-18-10; 8:45 am]
BILLING CODE 6355-01-P


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