Testing and Labeling Pertaining to Product Certification, 28336-28366 [2010-11365]

Agencies

• Consumer Product Safety Commission

[Federal Register Volume 75, Number 97 (Thursday, May 20, 2010)]
[Proposed Rules]
[Pages 28336-28366]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-11365]



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Part II





Consumer Product Safety Commission





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16 CFR Part 1107



Testing and Labeling Pertaining to Product Certification; Proposed Rule

Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / 
Proposed Rules

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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1107

[CPSC Docket No. CPSC-2010-0038]
RIN 3041-AC71


Testing and Labeling Pertaining to Product Certification

AGENCY: Consumer Product Safety Commission.

ACTION: Proposed rule.

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SUMMARY: The Consumer Product Safety Commission (``CPSC'' or 
``Commission'') is issuing a proposed rule that would establish 
requirements for a reasonable testing program and for compliance and 
continuing testing for children's products.\1\ The proposal would also 
address labeling of consumer products to show that the product complies 
with certification requirements under a reasonable testing program for 
nonchildren's products or under compliance and continuing testing for 
children's products. The proposed rule would implement section 14(a) 
and (d) of the Consumer Product Safety Act (``CPSA''), as amended by 
section 102(b) of the Consumer Product Safety Improvement Act of 2008 
(``CPSIA'').
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    \1\ The Commission voted 5-0 to approve publication of this 
proposed rule. Chairman Inez Tenenbaum and Commissioners Nancy Nord 
and Anne Northup filed statements concerning this action. These 
statements may be viewed on the Commission's Web site at https://www.cpsc.gov/pr/statements.html or obtained from the Commission's 
Office of the Secretary.

DATES: Written comments and submissions in response to this notice must 
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be received by August 3, 2010.

ADDRESSES: You may submit comments, identified by Docket No. CPSC-2010-
0038, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way: Federal 
eRulemaking Portal: https://www.regulations.gov. Follow the instructions 
for submitting comments.
    To ensure timely processing of comments, the Commission is no 
longer accepting comments submitted by electronic mail (e-mail) except 
through https://www.regulations.gov.

Written Submissions

    Submit written submissions in the following 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 502, 4330 East West Highway, 
Bethesda, MD 20814; telephone (301) 504-7923.
    Instructions: All submissions received must include the agency name 
and docket number for this proposed rulemaking. 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.
    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, U.S. Consumer Product 
Safety Commission, 4330 East West Highway, Bethesda, Maryland 20814; 
301-504-7562; e-mail: RButturini@cpsc.gov.

SUPPLEMENTARY INFORMATION: 

A. Statutory Authority

    Section 14(a)(1) of the CPSA, (15 U.S.C. 2063(a)(1)), as amended by 
section 102 of the CPSIA, establishes requirements for the testing and 
certification of products subject to a consumer product safety rule 
under the CPSA or similar rule, ban, standard, or regulation under any 
other act enforced by the Commission and which are imported for 
consumption or warehousing or distributed in commerce. Under section 
14(a)(1)(A) of the CPSA, manufacturers and private labelers must issue 
a certificate which ``shall certify, based on a test of each product or 
upon a reasonable testing program, that such product complies with all 
rules, bans, standards, or regulations applicable to the product under 
the CPSA or any other Act enforced by the Commission.'' CPSC 
regulations, at 16 CFR part 1110, limit the certificate requirement to 
importers and domestic manufacturers. Section 14(a)(1)(B) of the CPSA 
further requires that the certificate provided by the importer or 
domestic manufacturer ``specify each such rule, ban, standard, or 
regulation applicable to the product.'' The certificate described in 
section 14(a)(1) of the CPSA is known as a General Conformity 
Certification (GCC).
    Section 14(a)(2) of the CPSA (15 U.S.C. 2063(a)(2)) establishes 
testing requirements for children's products that are subject to a 
children's product safety rule. (Section 3(a)(2) of the CPSA (15 U.S.C. 
2052(a)(2)) defines a children's product, in part, as a consumer 
product designed or intended primarily for children 12 and younger.) 
Section 14(a)(2)(A) of the CPSA also states that, before a children's 
product subject to a children's product safety rule is imported for 
consumption or warehousing or distributed in commerce, the manufacturer 
or private labeler of such children's product must submit sufficient 
samples of the children's product ``or samples that are identical in 
all material respects to the product'' to an accredited ``third party 
conformity assessment body'' to be tested for compliance with the 
children's product safety rule. Based on such testing, the manufacturer 
or private labeler, under section 14(a)(2)(B) of the CPSA, must issue a 
certificate that certifies that such children's product complies with 
the children's product safety rule based on the assessment of a third 
party conformity assessment body accredited to perform such tests.
    Section 14(d)(2)(A) of the CPSA requires the Commission to initiate 
a program by which a manufacturer or private labeler may label a 
consumer product as complying with the certification requirements. This 
provision applies to all consumer products that are subject to a 
product safety rule administered by the Commission.
    Section 14(d)(2)(B) of the CPSA requires the Commission to 
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;
     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.
    Section 14(d)(2)(B)(iii) of the CPSA provides for verification that 
a children's product tested by a conformity assessment body complies 
with applicable children's product safety rules. At this time, the 
Commission is not imposing any verification obligations on 
manufacturers because the Commission intends to conduct the 
verification itself under its inherent authorities while it gains more 
experience with the testing and certification requirements. When the 
Commission finds that a children's

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product accompanied by a certificate of conformity does not pass the 
tests upon which the certification was based, it may initiate an 
investigation of the manufacturer, third party conformity assessment 
body, and any other relevant party in the supply chain, to determine 
the cause of the discrepancy.
    The proposed rule would implement sections 14(a) and (d) of the 
CPSA, as amended by section 102(b) of the CPSIA, by:
     Defining the elements of a ``reasonable testing program'' 
for purposes of section 14(a)(1)(A) of the CPSA;
     Establishing the protocols and standards for continuing 
testing of children's products under section 14(d)(2)(B)(i), (ii), and 
(iv) of the CPSA; and
     Describing the label that manufacturers may place on a 
consumer product to show that the product complies with the 
certification requirements for purposes of section 14(d)(2)(A) of the 
CPSA.
    The proposed rule also builds upon previous documents and 
activities by the Commission. For example, on November 3, 2009, 
Commission staff made available a draft guidance document titled, 
``Guidance Document: Testing and Certification Requirements Under the 
Consumer Product Safety Improvement Act of 2008.'' The draft guidance 
document, which is available at https://www.cpsc.gov/library/foia/foia10/brief/102testing.pdf, was intended to provide the Commission's 
interpretation of the requirements of section 102 of the CPSIA. 
Specifically, it sought to describe the Commission's position on a 
reasonable testing program and how to certify that a product complies 
with all rules, bans, standards, or other regulations applicable to the 
product under the laws enforced by the Commission. The guidance 
document also sought to explain when and how component testing to 
certain specific requirements would be allowed. Although the Commission 
never voted on whether to approve or to not approve the issuance of the 
draft guidance document, the draft did represent the Commission staff's 
thinking on the subject. Shortly thereafter, in the Federal Register of 
November 13, 2009 (74 FR 58611), the Commission announced that it would 
hold a two-day public workshop to discuss issues relating to the 
testing, certification, and labeling of consumer products pursuant to 
section 14 of the CPSA. The workshop was held on December 10 through 
11, 2009, in Bethesda, Maryland, and the Commission invited interested 
parties to attend and participate in the meeting. Commission staff made 
presentations on specific topics and held breakout sessions on:
     Sampling and statistical considerations;
     Verification of third party test results;
     Reasonable test programs and third party testing;
     Challenges for small manufacturer/low-volume production;
     Component testing and material changes; and
     Protection against undue influence.

    The notice also stated that the Commission wanted to use the 
workshop to discuss possible options for implementing section 14 of the 
CPSA. Several hundred individuals attended the workshop.

    The Commission understands the economic ramifications that small 
businesses (and even large businesses) face regarding the testing costs 
required by section 102 of the CPSIA. Moreover, retailers and importers 
may be imposing significant additional testing cost on manufacturers by 
requiring that products that have already been tested by a third party 
conformity assessment body be tested again by a specific third party 
conformity assessment body selected by the retailer or importer. The 
Commission wants to emphasize to retailers and sellers of children's 
products that they can rely on certificates provided by product 
suppliers if those certificates are based on testing conducted by a 
third party conformity assessment body. Section 19(b) of the CPSA 
provides that a retailer or seller of a children's product shall not be 
subject to civil or criminal penalties for selling products that do not 
comply with applicable safety standards if it holds a certificate 
issued in accordance with section 14(a) of the CPSA to the effect that 
such consumer product conforms to all applicable consumer product 
safety rules, unless such person knows that such consumer product does 
not conform. The Commission notes that section 19(b) of the CPSA does 
not relieve any person of the obligation to conduct a corrective action 
should any product violate an applicable safety standard and need to be 
recalled.
    In order to provide some relief from testing costs, elsewhere in 
this issue of the Federal Register, the Commission has issued a 
separate proposed rule which would allow for testing of component parts 
as a basis for certification of finished products in certain 
circumstances. The Commission intends to make clear in the two proposed 
rules that, in some cases, the required certificate for children's 
products can be based on component part testing as described in 
proposed 16 CFR part 1109, rather than testing of the finished product, 
if components are tested by a third party testing conformity assessment 
body. Furthermore, these proposed rules would allow importers to base 
their product certification for a children's product on a certificate 
provided by a foreign manufacturer as long as that manufacturer has 
based its certificate on third party testing conducted by a third party 
conformity assessment body.

B. Responses to Comments on the Notice of Availability and the Public 
Workshop

    In connection with the public workshop, the Commission invited 
public comment on its implementation of various aspects of section 14 
of the CPSA.
    The Federal Register notice announcing the meeting identified 
specific issues for public comment; for example, in the section titled, 
``What are the issues regarding additional third party testing of 
children's products?'' the Commission asked:
     Should the potential hazard (either the severity or the 
probability of occurrence) be considered in determining how frequently 
the periodic testing is conducted? For example, should a product 
subject to a consumer product safety rule, where the potential hazard 
is death, be tested more frequently than a product where the potential 
hazard is some lesser degree of harm? If so, how might a rule 
incorporate potential hazard into testing frequency?
     What changes should constitute a ``material change'' in a 
product's design or manufacturing process? Are there criteria by which 
one might determine whether a change is a ``material'' change? For 
example, a material change in a product's design or manufacturing 
process could be described as a change that affects the product's 
ability to comply with a consumer product safety rule. However, as a 
practical matter, it may be difficult to determine what consumer 
product safety rules apply to the product and the extent to which 
compliance with those rules is affected by a change.

See 74 FR at 58614.

    The Commission received 38 comments, and we discuss those comments, 
and our responses, in parts B.1 through B.12 of this document. To make 
it easier to identify comments and our responses, the word ``Comment'' 
or ``Comments'' will appear before the

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comment's description, and the word ``Response'' will appear before our 
response.

 1. The Reasonable Testing Program

    In the Federal Register notice announcing the public workshop, the 
Commission had described a ``reasonable testing program'' as consisting 
of:
     Product specifications that describe the consumer product 
and list the safety rules, standards, etc., with which the product must 
comply. The product specification should include a complete description 
of the product and any other information, including, but not limited 
to, a bill of materials, parts listing, raw material selection and 
sourcing, and/or model names or numbers of items necessary to describe 
the product and differentiate it from other products;
     Certification tests which are performed on samples of the 
manufacturer's consumer product to demonstrate that the product is 
capable of passing the tests prescribed by the standard;
     A production testing plan which describes the tests that 
must be performed and the testing intervals to provide reasonable 
assurance that the products as produced meet all applicable safety 
rules;
     A remedial action plan which must be employed whenever 
samples of the consumer product or results from any other tests used to 
assess compliance yield unacceptable or failing test results; and
     Documentation of the reasonable testing program and how it 
was implemented.

See 74 FR at 58613.

    Comments: Most comments addressed the five elements of the 
reasonable testing program, either by suggesting that the Commission 
allow for some flexibility as to what constitutes a reasonable testing 
program or by suggesting specific exceptions or tests as part of a 
reasonable testing program.
    Several comments expressed concern that many manufacturers may not 
be able to specify their products down to the component or raw material 
level because proprietary information from offshore manufacturers may 
prevent importers from knowing every component of the products they 
purchase. One comment noted that importers typically do not control the 
production process of the products they import, so the Commission 
should define a reasonable testing program differently to address an 
importer's special circumstances.
    Another comment suggested that ``reasonable'' for some products 
would involve less than the five elements outlined by CPSC in the 
notice for a reasonable testing program. For example, because some 
regulations require placement of a label, the comment said that 
``testing'' in that circumstance would consist of observing that the 
label was placed properly.
    One comment stated that any testing program that results in an 
acceptable confidence level that a product complies with the applicable 
standards should be considered an acceptable reasonable testing 
program. The comment also suggested that other items, such as factory 
certification (to recognized standards), audits, risk assessment plans, 
certification of a manufacturer's quality system, etc., should be 
allowed as elements of a reasonable testing plan.
    One comment suggested allowing process capability testing, where, 
for a continuous-flow process, first-run samples are tested, as a form 
of certification testing. The comment urged the Commission to allow a 
manufacturer to search ``backwards'' and ``forwards'' in continuous-
flow process for good product in the event that a test during 
manufacturing shows noncompliance.
    Several comments noted that, for seasonal or short-run products, 
only prototype samples may exist before production begins. Some 
comments stated that neither the same materials nor the same 
manufacturing processes were used to manufacture the prototype samples 
as would be used to manufacture the consumer product.
    Multiple comments stated that the relative hazard should be a 
factor in determining the test frequency. Some stated that higher risks 
should necessitate a higher test frequency, and where the perceived 
risk is low, third party testing should not be mandatory for some 
products.
    One comment suggested that a manufacturer's record of manufacturing 
products with low-lead levels should result in relaxed testing 
requirements.
    One comment remarked on the differences between conformity 
assessment and certification. The comment suggested that CPSC 
regulations should clarify that a ``reasonable testing program'' means 
a conformity assessment process such as that in Annex A of ISO/IEC 
17000 and describe the five elements in generic terms that avoid the 
implication that ``testing'' will always be the evaluation activity. 
This comment noted that the phrase ``production testing plan'' is 
misleading in that only testing is anticipated, and would expand the 
interpretation to include activities certification bodies use to assess 
continuing compliance.
    One comment said that the Commission must issue regulations 
clarifying what will constitute ``unacceptable or failing'' test 
results for product testing. Additionally, the comment stated that the 
Commission's regulations should explicitly allow for retesting prior to 
remanufacturing or redesigning. One comment specifically stated that 
the reasonable testing program should be implemented for children's 
products.
    Response: The Commission believes that the five elements of a 
reasonable testing program are adaptable to manufacturers' and 
importers' circumstances, are present in most testing programs (even if 
some of the elements might seem trivial), and can be accomplished with 
seemingly little effort. However, the five elements are essential and 
should be included to ensure a high degree of assurance of compliance 
to the applicable rules, bans, standards, or regulations.
    For the product specification component of a reasonable testing 
program, a manufacturer is not required to specify every component or 
raw material of a product. The manufacturer is free to describe its 
product by model number, general description, photograph, etc., as long 
as the product is identifiable and differentiable from other products.
    The Commission agrees that other elements such as risk assessment 
plans, quality system certification, and factory certifications could 
be added to provide a manufacturer with a high degree of assurance that 
the product produced complies with all applicable requirements. 
However, many methods suggested in the comments would require CPSC to 
assess and recognize or certify the certification services providers 
and require the manufacturer and importer to purchase these 
certification services. The approach in the proposed rule seeks to 
identify a method whereby a manufacturer or importer can independently 
establish a reasonable testing program and establish a set of minimum 
requirements for these reasonable testing programs that reflect 
commonly used elements of a quality assurance/quality control system. 
If process capability testing can ensure with a high degree of 
assurance that the product is capable of meeting the applicable rules, 
bans, standards, or regulations, that form of testing can be used for 
certification testing. Similarly, techniques used during production to 
ensure, with a high degree of assurance, that the continuing production 
is

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compliant can be considered as acceptable production testing plans.
    For children's products, section 14(a)(2) of the CPSA requires 
manufacturers to submit ``sufficient samples of the children's product, 
or samples that are identical in all material respects to the 
product,'' to a third party conformity assessment bodies for testing. A 
prototype manufactured with different materials or manufacturing 
processes than the finished product cannot be considered the same in 
all material respects as the finished product with respect to 
compliance. Therefore, section 14(a)(2) of the CPSA does not allow for 
testing of prototype samples unless they are identical in all material 
respects to the finished product. The proposed rule would extend the 
requirement to test only prototype samples that are identical in all 
material respects to the finished product that will be imported for 
consumption, warehoused, or distributed in commerce to manufacturers of 
nonchildren's products under section 14(a)(1) of the CPSA.
    While the Commission agrees that a higher risk level should 
necessitate a greater testing frequency, it should be noted that risk 
and potential severity are not indicators of the level of compliance to 
the legal standards, regulations, rules, and bans. Section 14 of the 
CPSA does not allow for the exclusion of any children's product from 
third party testing based on a perceived low level of risk. Thus, 
regardless of other existing means of determining compliance, products 
must be tested for compliance to the applicable rules, bans, standards, 
or regulations.
    As for the conformity assessment process in ISO/IEC 17000, the 
Commission does not consider it to be equivalent to a reasonable 
testing program. In sections 14(a) and 14(d)(2)(B) of the CPSA, testing 
is specifically mentioned as the evaluation activity. Thus, regardless 
of other means of determining compliance, products must be tested for 
compliance to the applicable rules. The conformity assessment process 
mentioned in Annex A of ISO/IEC 17000 includes attestations in its 
principles of conformity assessment. However, the CPSA requires the 
manufacturer to perform the attestation that its products comply with 
the applicable rules. If the manufacturer uses a third party conformity 
assessment body to conduct the testing of its products, then the 
determination and attestation functions would be performed by two 
separate parties. Thus, the conformity assessment process in ISO/IEC 
17000 is not equivalent to the reasonable testing program mentioned in 
section 14(a) of the CPSA. However, the certification testing and the 
production testing plan in the reasonable testing program do allow a 
wide latitude of actions in determining initial and continuing 
compliance to the applicable rules for a product.
    Test results that indicate noncompliance to the applicable rules 
are unacceptable or failing test results. Retesting, as a general 
matter, should not be allowed because doing so may tempt unscrupulous 
parties to attempt to ``test the product into compliance,'' (i.e., to 
repeat testing a product until a sample passes the test and then reject 
the earlier unacceptable or failing test results). The intent of 
section 14 of the CPSA is to conduct tests to provide assurance that 
all the products being imported, warehoused, or distributed in 
interstate commerce comply with all applicable rules.

2. Flexibility in Testing

    Comments: Many comments stressed the need for flexibility in test 
protocols. Some comments stated that the types of products are so 
varied that no one prescribed system could be devised to effectively 
and efficiently apply to all of them. Other comments noted that 
determining the number of samples to be tested should be left to the 
manufacturer, who has intimate knowledge of the product's manufacturing 
process, to decide.
    Response: The Commission agrees that it is difficult to develop 
rigid protocols for testing across all categories of products, 
manufacturers, and importers. A manufacturer may tailor the tests to 
the needs of the individual product, and the tests do not need to be 
the same tests that are specified in the applicable rules, provided 
that they are at least as effective in assessing compliance. The 
proposed rule would leave decisions on procedures, such as the number 
of samples to test, up to the manufacturer provided that the testing 
plan provides a high degree of assurance that noncompliant products are 
not introduced into the stream of commerce.

3. Existing Testing Programs

    Comments: One comment asked if the Toy Safety Certification Program 
initiated by the Toy Institute of America (TIA) could be accepted as a 
reasonable testing program under section 14(a)(1) of the CPSA. Two 
other comments recommended that CPSC recognize the value of industry-
specific certification programs prescribing testing methods for a 
product category and verifying conformance. Another two comments 
suggested that CPSC should consider the testing requirements in 
existing product safety standards to be acceptable in meeting the 
requirements of section 14 the CPSA, including existing regulations 
with their own reasonable testing program requirements. One comment 
noted that, unless the Commission can show that current industry 
testing programs are insufficient, no prescribed reasonable testing 
program should be implemented. One comment stated that CPSC should 
establish a safe harbor enforcement policy regarding recognized 
programs. The comment noted that an enforcement policy that accepts 
participation in such programs as demonstrable good faith, without 
imposition of civil or criminal liability under CPSIA's expanded 
penalty limits, could act to promote participation in effective 
certification programs.
    Response: Manufacturers will need to ensure that any reasonable 
testing programs, whether they are industry-specific programs or not, 
also conform to the requirements of the CPSA and any implementing 
regulations promulgated by the Commission. If, in a manufacturer's 
determination, a prescribed testing program ensures with a high degree 
of assurance that the products distributed in commerce will comply with 
the applicable rules, then the manufacturer is free to choose that 
program for its product. CPSC cannot generally consider all preexisting 
testing regulations to be acceptable for purposes of complying with 
section 14 of the CPSA. For example, preexisting CPSC regulations may 
not mandate third party conformity assessment body testing for 
children's products because those preexisting CPSC regulations were 
promulgated before the CPSIA's enactment. Further, nothing in section 
14(a)(1) or 14(b) of the CPSA, nor section 3 of the CPSIA, which gives 
the Commission the authority to issue regulations to implement the 
CPSIA, requires the Commission to find industry testing programs to be 
insufficient before implementing a reasonable testing program.
    The proposed rule would not include any provision for a ``safe 
harbor'' enforcement policy based on a manufacturer's participation in 
a voluntary or industry-sponsored program, nor has the Commission 
recognized any such program as indicating compliance within the 
requirements of the proposed rule. Section 14 of the CPSA does not 
contain a ``safe harbor'' exception nor does it establish any criteria 
by which the Commission could ``recognize'' testing programs for 
purposes of a ``safe harbor.''

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4. Random Samples

    In the Federal Register notice announcing the public workshop, the 
Commission explained that section 14(d)(2)(B)(ii) of the CPSA refers to 
the ``testing of random samples to ensure continued compliance'' and 
asked (among other things), ``What constitutes a `random' sample?'' See 
74 FR at 58614. At the workshop itself, CPSC staff presented a 
statistically-based rationale for selecting random samples.
    Comments: Many comments suggested that the word ``random'' should 
not be interpreted by its strict statistical definition, but should be 
adapted to the product type, how it is manufactured, and its intended 
use. One comment stated that random should be interpreted to mean free 
from overt selection bias and that it is more important that a sample 
be reasonably representative of the population from which it is 
selected. One comment suggested that, with the assistance of industry, 
the CPSC should develop guidelines regarding the circumstances and 
elements to consider when determining what constitutes a reasonable 
random sample. One comment mentioned the problems associated with 
random sampling of single-unit production and with very small 
production volumes (less than 10, for example). One comment noted that 
some manufacturing processes are of a continuous-flow type, and 
randomly selecting a sample would be disruptive to the production 
system. Another comment stated that products that are subjected to 
continuous testing with a specified frequency should be exempt from any 
additional random testing.
    Response: The Random House Dictionary of the English Language 
defines ``random sampling'' as ``a method of selecting a sample from a 
statistical population in such a way that every possible sample that 
could be selected has the same probability of being selected.'' The 
Commission believes that this is the most appropriate technical 
definition. It also seems more appropriate to use a definition where 
both terms (random and sampling) are defined together rather than two 
separate definitions, one of random and the second of sampling. More 
generally, terms such as a ``representative'' sample, a ``non-
fraudulent'' sample, or a ``non-golden'' sample, do not have the 
underlying statistical attributes necessary to generalize about 
compliance of the untested portion of the product population from the 
tested samples.
    With regard to low-volume production, the proposed rule would not 
require random sampling unless a manufacturer produces 10,000 units of 
a product at which time the product would be subject to the proposed 
periodic testing requirements. Regardless of how random sampling is 
defined, section 14(d)(2)(B) of the CPSA requires samples to be tested. 
The samples must be selected from products in production or supply and 
must be tested by a third party conformity assessment body.
    Products manufactured in a continuous-flow process ultimately 
create individual products. If those products are subject to periodic 
testing, the requirement for random samples may constrain where in the 
manufacturing process periodic testing samples are selected. In 
general, product tests at a specific frequency are susceptible to 
transient events that could affect compliance and would be undetected. 
Random sampling has the capability of detecting such transient events 
and is thus required to ensure continued compliance of the product.

5. Challenges for Small Manufacturers/Low-Volume Production

    In the Federal Register notice announcing the public workshop, the 
Commission asked, ``What provisions (if any) should be made for small 
manufacturers and manufacturers with low production volumes and why?'' 
See 74 FR at 58614. The Commission explained that specifying the 
frequency of periodic testing or the number of random samples to be 
tested may be inappropriate where the volume of children's products 
being manufactured is low or where the children's product is one-of-a-
kind.
    Comments: Several comments were received specific to small 
manufacturers who may not have the technical, legal, or financial 
resources of large-volume manufacturers. One comment stressed the need 
for step-by-step guidance from the CPSC on how to follow the rules. 
Another comment noted that, for very small production volumes (often 
one or two custom items), testing of a representative sample should be 
allowed to suffice for all items. Two comments concurred with the draft 
Guidance Policy document text that did not require periodic testing for 
production volumes less than 10,000 units or once a year, whichever is 
less. One comment suggested that, due to the economic ramifications 
associated with the development of a reasonable testing program, the 
CPSC should convene a Small Business Regulatory Enforcement Fairness 
Act (SBREFA) panel for this rulemaking.
    Response: While the Commission will provide general guidance on how 
to comply with the requirements of the CPSIA, manufacturers are 
responsible for fully understanding their manufacturing process and 
knowing how the regulations would apply to their products. Because 
there may be a disproportionate effect on small-volume manufacturers 
relative to large volume manufacturers, the proposed rule would not 
require periodic testing for production volumes of less than 10,000 
units because certification and periodic testing costs are largely 
independent of manufacturing volume. Certification testing and testing 
after a material change are still required and may be performed on 
portions of the finished product or representative samples that are the 
same with respect to compliance as the finished product.
    As for the comment regarding a SBREFA panel, the requirements for a 
SBREFA panel only apply to the Environmental Protection Agency and the 
Occupational Safety and Health Administration (OSHA).

6. Verification of Third Party Conformity Assessment Bodies

    Comments: Several comments suggested that the CPSC, rather than 
manufacturers, should perform any verification of third party 
conformity assessment bodies. Another comment proposed that, upon 
demand by the CPSC, the conformity assessment body be required to 
produce a copy of the mandatory or voluntary standard against which the 
children's product is being tested, a copy of the test protocol used 
for the test procedure, and a copy of the test results that can be 
traced back to the specific sample tested. Another comment noted that 
variations in sample preparation by conformity assessment bodies can 
and do lead to differing test results. One comment, noting lab-to-lab 
variations in test results for the same product, suggested that CPSC 
should require third party conformity assessment bodies to conduct 
blind correlation studies and lab audits. Another comment asserted that 
proficiency testing is the only true outside independent verification 
option for laboratories and should be limited to chemical tests only.
    Response: The Commission's limited resources preclude CPSC from 
directly conducting verification of the numerous conformity assessment 
bodies. As stated earlier in part A of this document, at this time, the 
Commission is not proposing any verification obligations on 
manufacturers because the Commission intends to conduct the 
verification itself under its inherent

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authorities while it gains more experience with the testing and 
certification requirements. Additionally, the activities and 
requirements for accrediting conformity assessment bodies are outside 
the scope of this rulemaking.
    The Commission acknowledges that variations in sample preparation 
can lead to some differences in test results. However, these variations 
should not be significant enough to alter the general determination of 
whether a product complies with the applicable children's product 
safety rule.
    As for proficiency testing (by which the Commission means testing 
conducted by an independent evaluator of the competence of a ``body'' 
(organization, person, etc.) to perform specific tasks), the Commission 
considers proficiency testing to be one option for domestic 
manufacturers and importers to use for verification purposes. However, 
the requirements for verifying that a children's product complies with 
the applicable children's product safety rules are not limited to only 
chemical tests.

7. Protection of Conformity Assessment Bodies Against Undue Influence

    Comments: One comment suggested that provisions of ISO/IEC Guide 65 
be used to prevent undue influence from being exerted over third party 
testing body by a manufacturer or private labeler. Other comments 
suggested that laboratory certification beyond ISO/IEC 17025 is neither 
productive nor necessary. Another comment suggested that the Commission 
should look to OSHA's Nationally Recognized Testing Laboratory (NRTL) 
program to ensure impartiality and prevent conflict of interest. One 
comment stated that CPSC should extend existing CPSC fines and 
penalties that the CPSC can currently impose on manufacturers and 
retailers to apply to exerting or attempting to exert undue influence 
on third party conformity bodies.
    Response: ISO/IEC Guide 65 and OSHA's NRTL program both deal with 
certifying bodies that perform many functions in addition to the 
testing functions performed by third party conformity assessment 
bodies. The ISO/IEC 17025 certification system appears to be working as 
intended. There is no need to implement duplicative or additional 
requirements by requiring them in this proposed rule.
    With regard to extending fines, section 19 the CPSA already 
addresses fines and penalties. Section 19(a)(4) of the CPSA prohibits 
any attempt to exercise undue influence on a third party conformity 
assessment body. Sections 20 and 21 of the CPSA establish monetary and 
criminal penalties for violations of section 19 of the CPSA.

8. Certificates

    Comments: One comment urged the Commission to recognize the 
registered certification marks of recognized product certification 
bodies, like those accredited under the OSHA NRTL program for 
applicable product scopes, in lieu of paper certificates of conformity. 
Another comment asserted that the CPSC has no jurisdiction to issue 
certification regulations except as part of a reasonable labeling rule 
adopted under section 14 of the CPSA. The comment argued that section 
14(a) of the CPSA gives the manufacturer the option to select its own 
form and medium to convey certification of compliance with a CPSC 
standard. Finally, the comment contended that section 14 of the CPSA 
does not authorize the Commission to adopt any rule prescribing the 
content of the certificate or method of its distribution. Another 
comment stated that the CPSC has no jurisdiction to require that a 
certificate be on a separate piece of paper that accompanies the 
product. The comment also suggested that at least 180 days would be 
needed to comply with any new requirements.
    Response: The Commission does not believe that registered 
certification marks, by themselves, would provide the information 
required for certificates under section 14 of the CPSA. With respect to 
children's products, third party conformity assessment bodies only test 
children's products for compliance with the applicable children's 
product safety rules. Third party conformity assessment bodies are not 
responsible for issuing certificates under section 14(a)(2) of the 
CPSA; to the contrary, under existing CPSC regulations, only domestic 
manufacturers and importers are required to issue certificates (see 16 
CFR part 1110; see also 73 FR 68328 (November 18, 2008)).
    Regarding the Commission's jurisdiction to issue certification 
regulations, the Commission has the authority to issue implementing 
regulations under section 3 of the CPSIA, which provides that ``[t]he 
Commission may issue regulations, as necessary, to implement this Act 
and the amendments made by this Act.'' The Commission has not required 
certificates to be only in the form of a separate piece of paper. 
Certificates can be in electronic form.
    As for the effective date of any final rule, the Commission intends 
that any final rule resulting from this rulemaking become effective 180 
days after its date of publication in the Federal Register. Interested 
parties who believe that the effective date should be longer or shorter 
should submit a comment to the proposed rule. The comment should 
include the specific facts on which they base their conclusion.

9. Reliance on Test Results of Others for Certification Purposes

    Comments: Two comments noted that a foreign manufacturer may supply 
the same product to several importers, who would then be required to 
test the same product. The comments considered such testing of the same 
product by multiple importers to be wasteful and inefficient. Another 
comment stated that importers of many products will be overburdened 
with testing costs, whereas manufacturers making one product can 
efficiently test their products. The comment added that the importer 
would still be responsible for the product's certificate, but would use 
test data furnished by the manufacturer. Finally, the comment noted 
that importers have little control over the design, manufacturing 
process, or sourcing of component parts, but manufacturers control all 
those aspects of production. Two other comments asserted that importers 
should be allowed to base their certificates on test reports and 
results of other entities. Another comment proposed that CPSC should 
recognize the vendor's assumption of liability in making such 
certification and deem that retailers, importers and distributors of 
product subject to such certification may rely upon it without facing 
civil or criminal liability.
    One comment asked for clarification for importers who rely on 
foreign manufacturers' certificates of conformity regarding what level 
of diligence can reasonably and effectively be exercised by the 
importers.
    One comment recommended that ink manufacturers be allowed to group, 
test and certify product families for component testing because product 
families represent the same core formula. The comment asserted that 
product family certification provides a reasonable, economically 
viable, testing model for these ink manufacturers.
    Response: While an importer is not required to commission testing 
itself and may, in certain cases, use component part test reports from 
the manufacturer, the importer is responsible for issuing the 
certificate for a children's product (see 16 CFR 1110.7(a)). The 
importer also must ensure that the proper testing was

[[Page 28342]]

conducted (i.e., a third party conformity assessment body accredited 
for the correct test conducted the testing). The importer is ultimately 
responsible for ensuring that its product meets CPSC requirements. In 
those cases in which the importer has little or no control over the 
manufacturing process and is relying on the manufacturer's test data, 
the importer should take measures to understand the manufacturing and 
testing process. An importer needs to ensure that all necessary tests 
are conducted in an appropriate manner to ensure, with a high degree of 
assurance, that no noncompliant product is placed into commerce. In the 
Commission's proposed rule on ``Conditions and Requirements for Testing 
of Component Parts of Consumer Products'' (which appears elsewhere in 
this issue of the Federal Register), the Commission is considering 
additional issues related to the reliance of a manufacturer on the test 
results of others for certification purposes.
    As for the comment regarding ink, an ink that has a similar base 
formula and varies only in color could contain some pigments that 
contain lead while the same base with different pigments did not. Thus, 
families of inks cannot be grouped for compliance testing. However, the 
Commission has previously made a determination that CYMK inks do not 
need to be tested since they do not contain lead. See 16 CFR 1500.91.

10. Additional Third Party Testing Requirements for Children's Products

    Comments: One comment remarked that the Commission should offer 
guidance on the adequacy of specific programs to firms who request it. 
The comment also sought clarification on whether a test could be any 
reasonable, objective method for evaluating compliance with a standard. 
The comment suggested that any attempt to specify protocols and 
standards for testing children's products, such as sample size and 
frequency, should be tied to specific standards. The comment also 
expressed interest in having the Commission provide a clearer 
definition of reasonable certainty, especially in the context of 
specific standards. Finally, the comment advised against attempting to 
establish any numerical standard, such as a specified confidence level 
with a specific number of samples to test.
    Another comment requested that the Commission should provide 
reasonably specific guidelines with regard to both periodic testing 
frequency and sample size to be used in such testing. The comment 
suggested a period of at least twice per year or once every 50,000 
units in any event, whichever occurs first. With regard to the sample 
size for periodic testing, the comment suggested (at least for toys) 
using the 12-unit sample size which has been the requirement of the 
CPSC Engineering Test Manual for many years as a starting point. A 
sample size of 18 pieces could be required for higher-risk products 
such as infant and toddler toys, and a lesser sample could be allowed 
for large, bulky, or expensive products to minimize cost.
    Many comments asserted that risk should be factored into any 
testing program. A product that poses a higher level of risk should 
undergo closer scrutiny.
    One comment provided a list of activities that would more precisely 
define a material change. The list included changes in tooling, product 
materials, assembly method, or the manufacturing facility.
    Another comment contended that once the children's product has 
passed its certification testing, periodic testing is not required, and 
that only a material change would require retesting.
    One comment noted that first-party production testing is used 
extensively to control manufacturing and is effective in detecting 
problems that could lead to nonconforming products. The comment noted 
that the information can be used to reduce the number of samples 
required for periodic testing to one.
    One comment suggested that, in establishing procedures and 
standards for periodic testing of children's products, CPSC should 
consider the potential for lead exposure in order to distinguish 
between products that pose a reasonable risk of noncompliance with the 
lead content limits and products that pose only a theoretical risk of 
noncompliance.
    Response: Several existing CPSC regulations are product-specific, 
allowing the Commission to develop guidance for those particular 
manufactured goods. However, section 14(a) of the CPSA covers all 
products subject to a consumer product safety standard enforced by the 
Commission. In light of that fact, the CPSC cannot provide guidance for 
every product and every manufacturing process. For children's products, 
only a third party conformity assessment body accredited to perform the 
required tests is allowed to test for compliance to the applicable 
children's product safety rules.
    The proposed rule would consider non-conformity assessment body 
tests, such as production tests, process control measurements, or other 
means of assessing compliance, to be acceptable if they are as 
effective in discriminating compliance and noncompliance as the tests 
specified in the standards as part of a reasonable testing program. 
Neither the reasonable testing program for nonchildren's products nor 
the certification and periodic tests for children's products specify 
values for sample size or test frequency.
    The Commission recognizes that no one-size-fits-all testing program 
will be sufficient for all manufacturers. The proposed rule would state 
that a reasonable testing program is a program that, when structured 
with appropriate specifications, measurements, controls, and test 
intervals, will provide a high degree of assurance that the consumer 
products manufactured under the reasonable testing program will comply 
with all the requirements of the applicable rules. If a high degree of 
assurance is interpreted to be a statistical likelihood of not 
producing noncompliant products, the sample size for periodic testing 
will depend upon the number of samples that need to be tested to 
provide that statistical assurance. The number of samples could be 
fewer than 12 or more than 18. The Commission agrees that products with 
a higher potential for injury or death should undergo greater scrutiny.
    Because of the many types of children's products and manufacturing 
processes that will be covered by the rule, the description of the 
activities that would trigger additional third party testing due to 
material changes needs to be described in general terms. A more general 
description gives manufacturers, who are experts in their product areas 
and are better suited to understand when a change in their product 
could affect the product's ability to comply with applicable rules, the 
flexibility to develop testing programs to suit their products and 
manufacturing operations. For children's products, section 
14(d)(2)(B)(i) of the CPSA says explicitly that the rule is intended to 
establish protocols and standards to ensure that children's products 
are tested ``periodically,'' as well as when there has been a material 
change to the product. Thus, even if no changes are made to a 
children's product, it must be tested periodically.
    For children's products with a reasonable testing program, it may 
be possible to show that one periodic test sample verifies and 
validates the program. However, for children's products without a 
reasonable testing program, in order for third party testing to provide 
a high degree of assurance that the products produced comply with the 
rule, the Commission believes that testing only a single sample would 
not

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be acceptable. Other than the exceptions for lead that are specified in 
section 101 of the CPSIA and the lead determinations regarding certain 
materials or products in 16 CFR 1500.91, all children's products are 
required to be tested for lead content.

11. Labeling Program

    As stated earlier in part A of this document, section 14(d)(2)(A) 
of the CPSA requires the Commission to initiate a program by which a 
manufacturer or private labeler may label a consumer product as 
complying with the certification requirements. This provision applies 
to all consumer products that are subject to a product safety rule 
administered by the Commission.
    Comments: One comment recommended that the Commission not initiate 
a labeling program because it will contribute to confusion within the 
small business community about the tracking label. Another comment 
suggested that the Commission should provide examples of allowable text 
for such labels, but should not have specific requirements for things 
such as size, color, font or location as these will depend on the 
product. The comment further noted that it would be a huge burden to 
impose specifications such as ``label'' text or size.
    One comment noted that some children's products currently must 
contain a label and that label should be considered sufficient. Two 
comments stated that, if a consumer compares a children's product with 
a label stating compliance to all applicable rules to a comparable 
product with no applicable rules (and thus no label), the absence of 
the label will be misperceived as noncompliance by the consumer and 
will thus disadvantage the second product. One comment suggested that 
the label requirement be harmonized as best as possible with existing 
Federal regulations such as U.S. Customs and Border Production country 
of origin labeling (19 U.S.C. 1304 and 19 CFR 134.33) and the Federal 
Trade Commission's Textile and Wool Products Identification Act's fiber 
content labeling requirements (15 U.S.C. 70 and 16 CFR part 303). 
Another comment said that the use of the label should be restricted to 
identifying the manufacturer/importer and the batch to help facilitate 
and narrow the scope of recalls. One comment suggested that there needs 
to be accommodations or exclusions for products that are impossible to 
mark that are similar to exclusions provided in the J list of the U.S. 
Customs and Border Protection regulations for country of origin 
markings or products that would be destroyed by marking. One comment 
urged CPSC to include the certification requirements of section 14(a) 
of the CPSA on a label on the product.
    Response: Section 14(d)(2)(A) of the CPSA requires the Commission 
to initiate a program by which a manufacturer or private labeler may 
label their products as complying with the certification requirements. 
The Commission staff's suggested text and format for the label will 
make it easier for consumers, small businesses, and any other 
interested party to notice it, understand its meaning, and distinguish 
it from tracking labels. Varying the text and the font size and style 
on the label could lead to greater confusion in understanding than a 
consistent label. Because the use of the label is optional for 
manufacturers, similar-looking products, or even units of the same 
product, may or may not contain the label. The label is intended to 
show compliance with CPSC certification requirements. It is not 
intended to be a tracking label or demonstrate compliance with laws or 
regulations administered by other federal agencies. The comment 
suggesting the Commission should include the certification requirements 
of section 14(a) of the CPSA on a label on the product is outside the 
scope of the labeling program in the proposed rule which is being 
promulgated pursuant to section 14(d)(2)(A) of the CPSA. Additionally, 
on November 18, 2008, the Commission issued a rule (see 16 CFR part 
1110; see also 73 FR 68328) addressing the requirements for 
certificates under section 14(a) of the CPSA.

12. Comments Outside the Scope of the Rule

    Comments: Several comments addressed issues pertaining to specific 
tests or other provisions in the CPSIA, such as tracking labels and the 
interpretation of statutory definitions.
    Several comments suggested that x-ray fluorescence (XRF) technology 
should be an acceptable method to test for the presence of lead.
    Two comments suggested that CPSC require a hazard analysis of 
children's products if manufacturers are permitted to perform the 
analysis themselves without a third party check of the results.
    One comment would interpret the CPSIA's definition of ``children's 
product'' as a product with which a child plays.
    One comment suggested that the CPSC tracking label require the name 
of the manufacturer or importer, the production date, the compliance 
identifier, and the model number.
    One comment said that the electronic availability of certificates 
should satisfy the ``accompany'' and ``furnish'' requirements as 
opposed to requiring a paper certificate. One comment stated that the 
CPSC cannot require the certificate to contain the specific week of 
manufacture or the particular unit of equipment used to manufacture the 
product.
    One comment argued that the Commission has no jurisdiction over 
architectural glass (e.g., glass used in windows and doors).
    Response: Because these comments address issues that are unrelated 
to reasonable testing programs, continued testing of children's 
products, and labels to show that a product complies with the 
certification requirements in section 14(a) of the CPSA, they are 
outside the scope of this rule. Consequently, we decline to address 
them here.

C. Description of the Proposed Rule

    The proposal would create a new part in Title 16 of the Code of 
Federal Regulations: Part 1107, titled ``Testing and Labeling 
Pertaining to Product Certification.'' The new part 1107 would consist 
of four subparts: Subpart A would be ``General Provisions''; Subpart B 
would be the requirements for a ``Reasonable Testing Program for 
Nonchildren's Products''; Subpart C would be the requirements for 
``Certification of Children's Products''; and Subpart D would be the 
requirements for a ``Consumer Product Labeling Program.''

1. Proposed Subpart A General Provisions

a. Proposed Sec.  1107.1--Purpose
    Proposed Sec.  1107.1 would state that part 1107 establishes the 
requirements for: a reasonable testing program for nonchildren's 
products; third party conformity assessment body testing to support 
certification and continuing testing of children's products; and 
labeling of consumer products to indicate that the certification 
requirements have been met pursuant to sections 14(a)(1), and (a)(2), 
(d)(2)(B) of the CPSA (15 U.S.C. 2063(a)(1), (a)(2), (d)(2)(B)).
b. Proposed Sec.  1107.2--Definitions
    Proposed Sec.  1107.2 would state that, unless otherwise stated, 
the definitions of the Consumer Product Safety Act and the Consumer 
Product Safety Improvement Act of 2008 apply to this part. Proposed 
Sec.  1107.2 also would define certain terms or abbreviations for

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purposes of part 1107. For example, with respect to abbreviations, 
proposed Sec.  1107.2 would define ``CPSA'' to mean the Consumer 
Product Safety Act. Proposed Sec.  1107.2 would define ``CPSC'' to mean 
the Consumer Product Safety Commission.
    Proposed Sec.  1107.2 would define ``detailed bill of materials'' 
to mean a list of the raw materials, sub-assemblies, intermediate 
assemblies, sub-component parts, component parts, and the quantities of 
each needed to manufacture a finished product.
    Proposed Sec.  1107.2 would define ``due care'' to mean the degree 
of care that a prudent and competent person engaged in the same line of 
business or endeavor would exercise under similar circumstances.
    Proposed Sec.  1107.2 would define ``high degree of assurance'' to 
mean an evidence-based demonstration of consistent performance of a 
product regarding compliance based on knowledge of a product and its 
manufacture. The term ``high degree of assurance'' appears in several 
proposed provisions, and so the concept of what constitutes a ``high 
degree of assurance'' would be important for purposes of interpreting 
and complying with certain proposed sections. We considered several 
alternative definitions for a high degree of assurance. One alternative 
definition would be, for quantitative tests, where a high degree of 
assurance would be at least a 95 percent probability that all the 
product produced meets the requirements of the applicable rules; for 
non-quantitative (pass/fail) tests, a high degree of assurance could 
mean a 95 percent confidence that at least 95 percent of the product 
produced meets the requirements of the applicable rules. The 95 percent 
level is widely used in the natural and social sciences as the minimum 
acceptable probability for determining statistical significance and has 
been found to be effective. However, we recognize that defining a 
``high degree of assurance'' as a 95 percent or greater probability 
could result in greater testing demands on small manufacturers. For 
example, for a non-quantitative test, a method such as the ``rule of 
three'' could be used to determine the number of samples needed for 
testing. For a 95 percent confidence that no more than five percent of 
the production fails to comply, 3/0.05 = 60 units will be needed for 
testing. For small production volumes where 60 samples would be 
considered excessive, alternative methods would be needed. Thus, we 
decided against defining ``high degree of assurance'' with respect to a 
95 percent probability or confidence level because there may be 
difficulty in applying the statistical methods to all manufacturing 
processes. We invite comment on possible amendments or revisions to the 
proposed definition of ``high degree of assurance.''
    Proposed Sec.  1107.2 would define ``identical in all material 
respects'' to mean there is no difference with respect to compliance to 
the applicable rules between the samples and the finished product.
    Proposed Sec.  1107.2 would define ``manufacturer'' to mean the 
parties responsible for certification of a consumer product pursuant to 
16 CFR part 1110. Currently, 16 CFR part 1110 limits the certification 
requirement to domestic manufacturers and importers.
    Proposed Sec.  1107.2 would define ``manufacturing process'' to 
mean the techniques, fixtures, tools, materials, and personnel used to 
create the component parts and assemble a finished product.
    Proposed Sec.  1107.2 would define ``production testing plan'' to 
mean a document that shows what tests must be performed and the 
frequency at which those tests must be performed to provide a high 
degree of assurance that the products manufactured after certification 
continue to meet all the applicable safety rules.
    Proposed Sec.  1107.2 would define ``third party conformity 
assessment body'' to mean a third party conformity assessment body 
recognized by the CPSC to conduct certification testing on children's 
products.

2. Proposed Subpart B--Reasonable Testing Program for Nonchildren's 
Products

    Proposed subpart B would consist of one provision and would 
describe the ``reasonable testing program'' for nonchildren's products.
a. Proposed Sec.  1107.10--Reasonable Testing Program for Nonchildren's 
Products
    Proposed Sec.  1107.10(a) would state that, except as otherwise 
provided in a specific regulation under this title or a specific 
standard prescribed by law, a manufacturer certifying a product 
pursuant to a reasonable testing program must ensure that the 
reasonable testing program provides a high degree of assurance that the 
consumer products covered by the program will comply with all 
applicable rules, bans, standards or regulations. The proposed 
exception for specific regulations or standards prescribed by law is 
meant to recognize that certain preexisting CPSC regulations or 
standards that were previously voluntary standards which, by statute, 
are now considered to be mandatory consumer product safety standards or 
are to be adopted as mandatory stand