[Federal Register Volume 75, Number 97 (Thursday, May 20, 2010)]
[Proposed Rules]
[Pages 28336-28366]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-11365]
[[Page 28335]]
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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 http://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: http://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 http://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 http://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 http://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: [email protected].
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
[[Page 28337]]
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 http://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
[[Page 28338]]
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.''
[[Page 28340]]
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
[[Page 28341]]
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
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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 standards may have specific testing
requirements or protocols. The reasonable testing programs requirements
under proposed Sec. 1107.10 are not intended to supersede those
preexisting testing requirements listed in Table 1. Table 1 only lists
testing requirements as they pertain to nonchildren's products because
proposed Sec. 1107.10 would not apply to children's products.
Table 1--Existing Testing Programs That Would Not Be Superseded by
Proposed Sec. 1107.10 Regarding a Reasonable Testing Program
------------------------------------------------------------------------
16 CFR part Subject
------------------------------------------------------------------------
1201......................... Safety Standard for Architectural Glazing
Materials.
1202......................... Safety Standard for Matchbooks.
1203......................... Safety Standard for Bicycle Helmets.
1204......................... Safety Standard for Omnidirectional
Citizen Band Base Station Antennas.
1205......................... Safety Standard for Walk-Behind Power
Lawn Mowers.
1207......................... Safety Standard for Swimming Pool Slides.
1209......................... Interim Safety Standard for Cellulose
Insulation.
1210......................... Safety Standard for Cigarette Lighters.
1211......................... Safety Standard for Automatic Residential
Garage Door Operators.
1212......................... Safety Standard for Multi-Purpose
Lighters.
1610......................... Standard for the Flammability of Clothing
Textiles.
1611......................... Standard for the Flammability of Vinyl
Plastic Film.
[[Page 28345]]
1630, 1631................... Standards for the Surface Flammability of
Carpets and Rugs.
------------------------------------------------------------------------
A reasonable testing program serves as the basis for issuance of
the general conformity certification for nonchildren's products unless
the manufacturer conducts a test of each product. 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.
The manufacturer is responsible for establishing a reasonable
testing program because it is necessary to support the issuance of a
general conformity certificate where a test of each product is not
undertaken. All the elements of the reasonable testing program should
be in place, and certification tests completed with passing results
before a general conformity certificate can be issued for a product.
Several existing nonchildren's product standards issued by the
Commission already contain product-specific testing programs that were
developed by the Commission at the time the standard was issued and for
which certification was required before the CPSIA's enactment. For
existing rules that contain testing requirements, and do not contain
specific testing programs, the reasonable testing program establishes
the minimum set of requirements to be met for certification. For the
remaining applicable rules, the implementation of reasonable testing
programs will vary depending on the product under consideration and the
compliance characteristics being tested. Persons issuing general
conformity certificates should exercise due care in developing and
implementing a reasonable testing program that demonstrates that their
products comply with the applicable rules.
Commission staff examined existing CPSC regulations, such as the
regulations pertaining to omnidirectional citizens band base station
antennas, walk-behind lawn mowers, and automatic residential garage
door openers, and selected common features of existing reasonable
testing programs that CPSC has found to be effective. The proposed
elements of a reasonable testing program would be necessary to
demonstrate a product's compliance at the time of certification and as
production of the product continues after certification. Because the
requirement for a reasonable testing program would apply to a wide
variety of product types and manufacturing processes, it is designed to
be scalable to production volumes and adaptable to the specifics of the
product. A manufacturer may develop the scope and details of each
element of a reasonable testing program based on the manufacturer's
knowledge and expertise regarding the product and its manufacturing
processes.
The Commission's primary concern is ensuring that manufacturers
produce safe and compliant products. Testing is not an end in itself,
but rather one part of a process to ensure the safety of consumer
products. For this reason, the Commission believes the primary
objective in a reasonable testing program is determining whether or not
a manufacturer produces safe and compliant products. When CPSC staff
discovers unsafe or noncompliant products, CPSC may have reason to
examine a manufacturer's programs and processes. Because the Commission
recognizes that even the best processes can occasionally yield
noncompliant products, the Commission is especially concerned about
unsafe or noncompliant products emerging from defective processes.
Proposed Sec. 1107.10(b) would describe the five elements that a
reasonable testing program must contain. The Commission invites
comments on these five elements of a reasonable testing program. How
well do these elements fall within the elements of existing quality
assurance/quality control programs? In cases where no quality
assurance/quality control programs exist, what activities will have to
occur to implement the proposed reasonable testing program? Please
explain.
Proposed Sec. 1107.10(b)(1) would state that a reasonable testing
program must have a product specification. The product specification
would contain a description of the consumer product and lists the
applicable rules, bans, standards or regulations to which the product
is subject. A product specification should describe the product listed
on a general conformity certification in sufficient detail to identify
the product and distinguish it from other products made by the
manufacturer. Proposed Sec. 1107.10(b)(1) would state that the product
specification may include items such as a color photograph or
illustration, model names or numbers, a detailed bill of materials, a
parts listing, raw material selection and sourcing requirements.
Proposed Sec. 1107.10(b)(1)(i) would state that a product
specification must include any component parts that are certified
pursuant to 16 CFR part 1109. (Elsewhere in this issue of the Federal
Register, the Commission is issuing a proposed rule regarding component
part testing.)
Proposed Sec. 1107.10(b)(1)(ii) would state that product
specifications that identify individual features of a product that
would not be considered a material change may use the same product
specification for all products manufactured with those specific
features. Features that would not be considered a material change
include different product sizes or other features that cover variations
of the product where those variations do not affect the product's
ability to comply with applicable rules. For example, several sizes of
the same article of clothing made with the same materials would not be
considered a material change. Another example would be if a product
specification lists a number of complying component parts that are
grouped in a number of different combinations for separate products,
the differences in the number of component parts between the products
would not be considered a material change. Additionally, a product with
different versions of software downloaded into various units that would
not affect compliance, such as various language packages downloaded
into various educational toys, would not be considered a material
change.
Proposed Sec. 1107.10(b)(1)(iii) would state that each
manufacturing site must have a separate product specification. This
would be required because a manufacturer cannot assume that units of
the same product manufactured in more than one location are identical
in all material respects.
[[Page 28346]]
Proposed Sec. 1107.10(b)(2) would state that a manufacturer must
conduct certification tests on a product before issuing a general
conformity certificate for that product. Certification tests provide
evidence that a product identified in a product specification complies
with the applicable rules, bans, standards, or regulations.
Certification tests are required as part of a reasonable testing
program in lieu of a test of each product. Proposed Sec. 1107.10(b)(2)
would state that a certification test would be a test performed on
samples of the product that are identical to the finished product in
all material respects to demonstrate that the product complies with the
applicable safety rules. Proposed Sec. 1107.10(b)(2) would require
certification tests to contain certain elements.
Proposed Sec. 1107.10(b)(2)(i) would state that, for purposes of
proposed Sec. 1107.10, a sample means a component part of the product
or the finished product which is subjected to testing. Samples
submitted for certification testing would be required to be identical
in all material respects to the product to be distributed in commerce.
The manufacturer would be required to submit a sufficient number of
samples for certification testing so as to provide a high degree of
assurance that the certification tests accurately represent the
product's compliance with all applicable rules.
Proposed Sec. 1107.10(b)(2)(i)(A) would only allow finished
products or component parts listed on the product specification to be
submitted for certification testing. Proposed Sec. 1107.10(b)(2)(i)(B)
would allow a manufacturer to substitute component part testing for
finished product testing pursuant to 16 CFR part 1109 unless the rule,
ban, standard or regulation applicable to the product requires testing
of the finished product. If a manufacturer relies upon certification
testing of component part(s) (rather than tests of the finished
product), the manufacturer would be required to demonstrate how the
combination of testing of component part(s), portions of the finished
product, and finished product samples demonstrate, with a high degree
of assurance, compliance with all applicable rules, bans, standards, or
regulations.
Proposed Sec. 1107.10(b)(2)(ii) would state that a material change
is any change in the product's design, manufacturing process, or
sourcing of component parts that a manufacturer exercising due care
knows, or should know, could affect the product's ability to comply
with the applicable rules, bans, standards, or regulations. Proposed
Sec. 1107.10(b)(2)(ii)(A) would state that when a previously-certified
product undergoes a material change that only affects the product's
ability to comply with certain applicable rules, bans, standards, or
regulations, certification for the new product specification may be
based on certification testing of the materially changed component
part, material, or process, and the passing certification tests of the
portion of the previously-certified product that were not materially
changed. For example, if a material change is limited to using a
different paint on the product, new certification testing of that
product may be limited to evaluating the paint to the applicable safety
rules.
Proposed Sec. 1107.10(b)(2)(ii)(B) would require a manufacturer to
conduct a certification test of the finished product if a material
change affects the finished product's ability to comply with an
applicable rule, ban, standard, or regulation. Proposed Sec.
1107.10(b)(2)(ii)(C) would require a manufacturer to exercise due care
to ensure that reliance on anything other than retesting of the
finished product after a material change occurs does not allow a
noncompliant product to be distributed in commerce. A manufacturer
should resolve any doubts in favor of retesting the finished product
for certification.
Proposed Sec. 1107.10(b)(3) would explain that a production
testing plan describes 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, bans, standards, or
regulations. A production testing plan may include recurring testing or
the use of process management techniques, such as control charts,
statistical process control programs, or failure modes and effects
analyses (FMEAs), designed to control potential variations in product
manufacturing that could affect the product's ability to comply with
the applicable rules, bans, standards, or regulations.
Proposed Sec. 1107.10(b)(3)(i) through (iii) would require a
production test plan to contain the following elements:
A description of the production testing plan, including,
but not limited to, a description of the tests to be conducted or the
measurements to be taken, the intervals at which the tests or
measurements will be made, the number of samples tested, and the basis
for determining that such tests provide a high degree of assurance of
compliance if they are not the tests prescribed in the applicable rule,
ban, standard, or regulation.
A separate production testing plan for each manufacturing
site; and
Production testing intervals selected to be short enough
to ensure that, if the samples selected for production testing comply
with an applicable rule, ban, standard, or regulation, there is a high
degree of assurance that the untested products manufactured during that
interval also will comply with the applicable rule, ban standard, or
regulation. Production test intervals should be appropriate for the
specific testing or alternative measurements being conducted.
Proposed Sec. 1107.10(b)(3)(iii)(A) would allow a manufacturer to
use measurement techniques that are nondestructive and tailored to the
needs of an individual product instead of conducting product
performance tests to assure a product complies with all applicable
rules, bans, standards, or regulations. For example, a manufacturer may
have determined that, by controlling the particle size and water
content of cellulose insulation, it is possible to determine compliance
to the cellulose insulation critical radiant flux test (16 CFR part
1209.6) by examination of a sample of a fixed volume under a graduated
microscope and measuring its weight. Sizes and weights within certain
limits mean that the insulation will pass the critical radiant flux
test. As another example, a manufacturer may choose to determine
compliance to the requirements for garage door opener photoelectric
sensors (16 CFR 1211.11) by placing the sensor in a fixture with a
calibrated light flux, then measuring the response voltage of the
light-sensitive element directly. An element output voltage above a
threshold would indicate passing performance for the tests described in
the safety standard.
Proposed Sec. 1107.10(b)(3)(iii)(B) would require any production
test method used to conduct production testing to be as effective in
detecting noncompliant products as the tests used for certification.
Proposed Sec. 1107.10(b)(3)(iii)(C) would state that if a manufacturer
is uncertain whether a production test is as effective as the
certification test, the manufacturer must use the certification test.
For example, if the probability that all production products are
compliant using the tests methods used for certification is 95 percent,
the probability that all production products are compliant using
alternative testing methods should be at least 95 percent. If there is
uncertainty whether the test method
[[Page 28347]]
will achieve the same level of detection of compliance, then the
specific tests required by the applicable rules should be used.
Proposed Sec. 1107.10(b)(4) would describe the remedial action
plan. Proposed Sec. 1107.10(b)(4)(i) would state that a remedial
action plan describes the steps to be taken whenever samples of a
product or a component part of a product fails a test or fails to
comply with an applicable rule, ban, standard, or regulation. A
remedial action plan would be required to contain procedures the
manufacturer must follow to investigate and address failing test
results in addition to any reporting obligation it may have.
Manufacturers would be required to take remedial action after any
failing test result to ensure with a high degree of assurance that the
products manufactured after the remedial action has been taken comply
with the applicable rules, bans, standards, or regulations. The type of
remedial action may differ depending upon the applicable rule, ban,
standard, or regulation. Proposed Sec. 1107.10(b)(4)(i) also would
state that a remedial action can include, but is not limited to, the
following:
Changes to the manufacturing process, the equipment used
to manufacture the product, the product's materials, or design;
Reworking the product produced; or
Other actions deemed appropriate by the manufacturer, in
the exercise of due care, to assure compliant products.
Proposed Sec. 1107.10(b)(4)(ii) would state that any remedial
action that results in a material change to a product's design, parts,
suppliers of parts, or manufacturing process that could affect the
product's ability to comply with any applicable rules would require a
new product specification for that product. Before a product covered by
the new product specification can be certified as compliant with the
applicable rules, bans, standards, or regulations, a manufacturer would
be required to have passing certification test results for the
applicable rules, bans, standards, or regulations.
Proposed Sec. 1107.10(b)(5) would impose recordkeeping
requirements to document the reasonable testing program. Documentation
is necessary to establish the identity of the product, and to
demonstrate that the product complies with the applicable rules, when
it is certified and on a continuing basis as production progresses.
Documentation supports the validity of a general conformity certificate
and provides validation that a test of each product produced is not
necessary.
Proposed Sec. 1107.10(b)(5)(i)(A) through (b)(5)(i)(E) would
identify the records that a manufacturer of a nonchildren's product
would be required to maintain. In brief, these records would be:
Records of the general conformity certificate for each
product;
Records of each product specification;
Records of each certification test and, if the
manufacturer elected to have a third party conformity assessment body
test the product, identification of any third party conformity
assessment body on whose testing the certificate depends. Records of
certification tests would be required to describe how the product was
certified as meeting the requirements, including how each applicable
rule was evaluated, the test results, and the actual values of the
tests;
Records to demonstrate compliance with the production
testing plan requirement, including a list of the applicable rules,
bans, standards, or regulations, a description of the types of
production tests conducted, the number of samples tested, the
production interval selected for performance of each test, and the test
results. Records of a production test program would be required to
describe how the production tests demonstrate that the continuing
production complies with the applicable rules. References to techniques
in relevant quality management and control standards, such as ANSI/ISO/
ASQ Q9001-2008: Quality management systems--Requirements, ANSI/ASQ
Z1.4-2008: Sampling Procedures and Tables for Inspection by Attributes,
and/or ANSI/ASQ Z1.9-2008: Sampling Procedures and Tables for
Inspection by Variables for Percent Nonconforming, would be allowed to
demonstrate that the production tests have the necessary accuracy,
precision sensitivity, repeatability, and confidence to distinguish
between compliant and noncompliant products. These standards are widely
recognized in industry and were developed by organizations with
international exposure and millions of members. Retaining test results
can help identify the events that led to the creation of noncompliant
products, the number of products affected, and their disposition; and
Records of all remedial actions taken, including the
specific action taken, the date the action was taken, the person who
authorized the actions, and any test failure which necessitated the
action. Records of remedial action would be required to relate the
action taken to the product specification of the product that was the
subject of that remedial action and the product specification of any
new product resulting from any remedial action.
Proposed Sec. 1107.10(b)(5)(ii) would require a manufacturer to
create a new set of records for a product if a remedial action results
in a new product specification.
Proposed Sec. 1107.10(b)(5)(iii) would require a manufacturer to
maintain the records specified in subpart B at the location within the
United States specified in 16 CFR 1110.11(d) or, if the records are not
maintained at the custodian's address, at a location within the United
States specified by the custodian. The manufacturer would be required
to make these records available, either in hard copy or electronically,
for inspection by the CPSC upon request.
Proposed Sec. 1107.10(b)(5)(iv) would require a manufacturer to
maintain records (except for test records) for as long as the product
is being produced or imported by the manufacturer plus five years. The
proposal also would require test records to be maintained for five
years and all records to be available in the English language. Records
would be required to be maintained for five years because the statute
of limitations under 28 U.S.C. 2462 allows the Commission to bring an
action within that time. It would be unnecessarily burdensome to
require a manufacturer to maintain records beyond the time the
Commission could pursue an action.
Proposed Sec. 1107.10(c) would state that, if any certification
test results in a failure, a manufacturer cannot certify a product
until the manufacturer has taken remedial action, and the product
manufactured after the remedial action passes certification testing.
Proposed Sec. 1107.10(d) would state that a manufacturer of a
nonchildren's product may, but is not required to, use a third party
conformity assessment body to conduct certification testing. The third
party conformity assessment body would not have to be a third party
conformity assessment body recognized by the CPSC to conduct
certification testing on children's products.
Proposed Sec. 1107.10(e) would state that manufacturers of
children's products may voluntarily establish a reasonable testing
program consistent with this subpart.
3. Proposed Subpart C--Certification of Children's Products
Proposed subpart C would contain the requirements pertaining to the
certification of children's products. The subpart would consist of
seven sections, and most sections would implement the
[[Page 28348]]
requirements in section 14(d)(2)(B) of the CPSA.
Some industries have developed and implemented testing and
certification programs that are intended to determine compliance with
specific standards. The Commission invites comments about such
programs.
a. Proposed Sec. 1107.20--General Requirements
Proposed Sec. 1107.20(a) would require manufacturers to submit a
sufficient number of samples of a children's product, or samples that
are identical in all material respects to the children's product, to a
third party conformity assessment body for testing to support
certification. The proposal would not specify the exact number of
samples to be tested; instead, the proposal would require that the
number of samples selected provide a high degree of assurance that the
tests conducted for certification purposes accurately demonstrate the
ability of the children's product to meet all applicable children's
product safety rules.
Proposed Sec. 1107.20(b) would state that, if the manufacturing
process for a children's product consistently creates parts that are
uniform in composition and quality, a manufacturer may submit fewer
samples to provide a high degree of assurance that the finished product
complies with the applicable children's product safety rules. If the
manufacturing process for a children's product results in variability
in the composition or quality of children's products, a manufacturer
may need to submit more samples to provide a high degree of assurance
that the finished product complies with the applicable children's
product safety rules. An example of a manufacturing process that
consistently creates highly similar parts would be die casting.
Manufacturing processes with greater inherent variability may
necessitate testing of more samples to provide a high degree of
assurance that the finished product complies with the applicable
children's product safety rules. An example of a manufacturing process
with greater inherent variability would be hand assembly of the
product.
Proposed Sec. 1107.20(c) would state that, except where otherwise
specified by a children's product safety rule, a manufacturer may
substitute component part testing for finished product testing pursuant
to 16 CFR part 1109 if the component part, without the remainder of the
finished product, is sufficient to determine compliance for the
finished product. For example, assume that a children's product is a
cotton sweater with a metal zipper and that the manufacturer wishes to
test the sweater for compliance to the lead limits in section 101 of
the CPSIA. Because the Commission has determined that textiles, such as
cotton, do not exceed the statutory lead limits, the manufacturer would
test the metal zipper only for lead rather than the cotton in the
sweater. In this example, therefore, testing the component part (the
metal zipper) is sufficient to determine the finished product's
compliance with the lead limit.
Proposed Sec. 1107.20(d) would state that, if a product sample
fails certification testing, even if other samples have passed the same
certification test, the manufacturer must investigate the reasons for
the failure and take remedial action. A manufacturer would not be
allowed to certify the children's product until the manufacturer
establishes, with a high degree of assurance, that the finished product
does comply with all applicable children's product safety rules.
b. Proposed Sec. 1107.21 Periodic Testing
Section 14(d)(2)(B)(i) of the CPSA requires children's products to
be tested periodically for compliance with all applicable children's
product safety rules. Although the statute does not require all
periodic testing to be conducted by a third party conformity assessment
body, the Commission proposes to require that manufacturers submit
samples of their products to a third party conformity assessment body
for testing to the applicable children's product safety rules at least
once every two years if they have a reasonable testing program. As
proposed by the Commission, not every periodic test has to be done by a
third party conformity assessment body if the manufacturer has
implemented four elements of a reasonable testing program as described
in subpart B of this part (certification for children's products is
covered by proposed Sec. 1107.20 of this part). Depending upon the
type and rigor of the production testing done by a manufacturer, and
the manufacturer's ability to do in-house compliance testing of the
product or component part to the applicable children's product safety
rule(s), production testing may serve as the non-third party periodic
compliance testing. The Commission recognizes that some compliance
testing may be too complex for a manufacturer to undertake in-house. In
that case, the manufacturer may elect to have the product or a
component part tested by a third party which may or may not be a third
party conformity assessment body, depending upon whether the test
satisfies the schedule for periodic testing described above. Other
circumstances may arise during production of the product that may
require consideration of additional testing by a third party conformity
assessment body. The factors described in proposed Sec. 1107.21(c)(2)
may provide some guidance in those circumstances.
Proposed Sec. 1107.21(a) would implement the periodic testing
requirement in section 14(d)(2)(B)(i) of the CPSA by requiring each
manufacturer to conduct periodic testing at least annually, except as
otherwise provided in paragraphs (b) and (d) of this section (which we
discuss later in this part of the preamble) or as provided in
regulations under this title. Manufacturers may need to conduct
periodic tests more frequently than on an annual basis to ensure a high
degree of assurance that the product being tested complies with all
applicable children's product safety rules. More frequent periodic
testing may help a manufacturer identify noncompliant products more
quickly and, as a result, may limit the scope of any potential product
recall. In addition, more frequent testing may reduce the
manufacturer's liability for civil penalties resulting from a
noncompliant product, reduce potential damage to a manufacturer's
reputation, and increase the manufacturer's confidence in the
effectiveness of the periodic testing.
Proposed Sec. 1107.21(b) would state that, if a manufacturer has
implemented a reasonable testing program as described in subpart B of
this part (with the exception of the certification element which, for
children's products, would be required to comply with the requirements
in proposed Sec. 1107.20), it would be required to submit samples of
its product to a third party conformity assessment body for periodic
testing to all applicable children's product safety rules at least once
every two years. If a manufacturer's reasonable testing program fails
to provide a high degree of assurance of compliance with all applicable
children's product safety rules, the Commission may require the
manufacturer to meet the requirements of proposed Sec. 1107.21(c) or
modify its reasonable testing program to ensure a high degree of
assurance. Currently, the rule on children's bicycle helmets is the
only children's product safety rule that contains requirements for a
reasonable testing program. The reasonable testing program requirements
in this rule are not intended to replace that preexisting testing
requirement. For existing rules that contain testing requirements and
do not contain specific testing programs, the reasonable testing
program and the
[[Page 28349]]
two year minimum third party conformity assessment testing requirement
establishes the minimum set of requirements for periodic testing. As
the Commission promulgates new or revised children's product safety
rules, it may establish different testing requirements for those
children's products than the requirements described in this proposed
rule.
Proposed Sec. 1107.21(c) would state that, if a manufacturer has
not implemented a reasonable testing program as described in subpart B
of this part, then all periodic testing would be required to be
conducted by a third party conformity assessment body, and the
manufacturer would be required to conduct periodic testing described in
proposed Sec. 1107.21(c)(1) and (c)(2). In brief, proposed Sec.
1107.21(c)(1) would require the manufacturer to develop a periodic test
plan to assure that children's products manufactured after the issuance
of a children's product certification, or when the previous periodic
testing was conducted, continue to comply with all applicable
children's product safety rules. The periodic test plan would have to
include the tests to be conducted, the intervals at which the tests
will be conducted, the number of samples tested, and the basis for
determining that the periodic testing plan provides a high degree of
assurance that the product being tested continues to comply with all
applicable children's product safety rules. The proposal would require
the manufacturer to have a separate periodic testing plan for each
manufacturing site producing a children's product.
Proposed Sec. 1107.21(c)(2) would require the periodic testing
interval selected to be short enough to ensure that, if the samples
selected for periodic testing pass the test, there is a high degree of
assurance that the other untested children's products manufactured
during the interval comply with the applicable children's product
safety rules. The interval for periodic testing may vary depending upon
the specific children's product safety rules that apply to the
children's product. For example, the intervals selected to test for
small parts where there is variability in the factors assuring that no
small parts are created, and for lead in paint, where one tested
container is used for a large production volume, may not be the same.
Assuring that products do not generate small parts may require more
frequent testing than that required to assure that the paint used does
not contain lead in excess of the acceptable limits. The appropriate
periodic testing interval may vary for a manufacturer depending on the
manufacturer's knowledge of the product and its manufacturing
processes. Under proposed Sec. 1107.21(c)(2)(i) through (c)(2)(ix),
factors to be considered when determining the periodic testing interval
would include, but not be limited to:
High variability in test results, as indicated by a
relatively large sample standard deviation in quantitative tests;
Measurements that are close to the allowable numerical
limit for quantitative tests;
Known manufacturing process factors which could affect
compliance with a rule. For example, if the manufacturer knows that a
casting die wears down as the die nears the end of its useful life, the
manufacturer may wish to test more often as the casting die wears down;
Consumer complaints or warranty claims;
Nonmaterial changes such as introduction of a new set of
component parts into the assembly process, or the manufacture of a
fixed number of products;
Potential for serious injury or death resulting from a
noncompliant children's product;
The number of children's products produced annually, such
that a manufacturer should consider testing a children's product more
frequently if the product is produced in very large numbers or
distributed widely throughout the United States;
The children's product's similarity to other children's
products with which the manufacturer is familiar and/or whether the
children's product has many different component parts compared to other
children's products of a similar type; and
The inability to determine the children's product's
noncompliance easily through means such as visual inspection.
Proposed Sec. 1107.21(d) would pertain to the periodic testing
frequency for low-volume manufacturers. In brief, the proposal would
not require a manufacturer to conduct periodic testing unless it has
produced or imported more than 10,000 units of a particular product.
(See Appendix A of the Memorandum Requirements for Certification and
Continued Testing of Children's Products, Established by the Consumer
Product Safety Improvement Act of 2008 from Randy Butturini, Office of
Hazard Identification and Reduction, for Commission staff's rationale
for selecting the 10,000 number). The proposed rule would not require
periodic testing at every 10,000 units manufactured; instead, once that
threshold has been reached, the manufacturer would be subject to the
periodic testing requirements of proposed Sec. 1107.21(a), and (b) or
(c). The manufacturer is responsible for deciding how often such
periodic testing will occur. In other words, assume that a manufacturer
produces 9,000 units of product X. Under the proposal, the manufacturer
would not have to engage in periodic testing unless it produces 10,000
units of product X; at that time, the manufacturer would be required to
conduct periodic testing on an annual basis (under proposed Sec.
1107.21(a)) and it would be required to comply with the requirements of
proposed Sec. 1107.21(b) or Sec. 1107.21 (c) (depending on whether
the manufacturer has implemented a reasonable testing program under
subpart B). The proposal would not require the manufacturer to engage
in periodic testing every time it produces 10,000 units of product X.
The low-volume exception would apply both to manufacturers and
importers who produce or import a specific product at a low volume
(10,000 units under the proposed rule). In other words, proposed Sec.
1107.21(d) would focus on the volume of a specific product rather than
attempt to distinguish between ``large'' and ``small'' manufacturers.
Thus, an individual who hand carves 30 products would fall within
proposed Sec. 1107.21(d), as would a multinational corporation who
makes 9,000 units of a particular product.
c. Proposed Sec. 1107.22--Random Samples
Proposed Sec. 1107.22 would implement the testing of random
samples requirement in section 14(d)(2)(B)(ii) of 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. We
recognize that there are alternative approaches for deciding whether
something represents a ``random'' sample. One alternative approach
would be to say that a random sample is a sample not intentionally
identified beforehand for testing. Another possible approach would be
to require only that a random sample adequately represent the
production sample pool from which it was chosen. The Commission chose
neither alternative because the purpose of random sampling is to
establish a basis for inferring compliance about a population of
untested products from a set of tested products. If the products
selected for testing are not randomly selected, there is no statistical
basis for inferring the compliance of the untested
[[Page 28350]]
products. Manufacturers may select additional samples based on the
manufacturer's knowledge of the product and its production to provide
greater assurance of compliance. For example, if a manufacturer knows
its control over compliance degrades with continuing production, the
manufacturer may always test the last unit produced. Proposed Sec.
1107.22 would state that the production population is the number of
products manufactured or imported after the initial certification or
last periodic testing of a children's product. Proposed Sec. 1107.22
would allow a manufacturer to use a procedure that randomly selects
items from a list to determine which samples are the random samples for
testing before production begins. For example, if the planned
production quantity in a period is 50,000, and 12 random samples are to
be selected for periodic testing, before the products are manufactured,
a random process would have to identify which 12 of the 50,000 will be
selected for periodic testing. Manufacturers that produce products that
continue to be distributed in commerce as they are manufactured may
wish to test the random samples as they are selected to minimize the
potential quantity of noncompliant products if a test has failing test
results.
Proposed Sec. 1107.22 would allow manufacturers to select samples
for testing as they are manufactured. Proposed Sec. 1107.22 would
allow manufacturers who produce children's products that continue to be
distributed in commerce as they are manufactured to test the samples as
they become available instead of waiting until all the random samples
have been selected before conducting testing.
d. Proposed Sec. 1107.23--Material Change
Proposed Sec. 1107.23 would implement the requirement in section
14(d)(2)(B)(i) of the CPSA to test a children's product when a material
change has occurred. Proposed Sec. 1107.23(a) would state that if a
children's product undergoes a material change in product design or
manufacturing process, including the sourcing of component parts, that
a manufacturer exercising due care knows or should know that such
material change could affect the product's ability to comply with the
applicable children's product safety rules, the manufacturer must
submit a sufficient number of samples of the materially changed product
for testing by a third party conformity assessment body. Such testing
would be required before a manufacturer could certify the children's
product. The extent of such testing would depend on the nature of the
material change. Proposed Sec. 1107.23(a) would state that, when a
material change is limited to a component part of the finished
children's product and does not affect the ability of the children's
product to meet other applicable children's product safety rules, a
manufacturer may issue a children's product certificate based on the
earlier third party certification tests and on test results of the
changed component part conducted by a third party conformity assessment
body. For example, if the paint is changed on a children's product,
issuance of a children's product certificate may be based on previous
product testing and on tests of the new paint for compliance to lead,
heavy metal, and phthalate concentrations.
Proposed Sec. 1107.23(a) also would state that changes that cause
a children's product safety rule to no longer apply to a children's
product are not considered to be material changes. For example, assume
that a children's product consists of a cotton sweater with metal
buttons and that the children's product would be subject to the lead
limits in section 101 of the CPSIA. If the manufacturer decided to use
wooden buttons instead of metal buttons, the use of wooden buttons
would eliminate the need to test the product for lead, and the change
to wooden buttons, while arguably a change in the product's component
parts, would not be a ``material change'' under proposed Sec.
1107.23(a) for the purposes of complying with the lead content limits.
However, for other children's product safety rules, such as small
parts, the change may be a material change.
Proposed Sec. 1107.23(a) also would require a manufacturer to
exercise due care to ensure that reliance on anything other than
retesting of the finished product after a material change would not
allow a noncompliant children's product to be distributed in commerce.
A manufacturer should resolve any doubts in favor of retesting the
finished product for certification. Additionally, a manufacturer would
be required to exercise due care to ensure that any component part
undergoing component-part-level testing is the same as the component
part on the finished children's product in all material respects.
Proposed Sec. 1107.23(b) would state that, for purposes of
proposed subpart B, the term ``product design'' includes all component
parts, their composition, and their interaction and functionality when
assembled. To determine which children's product safety rules apply to
a children's product, a manufacturer should examine the product design
for the children's product as received by the consumer. For example, if
a children's product has a component part that contains lead or has a
sharp edge, but is inaccessible when the product is assembled, then the
lead and sharp edge requirements would not be applicable to the
finished product. Changes to a product's design may result in a product
being subject to additional children's product safety rules. For
example, if a wooden button on a children's product is replaced with a
plastic button, the wooden button previously excluded from testing for
lead content has been replaced with a component part that would be
subject to testing for compliance with the lead content requirements.
Proposed Sec. 1107.23(c) would state that a material change in the
manufacturing process is a change in how the children's product is made
that could affect the finished children's product's ability to comply
with the applicable children's product safety rules. For each change in
the manufacturing process, a manufacturer should exercise due care to
determine if compliance to an existing applicable children's product
safety rule could be affected or if the change results in a newly-
applicable children's product safety rule. The following are some
examples of a material change to the manufacturing process of a
children's product:
A new technique is used to fasten buttons to a doll's
dress which could affect the children's products ability to comply with
the small parts rule;
New solvents are used to clean equipment employed in the
manufacture of children's products; the new solvents could affect the
children's products ability to comply with the lead content and
phthalates requirements; and
A new mold for an accessible metal component part of a
children's product is introduced into the assembly line which could
affect the children's products ability to comply with requirements for
sharp edges.
Proposed Sec. 1107.23(d) would state that a material change in the
sourcing of component parts results when the replacement of one
component part of a children's product with another component part
could affect compliance with the applicable children's product safety
rules. This would include, but is not limited to, changes in component
part composition, component part supplier, or the use of a different
component part from the same supplier who provided the initial
component part.
[[Page 28351]]
e. Proposed Sec. 1107.24--Undue Influence
Proposed Sec. 1107.24(a) would implement the requirement to
safeguard against undue influence, pursuant to section 14(d)(2)(B)(iv)
of the CPSA, by requiring each manufacturer to establish procedures to
safeguard against the exercise of undue influence by a manufacturer on
a third party conformity assessment body.
Proposed Sec. 1107.24(b)(1) would require the procedures
established under proposed Sec. 1107.24(a) to include, at a minimum:
Safeguards to prevent attempts by the manufacturer to
exercise undue influence on a third party conformity assessment body,
including a written policy statement from company officials that the
exercise of undue influence is not acceptable, and directing that
appropriate staff receive annual training on avoiding undue influence,
and sign a statement attesting to participation in such training;
A requirement to notify the Commission immediately of any
attempt by the manufacturer to hide or exert undue influence over test
results; and
A requirement to inform employees that allegations of
undue influence may be reported confidentially to the Commission and to
describe the manner in which such a report can be made.
f. Proposed Sec. 1107.25--Remedial Action
Proposed Sec. 1107.25(a) would require each manufacturer of a
children's product to have a remedial action plan that contains
procedures the manufacturer must follow to investigate and address
failing test results. A manufacturer would be required to take remedial
action after any failing test result to ensure, with a high degree of
assurance, that the children's products manufactured after the remedial
action has been taken comply with all applicable children's product
safety rules.
Proposed Sec. 1107.25(b) would not permit a manufacturer to
certify a product if any certification test by a third party conformity
assessment body results in a failure, until the manufacturer has taken
remedial action and the product manufactured after the remedial action
passes certification testing.
Proposed Sec. 1107.25(c) would require a manufacturer whose
children's product has received a failing test result to take remedial
action to ensure, with a high degree of assurance, that the children's
product complies with all applicable children's product safety rules.
The proposal would state that remedial action can include, but is not
limited to, redesign, changes in the manufacturing process, or changes
in component part sourcing. For existing production, remedial action
may include rework, repair, or scrap of the children's product. If a
remedial action results in a material change, the proposed rule would
require a manufacturer to have a third party conformity assessment body
retest the redesigned or remanufactured product before the manufacturer
can certify the product.
g. Proposed Sec. 1107.26--Recordkeeping
Proposed Sec. 1107.26(a) would require a children's product
manufacturer subject to an applicable children's product safety rule to
maintain the following records:
Records of the children's product certificate for each
product. The children's product covered by the certificate must be
clearly identifiable and distinguishable from other products;
Records of each third party certification test. The
manufacturer must have separate certification tests records for each
manufacturing site;
Records of the periodic test plan and periodic test
results for a children's product;
Records of descriptions of all material changes in product
design, manufacturing process, and sourcing of component parts, and the
certification tests run and the test values;
Records of the undue influence procedures, including
training materials and training records of all employees trained on
these procedures; and
Records of all remedial actions taken following a failing
test result, including the rule that was tested, the specific remedial
action taken, the date the action was taken, the person who authorized
the action, any test failure which necessitated the action, and the
results from certification tests showing compliance after the remedial
action was taken.
Proposed Sec. 1107.26(b) would require a manufacturer to maintain
the records specified in subpart C at the location within the United
States specified in 16 CFR 1110.11(d) or, if the records are not
maintained at the custodian's address, at a location within the United
States specified by the custodian. The manufacturer would be required
to make these records available, either in hard copy or electronically,
for inspection by the CPSC upon request.
Proposed Sec. 1107.26(c) would require a manufacturer to maintain
records (except for test records) for as long as the product is in
production or imported by the manufacturer plus 5 years. Test records
would be required to be maintained for 5 years. All records would be
required to be available in the English language.
4. Proposed Subpart D--Consumer Product Labeling Program
a. Introduction
Proposed subpart D, consisting of one section, would implement the
label provision at section 14(d)(2)(A) of the CPSA. 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 in section 14(a) of the
CPSA.
b. Proposed Sec. 1107.40 Labeling Consumer Products To Indicate That
the Certification Requirements of Section 14 of the CPSA Have Been Met
Proposed Sec. 1107.40(a) would allow manufacturers and private
labelers of a consumer product to indicate, by a uniform label on or
provided with the product, that the product complies with any consumer
product safety rule under the CPSA, or with any similar rule, ban,
standard or regulation under any other act enforced by the CPSC.
Proposed Sec. 1107.40(b) would require the label to be printed in
bold typeface, using an Arial font of not less than 12 points, be
visible and legible, and state ``Meets CPSC Safety Requirements''.
The Commission considered whether a shorter label statement would
adequately convey the intended message and concluded that it would not.
Acronyms such as ``CPSIA'' or ``CPSA'' were considered. However, the
Commission concluded that the meaning of the acronym might not be known
to a sufficient number of people. Further, even those persons who might
know what the acronyms stood for would not necessarily know why it was
marked on the label or product. The acronym ``CPSC'' might be more
widely recognized, but viewers still may not know why it is present.
Further, the Commission does not want the presence of a ``CPSC''
marking on a label, package, or product to give the impression that the
CPSC has tested, approved, or endorsed the product.
The Commission also considered the statement ``Meets CPSC
Requirements,'' but this statement did not seem very informative for
persons who did not recognize the term ``CPSC.'' Inserting the word
``safety'' to form the statement ``Meets CPSC Safety Requirements''
would convey the message that the product met some safety requirements,
even to those persons who are not familiar with CPSC. Giving the full
[[Page 28352]]
name of the CPSC would make the statement too long to be practical in
some cases, and the length could discourage viewers from reading the
message. Therefore, the proposal would have the statement say ``Meets
CPSC Safety Requirements'' to indicate that the product has been
certified by the manufacturer or private labeler as complying with all
applicable safety requirements enforced by CPSC.
Proposed Sec. 1107.40(c) would allow a consumer product to bear
the label if the manufacturer or private labeler has certified,
pursuant to section 14 of the CPSA, that the consumer product complies
with all applicable consumer product safety rules under the CPSA and
with all rules, bans, standards, or regulations applicable to the
product under any other act enforced by the Consumer Product Safety
Commission.
Proposed Sec. 1107.40(d) would allow a manufacturer or private
labeler to use another label on the consumer product as long as such
label does not alter or mislead consumers as to the meaning of the
label described in proposed Sec. 1107.40(b). A manufacturer or private
labeler would not be allowed to imply that the CPSC has tested,
approved, or endorsed the product.
D. Regulatory Flexibility Act
1. Introduction
The Commission has examined the impact of the proposed rule under
the Regulatory Flexibility Act (5 U.S.C. 601 through 612). The
Regulatory Flexibility Act requires agencies to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. The Commission has conducted an initial regulatory
flexibility analysis of the proposed rule regarding the potential
impact on small entities.
2. Objectives and Legal Basis for Proposed Rule
The Commission is proposing this rule to implement sections 14(a)
and 14(d)(2)(A) and (B) of the CPSA, as amended by the CPSIA. The
objective of the rule is to reduce the risk of injury from consumer
products, especially from products intended for children aged 12 years
and younger. The rule will accomplish this objective by requiring that
manufacturers of nonchildren's products that are subject to consumer
product safety rules develop and maintain a reasonable testing program
that provides a high degree of assurance that their products conform to
all the applicable safety standards. For children's products, an
additional layer of protection is provided by requiring that certain
testing be performed by a third party conformity assessment body. The
proposed testing programs should allow manufacturers to discover
noncompliant products and take the necessary corrective actions to keep
noncompliant products from entering commerce or to remove them
expeditiously if they have been introduced into commerce.
3. Number of Small Firms Impacted
The number of firms that could be impacted was estimated by
reviewing every category in the North American Industrial
Classification System (NAICS) and selecting those firms that
manufacture or sell any consumer product that could be covered by a
consumer product safety rule. These firms include any establishment
that could manufacture or sell a nonchildren's product or children's
products. Firms are classified by an NAICS code that describes their
primary activity. Therefore, firms that might manufacture or import
consumer products covered by a consumer product safety rule as a
secondary or tertiary activity might not have been counted. There is no
separate NAICS category for importers. Firms that import product might
be classified as manufacturers, wholesalers, or retailers.
a. Manufacturers
According to the criteria established by the 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 manufacturers that are classified by the NAICS categories
that cover most children's and general use products that are subject to
a consumer product safety rule. Although there are more than 36,000
manufacturers that would be considered small in these categories, not
all of these firms are engaged in manufacturing children's products or
general use products that are subject to a consumer 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, All Other Miscellaneous
Chemical Product and Preparation Manufacturing includes some products
such as matchbooks and fireworks, subject to consumer product safety
rules but also includes products, such as distilled water and hydraulic
fluids, that are not subject to consumer product safety rules. All
Other Miscellaneous Electrical Equipment and Component Manufacturing
includes consumer products such as garage door openers as well as non
consumer products such as particle accelerators. The Surgical Appliance
and Supplies Manufacturing category includes bicycle helmets, but most
of the other products in this category are not under CPSC jurisdiction.
Table 2--Manufacturers
------------------------------------------------------------------------
NAICS code Description Small firms Total firms
------------------------------------------------------------------------
31411............... Carpet and Rug 261 284
Mills.
31519............... Other Apparel 235 246
Knitting Mills
(Outerwear,
Underwear, and
Sleepwear).
3152................ Cut and Sew 9,313 9,388
Apparel
Manufacturing.
3159................ Apparel 907 920
Accessories and
Other Apparel
Manufacturing.
316211.............. Rubber and Plastic 52 56
Footwear
Manufacturing.
316212.............. House Slipper 2 2
Manufacturing.
316219.............. Other Footwear 68 69
Manufacturing.
321911.............. Wood Window and 1,241 1,297
Door
Manufacturing.
32551............... Paint and Coating 1,042 1,093
Manufacturing.
325998.............. All Other Misc. 957 1,045
Chemical Product
and Preparation
Manufacturing.
326191.............. Plastics Plumbing 465 488
Fixture
Manufacturing.
326299.............. All Other Rubber 633 681
Product
Manufacturing.
332321.............. Metal Window and 1,071 1,138
Door
Manufacturing.
332998.............. Enameled Iron and 60 72
Metal Sanitary
Ware
Manufacturing.
333112.............. Lawn and Garden 117 134
Tractor and Home
Lawn and Garden
Equip. Mfg..
33422............... Radio, Television 811 894
Broadcasting and
Wireless Comm.
Equip. Mfg..
335222.............. Household 12 18
Refrigerator and
Home Freezer
Manufacturing.
[[Page 28353]]
335999.............. All Other Misc. 737 791
Electrical
Equipment and
Component Mfg..
336991.............. Motorcycle, 456 466
Bicycle, and
Parts
Manufacturing.
33712............... Household and 6,052 6,179
Institutional
Furniture
Manufacturing.
33791............... Mattress 448 462
Manufacturing.
339113.............. Surgical Appliance 1,601 1,691
and Supplies
Manufacturing.
33991............... Jewelry and 2,737 2,752
Silverware
Manufacturing.
33992............... Sporting and 1,886 1,930
Athletic Goods
Manufacturing.
33993............... Doll, Toy and Game 763 776
Manufacturing.
339999.............. All Other 4,440 4,499
Miscellaneous
Manufacturing.
-------------------------------
Total Manufacturers................. 36,367 37,371
------------------------------------------------------------------------
Source: U.S. Census Bureau, 2006 County Business Patterns.
b. Wholesalers
Wholesalers would be impacted by the proposed rule if they import
any children's products or general use products that are subject to a
consumer product safety rule. Wholesalers that obtain their products
strictly from domestic manufacturers or from other wholesalers would
not be impacted by the proposed rule since the manufacturer would be
responsible for testing and certifying the product. Table 3 shows the
number of wholesalers by NAICS code that would cover most children's
products and general use products that are subject to a consumer
product safety rule. According to the SBA criteria, wholesalers are
generally considered to be small entities if they have fewer than 100
employees. Although there are more than 77,000 wholesalers that would
be considered small in these categories, not all of these firms are
engaged in importing children's or general use products that are
subject to a consumer 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 would be those that import all terrain vehicles or other off-
road vehicles, especially those intended for children age 12 years and
younger.
Table 3--Wholesalers
------------------------------------------------------------------------
NAICS Code Description Small firms Total firms
------------------------------------------------------------------------
4231................ Motor Vehicle and 16,947 17,858
Motor Vehicle
Parts and
Suppliers.
4232................ Furniture and Home 10,534 10,981
Furnishing
Merchant
Wholesalers.
42362............... Electrical and 2,147 2,269
Electronic
Appliance,
Television, and
Radio Set
Merchant
Wholesalers.
42391............... Sporting and 4,397 4,552
Recreational
Goods and
Supplies Merchant
Wholesalers.
42392............... Toy and Hobby 2,170 2,248
Goods and
Supplies Merchant
Wholesalers.
42394............... Jewelry, Watch, 7,735 7,815
Precious Stone,
and Precious
Metal Merchant
Wholesalers.
42399............... Other 10,146 10,367
Miscellaneous
Durable Goods
Merchant
Wholesalers.
42432............... Men's and Boy's 3,235 3,393
Clothing and
Furnishings
Merchant
Wholesalers.
42433............... Women's, 5,965 6,186
Children's, and
Infant's
Clothing, and
Accessories
Merchant
Wholesalers.
42434............... Footwear Merchant 1,434 1,493
Wholesalers.
42499............... Other 12,497 12,753
Miscellaneous
Nondurable Goods
Merchant
Wholesalers.
---------------------------------------------------
Total........... .................. 77,207 79,915
------------------------------------------------------------------------
Source: U.S. Census Bureau, 2006 County Business Patterns.
c. Retailers
Retailers that obtain all of their products from domestic
manufacturers or wholesalers will not be directly impacted by the
proposed rule, since the direct impact of the proposed rule would be
experienced by the manufacturer. However, there are some retailers that
manufacture or directly import some products and, therefore, would be
responsible for ensuring that these products are subjected to testing
by third party conformity assessment bodies. 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 the SBA
criteria, retailers are generally considered to be small entities if
their annual sales are less than $7 million ($27 million in the case of
general merchandise stores). Because of the way in which the data were
reported, Table 4 shows the total number of firms in each of the
categories that operated all year and the number with sales of less
than $5 million ($25 million in the case of general merchandise
stores). Although there are more than 125,000 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 or
general use products that are subject to a consumer product safety
rule. Many of these firms probably obtain all of their products from
domestic wholesalers or manufacturers and would not be directly
impacted by the rule.
[[Page 28354]]
Table 4--Retailers
------------------------------------------------------------------------
NAICS Code Description Small firms Total firms
------------------------------------------------------------------------
441221.............. Motorcycle, ATV, 3,969 4,001
and Personal
Watercraft
Dealers.
4421................ Furniture Stores.. 16,282 17,542
44813............... Children's and 2,146 2,200
Infant's Clothing
Stores.
44814............... Family Clothing 5,998 6,240
Stores.
4482103............. Children's & 300 305
juveniles' shoe
stores.
4483................ Jewelry, luggage, 16,341 16,778
& leather goods
stores.
45111............... Sporting goods 14,451 14,831
stores.
45112............... Hobby, toy, & game 4,832 4,903
stores.
452................. General 7,387 7,494
Merchandise
Stores.
45322............... Gift, Novelty, and 21,412 21,637
Souvenir Store.
453998.............. All Other Misc. 11,934 12,228
Store Retailers
(except Tobacco
Stores).
4542................ Vending machine 4,081 4,278
operators.
45439............... Other direct 15,938 16,431
selling
establishments.
---------------------------------------------------
Total........... .................. 125,071 128,868
------------------------------------------------------------------------
Source: U.S. Census Bureau, 2002 Economic Census, Release date 11/25/
2005.
4. The Potential Effects of the Proposed Rule
a. Reasonable Testing Program
The proposed rule would require any manufacturer of a nonchildren's
product to establish a reasonable testing program for the product
unless they test every product. Most manufacturers probably have some
quality control programs in place that are intended to demonstrate that
the products as manufactured meet the manufacturer's specifications,
including their specifications for complying with any safety
regulations. In some cases, these programs would meet the requirements
of the reasonable testing program as described in the proposed rule.
Other manufacturers may have to modify their current programs to ensure
that they meet the requirements of the proposed rule. For example, some
manufacturers might have to modify their programs to ensure that the
testing program adequately covers all consumer product safety rules
that are applicable to their products. Some manufacturers might have to
increase their testing frequency. Some manufacturers might have some
informal testing programs that would have to be formalized and better
documented. There may also be some manufacturers that do not have a
program in place. These firms will have to develop reasonable testing
programs.
Compliance with the proposed rule would require a variety of
professional skills on the part of manufacturers. Lawyers may be
required to review CPSC regulations in order to determine which
regulations are applicable to a product. Depending upon the specific
product and the safety rules that are applicable to it, people with
knowledge of subjects such as engineering and chemistry may be required
to develop the product specifications, conduct the certification tests,
and to design a program for production testing. Statistical skills or
statistical consultants may be required to determine the frequency,
sample size, and collection method for production testing. For some
production tests, professionals such as engineers or chemists might be
required, depending upon the consumer product safety rules applicable
to the product. In some cases, the production tests could be carried
out by the firm's production workers or technicians, perhaps working
under the supervision of an engineer, chemist, or similar professional.
When the manufacturer does not have the internal capability to perform
some of the required production testing, the testing may need to be
performed by a third party testing assessment body.
The cost to firms of complying with this provision of the proposed
rule would depend upon the extent of the changes that firms will have
to make to their existing testing programs. For firms that already have
testing programs that would meet the requirements of the proposed rule,
there could be no additional costs. For other firms, the cost of
complying with the requirements of the proposed rule will depend upon
several factors, including the characteristics of their products and
the steps that the firm will have to take to comply with the
requirements. Because of the wide variety of products and manufacturers
that would be covered by the proposed rule and because the
characteristics of each product and the circumstances of each firm are
different, the Commission cannot reliably estimate the cost to
manufacturers of the reasonable testing program requirement of the
proposed rule. The Commission invites comments that provide more
information on the cost and other impacts of this requirement on
manufacturers.
b. Third Party Testing of Children's Products
The proposed rule would establish requirements for the continued
testing of children's products by third party conformity assessment
bodies for certification, periodically, and when there has been a
material change in the products design or manufacturing process,
including the sourcing of component parts.
Manufacturers will have to develop and maintain records that
demonstrate compliance with the third party testing requirements. The
Commission welcomes comment on these requirements, including comments
on the possible burden that these recordkeeping requirements might
impose.
It is expected that the cost of the third party testing
requirements could have a significant impact on a substantial number of
small entities. The cost of third party testing is influenced by many
factors, including the amount and skill of the labor required to
conduct the tests, the cost of the equipment involved, the cost of
transporting the product samples to the test facility, and the
geographic area where the tests are conducted. Some tests require a
substantial amount of time to conduct including the preparation of the
sample. It might take a couple of days, for example, to test a bicycle
for compliance with the bicycle standard (16 CFR part 1512). Similarly,
a chemist testing the lead content of a product might be able to test
only a few component parts a day due to the amount of time required to
prepare the samples and to clean and calibrate the equipment between
tests.
It should be noted that the price that a given manufacturer pays
for testing is often the result of negotiations between the testing
laboratory and the
[[Page 28355]]
manufacturer. Manufacturers that do a large volume of business with a
testing laboratory can frequently obtain substantial discounts on the
laboratory's normal charges, whereas manufacturers that do only a small
volume of business may not.
Some information on the cost of third party testing for some of the
applicable tests is provided below. The information was collected from
a number of sources, including published price lists from some testing
laboratories, conversations with representatives of testing
laboratories, and actual invoices provided by consumer product
manufacturers. The data are not based upon a statistically valid survey
of testing laboratories. Additionally, the costs are only the costs
that would be charged by the testing laboratory and do not include the
costs of the products consumed in destructive tests or the cost of
shipping the samples to the laboratories.
i. Costs Associated With Various Third Party Tests
Lead Content and Lead-in-Paint: The cost per component part for
testing for lead content and lead-in-paint using inductively coupled
plasma (ICP) analysis will range from a low of about $20 per test to
more than $100 per test. The lowest per unit cost represents a
substantially discounted price charged to a particular customer by a
laboratory in China and might not be typical. Within the United States,
typical prices range from around $50 to more than $100 per test.
The cost of testing for lead content using XRF technology is
significantly less expensive. Some firms have offered to screen
products for lead content for as little as $2 per test. These offers
were generally directed to stores or businesses that wanted to check
their inventory for conformity with the retroactive lead content
requirements that were contained in the CPSIA. Some testing
laboratories will charge for XRF testing at an hourly rate, which can
be around $100. Ten to 30 components parts can be tested in an hour.
However, with the exception of some plastics, XRF is not acceptable for
all certification purposes.
Phthalates: The cost of testing for phthalate content will range
from around $100 (a discounted price by a laboratory in China) to about
$350. These are the costs per component part and include testing for
all six of the prohibited phthalates specified in the CPSIA.
Bicycle Standard: According to one testing laboratory, it takes 1
to 2 days to test a bicycle. The estimated price for testing one
bicycle may range from around $700, if the testing is performed in
China, to around $1,100 if the testing is performed in the United
States. A manufacturer that needs several models of bicycle tested at
the same time might be able to obtain discounts from these prices.
However, this does not include the testing of component parts for lead
and phthalates, which would add to the costs of bicycle testing.
Bicycle Helmets: One laboratory quoted a price of $600 for testing
one model of a bicycle helmet to the CPSC bicycle helmet standard. A
price list from another laboratory stated that conducting the
certification testing to the Snell Foundation's bicycle helmet standard
(which is similar to the CPSC standard, but considered by some to be
more stringent) was $830.
Full-Size Cribs: As with bicycles, testing cribs requires a
substantial amount of labor time to assemble the crib, take the
appropriate measurements and perform the required tests. The cost of
testing a full-size crib will be around $1,200 in the United States.
The cost can vary depending on the features of the individual cribs
that require testing and between laboratories. Some manufacturers might
receive discounted prices. This does not include testing the crib for
lead and phthalates, which, to the extent necessary, would add to the
cost of testing a crib to all applicable safety rules.
Toys: The ASTM F963 toy standard was made a mandatory standard by
the CPSIA. The standard includes a wide variety of tests, including
tests for soluble heavy metals in surface coatings and for various
physical and mechanical criteria. Based on the itemized prices on
several invoices from testing laboratories that have been provided to
CPSC staff or otherwise made public, the cost of the physical and
mechanical tests range from about $50 to $245. The cost of the chemical
test for the presence of heavy metals ranges from about $60 to $190 per
surface coating. Again, these costs do not include testing for lead and
phthalates, which add to the total cost.
The flammability requirements of ASTM F963 were not made mandatory
by the CPSIA, but the Commission was directed to examine the
flammability requirements and consider promulgating rules addressing
the issue. If some flammability tests are eventually required, the cost
per test could be in the range of $20 to $50 based on some observed
costs for the ASTM F963 flammability tests.
ii. Cost of Third Party Testing by Product
The cost to obtain the required third party testing for a product
depends on the types and number of tests that must be performed on each
product, the size of the sample that is required to provide a high
degree of assurance that the products comply with the applicable safety
rules, and the extent to which component part testing can be used.
Because of the wide variety of manufacturers, and importers, and
products that would be affected by the proposed rule, we cannot provide
comprehensive estimates of the impact of the proposed rule on all
products or firms. The discussion immediately below is intended to
provide some perspective on the potential impact. The Commission
invites additional public comments on the discussion and more specific
information on the impact and cost of the third party testing
requirements of the proposed rule.
The third party testing costs discussed in this section apply to
the costs associated with either the periodic testing requirement or
the requirement that additional third party testing be conducted if
there is a material change in the product's design or manufacturing
process. However, in the latter case, the testing might be limited to
those rules where compliance might have been impacted by the change.
Number of units for testing: The proposed rule would require the
manufacturer to submit enough units to the conformity assessment body
to provide a high degree of assurance that the products comply with the
applicable consumer product safety rules. The exact number will depend
upon the characteristics of the product, the lot size, whether the
tests produce quantitative or qualitative data, whether the product has
an established reasonable testing program, and the interpretation of a
high degree of assurance. A discussion of the statistical aspects of
designing a sampling plan was presented by Dr. Michael Greene of the
CPSC staff at the Product Testing Workshop on December 10, 2009.
Quantitative testing data is data where the relevant variable can
be measured with some degree of precision. For example, the lead
content of a substance can be measured in terms of parts per million
(ppm). Qualitative data is where the outcome of a test is simply a
``pass'' or ``fail.'' For example, in a drop test the result might
simply be whether a sharp edge was exposed (a ``fail'') or a sharp edge
was not exposed (a ``pass''). When the data is qualitative, the sample
size
[[Page 28356]]
will usually have to be larger than when the data is quantitative.
For example, as of August 14, 2011 the lead content of children's
products must be no greater than 100 ppm unless the Commission
determines that a limit of 100 ppm is not technologically feasible for
a product or product category. If, for illustrative purposes, a high
degree of assurance means at least a 95 percent probability that all
products are in compliance and a manufacturer is testing a component
part for lead content, then the manufacturer could determine the
appropriate sample size if it knew the mean lead content of the
component part, the standard deviation about the mean, and the size of
the lot that was to be tested. Table 5 shows the sample sizes that
would be required to provide a high degree of assurance for different
lot sizes by mean and standard deviation (assuming a normal
distribution). Larger sample sizes would be required for products with
higher means, larger standard deviations, and larger lot sizes. Smaller
sample sizes would be required for products with lower means, standard
deviations and lot sizes.
Table 5--Sample Sizes Required To Provide at Least 95 Percent Probability That the Lot is Compliant (Given the
Availability of Quantitative Test Data)
----------------------------------------------------------------------------------------------------------------
Probability that
Mean (ppm) Standard Lot size (units) Sample size the lot is
deviation (ppm) (units) compliant
----------------------------------------------------------------------------------------------------------------
10.................................. 1 1,000 4 .998
10.................................. 1 2,500 4 .995
10.................................. 1 10,000 4 .992
10.................................. 1 25,000 5 .978
10.................................. 1 50,000 5 .957
15.................................. 3 1,000 5 .993
15.................................. 3 2,500 5 .983
15.................................. 3 10,000 6 .992
15.................................. 3 25,000 6 .981
15.................................. 3 50,000 6 .962
35.................................. 5 1,000 6 .965
35.................................. 5 2,500 7 .976
35.................................. 5 10,000 8 .972
35.................................. 5 25,000 9 .978
35.................................. 5 50,000 9 .957
----------------------------------------------------------------------------------------------------------------
Where only qualitative (e.g., pass/fail) testing data is available,
the sample sizes needed to provide a high degree of assurance will be
higher than those in Table 5. Such tests include some of the use and
abuse tests for testing children's products (e.g., the drop test). As
discussed by Dr. Michael Greene at the CPSIA Product Testing Workshop,
more samples may be necessary because there is more uncertainty in the
test data. In other words, with only pass/fail data, it is not known if
the result was close to the threshold or far from the threshold. In
these cases, it might be necessary to define a high degree of assurance
as a probability that no more than a given proportion of noncompliant
products. For example, as discussed by Dr. Greene at the Product
Testing Workshop, a 95 percent probability that no more than a certain
proportion ``p'' of the units in a lot do not comply is approximately
given by the formula p [ap] 3/k, where ``k'' is the sample size. Thus,
if 50 items were tested and no noncompliant items were found, there is
a 95 percent probability that no more than 6 percent of the items in
the lot do not comply. In other words, if the lot size were 1,000 and
50 units were tested and no noncompliant product were found, there is a
95 percent probability that no more than 60 units in the entire lot are
not in compliance. If the lot size were 10,000 units, there would be a
95 percent probability that no more than 600 of the products would be
noncompliant. If a higher level of assurance were required, the sample
size would have to be larger. If a lower level of assurance were
acceptable the sample size could be smaller.
The examples in Table 5 illustrate the disproportionate impact that
the proposed rule could have on small businesses or businesses with
low-volume products. In the first example in Table 5, the same number
of units would have to be submitted to a third party testing conformity
assessment body whether 1,000 units or 10,000 units were in the lot. In
other words, the total third party testing costs would be the same, but
the cost per unit for a manufacturer producing only 1,000 units would
be 10 times the cost per unit for a manufacturer producing 10,000
units.
The examples in table 5 also illustrate the potential that
component part testing could offer for reducing the cost of testing.
For example, assume a manufacturer produces five products in lots of
10,000 units, but uses a common component part on each of the products
that it purchases in lots of 50,000. The manufacturer could conduct the
applicable chemical tests on the component part rather than on the
finished product. If, following the sample sizes in Table 5, the mean
of the component was 10 and the standard deviation was 1, this would
reduce the cost of testing that component part by a factor of four over
the cost that would apply if only tests on the finished product were
acceptable. This is because without component part testing, the
manufacturer would have to conduct tests on the component part as it
was used in each of the five products. If each product were produced in
lots of 10,000 units, this would amount to four tests on the component
for each product or 20 total tests on the same component part. With
component part testing, the manufacturer could simply conduct the tests
on the component part, which was assumed to be purchased in a lot of
50,000 units, which would only require five tests of the component to
provide a 95 percent probability that all of the units in the lot were
in compliance.
Random Samples: The proposed rule would require that samples for
periodic testing for children's products be selected randomly. A random
sample is one in which each unit has an equal chance of being included
in the sample. The proposed rule would specify that each unit produced
or imported by the firm since the last random sample was drawn must
have an equal chance of being selected. There will be some
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additional cost associated with selecting a random sample rather than a
convenience sample. The Commission invites comments on this proposed
provision and is especially interested in comments describing the cost
or other burdens that this proposed provision would impose.
iii. Hypothetical Product Testing Examples
To provide some information on what the magnitude of the third
party testing costs may be for some manufacturers of children's
products, this section discusses the potential cost of conducting third
party testing for two product categories: Bicycles and toys. These
examples are hypothetical and are intended to illustrate some potential
cost implications of the proposed rule but might not be representative
of every manufacturer in each category. The costs per test that are
assumed in the examples can vary significantly. The Commission invites
any comments that provide better information on the potential impacts
on individual manufacturers.
Bicycles: Children's bicycles must be tested for compliance with
the CPSC bicycle standard, which was estimated above to cost between
$700 and $1,100. Additionally, the paint used on the bicycle must be
tested for compliance with the lead-in-paint standard and the
accessible component parts on the bicycle must be tested for lead
content. The number of paints and component parts that require testing
can vary among different models, but information provided by CPSC
Compliance staff suggests that 75 components parts might be a
reasonable estimate for the average. This example will use estimates in
the middle of these ranges for the testing costs discussed above and
assume that the cost of testing to the bicycle standard is $900 and the
cost for testing a component part for lead content is $50. It is
further assumed that quantitative data is available for all applicable
tests and that the variation is low enough that testing four units will
provide the high degree of assurance desired that products comply with
the applicable safety rules. To the extent that some of the tests in
the bicycle standard might be qualitative in nature, the sample size
for testing would need to be larger.
If component part testing is not available to this manufacturer,
the cost of testing the bicycle to each applicable safety rule one time
would be about $4,650 (testing to the bicycle standard itself at $900
and testing 75 components parts for lead content). If a sample of four
units were required to be tested to provide the required high degree of
assurance, then the cost of the third party testing to the manufacturer
would be $18,600.
The manufacturer in this example might be able to reduce the
testing costs with component part testing if some of the components
parts were used on more than one model. If component part testing
reduced the cost of the lead content testing by this manufacturer by a
factor of four, then the cost of testing to the bicycle standard itself
would still be $900, but the average cost of testing the lead content
of the component parts would be reduced to $12.50 per component part.
Therefore the cost of testing the bicycle once would be $1,837.50. The
cost to test four units to provide the required high degree of
assurance would be $7,350.
The total cost of the third party testing to the manufacturer would
depend upon the number of youth model bicycles that the manufacturer
offered. If the manufacturer had five different models, and if
component part testing could reduce the costs of the lead-content
testing by a factor of four, the total cost of the third party testing
to the firm would be about $36,750.
Toys: Toys are subject to the requirements for lead and phthalate
content, and to several physical and mechanical requirements, including
the requirements of ASTM F963, which was made a mandatory standard by
the CPSIA. In this example, it is assumed that the testing costs are at
the low to middle part of the ranges and that the hypothesized toy
contains one metal component part that must be tested for lead content
using ICP analysis (at $50) and two plastic component parts for which
XRF analysis can be used for determining the lead content (two tests at
$6 each). The plastic component parts also must be tested for phthalate
content (two tests at $225 each). Additionally, it is assumed that the
toy contains four different paints that must be tested for both lead
content ($50/test) and soluble heavy metals ($125/test). Finally, it is
assumed that the toy is subject to some mechanical requirements that
include use and abuse testing for which only qualitative data is
available at $50 per test. Thus, the cost of testing this toy for
compliance to each applicable rule one time would be $1,262: $1,212 is
associated with the chemical (lead, heavy metal, and phthalate) testing
and $50 is associated with the mechanical testing (including use and
abuse testing).
If the means and standard deviations of the lead, heavy metal, and
phthalate contents of all of the product components parts are
sufficiently low that testing four units could statistically provide
the required high degree of assurance, then the cost the chemical
testing for this toy would be $4,848 ($1,212 x 4). If the means or
standard deviations of the lead, heavy metal, or phthalate content were
higher, which is likely the case for some materials, more units might
have to be tested to provide the required high degree of assurance and
the resulting cost would also be higher.
Because the testing data for mechanical requirements are
qualitative in nature, the number of units that might have to be tested
to provide the required high degree of assurance would be more than
required for the chemical tests. If a high degree of assurance were
considered to be a 95 percent probability that no more than 6 percent
of the units in the lot did not comply, then 50 units would have to be
tested. In this case, the cost of mechanical testing would be $2,500
($50 x 50).
Combining the cost of the chemical tests and the cost of the tests
for mechanical or physical requirements, the total cost to this
hypothetical manufacturer to obtain the required high degree of
assurance that the products complied with all applicable safety rules
would be $7,348. If, as in the bicycle example, component part testing
could be used to reduce the cost of the chemical testing by a factor of
four, then the total cost of testing the toy could be reduced to $3,712
($4,848/4 + $2,500).
Again, the total cost to the manufacturer would depend upon factors
such as the complexity of the products, the variation in the materials
used, the opportunities to use component part testing, and the number
of different toys that were offered. For example, if the manufacturer
offered five similar toys and the third party testing costs were
similar for each toy and component part testing allowed the
manufacturer to reduce the costs of chemical testing by a factor of
four, the total cost to the manufacturer for testing the toys would be
$18,560. The annual cost would be higher if the testing had to be
repeated more than once annually or there were material changes in the
design of the products or production processes during the year.
iv. Impact of Third Party Testing on Firms
Whether such costs would have a substantial adverse impact on a
firm depends upon the individual circumstances of the firm. One factor
that can give an indication of whether something will have a
significant impact is the magnitude of the impact in
[[Page 28358]]
relation to the revenue of the firm. A typical profit rate is about 5
percent of revenue. In other words, for every $1 of revenue, only 5
cents might remain after paying all expenses. Therefore, a new cost
that amounted to 1 percent of revenue could, all other things equal,
reduce the profit by 20 percent and might be considered to be a
significant impact by some firms. This would be consistent with what
some other agencies consider to be significant. OSHA, for example,
considers an impact to be significant if the costs exceed 1 percent of
revenue or 5 percent of profit.
Using the toy example above, with component part testing, if the
third party testing costs were spread over 10,000 units, the cost of
the testing would be about $0.37 per unit ($3,712/10,000). According to
a toy industry representative, the average retail price of a toy is
about $8. However, depending upon the channels of distribution and the
practices in the particular market or industry, the price that a
manufacturer receives for a product can be less than half of what the
product eventually sells for at retail. Therefore, if the manufacturer
received $4 for the toy that cost $0.37 per unit to test, the third
party testing costs would be 9.2 percent of revenue ($0.37/$4) and
could exceed the expected profit. Even if the manufacturer received $30
per unit for the toy (which might indicate a retail price of around $60
or more), the third party testing cost would still exceed 1 percent of
the revenue per unit and might be considered to be a significant
impact.
It is possible that the impact could be reduced if the manufacturer
had an established reasonable testing program that met the requirements
of the proposed rule. In such cases, manufacturers would be required to
conduct periodic third party tests per rule at least once every two
years rather than at least once a year. For example, if the
hypothetical manufacturer of the toy used in the above example had a
reasonable testing program and determined that obtaining one periodic
third party test per applicable rule were sufficient, and the annual
production volume were 10,000 units, then the per unit testing cost
(without any component testing) would be about $0.06 ($1,262/20,000).
(However, it should be noted that testing a product for compliance with
each applicable rule one time is likely to require that the
manufacturer submit more than one sample of the product to the testing
laboratory. This is because some required tests cannot be performed on
the same sample that has been used for another test. For some chemical
tests, it may be necessary to use more than one sample of the product
to obtain enough of a component to test.) If the manufacturer received
$4 for each unit, then the periodic third party testing costs would
amount to about 1.5 percent of revenue ($0.06/$4), which still could be
considered to be a significant impact. If component part testing
reduced the cost of the chemical tests by a factor of four, then the
cost of the periodic third party testing could be reduced to $353 ($50
+ $1,212/4) or about $0.02 per unit, if 10,000 units were produced
annually and third party testing were conducted only once every two
years. This would be about 0.5 percent of revenue if the manufacturer
received $4 for each unit, which might not be considered significant.
If the production volume were lower or the revenue per unit received by
the manufacturer were lower, the impact would be greater. If the
production volume were higher or the revenue per unit received by the
manufacturer were higher, then the impact of the third party testing
requirement would be lower.
It should be noted that the only cost considered in this
hypothetical example is the cost of the third party testing. Any
additional costs associated with in-house periodic testing or a
reasonable testing program would be in addition to these costs and
increase the impact, as would any additional third party testing costs
associated with material changes in the product's design, the
manufacturing processes, or the sourcing of component parts. Other
costs that were not considered were the cost of the samples consumed in
the testing and the cost of shipping the samples to the third party
conformity assessment body.
v. Caveats and Possible Market Reactions to Third Party Testing
Requirements
Manufacturers can be expected to react to a significant increase in
their costs due to testing requirements in several ways. Some
manufacturers might attempt to redesign their products to reduce the
number of tests required, by reducing the features or the number of
components parts used in their products. Manufacturers could also be
expected to reduce the number of children's products that they offer
or, in some cases, exit the market for children's products entirely.
Some may go out of business altogether.
The requirement for third party certification testing could be a
barrier to new firms entering the children's product market, unless
they expect to have relatively high volume products. This could be
especially important for firms that expected to serve a niche market,
including products intended for children with special needs. The
requirement for third party testing when there is a material change in
a product's design or manufacturing process could cause some small or
low-volume manufacturers to forgo or delay implementing some
improvements to a product's design or manufacturing process in order to
avoid the cost of the third party testing.
The cost of testing some toys and other children's products could
be higher than those in the above examples. The cost would be higher,
for example, for products that had more components parts or where the
variability in the test results was greater, which would require more
samples to be tested. The cost of testing would also be higher if there
was less opportunity for component part testing. The cost of testing
could be lower for products that were subject to fewer safety rules or
that contained fewer component parts. For some apparel articles, for
example, the only tests required might be for lead content on some
components parts for which component part testing might be permissible.
Although the above examples illustrate the potential for component
part testing to reduce the costs of testing, it might not be an option
for all products or manufacturers. Component part testing is most
likely to be an option for component parts that are common to multiple
products (e.g., paints, bolts of a standard size). The potential for
component part testing to reduce the cost of testing would be less for
products that have component parts that are unique to that product.
5. Protection Against Undue Influence
The proposed rule would require all manufacturers of children's
products to establish procedures to prevent attempts to exercise undue
influence on a third party conformity assessment body and to report to
the Commission immediately of any attempt by any interested party to
exert undue influence over test results, and that employees are aware
that they may report any allegations of undue influence to the
Commission confidentially. There would be some cost to firms to develop
the materials or training programs to comply with these requirements.
The Commission invites comments from the public providing information
on the cost and other impacts of this provision.
[[Page 28359]]
6. Consumer Product Labeling Program
The consumer product labeling program that would be established by
the proposed rule would allow firms to label any product that complies
with the certification requirements for the product with a label that
states that the product ``Meets CPSC Safety Requirements.'' This
provision is not expected to have a significant impact on firms because
the program is voluntary and the costs of adding or modifying a label
on a product are expected to be low.
7. Summary of Impact on Small Businesses
The proposed rule, if finalized, could have a significant adverse
impact on a substantial number of small businesses. The provisions of
the proposed rule that are expected to have the most significant impact
are provisions related to requirements for the third party testing of
children's products with and without a reasonable testing program. The
impact of the proposed rule would be expected to be disproportionate on
small and low-volume manufacturers. This is because testing costs are
relatively fixed. Therefore, the per unit impact of testing costs will
be greater on low-volume producers than on high- volume producers.
The provisions of the proposed rule that would require
manufacturers of nonchildren's products to establish and maintain a
reasonable testing program also could have an adverse impact on some
manufacturers. The impact of these provisions are expected to be less
significant than the impact of the provisions related to children's
products because many manufacturers are believed to already have at
least some quality assurance or testing programs in place. The
provisions related to the proposed requirement for a reasonable testing
program are intended to provide manufacturers with a high degree of
flexibility in designing and implementing the programs, which would
also serve to reduce the potential impact on a firm.
The other requirements in the proposed rule for protection against
undue influence over a conformity assessment body and the consumer
product labeling program are less likely to have a significant adverse
impact on a substantial number of small businesses. The Commission
invites comments on these provisions.
8. Federal Rules Which May Duplicate, Overlap, or Conflict With the
Proposed Rule
The proposed rule would establish the minimum requirements for
testing and certification of consumer products. Some individual
consumer product safety rules contain specific testing requirements.
Manufacturers would be expected to meet the more stringent requirements
whether they are the provisions of this proposed rule or the
requirements in the specific safety rule. However, the rules would not
require manufacturers to duplicate their efforts to comply with both
sets of requirements. Testing and recordkeeping required to comply with
the more stringent rule would also meet the requirements of the less
stringent rule. Manufacturers will not be required to duplicate tests
or recordkeeping to comply with both sets of rules. There are no known
Federal rules that conflict with the proposed rule.
9. Alternatives for Reducing the Adverse Impact on Small Businesses
The Commission recognizes that the proposed rule could have a
significant and disproportionate impact on small and low-volume
manufacturers. The Commission has incorporated some provisions into the
proposed rule that are intended to lessen the impact on small
businesses. These include some relief from the periodic testing
requirement for children's products, the ability to use component part
testing (which would be addressed by a separate Commission rule
elsewhere in this issue of the Federal Register). The Commission
invites comments on these provisions and other provisions or
alternatives that could lessen the adverse impact on small or low-
volume businesses.
The Commission is proposing that manufactures that have implemented
reasonable testing programs that meet the requirements contained in the
proposed rule would be obligated to conduct third party periodic tests
at least once every two years instead of at least once every year if
they have not implemented reasonable testing programs. This provision
could significantly reduce the third party periodic testing costs of
manufacturers that have such programs. However, the reduction could be
limited for firms that do not have the ability to conduct the tests in-
house, for importers that do have significant control over the actual
production of their products, and for manufacturers who might have more
frequent material changes in their products' designs, manufacturing
processes, or sourcing of component parts. The Commission invites
comment on this provision, including whether this provision would
provide sufficient relief to enough firms to maintain this provision in
the final rule.
a. Partial Exemption From Periodic Testing
The proposed rule would require that all children's products be
tested periodically by a third party conformity assessment body and
establishes one year as the maximum interval between third party
periodic tests if the manufacturer does not have a reasonable testing
program and two years if the manufacturer does have a reasonable
testing program. However, if fewer than 10,000 units of a product have
been manufactured or imported since the last time the product was
submitted to a third party conformity assessment body, the manufacturer
would not be subject to the periodic testing requirements unless 10,000
units have been manufactured or imported. This provision would allow
low-volume manufacturers to spread their periodic testing costs over
more units. The exemption would not relieve the manufacturer from the
obligation to have the product tested by a third party conformity
assessment body before the product is introduced into commerce, or when
there has been a material change in the product's design or production
processes, nor would the exemption extend beyond the initial exemption
for the first 10,000 units.
b. Component Testing
The proposed rule would allow firms to submit component parts for
third party testing when the required testing does not need to be
performed on the finished product. This can reduce the cost to
manufacturers particularly where one component part might be common to
more than one product. Such component parts might include paints,
polymers used in molding different parts, and standard-sized bolts. In
these cases the component parts might be received in larger lots than
the production lots of the products in which they are used. Therefore,
the testing costs for those component parts will be spread over more
units than if they were required to be tested on the finished products.
10. Alternatives That May Further Reduce the Impact on Small Businesses
The Commission also invites comments on other alternatives that
could provide some relief to small businesses that would be adversely
impacted by the proposed rule. Alternatives could include things such
as: (1) The establishment of different compliance or reporting
requirements that take into account the resources available to small
businesses; (2) the clarification, consolidation, or
[[Page 28360]]
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 to the extent statutorily permissible under
section 14 of the CPSA. In providing such comments, the Commission
requests that the comments provide specific suggestions and well
developed justifications for the suggestions. Some possible
alternatives that could be considered are discussed below.
a. Less Stringent Requirements for Third Party Testing
The proposed rule would require that enough third party tests be
conducted to provide a high degree of assurance that the products
comply with the applicable rules. This could require most manufacturers
to submit multiple samples for third party testing each year,
especially if they have not implemented a reasonable testing program.
However, the Commission could adopt an alternative that would limit the
number of samples required for third party testing. For example, the
Commission could simply require that manufacturers submit sufficient
samples to a third party conformity assessment body so that compliance
with each rule could be assessed at least once annually.
The proposed rule would require that periodic third party testing
be conducted at least once a year or at least once every two years if
the manufacturer has established a reasonable testing program. A year
was chosen as the maximum interval between periodic testing because
many children's products are produced on an annual or seasonal cycle,
but, in the case of manufacturers with reasonable testing programs, the
Commission believed that the information about the products provided
the manufacturer by the internal testing programs could substitute for
some third party tests. The Commission could, however, consider a
different maximum interval between the periodic tests. For example, the
Commission could consider requiring that third party tests be conducted
at less frequent or more frequent intervals.
The advantage of less stringent requirements is that they could
significantly reduce the cost of the third party testing requirement.
The disadvantage is that the testing would provide less information
about whether all of the products produced were in compliance with the
applicable safety rules. Requiring third party tests more frequently
would provide additional assurance that the products comply with the
applicable safety rules. However, this would also increase the costs
associated with third party testing.
The Commission invites comments on these and similar alternatives.
For example, should the Commission consider a less stringent
requirement? If so, what should the alternative requirement be? Should
the less stringent requirement apply to all manufacturers or only those
that meet certain criteria, such as to small or low-volume
manufacturers?
b. Limits on Third Party Testing for Small or Low-Volume Manufacturers
The Commission could consider additional alternatives that would
provide relief to small or low-volume manufacturers. Substantial relief
could be provided to small or low-volume manufacturers. The Commission
invites comments on third party testing limits for small or low-volume
manufacturers that still meet statutory requirements of section 14(d)
of the CPSA. In providing such comments, it is important to note that
the Commission cannot exempt small or low-volume manufacturers of
children's products from initial third party certification testing to
applicable standards, regulations, or bans or from third party testing
when there is a material change to the product and has already
specified limits on periodic testing where a manufacturer produces less
than 10,000 units of a particular product. The Commission seeks
comments on additional alternatives that may provide testing cost
relief to small or low-volume manufacturers while still satisfying the
testing and compliance requirements of section 14(d) of the CPSA.
c. Alternative Test Methods for Small or Low-Volume Manufacturers
Some small manufacturers have encouraged the Commission to allow
alternative test methods such as those relying on XRF technology. XRF
testing methods are significantly less expensive than the ICP analysis
that the Commission currently requires for most lead content testing
(with the exception of homogenous polymer products). The Commission
staff uses XRF for screening samples.
The Commission invites comments on the possibility of using
alternative testing technologies for reducing the burden on small and
low-volume manufacturers. For example, could the Commission allow small
or low-volume manufacturers to use less expensive, but potentially less
accurate third party testing methods? If so, under what conditions?
E. 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 through 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,
gathering and maintaining the data needed, and completing and reviewing
each collection of information.
We particularly 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
methodology 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: Testing and Labeling Pertaining to Product Certification.
Description: The proposed rule would implement section 102(b) of
the CPSIA, which requires certifications of compliance with safety
standards for each product subject to a consumer product safety rule,
ban, standard, or regulation promulgated and/or enforced by the CPSC. A
certification that a nonchildren's product complies with applicable
consumer products safety rules, bans, standards, and regulations must
be supported by a reasonable testing program or a test of each product.
A certification that a children's product complies with the applicable
children's product safety rules must be supported by testing performed
by an approved third party conformity assessment body. The proposed
rule would impose recordkeeping requirements related to those testing
and certification requirements. The recordkeeping requirements are
intended to allow one to uniquely identify each product and establish
that it was properly certified before it enters commerce and has been
properly retested for conformity with all applicable rules on a
continuing basis, including after a material change in the product's
design or manufacturing
[[Page 28361]]
processes, including the sourcing of component parts.
Each manufacturer or importer of a consumer product subject to an
applicable safety rule would be required to establish and maintain the
following records:
A copy of the certificate of compliance for each product.
In the case of nonchildren's products, the required certificate is a
general conformity certificate. In the case of children's products, the
certificate must be based upon testing by a third party conformity
assessment body. (Proposed Sec. Sec. 1107.10(a)(5)(i)(A),
1107.26(a)(1))
For nonchildren's products, a record of each product
specification, including any new product specification resulting from
remedial action. (Proposed Sec. 1107.10(a)(5)(i)(B) and (E))
Records of each certification test, including
identification of the third party conformity assessment body, if any,
that conducted the test. (Proposed Sec. Sec. 1107.10(a)(5)(i)(C),
1107.26(a)(2))
Records of the production testing and periodic test plans
and results. (Proposed Sec. Sec. 1107.10(a)(5)(i)(D), 1107.26(a)(3))
For children's products, records relating to all material
changes. (Proposed Sec. 1107.26(a)(4))
Records of all remedial actions taken. (Proposed
Sec. Sec. 1107.10(a)(5)(i)(E), 1107.26(a)(6))
For children's products, records of undue influence
procedures. (Proposed Sec. 1107.26(a)(5))
Description of Respondents: The recordkeeping requirements
contained in this proposed rule would apply to all manufacturers or
importers of consumer products that are covered by one or more consumer
product safety rules promulgated and/or enforced by the CPSC. The CPSC
reviewed every category in the NAICS and selected those that included
firms that could manufacture or sell any consumer product that could be
covered by a consumer product safety rule. Using data from the U.S.
Census Bureau, we determined that there were over 37,000 manufacturers,
almost 80,000 wholesalers, and about 128,000 retailers in these
categories. However, not all of the firms in these categories
manufacture or import products that are covered by consumer product
safety rules. Therefore, these numbers would constitute a high estimate
of the number of firms that are subject to the recordkeeping
requirements.
Estimate of the Burden: The hour burden of the recordkeeping
requirements will likely vary greatly from product to product depending
upon such factors as the complexity of the product and the amount of
testing that must be documented. CPSC staff does not have comprehensive
data on the universe of products that will be impacted. Therefore,
estimates of the hour burden of the recordkeeping requirements are
somewhat speculative. The CPSC invites comments that can provide more
information about the number of hours required for the recordkeeping
requirements of the proposed rule.
Previously, the CPSC staff estimated that the recordkeeping burden
of the mattress open flame flammability standard would be about one
hour per model (prototype) per year. Many of the recordkeeping
requirements in that standard are comparable to the requirements in
this proposed rule. However, that rule concerned only the recordkeeping
requirements for one rule (mattress flammability) while manufacturers
of children's products will frequently have to document their
compliance with more than one product safety rule (e.g., lead-in-paint,
lead content, phthalates, and some product specific rules, such as the
ASTM F963 toy standard). Therefore, one can assume the burden of the
proposed rule could be twice the hour burden of the recordkeeping
required for the mattress flammability rule. (Information on the
product safety rules that apply to different consumer products can be
found at http://www.cpsc.gov/businfo/regsbyproduct.html.)
According to a representative of a trade association, there are an
estimated 50,000 to 60,000 individual toys on the market. It is likely
that there are at least that many other children's products in product
categories such as wearing apparel, accessories, jewelry, juvenile
products, children's furniture, etc. Additionally nonchildren's
products that are subject to product safety rules include paints,
nonmetal furniture (for lead-in-paint), all-terrain vehicles, bicycles,
and bunk beds. Therefore, we estimate that there are approximately
100,000 to 150,000 individual products to which the recordkeeping
requirements would apply.
Assuming the annual recordkeeping burden per product will be two
hours and that there are between 100,000 and 150,000 products to which
the recordkeeping requirements would apply, the total hour burden for
the recordkeeping requirements is estimated to be between 200,000 and
300,000 hours.
The total cost burden of the recordkeeping requirements is expected
to be between $9.8 and $14.7 million. This estimate is obtained by
multiplying the total burden hours by $48.91, which is the total hourly
compensation for private sector workers in management, professional,
and related occupations. The recordkeeping requirements are not
expected to result in any additional cost to the Federal government.
The CPSC will likely request access to these records only when it is
investigating potentially defective or noncomplying products.
Investigating potentially defective or noncomplying product is a
regular ongoing activity of the Commission. It is anticipated that
access to the records required by this rule will make it easier for the
investigators to narrow the scope of their investigations to particular
production or import lots.
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 June 21, 2010, to the
Office of Information and Regulatory Affairs, OMB (see ADDRESSES).
F. Environmental Considerations
This proposed rule falls within the scope of the Commission's
environmental review regulations at 16 CFR 1021.5(c)(2) which provides
a categorical exclusion from any requirement for the agency to prepare
an environmental assessment or environmental impact statement for
product certification rules.
G. Executive Order 12988
Executive Order 12988 (February 5, 1996), requires agencies to
state in clear language the preemptive effect, if any, of new
regulations. The proposed regulation would be issued under 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 in by a court of competent
jurisdiction.
H. Effective Date
The Commission is proposing that any final rule based on this
proposal become effective 180 days after its date of publication in the
Federal Register.
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 add 16 CFR part 1107 to
read as follows:
[[Page 28362]]
PART 1107--TESTING AND LABELING PERTAINING TO PRODUCT CERTIFICATION
Subpart A--General Provisions
Sec.
1107.1 Purpose.
1107.2 Definitions.
Subpart B--Reasonable Testing Program for Nonchildren's Products
1107.10 Reasonable testing program for nonchildren's products.
Subpart C--Certification of Children's Products
1107.20 General requirements.
1107.21 Periodic testing.
1107.22 Random samples.
1107.23 Material change.
1107.24 Undue influence.
1107.25 Remedial action.
1107.26 Recordkeeping.
Subpart D--Consumer Product Labeling Program
1107.40 Labeling consumer products to indicate that the
certification requirements of section 14 of the CPSA have been met.
Authority: 15 U.S.C. 2063, Sec. 3, 102 Pub. L. 110-314, 122
Stat. 3016, 3017, 3022.
Subpart A--General Provisions
Sec. 1107.1 Purpose.
This part 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 Consumer Product Safety Act
(CPSA) (15 U.S.C. 2063(a)(1), (a)(2), (d)(2)(B)).
Sec. 1107.2 Definitions.
Unless otherwise stated, the definitions of the Consumer Product
Safety Act and the Consumer Product Safety Improvement Act of 2008
apply to this part. The following definitions apply for purposes of
this part:
CPSA means the Consumer Product Safety Act.
CPSC means the Consumer Product Safety Commission.
Detailed bill of materials means 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.
Due care means the degree of care that a prudent and competent
person engaged in the same line of business or endeavor would exercise
under similar circumstances.
High degree of assurance means an evidence-based demonstration of
consistent performance of a product regarding compliance based on
knowledge of a product and its manufacture.
Identical in all material respects means there is no difference
with respect to compliance to the applicable rules between the samples
and the finished product.
Manufacturer means the parties responsible for certification of a
consumer product pursuant to 16 CFR part 1110.
Manufacturing process means the techniques, fixtures, tools,
materials, and personnel used to create the component parts and
assemble a finished product.
Production testing plan means 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.
Third party conformity assessment body means a third party
conformity assessment body recognized by the CPSC to conduct
certification testing on children's products.
Subpart B--Reasonable Testing Program for Nonchildren's Products
Sec. 1107.10 Reasonable testing program for nonchildren's products.
(a) 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.
(b) A reasonable testing program must consist of the following
elements:
(1) Product Specification. The product specification is a
description of the consumer product and lists the applicable rules,
bans, standards or regulations to which the product is subject. A
product specification should describe the product listed on a general
conformity certification in sufficient detail to identify the product
and distinguish it from other products made by the manufacturer. The
product specification may include, but is not limited to, a color
photograph or illustration, model names or numbers, a detailed bill of
materials, a parts listing, raw material selection and sourcing
requirements.
(i) A product specification must include any component parts that
are certified pursuant to 16 CFR Part 1109.
(ii) Product specifications that identify individual features of a
product that would not be considered a material change may use the same
product specification for all products manufactured with those specific
features. Features that would not be considered a material change
include different product sizes or other features that cover variations
of the product where those variations do not affect the product's
ability to comply with applicable rules, bans, standards, or
regulations.
(iii) Each manufacturing site must have a separate product
specification.
(2) Certification Tests. A manufacturer must conduct certification
tests on a product before issuing a general conformity certificate for
that product. A certification test is a test performed on samples of
the product that are identical to the finished product in all material
respects to demonstrate that the product complies with the applicable
safety rules, bans, standards, or regulations. Certification tests must
contain the following elements:
(i) Samples. For purposes of this section, a sample means a
component part of the product or the finished product which is subject
to testing. Samples submitted for certification testing must be
identical in all material respects to the product to be distributed in
commerce. The manufacturer must submit a sufficient number of samples
for certification testing so as to provide a high degree of assurance
that the certification tests accurately represent the product's
compliance with all applicable rules.
(A) Only finished products or component parts listed on the product
specification can be submitted for certification testing.
(B) A manufacturer may substitute component part testing for
finished product testing pursuant to 16 CFR part 1109 unless the rule,
ban, standard or regulation applicable to the product requires testing
of the finished product. If a manufacturer relies upon certification
testing of component part(s) (rather than tests of the finished
product), the manufacturer must demonstrate how the combination of
testing of component part(s), portions of the finished product, and
finished product samples demonstrate, with a high degree of assurance,
compliance with all applicable rules, bans, standards, or regulations.
(ii) Material Change. A material change is any change in the
product's design, manufacturing process, or
[[Page 28363]]
sourcing of component parts that a manufacturer exercising due care
knows, or should know, could affect the product's ability to comply
with the applicable rules, bans, standards, or regulations.
(A) When a previously-certified product undergoes a material change
that only affects the product's ability to comply with certain
applicable rules, bans, standards, or regulations, certification for
the new product specification may be based on certification testing of
the materially changed component part, material, or process, and the
passing certification tests of the portions of the previously-certified
product that were not materially changed.
(B) A manufacturer must conduct certification tests of the finished
product if a material change affects the finished product's ability to
comply with an applicable rule, ban, standard, or regulation.
(C) A manufacturer must exercise due care to ensure that reliance
on anything other than retesting of the finished product after a
material change occurs does not allow a noncompliant product to be
distributed in commerce. A manufacturer should resolve any doubts in
favor of retesting the finished product for certification.
(3) Production Testing Plan. A production testing plan describes
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, bans, standards, or regulations. A production
testing plan may include recurring testing or the use of process
management techniques such as control charts, statistical process
control programs, or failure modes and effects analyses (FMEAs)
designed to control potential variations in product manufacturing that
could affect the product's ability to comply with the applicable rules,
bans, standards, or regulations. A production testing plan must contain
the following elements:
(i) A description of the production testing plan, including, but
not limited to, a description of the tests to be conducted or the
measurements to be taken, the intervals at which the tests or
measurements will be made, the number of samples tested, and the basis
for determining that such tests provide a high degree of assurance of
compliance if they are not the tests prescribed in the applicable rule,
ban, standard, or regulation;
(ii) Each manufacturing site must have a separate production
testing plan;
(iii) The production testing interval selected must be short enough
to ensure that, if the samples selected for production testing comply
with an applicable rule, ban, standard, or regulation, there is a high
degree of assurance that the untested products manufactured during that
interval also will comply with the applicable rule, ban, standard, or
regulation. Production test intervals should be appropriate for the
specific testing or alternative measurements being conducted.
(A) A manufacturer may use measurement techniques that are
nondestructive and tailored to the needs of an individual product
instead of conducting product performance tests to assure a product
complies with all applicable rules, bans, standards, or regulations.
(B) Any production test method used to conduct production testing
must be as effective in detecting noncompliant products as the tests
used for certification.
(C) If a manufacturer is uncertain whether a production test is as
effective as the certification test, the manufacturer must use the
certification test.
(4) Remedial Action Plan.
(i) A remedial action plan describes the steps to be taken whenever
samples of a product or a component part of a product fails a test or
fails to comply with an applicable rule, ban, standard, or regulation.
A remedial action plan must contain procedures the manufacturer must
follow to investigate and address failing test results. Manufacturers
must take remedial action after any failing test result to ensure with
a high degree of assurance that the products manufactured after the
remedial action has been taken comply with the applicable rules, bans,
standards, or regulations. The type of remedial action may be different
depending upon the applicable rule, ban, standard, or regulation.
Remedial action can include, but is not limited to:
(A) Changes to the manufacturing process, the equipment used to
manufacture the product, the product's materials, or design;
(B) reworking the product produced; or
(C) other actions deemed appropriate by the manufacturer, in the
exercise of due care, to assure compliant products.
(ii) Any remedial action that results in a material change to a
product's design, parts, suppliers of parts, or manufacturing process
that could affect the product's ability to comply with any applicable
rules requires a new product specification for that product. Before a
product covered by the new product specification can be certified as
compliant with the applicable rules, bans, standards, or regulations, a
manufacturer must have passing certification test results for the
applicable rules, bans, standards, or regulation.
(5) Recordkeeping.
(i) A manufacturer of a nonchildren's product must maintain the
following records:
(A) Records of the general conformity certificate for each product;
(B) Records of each product specification;
(C) Records of each certification test and, if the manufacturer
elected to have a third party conformity assessment body test the
product, identification of any third party conformity assessment body
on whose testing the certificate depends. Records of certification
tests must describe how the product was certified as meeting the
requirements, including how each applicable rule was evaluated, the
test results, and the actual values of the tests;
(D) Records to demonstrate compliance with the production testing
plan requirement, including a list of the applicable rules, bans,
standards, or regulations, a description of the types of production
tests conducted, the number of samples tested, the production interval
selected for performance of each test, and the test results. Records of
a production test program must describe how the production tests
demonstrate that the continuing production complies with the applicable
rules. References to techniques in relevant quality management and
control standards, such as ANSI/ISO/ASQ Q9001-2008: Quality management
systems--Requirements, ANSI/ASQ Z1.4-2008: Sampling Procedures and
Tables for Inspection by Attributes, and/or ANSI/ASQ Z1.9-2008:
Sampling Procedures and Tables for Inspection by Variables for Percent
Nonconforming, may be used to demonstrate that the production tests
have the necessary accuracy, precision sensitivity, repeatability, and
confidence to distinguish between compliant and noncompliant products;
(E) Records of all remedial actions taken, including the specific
action taken, the date the action was taken, the person who authorized
the actions, and any test failure which necessitated the action.
Records of remedial action must relate the action taken to the product
specification of the product that was the subject of that remedial
action and the product specification of any new product resulting from
any remedial action;
[[Page 28364]]
(ii) If a remedial action results in a new product specification,
the manufacturer must create a new set of records for the product.
(iii) A manufacturer must maintain the records specified in this
subpart at the location within the United States specified in 16 CFR
1110.11(d) or, if the records are not maintained at the custodian's
address, at a location within the United States specified by the
custodian. The manufacturer must make these records available, either
in hard copy or electronically, for inspection by the CPSC upon
request.
(iv) A manufacturer must maintain records (except for test records)
for as long as the product is in production or imported by the
manufacturer plus five years. Test records must be maintained for five
years. All records must be available in the English language.
(c) If any certification test results in a failure, a manufacturer
cannot certify a product until the manufacturer has taken remedial
action, and the product manufactured after the remedial action passes
certification testing.
(d) Manufacturers of a nonchildren's product may use a third party
conformity assessment body to conduct certification testing but are not
required to use a third party conformity assessment body recognized by
the CPSC to conduct certification testing on children's products.
(e) Manufacturers of children's products may voluntarily establish
a reasonable testing program consistent with this subpart.
Subpart C--Certification of Children's Products
Sec. 1107.20 General requirements.
(a) Manufacturers must submit a sufficient number of samples of a
children's product, or samples that are identical in all material
respects to the children's product, to a third party conformity
assessment body for testing to support certification. The number of
samples selected must provide a high degree of assurance that the tests
conducted for certification purposes accurately demonstrate the ability
of the children's product to meet all applicable children's product
safety rules.
(b) If the manufacturing process for a children's product
consistently creates finished products that are uniform in composition
and quality, a manufacturer may submit fewer samples to provide a high
degree of assurance that the finished product complies with the
applicable children's product safety rules. If the manufacturing
process for a children's product results in variability in the
composition or quality of children's products, a manufacturer may need
to submit more samples to provide a high degree of assurance that the
finished product complies with the applicable children's product safety
rules.
(c) Except where otherwise specified by a children's product safety
rule, a manufacturer may substitute component part testing for complete
product testing pursuant to 16 CFR part 1109 if the component part,
without the remainder of the finished product, is sufficient to
determine compliance for the entire product.
(d) If a product sample fails certification testing, even if other
samples have passed the same certification test, the manufacturer must
investigate the reasons for the failure and take remedial action. A
manufacturer cannot certify the children's product until the
manufacturer establishes, with a high degree of assurance, that the
finished product does comply with all applicable children's product
safety rules.
Sec. 1107.21 Periodic testing.
(a) Each manufacturer must conduct periodic testing at least
annually, except as otherwise provided in paragraphs (b) and (d) of
this section or as provided in regulations under this title.
Manufacturers may need to conduct periodic tests more frequently than
on an annual basis to ensure a high degree of assurance that the
product being tested complies with all applicable children's product
safety rules.
(b) If a manufacturer has implemented a reasonable testing program
as described in subpart B of this part, it must submit samples of its
product to a third party conformity assessment body for periodic
testing to the applicable children's product safety rules at least once
every two years. If a manufacturer's reasonable testing program fails
to provide a high degree of assurance of compliance with all applicable
children's product safety rules, the Commission may require the
manufacturer to meet the requirements of paragraph (c) of this section
or modify its reasonable testing program to ensure a high degree of
assurance.
(c) If a manufacturer has not implemented a reasonable testing
program as described in subpart B of this part, then all periodic
testing must be conducted by a third party conformity assessment body,
and the manufacturer must conduct periodic testing as follows:
(1) Periodic Test Plan. Manufacturers must develop a periodic test
plan to assure that children's products manufactured after the issuance
of a children's product certification, or when the previous periodic
testing was conducted, continue to comply with all applicable
children's product safety rules. The periodic test plan must include
the tests to be conducted, the intervals at which the tests will be
conducted, the number of samples tested, and the basis for determining
that the periodic testing plan provides a high degree of assurance that
the product being tested continues to comply with all applicable
children's product safety rules. The manufacturer must have a separate
periodic testing plan for each manufacturing site producing a
children's product.
(2) Testing Interval. The periodic testing interval selected must
be short enough to ensure that, if the samples selected for periodic
testing pass the test, there is a high degree of assurance that the
other untested children's products manufactured during the interval
comply with the applicable children's product safety rules. The
interval for periodic testing may vary depending upon the specific
children's product safety rules that apply to the children's product.
Factors to be considered when determining the periodic testing interval
include, but are not limited to, the following:
(i) High variability in test results, as indicated by a relatively
large sample standard deviation in quantitative tests;
(ii) Measurements that are close to the allowable numerical limit
for quantitative tests;
(iii) Known manufacturing process factors which could affect
compliance with a rule. For example, if the manufacturer knows that a
casting die wears down as the die nears the end of its useful life, the
manufacturer may wish to test more often as the casting die wears down;
(iv) Consumer complaints or warranty claims;
(v) Nonmaterial changes, such as introduction of a new set of
component parts into the assembly process, or the manufacture of a
fixed number of products;
(vi) Potential for serious injury or death resulting from a
noncompliant children's product;
(vii) The number of children's products produced annually, such
that a manufacturer should consider testing a children's product more
frequently if the product is produced in very large numbers or
distributed widely throughout the United States;
(viii) The children's product's similarity to other children's
products with which the manufacturer is familiar and/or whether the
children's product has many different component parts
[[Page 28365]]
compared to other children's products of a similar type; or
(ix) Inability to determine the children's product's noncompliance
easily through means such as visual inspection.
(d) For a product produced or imported at low volumes, a
manufacturer is not subject to the periodic testing requirements of
paragraphs (a) and (b) or (c) of this section unless it produces 10,000
units of the product. Once a manufacturer has produced or imported
10,000 units of the product, the frequency at which the manufacturer
must engage in periodic testing must comply with paragraph (a), and (b)
or (c) of this section and does not depend on how often the
manufacturer produces or imports every 10,000 units of the product.
Sec. 1107.22 Random samples.
Each manufacturer must select samples for periodic testing by using
a process that assigns each sample in the production population an
equal probability of being selected. For purposes of this section, the
production population is the number of products manufactured or
imported after the initial certification or last periodic testing of a
children's product. A manufacturer may use a procedure that randomly
selects items from a list to determine which samples are the random
samples used for periodic testing before production begins. A
manufacturer may select samples for testing as they are manufactured.
Manufacturers who produce children's products that continue to be
distributed in commerce as they are manufactured may wish to test the
samples as they become available instead of waiting until all the
random samples have been selected before conducting testing.
Sec. 1107.23 Material change.
(a) General Requirements. If a children's product undergoes a
material change in product design or manufacturing process, including
the sourcing of component parts, that a manufacturer exercising due
care knows, or should know, could affect the product's ability to
comply with the applicable children's product safety rules, the
manufacturer must submit a sufficient number of samples of the
materially changed product for testing by a third party conformity
assessment body. Such testing must occur before a manufacturer can
certify the children's product. The extent of such testing may depend
on the nature of the material change. When a material change is limited
to a component part of the finished children's product and does not
affect the ability of the children's product to comply with other
applicable children's product safety rules, a manufacturer may issue a
children's product certificate based on the earlier third party
certification tests and on test results of the changed component part
conducted by a third party conformity assessment body. Changes that
cause a children's product safety rule to no longer apply to a
children's product are not considered to be material changes. A
manufacturer must exercise due care to ensure that reliance on anything
other than retesting of the finished product after a material change
would not allow a noncompliant children's product to be distributed in
commerce. A manufacturer should resolve any doubts in favor of
retesting the finished product for certification. Additionally, a
manufacturer must exercise due care to ensure that any component part
undergoing component-part-level testing is the same as the component
part on the finished children's product in all material respects.
(b) Product Design. For purposes of this subpart, the term product
design includes all component parts, their composition, and their
interaction and functionality when assembled. To determine which
children's product safety rules apply to a children's product, a
manufacturer should examine the product design for the children's
product as received by the consumer.
(c) Manufacturing Process. A material change in the manufacturing
process is a change in how the children's product is made that could
affect the finished children's product's ability to comply with the
applicable children's product safety rules. For each change in the
manufacturing process, a manufacturer should exercise due care to
determine if compliance to an existing applicable children's product
safety rule could be affected, or if the change results in a newly-
applicable children's product safety rule.
(d) Sourcing of Component Parts. A material change in the sourcing
of component parts results when the replacement of one component part
of a children's product with another component part could affect
compliance with the applicable children's product safety rules. This
includes, but is not limited to, changes in component part composition,
component part supplier, or the use of a different component part from
the same supplier who provided the initial component part.
Sec. 1107.24 Undue influence.
(a) Each manufacturer must establish procedures to safeguard
against the exercise of undue influence by a manufacturer on a third
party conformity assessment body.
(b) The procedures required in paragraph (a) of this section, at a
minimum, must include:
(1) Safeguards to prevent attempts by the manufacturer to exercise
undue influence on a third party conformity assessment body, including
a written policy statement from company officials that the exercise of
undue influence is not acceptable, and directing that appropriate staff
receive annual training on avoiding undue influence, and sign a
statement attesting to participation in such training;
(2) A requirement to notify the Commission immediately of any
attempt by the manufacturer to hide or exert undue influence over test
results; and
(3) A requirement to inform employees that allegations of undue
influence may be reported confidentially to the Commission and to
describe the manner in which such a report can be made.
Sec. 1107.25 Remedial action.
(a) Each manufacturer of a children's product must have a remedial
action plan that contains procedures the manufacturer must follow to
investigate and address failing test results. A manufacturer must take
remedial action after any failing test result to ensure, with a high
degree of assurance, that the children's products manufactured after
the remedial action has been taken comply with all applicable
children's product safety rules.
(b) A manufacturer must not certify a product if any certification
test by a third party conformity assessment body results in a failure
until the manufacturer has taken remedial action and the product
manufactured after the remedial action passes certification testing.
(c) Following a failing test result, a manufacturer must take
remedial action to ensure, with a high degree of assurance, that the
children's product complies with all applicable children's product
safety rules. Remedial action can include, but is not limited to,
redesign, changes in the manufacturing process, or changes in component
part sourcing. For existing production, remedial action may include
rework, repair, or scrap of the children's product. If a remedial
action results in a material change a manufacturer must have a third
party conformity assessment body retest the redesigned or
remanufactured product before the manufacturer can certify the product.
[[Page 28366]]
Sec. 1107.26 Recordkeeping.
(a) A manufacturer of a children's product subject to an applicable
children's product safety rule must maintain the following records:
(1) Records of the children's product certificate for each product.
The children's product covered by the certificate must be clearly
identifiable and distinguishable from other products;
(2) Records of each third party certification test. The
manufacturer must have separate certification tests records for each
manufacturing site;
(3) Records of the periodic test plan and periodic test results for
a children's product;
(4) Records of descriptions of all material changes in product
design, manufacturing process, and sourcing of component parts, and the
certification tests run and the test values;
(5) Records of the undue influence procedures, including training
materials and training records of all employees trained on these
procedures; and
(6) Records of all remedial actions taken following a failing test
result, including the rule that was tested, the specific remedial
action taken, the date the action was taken, the person who authorized
the action, any test failure which necessitated the action, and the
results from certification tests showing compliance after the remedial
action was taken.
(b) A manufacturer must maintain the records specified in this
subpart at the location within the United States specified in 16 CFR
1110.11(d) or, if the records are not maintained at the custodian's
address, at a location within the United States specified by the
custodian. The manufacturer must make these records available, either
in hard copy or electronically, for inspection by the CPSC upon
request.
(c) A manufacturer must maintain records (except for test records)
for as long as the product is in production or imported by the
manufacturer plus five years. Test records must be maintained for five
years. All records must be available in the English language.
Subpart D--Consumer Product Labeling Program
Sec. 1107.40 Labeling consumer products to indicate that the
certification requirements of section 14 of the CPSA have been met.
(a) Manufacturers and private labelers of a consumer product may
indicate, by a uniform label on or provided with the product, that the
product complies with any consumer product safety rule under the CPSA,
or with any similar rule, ban, standard or regulation under any other
act enforced by the CPSC.
(b) The label must be printed in bold typeface, using an Arial font
of not less than 12 points, be visible and legible, and consist of the
following statement: Meets CPSC Safety Requirements
(c) A consumer product may bear the label if the manufacturer or
private labeler has certified, pursuant to section 14 of the CPSA, that
the consumer product complies with all applicable consumer product
safety rules under the CPSA and with all rules, bans, standards, or
regulations applicable to the product under any other act enforced by
the Consumer Product Safety Commission.
(d) A manufacturer or private labeler may use another label on the
consumer product as long as such label does not alter or mislead
consumers as to the meaning of the label described in paragraph (b) of
this section. A manufacturer or private labeler must not imply that the
CPSC has tested, approved, or endorsed the product.
Dated: May 7, 2010.
Todd A. Stevenson,
Secretary.
[FR Doc. 2010-11365 Filed 5-19-10; 8:45 am]
BILLING CODE 6355-01-P