Potentially burdensome regulations governing children's
products take effect in less than two months. The new regulations,
issued by the United States Consumer Product Safety Commission
(CPSC), apply to children's products manufactured after
February 8, 2013. "Children's products" are any
"consumer product designed or intended primarily for children
12 years of age or younger." 15 U.S.C. § 2052(a)(2). The
new regulations govern manufacturers and importers of those
products. 16 C.F.R. § 1107. Because of the likely burden of
implementing and complying with the new rules – particularly
testing and record-keeping requirements – companies must take
steps now to understand how the rules will impact them. Key
provisions of the new rules are summarized below.
Third-Party Testing. Beginning on February 8,
2013, covered manufacturers, and any wholesaler or importer that
issues the Children's Product Certificate for a
product, must submit a sufficient number of samples of a
children's product to an accredited third-party conformity
assessment body for testing to support certification and issuance
of the Certificate. Id. § 1107.20(a). The
covered entity must specify the number of samples to be tested. The
covered entity also must submit a sufficient number of samples to a
third party assessment body for re-certification of a product when
it undergoes a "material change" in design, manufacturing
process, or sourcing of components that could affect the
product's ability to comply with applicable safety rules.
Id. §§ 1107.2 and 1107.23(a). Should a
sample fail certification testing, the covered entity must
investigate and remedy the failure and then submit the corrected
product for testing. Id. § 1107.20(d). Certified
products may bear a label stating "Meets CPSC Safety
Requirements." Id. § 1107.30. To the extent that
a wholesaler or importer relies on a manufacturer or supplier for
the Children's Product Certificate, those entities must
exercise due care to ensure that appropriate testing is undertaken
by the manufacturer or supplier.
Ongoing Testing of Children's Products. Even
after a children's product has been certified, covered entities
must use third party conformity assessment bodies to periodically
test representative product samples to ensure, with a high degree
of assurance, ongoing compliance with all applicable product safety
rules. Covered entities can satisfy the periodic testing
requirement in several ways, including a "periodic testing
plan" involving at least annual tests of representative
samples sufficient to provide a high degree of assurance that
products manufactured after certification (or since previous
periodic testing) are compliant. Id. § 1107.21.
Covered entities must carefully document this process, including
the procedure used to select representative samples and the basis
for inferring compliance from the results of the tested samples.
Id. Companies may use component part testing under 16
C.F.R. § 1109 to support the periodic testing
requirement.
Avoiding Undue Influence Over Assessment Bodies.
Covered entities also are required to implement procedural
safeguards against the exercise of undue influence over third party
conformity assessment bodies. Id. § 1107.24. These
procedures include a written policy statement from the
manufacturer, training for all appropriate employees and a signed
statement attesting to participation, required reporting to the
CPSC of any attempt to hide or exert undue influence over test
results, and informing employees of how to confidentially report
undue influence to the CPSC. Id.
Required Recordkeeping. The new rules also set
forth detailed record keeping requirements, including meticulous
documentation of product testing. Covered entities are required to
keep the following types of records (electronically or in hardcopy)
for each children's product for five years
from the date of production: (1) a copy of the Children's
Product Certificate; (2) records of each third party certification
test for each manufacturing site; (3) records of testing plans,
actual testing and/or results, as applicable; (4) records of the
number of representative samples selected for periodic testing, the
procedure used to select them, the testing conducted on those
samples, and the basis for inferring compliance from the results of
those tested samples; (5) records of descriptions of all
"material changes" under § 1107.23; (6) records of
the undue influence procedures implemented by the manufacturer,
including training materials and employee attestations.
Id. § 1107.26(a).
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
