[Federal Register: May 26, 2006 (Volume 71, Number 102)]
[Proposed Rules]
[Page 30350-30352]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26my06-28]
=======================================================================
-----------------------------------------------------------------------
CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1115
Substantial Product Hazard Reports
AGENCY: Consumer Product Safety Commission.
ACTION: Proposed revision to interpretative rule.
-----------------------------------------------------------------------
SUMMARY: Section 15(b) of the Consumer Product Safety Act, 15 U.S.C.
2064(b), requires manufacturers, distributors, and retailers of
consumer products to report potential product hazards to the Consumer
Product Safety Commission. The Commission publishes proposed revisions
to its interpretative rule advising manufacturers, distributors, and
retailers how to comply with the requirements of section 15(b). The
proposed revisions identify certain factors the Commission and staff
consider when assessing whether a product is defective or not. The
proposed revisions also clarify that compliance with voluntary or
mandatory product safety standards may be considered by the Commission
in making certain determinations under section 15(b).\1\ In addition,
the Commission may consider the adoption of an interpretative
regulation related to the statutory factors for the assessment of civil
penalties pursuant to section 20, CPSA (15 U.S.C. 2069(b), (c)). A
separate Federal Register notice, if approved, will be issued for
public comment.
---------------------------------------------------------------------------
\1\ Commissioner Thomas H. Moore filed a statement which is
available from the Office of the Secretary or on the Commission's
Web site at http://www.cpsc.gov.
DATES: The Office of the Secretary must receive written comments not
later than June 26, 2006.
[[Page 30351]]
ADDRESSES: Written comments should be captioned ``Substantial Product
Hazard Reports'' and e-mailed to the Office of the Secretary at
cpsc-os@cpsc.gov. Written comments may also be sent to the Office of the
Secretary, Consumer Product Safety Commission, 4330 East West Highway,
Bethesda, Maryland 20814 or by facsimile at (301) 504-0127.
FOR FURTHER INFORMATION CONTACT: John Gibson Mullan, Assistant
Executive Director, Compliance and Field Operations at (301) 504-7626.
SUPPLEMENTARY INFORMATION: To provide further guidance, clarity and
transparency to the regulated community on reporting obligations under
section 15(b) of the Consumer Product Safety Act (CPSA), 15 U.S.C.
2064(b), the Commission proposes revisions to its interpretative rules
regarding reporting of possible substantial product hazards. Section
15(b) of the CPSA requires that every manufacturer (including an
importer), distributor or retailer of a consumer product who obtains
information which reasonably supports the conclusion that its product
fails to comply with an applicable consumer product safety rule or with
a voluntary consumer product safety standard upon which the Commission
has relied under section 9 of the CPSA, or contains a defect which
could create a substantial product hazard as defined in section
15(a)(2) of the CPSA, or creates an unreasonable risk of serious injury
or death, shall immediately inform the Commission of such failure to
comply, of such defect, or of such risk, unless the manufacturer,
distributor or retailer has actual knowledge that the Commission has
been adequately informed. In 1978, the Commission first published an
interpretative rule, 16 CFR part 1115, which explained the section
15(b) reporting requirement and provided guidance on filing section
15(b) reports. In this notice the Commission proposes revisions to the
interpretative rule to clarify factors relevant to section 15(b)
reporting determinations.
A. Section 1115.4 Defect
The first revision clarifies the Commission's definition of
``defect'' by adding four additional criteria Commission staff use to
evaluate whether a risk of injury is the type of risk that will render
a product defective, thus possibly triggering a reporting obligation
under section 15(b). The rule currently states that in determining
whether the risk of injury associated with a product is the type of
risk which will render a product defective, the Commission and staff
consider, as appropriate: The utility of the product involved; the
nature of the risk of injury which the product presents; the necessity
for the product; the population exposed to the product and its risk of
injury; the Commission's own experience and expertise; the case law
interpreting Federal and State public health and safety statutes; the
case law in the area of products liability; and other factors relevant
to the determination. The proposed revision adds the following factors:
The obviousness of such risk; the adequacy of warnings and instructions
to mitigate such risk; the role of consumer misuse of the product, and
the foreseeability of such misuse.
The determination of whether a product presents a risk of injury
that would render it defective is a threshold issue in evaluating
reporting obligations under section 15(b) of the CPSA and is one of the
most critical determinations a company is required to make under the
CPSA. A firm must report if it obtains information which reasonably
supports the conclusion that a product it manufactures and/or
distributes contains a defect which could create a substantial product
hazard. 15 U.S.C. 2064(b)(2). In determining whether a product contains
a defect that presents a substantial risk of injury, the Commission has
explained that certain products may not be defective although they
present a risk of injury because that risk is outweighed by the
usefulness of the product and its ability to function properly. The
classic example is a knife.
The regulatory criteria for evaluating whether a product presents a
risk of injury that may render it defective have been in effect since
1978. In the more than twenty years since then, the Commission and
staff have evaluated hundreds of products using, as appropriate, these
criteria. The Commission has concluded, based on experience and
practice in applying the criteria, that the four proposed additional
factors--the obviousness of such risk; the adequacy of warning and
instructions to mitigate such risk; the role of consumer misuse of the
product and the foreseeability of such misuse--will enable a better
analysis of whether the risk of injury associated with a product is the
type of risk which will render the product defective.
B. Section 1115.12(g)(1)(ii) Number of Defective Products Distributed
In Commerce
The Commission also clarifies that in evaluating the substantial
risk of injury involving a particular consumer product, it recognizes
that the risk of injury from a product may decline over time as the
number of products being used by consumers decreases. While there may
be other factors unique to a particular product which influence the
rate of the reduction, if any, of injury risk, Commission staff
believes that this factor is reasonable and appropriate to consider
when evaluating the impact of the number of defective products
distributed in commerce, authorized by 16 CFR 1115.12(g)(1)(ii), when
undertaking a substantial product hazard determination.
C. Section 1115.8 Compliance With Product Safety Standards
The proposed revisions also add a new Sec. 1115.8, ``Compliance
with Product Safety Standards.'' This section is intended to further
explain how the Commission views compliance with applicable voluntary
or mandatory standards, particularly in the context of decisions under
section 15(b) of the CPSA.
The Commission strongly encourages all firms to comply with
voluntary consumer product safety standards and advises that where
appropriate, compliance or non-compliance with such standards may be
considered by the Commission and staff in exercising its authority
under the CPSA, including when making determinations under section 15.
The section also provides that compliance or non-compliance with
applicable mandatory consumer product safety standards may be
considered by the Commission and staff in making relevant
determinations and exercising relevant federal authorities under the
CPSA and other federal statutes including when making corrective action
determinations under section 15 of the CPSA.
The Commission is providing this guidance to emphasize that
compliance with voluntary or mandatory standards are relevant
considerations to the exercise of its authorities, particularly in
evaluating section 15(b) obligations. The provision on voluntary
standards is added to emphasize that when the Commission staff
preliminarily determines whether a product presents a substantial
product hazard under section 15(b) of the CPSA, the Commission staff
will consider compliance with any relevant voluntary standard as part
of that determination. Therefore, by this provision the Commission
urges firms to consider compliance with voluntary standards in
evaluating whether or not a substantial product hazard should be
reported to the Commission.
In the context of mandatory standards, the Commission emphasizes
[[Page 30352]]
that the Commission will consider such compliance when making relevant
determinations and exercising relevant authorities under the CPSA and
other federal statutes. In particular, a product's compliance with a
mandatory standard will be considered in determining whether and to
what extent corrective action is necessary. This policy statement is
not intended to reduce the volume of reporting to the Office of
Compliance.
List of Subjects in 16 CFR Part 1115
Administrative practice and procedure, Business and Industry,
Consumer protection, Reporting and recordkeeping requirements.
Accordingly, 16 CFR part 1115 is proposed to be amended as follows:
PART 1115--SUBSTANTIAL PRODUCT HAZARD REPORTS
1. The authority citation for part 1115 continues to read as
follows:
Authority: 15 U.S.C. 2061, 2064, 2065, 2066(a), 2068, 2070,
2071, 2073, 2076, 2079 and 2084.
2. In Sec. 1115.4, amend the concluding text by adding a new
phrase after the phrase, ``the population exposed to the product and
its risk of injury;'' to read as follows:
Sec. 1115.4 Defect.
* * * the obviousness of such risk; the adequacy of warnings and
instructions to mitigate such risk; the role of consumer misuse of the
product and the foreseeability of such misuse;'' * * *
3. Section 1115.8 is added to read as follows:
Sec. 1115.8 Compliance with Product Safety Standards.
(a) Voluntary Standards. The CPSA and other federal statutes
administered by the Commission generally encourage the private sector
development of, and compliance with voluntary consumer product safety
standards to help protect the public from unreasonable risks of injury
associated with consumer products. To support the development of such
consensus standards, Commission staff participates in many voluntary
standards committees and other activities. The Commission also strongly
encourages all firms to comply with voluntary consumer product safety
standards and considers, where appropriate, compliance or non-
compliance with such standards in exercising its authorities under the
CPSA and other federal statutes, including when making determinations
under section 15 of the CPSA. Thus, for example, whether a product is
in compliance with applicable voluntary safety standards may be
relevant to the Commission staff's preliminary determination of whether
that product presents a substantial product hazard under section 15 of
the CPSA.
(b) Mandatory Standards. The CPSA requires that firms comply with
all applicable mandatory consumer product safety standards and to
report to the Commission any products which do not comply with either
mandatory standards or voluntary standards upon which the Commission
has relied. As is the case with voluntary consumer product safety
standards, compliance or non-compliance with applicable mandatory
safety standards may be considered by the Commission and staff in
making relevant determinations and exercising relevant authorities
under the CPSA and other federal statutes. Thus, for example, while
compliance with a relevant mandatory product safety standard may not,
of itself, relieve a firm from the need to report to the Commission a
product defect that creates a substantial product hazard under section
15 of the CPSA, it will be considered by staff in making the
determination of whether and what type of corrective action may be
required.
4. Section 1115.12 is amended by adding a new sentence at the end
of paragraph (g)(1)(ii) to read as follows:
Sec. 1115.12 Information which should be reported; evaluating
substantial product hazard.
* * * * *
(g) * * *
(1) * * *
(ii) * * * The Commission also recognizes that the risk of injury
from a product may decline over time as the number of products being
used by consumers decreases.
* * * * *
Dated: May 22, 2006.
Todd A. Stevenson,
Secretary , Consumer Product Safety Commission.
[FR Doc. 06-4888 Filed 5-25-06; 8:45 am]
BILLING CODE 6355-01-P