[Code of Federal Regulations]
[Title 16, Volume 2]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 16CFR1115.4]

[Page 158-160]
 
                     TITLE 16--COMMERCIAL PRACTICES
 
             CHAPTER II--CONSUMER PRODUCT SAFETY COMMISSION
 
PART 1115_SUBSTANTIAL PRODUCT HAZARD REPORTS--Table of Contents
 
                    Subpart A_General Interpretation
 
Sec.  1115.4  Defect.

    Section 15(b)(2) of the CPSA requires every manufacturer (including 
an importer), distributor, and retailer of a consumer product who 
obtains information which reasonably supports the conclusion that the 
product contains a

[[Page 159]]

defect which could create a substantial product hazard to inform the 
Commission of such defect. Thus, whether the information available 
reasonably suggests a defect is the first determination which a subject 
firm must make in deciding whether it has obtained information which 
must be reported to the Commission. In determining whether it has 
obtained information which reasonably supports the conclusion that its 
consumer product contains a defect, a subject firm may be guided by the 
criteria the Commission and staff use in determining whether a defect 
exists. At a minimum, defect includes the dictionary or commonly 
accepted meaning of the word. Thus, a defect is a fault, flaw, or 
irregularity that causes weakness, failure, or inadequacy in form or 
function. A defect, for example, may be the result of a manufacturing or 
production error; that is, the consumer product as manufactured is not 
in the form intended by, or fails to perform in accordance with, its 
design. In addition, the design of and the materials used in a consumer 
product may also result in a defect. Thus, a product may contain a 
defect even if the product is manufactured exactly in accordance with 
its design and specifications, if the design presents a risk of injury 
to the public. A design defect may also be present if the risk of injury 
occurs as a result of the operation or use of the product or the failure 
of the product to operate as intended. A defect can also occur in a 
product's contents, construction, finish, packaging, warnings, and/or 
instructions. With respect to instructions, a consumer product may 
contain a defect if the instructions for assembly or use could allow the 
product, otherwise safely designed and manufactured, to present a risk 
of injury. To assist subject firms in understanding the concept of 
defect as used in the CPSA, the following examples are offered:
    (a) An electric appliance presents a shock hazard because, through a 
manufacturing error, its casing can be electrically charged by full-line 
voltage. This product contains a defect as a result of manufacturing or 
production error.
    (b) Shoes labeled and marketed for long-distance running are so 
designed that they might cause or contribute to the causing of muscle or 
tendon injury if used for long-distance running. The shoes are defective 
due to the labeling and marketing.
    (c) A kite made of electrically conductive material presents a risk 
of electrocution if it is long enough to become entangled in power lines 
and be within reach from the ground. The electrically conductive 
material contributes both to the beauty of the kite and the hazard it 
presents. The kite contains a design defect.
    (d) A power tool is not accompanied by adequate instructions and 
safety warnings. Reasonably foreseeable consumer use or misuse, based in 
part on the lack of adequate instructions and safety warnings, could 
result in injury. Although there are no reports of injury, the product 
contains a defect because of the inadequate warnings and instructions.
    (e) An exhaust fan for home garages is advertised as activating when 
carbon monoxide fumes reach a dangerous level but does not exhaust when 
fumes have reached the dangerous level. Although the cause of the 
failure to exhaust is not known, the exhaust fan is defective because 
users rely on the fan to remove the fumes and the fan does not do so.

However, not all products which present a risk of injury are defective. 
For example, a knife has a sharp blade and is capable of seriously 
injuring someone. This very sharpness, how- ever, is necessary if the 
knife is to function adequately. The knife does not contain a defect 
insofar as the sharpness of its blade is concerned, despite its 
potential for causing injury, because the risk of injury is outweighed 
by the usefulness of the product which is made possible by the same 
aspect which presents the risk of injury. In determining whether the 
risk of injury associated with a product is the type of risk which will 
render the product defective, the Commission and staff will 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 
obviousness of such risk; the adequacy of

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warnings and instructions to mitigate such risk; the role of consumer 
misuse of the product and the foreseeability of such misuse; 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. If the information available to a subject firm does not 
reasonably support the conclusion that a defect exists, the subject firm 
need not report. However, if the information does reasonably support the 
conclusion that a defect exists, the subject firm must then consider 
whether that defect could create a substantial product hazard. (See 
Sec.  1115.12(f) for factors to be assessed in determining whether a 
substantial product hazard could exist.) If the subject firm determines 
that the defect could create a substantial product hazard, the subject 
firm must report to the Commission. Most defects could present a 
substantial product hazard if the public is exposed to significant 
numbers of defective products or if the possible injury is serious or is 
likely to occur. Since the extent of public exposure and/or the 
likelihood or seriousness of injury are ordinarily not known at the time 
a defect first manifests itself, subject firms are urged to report if in 
doubt as to whether a defect could present a substantial product hazard. 
On a case-by-case basis the Commission and the staff will determine 
whether a defect within the meaning of section 15 of the CPSA does, in 
fact, exist and whether that defect presents a substantial product 
hazard. Since a consumer product may be defective even if it is 
designed, manufactured, and marketed exactly as intended by a subject 
firm, subject firms should report if in doubt as to whether a defect 
exists. Defect, as discussed in this section and as used by the 
Commission and staff, pertains only to interpreting and enforcing the 
Consumer Product Safety Act. The criteria and discussion in this section 
are not intended to apply to any other area of the law.

[43 FR 34998, Aug. 7, 1978, as amended at 71 FR 42030, July 25, 2006]