[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: 16CFR1115.6]

[Page 161-162]
 
                     TITLE 16--COMMERCIAL PRACTICES
 
             CHAPTER II--CONSUMER PRODUCT SAFETY COMMISSION
 
PART 1115_SUBSTANTIAL PRODUCT HAZARD REPORTS--Table of Contents
 
                    Subpart A_General Interpretation
 
Sec.  1115.6  Reporting of unreasonable risk of serious injury or death.

    (a) General provision. Every manufacturer, distributor, and retailer 
of a consumer product distributed in commerce who obtains information 
which reasonably supports the conclusion that its product creates an 
unreasonable risk of serious injury or death is required to notify the 
Commission immediately. 15 U.S.C. 2064(b)(3). The requirement that 
notification occur when a responsible party ``obtains information which 
reasonably supports the conclusion that'' its product creates an 
unreasonable risk of serious injury or death is intended to require 
firms to report even when no final determination of the risk is 
possible. Firms must carefully analyze the information they obtain to 
determine whether such information ``reasonably supports'' a 
determination that the product creates an unreasonable risk of serious 
injury or death. (See Sec.  1115.12(f) for a discussion of the kinds of 
information that firms must study and evaluate to determine whether they 
have an obligation to report.) Firms that obtain information indicating 
that their products present an unreasonable risk of serious injury or 
death should not wait for such serious injury or death to actually occur 
before reporting. Such information can include reports from experts, 
test reports, product liability lawsuits or claims, consumer or customer 
complaints, quality control data, scientific or epidemiological studies, 
reports of injury, information from other firms or governmental 
entities, and other relevant information. While such information shall 
not trigger a per se reporting requirement, in its evaluation of whether 
a subject firm is required to file a report under the provisions of 
section 15 of the CPSA, the Commission shall attach considerable 
significance if such firm learns that a court or jury has determined 
that one of its products has caused a serious injury or death and a 
reasonable person could conclude based on the lawsuit and other 
information obtained by the firm that the product creates an 
unreasonable risk of serious injury or death.
    (b) Unreasonable risk. The use of the term ``unreasonable risk'' 
suggests that the risk of injury presented by a product should be 
evaluated to determine if that risk is a reasonable one. In determining 
whether a product presents an unreasonable risk, the firm should examine 
the utility of the product, or the utility of the aspect of the product 
that causes the risk, the level of exposure of consumers to the risk, 
the nature and severity of the hazard presented, and the likelihood of 
resulting serious injury or death. In its analysis, the firm should also 
evaluate the state of the manufacturing or scientific art, the 
availability of alternative designs or products, and the feasibility of 
eliminating the risk. The Commission expects firms to report if a 
reasonable person could conclude given the information available that a 
product creates an unreasonable risk of serious injury or death. In its 
evaluation of whether a subject firm is required to file a report under 
the provisions of section 15 of the CPSA the Commission shall, as a 
practical matter, attach considerable significance if such firm obtains 
information which reasonably

[[Page 162]]

supports the conclusion that its product violates a standard or ban 
promulgated under the FHSA, FFA, PPPA or RSA and the violation could 
result in serious injury or death.
    (c) Serious injury or death. The term ``serious injury'' is not 
defined in the CPSA. The Commission believes that the term includes not 
only the concept of ``grievous bodily injury,'' defined at Sec.  
1115.12(d), but also any other significant injury. Injuries 
necessitating hospitalization which require actual medical or surgical 
treatment, fractures, lacerations requiring sutures, concussions, 
injuries to the eye, ear, or internal organs requiring medical 
treatment, and injuries necessitating absence from school or work of 
more than one day are examples of situations in which the Commission 
shall presume that such a serious injury has occurred. To determine 
whether an unreasonable risk of serious injury or death exists, the firm 
should evaluate chronic or long term health effects as well as immediate 
injuries.

[57 FR 34228, Aug. 4, 1992]