[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: 16CFR1116.8]

[Page 178-179]
 
                     TITLE 16--COMMERCIAL PRACTICES
 
             CHAPTER II--CONSUMER PRODUCT SAFETY COMMISSION
 
PART 1116_REPORTS SUBMITTED PURSUANT TO SECTION 37 OF THE CONSUMER 
PRODUCT SAFETY ACT--Table of Contents
 
Sec.  1116.8  Determination of particular model.

    (a) The obligation rests with the manufacturer of a product to 
determine whether a reasonable basis exists to conclude that a product 
that is the subject of a settled or adjudicated lawsuit is sufficiently 
different from other similar products to be regarded as a ``particular 
model'' under section 37 because it is ``distinctive.'' To determine 
whether a product is ``distinctive'', the proper inquiry should be 
directed toward the degree to which a product differs from other 
comparable products in one or more of the characteristics enumerated in 
section 37(e)(2) and Sec.  1116.2(c) of this part. A product is 
``distinctive'' if, after an analysis of information relating to one or 
more of the statutory characteristics, a manufacturer, acting in 
accordance with the customs and practices of the trade of which it is a 
member, could reasonably conclude that the difference between that 
product and other items of the same product class manufactured or 
imported by the same manufacturer is substantial and material. 
Information relevant to the determination of whether a product is a 
``particular model'' includes:
    (1) The description of the features and uses of the products in 
question in written material such as instruction manuals, description 
brochures, marketing or promotional programs, reports of certification 
of products, specification sheets, and product drawings.
    (2) The differences or similarities between products in their 
observable physical characteristics and in components or features that 
are not readily observable and that are incorporated in those products 
for safety-related purposes;
    (3) The customs and practices of the trade of which the manufacturer 
is a member in marketing, designating, or evaluating similar products.
    (4) Information on how consumers use the products and on consumer 
need

[[Page 179]]

or demand for different products, such as products of different size. In 
analyzing whether products are different models, differences in size or 
calibration afford the basis for distinguishing between products only if 
those differences make the products distinctive in functional design or 
function.
    (5) The history of the manufacturer's model identification and 
marketing of the products in question;
    (6) Whether variations between products relate solely to appearance, 
ornamentation, color, or other cosmetic features; such variations are 
not ordinarily sufficient to differentiate between models.
    (7) Whether component parts used in a product are interchangeable 
with or perform substantially the same function as comparable components 
in other units; if they are, the use of such components does not afford 
a basis for distinguishing between models.
    (8) Retail price. Substantial variations in price arising directly 
from the characteristics enumerated in section 37(e)(2) for evaluating 
product models may be evidence that products are different models 
because their differences are distinctive. Price variations imposed to 
accommodate different markets or vendors are not sufficient to draw such 
a distinction.
    (9) Manufacturer's designation, model number, or private label 
designation. These factors are not controlling in identifying 
``particular models''.
    (10) Expert evaluation of the characteristics of the products in 
question, and surveys of consumer users or a manufacturer's retail 
customers.
    (b) The definition of ``consumer product'' expressly applies to 
components of consumer products. Should a component manufacturer be 
joined in a civil action against a manufacturer of a consumer product, 
the section 37 reporting requirements may apply to that manufacturer 
after a combination of three judgments or settlements involving the same 
component model during a two year period, even though the manufacturer 
of the finished product is exempt from such reporting because the 
lawsuits do not involve the same particular model of the finished 
consumer product. The same proposition holds true for common components 
used in different consumer products. If the manufacturer of such a 
component is a defendant in three suits and the requisite statutory 
criteria are met, the reporting obligations apply.
    (c) Section 37 expressly defines the reporting obligation in terms 
of the particular model of a product rather than the manner in which a 
product was involved in an accident. Accordingly, even if the 
characteristic of a product that caused or resulted in the deaths of 
grievous injuries alleged in three or more civil actions is the same in 
all of the suits, the requirement to report under section 37 would arise 
only if the same particular model was involved in at least three of the 
suits. However, the existence of such a pattern would strongly suggest 
that the obligation to file a report under section 15(b) (2) or (3) (15 
U.S.C. 2064(b) (2) or (3)) exists because the information reasonably 
supports the conclusion that the product contains a defect that could 
present a substantial risk of injury to the public or creates an 
unreasonable risk of serious injury or death.
    (d) Section 37 does not require that the same category of injury be 
involved in multiple lawsuits for the reporting obligation to arise. As 
long as a particular model of a consumer product is the subject of at 
least three civil actions that are settled or adjudicated in favor of 
the plaintiff in one of the statutory two year periods, the manufacturer 
must report, even though the alleged category of injury and the alleged 
causal relationship of the product to the injury in each suit may 
differ.