[Federal Register Volume 60, Number 156 (Monday, August 14, 1995)]
[Rules and Regulations]
[Pages 41799-41801]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19628]



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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1117


Reporting Choking Incidents to the Consumer Product Safety 
Commission Pursuant to the Child Safety Protection Act; Revision to 
Interpretative Rule

AGENCY: Consumer Product Safety Commission.

ACTION: Revision to final interpretative rule.

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SUMMARY: The Child Safety Protection Act (``CSPA'') requires 
manufacturers, distributors, retailers, and importers of marbles, small 
balls, latex balloons, and toys or games that contain such items or 
other small parts, to report to the Commission when they learn of 
choking incidents involving such products. On February 27, 1995, the 
Commission issued a rule interpreting the reporting requirements of the 
CSPA, but left open the question of whether the reporting requirement 
applies to toys or games that are exempt from the Commission's 

[[Page 41800]]
small parts banning rule (16 CFR Part 1501). This revision states that 
the reporting requirements apply to toys and games that would otherwise 
be exempt from the Commission's small parts regulation. The revision 
also clarifies that firms must report any time a child chokes on a 
small part from a toy or game regardless of whether the part was a 
small part at the time the product was distributed or sold.

DATES: This regulation becomes effective on September 13, 1995.

FOR FURTHER INFORMATION CONTACT: Eric L. Stone, Office of Compliance 
and Enforcement, Consumer Product Safety Commission, 4330 East West 
Highway, Bethesda, MD 20814 (Mailing address: Washington, D.C. 20207), 
telephone (301) 504-0626 extension 1350.

SUPPLEMENTARY INFORMATION:

A. Background

    Section 102 of the Child Safety Protection Act of 1994 (Public Law 
103-267, 108 Stat. 722, June 16, 1994) requires, inter alia, that each 
manufacturer, distributor, retailer and importer of a toy or game that 
contains a small part report to the Commission information that 
reasonably supports the conclusion that an incident occurred in which a 
child choked on the small part and died, suffered serious injury, 
ceased breathing for any length of time, or was treated by a medical 
professional. On February 27, 1995, the Commission published a final 
interpretative rule defining several terms and resolving ambiguities 
and uncertainties in the statutory reporting scheme. 60 FR 10490. The 
Commission left unresolved one issue raised by commenters. Those 
commenters had questioned whether the reporting requirement applied to 
toys and games that are exempt from the Commission's small parts 
banning rule. 16 CFR Part 1501.
    A subsequent industry inquiry also indicated some confusion over 
the definition of the term ``small part'' in the regulation. The 
Commission has decided to clarify that definition.1

    \1\ On both of these issues, Commissioner Mary Gall dissented 
from the Commission's decision. A copy of her statement and those of 
the other Commissioners may be found in the Commission's Office of 
the Secretary.
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1. Products Exempt From the Small Parts Regulation

    Several industry commenters originally suggested that the 
Commission exempt from the choking hazard reporting requirement any 
products that are exempt from the small parts banning regulation (see 
16 CFR 1501.3). The banning regulation, which applies to toys and other 
articles intended for children under 3 years of age, exempted items 
such as balloons, books, writing materials, and certain children's 
grooming, hygiene, and feeding items because the Commission believed 
that the functional benefits of these products outweighed the risk of 
injury they presented.
    The Commission believes that Congress enacted the reporting 
requirements of the CSPA to assure that the Commission receives as much 
information as possible about serious choking incidents. Only then, can 
the Commission know whether some remedial action is necessary to 
protect children. Absent compelling reasons to do so, the Commission 
believes it should not carve out exceptions to the reporting 
obligations imposed by Congress.
    Congress required firms to report choking incidents involving small 
parts from toys and games. Congress did not limit this reporting 
obligation to products subject to the Commission's small parts banning 
regulation (16 CFR 1501). The Commission believes that no persuasive 
policy arguments support limiting the requirement imposed by Congress. 
Unlike a ban, the reporting requirement does not interfere with the 
sale of the exempt product or place an extraordinary burden on the 
reporting firm. The scope of the reporting obligation is limited, the 
report is protected from public disclosure, and the information may not 
be used as an admission against the firm. Therefore, the Commission 
sees no reason to limit reporting to products that would be subject to 
16 CFR Part 1501.

2. Definition of ``Small Part''

    The CSPA requires reporting when a child chokes on a small part 
contained in a toy or game. The final regulation defines a small part 
as any object which, when tested in accordance with the procedures of 
16 CFR 1501.4(a) and 1501.4(b)(1) fits entirely within the cylinder 
shown in Figure 1 appended to 16 CFR Part 1501. When the Commission 
issued rules interpreting the CSPA reporting requirements, the 
Commission intended that firms report to the Commission if the part 
involved in the choking incident fit within the small parts test 
cylinder. The Commission expected firms to report choking incidents 
involving parts that broke off a toy or game as well as those involving 
parts that were small parts at the time the toy or game was distributed 
or sold.
    Although firms who are reporting under this provision seem to 
understand the Commission's rule, one firm has suggested it is not 
clear. That firm thought the reporting provision should only apply to 
parts that are independent small parts at the time the toy or game is 
sold. It suggests that the phrase ``contained in such toy or game'' in 
section 102 limited the obligation to distinct small parts contained in 
the toy or game at the time of distribution or sale of the toy or game.
    The focus of the choking hazard reporting provision is upon the 
choking incident. If a small part causes a choking incident a 
manufacturer, importer, distributor, or retailer is obligated to report 
if that part was contained in its toy or game. The phrase ``contained 
in'' is an indicator of the origin of the part. The part was contained 
in the toy or game whether it was a separate small part at the time of 
distribution, or a component or piece of a toy that broke off during 
play. Limiting the reporting obligation to items that were small parts 
at the time of distribution would shift the focus away from reporting 
of choking incidents. Further, it would only capture a fraction of the 
choking incidents that occur each year involving parts of toys and 
games.
    In administering the small parts banning regulation, the Commission 
has seen that the great majority of violations arise because small 
parts detach from toys as a result of use or abuse. Excluding such 
parts from the reporting requirements could result in significant 
violations of the small parts regulation being undetected and 
uncorrected, even though those violations resulted in death or serious 
injury--the precise consequences that the reporting requirements were 
enacted to address.
    Accordingly, to resolve the confusion over the scope of the term 
``small part,'' the Commission is revising the interpretative rule to 
clarify that the inquiry as to whether an object involved in a choking 
incident is a small part should focus only on whether that object fits 
entirely within the small parts testing cylinder. How the object came 
to be a small part is irrelevant for the purposes of reporting, 
although such information may certainly be relevant in determining 
whether any remedial measures are appropriate.

C. Notice

    Because this is an interpretative rule, the Commission is not 
required to issue a notice of proposed rulemaking. 5 U.S.C. 553(b)(A). 
Nevertheless, the Commission did publish a notice of proposed 
rulemaking (``NPR'') concerning the reporting requirements under the 
CSPA on July 1, 1994. 59 FR 

[[Page 41801]]
33927. The scope of the NPR covered the issues of reporting for exempt 
products and for small parts that detach from a toy or game after 
purchase. Thus, no additional notice is necessary.

D. Impact on Small Businesses

    In accordance with section 3(b) of the Regulatory Flexibility Act, 
5 U.S.C. 605(b), the Commission certifies that this regulation will not 
have a significant economic impact upon a substantial number of small 
entities if issued on a final basis. Any obligations imposed upon such 
entities arise under the express provisions of section 102 of the Child 
Protection Safety Act, Pub. L. No. 103-267, June 17, 1994. This 
regulation simply revises a narrow aspect of the Commission's 
interpretation of the obligations imposed by that law. The regulation 
itself will not have a significant economic impact on small businesses, 
either beneficial or negative, beyond that which results from the 
statutory provisions.

E. Environmental Considerations

    This revision falls within the provisions of 16 CFR 1021.5(c), 
which designates categories of actions conducted by the Consumer 
Product Safety Commission that normally have little or no potential for 
affecting the human environment. The Commission does not believe that 
the rule contains any unusual aspects which may produce effects on the 
human environment, nor can the Commission foresee any circumstance in 
which the rule issued below may produce such effects. For this reason, 
neither an environmental assessment nor an environmental impact 
statement is required.

F. Effective Date
    This regulation will become effective 30 days after publication of 
the final regulation in the Federal Register.

List of Subjects in 16 CFR Part 1117

    Administrative practice and procedure, Business and industry, 
Consumer protection, Toy safety, Reporting and recordkeeping 
requirements, and Small parts.

Conclusion

    Therefore, pursuant to the authority of the Child Safety Protection 
Act [Pub. L. No. 103-267), section 16(b) of the CPSA (15 U.S.C. 
2065(b)) and 5 U.S.C. 553, the CPSC amends Part 1117, Chapter II, 
Subchapter B of Title 16 of the Code of Federal Regulations as follows:

PART 1117--REPORTING OF CHOKING INCIDENTS INVOLVING MARBLES, SMALL 
BALLS, LATEX BALLOONS AND OTHER SMALL PARTS

    1. The authority for Part 1117 continues to read as follows:

    Authority: Section 102 of the Child Safety Protection Act (Pub. 
L. No. 103-267) section 16(b), 15 U.S.C. 2065(b) and 5 U.S.C. 553.

    2. Section 1117.2(a) is revised to read as follows:


Sec. 1117.2  Definitions.

    (a) Small part means any part, component, or piece of a toy or 
game, which, when tested in accordance with the procedures in 16 CFR 
1501.4(a) and 1501.4(b)(1), fits entirely within the cylinder shown in 
Figure 1 appended to 16 CFR 1501.


Sec. 1117.2  [Amended]

    3. Section 1117.2 is amended by adding a new paragraph (h) to read 
as follows:
* * * * *
    (h) Toy or game includes any toy or game, including those exempt 
under 16 CFR 1501.3 from the small parts banning provisions of 16 CFR 
1500.18(a)(9).

    Dated: August 3, 1995.
Sadye E. Dunn,
Secretary, Consumer Product Safety Commission.
[FR Doc. 95-19628 Filed 8-11-95; 8:45 am]
BILLING CODE 6355-01-P