[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