[Federal Register Volume 59, Number 126 (Friday, July 1, 1994)]
[Unknown Section]
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From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-16083]


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[Federal Register: July 1, 1994]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1117

 

Proposed Rule; Requirements for Reporting Choking Incidents to 
the Consumer Product Safety Commission Pursuant to the Child Safety 
Protection Act

AGENCY: Consumer Product Safety Commission (CPSC).

ACTION: Proposed rule.

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SUMMARY: The ``Child Safety Protection Act'' 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 certain choking 
incidents involving such products. The Commission is proposing a rule 
to implement this reporting requirement.

DATES: Written comments in response to this notice must be received by 
the Commission no later than September 14, 1994.

ADDRESSES: Comments, preferably in five (5) copies, should be mailed to 
the Office of the Secretary, Consumer Product Safety Commission, 
Washington, DC 20207-0001, telephone (301) 504-0800, or delivered to 
room 502, East West Towers Building, 4330 East West Highway, Bethesda, 
MD. 20814.

FOR FURTHER INFORMATION CONTACT:
Eric L. Stone, Office of Compliance and Enforcement, at the above 
address, telephone (301) 504-0626, extension 1350.

SUPPLEMENTARY INFORMATION:

A. Background

    Section 101 of the Child Safety Protection Act, (Pub. L. No. 103-
267) (June 17, 1994) (the Act) adds a new Section 24 to the Federal 
Hazardous Substances Act (FHSA), 15 U.S.C. 1261-1277, to be codified at 
15 U.S.C. 1278. Section 24 of the FHSA requires the labeling of certain 
toys. The Commission's proposed amendments of 16 CFR Part 1500 
implementing those labeling requirements are published elsewhere in 
this issue of the Federal Register. Section 102 of the Child Safety 
Protection Act also added a new reporting requirement:
    Each manufacturer, distributor, retailer and importer of a marble, 
small ball, or latex balloon, or a toy or game that contains a marble, 
small ball, latex balloon or other small part, shall report to the 
Commission any information obtained by such manufacturer, distributor, 
retailer, or importer which reasonably supports the conclusion that--
    (A) an incident occurred in which a child (regardless of age) 
choked on such a marble, small ball, or latex balloon or on a marble, 
small ball, latex balloon, or other small part contained in such toy or 
game and
    (B) as a result of that incident the child died, suffered serious 
injury, ceased breathing for any length of time, or was treated by a 
medical professional.

(The full text of section 102 is published in the Appendix to this 
proposal because the language will not be codified in the United States 
Code.)
    Under the Act, a failure to report is a prohibited act under 
section 19(a)(3) of the Consumer Product Safety Act (CPSA), 15 U.S.C. 
2068(a)(3), punishable by a civil penalty under section 20 of the CPSA, 
15 U.S.C. 2069. The Act provides a high degree of confidentiality for 
such reports. In addition, the Act states that reports shall not be 
interpreted as admissions of liability or of the truth of the 
information in the reports.
    Several terms are not defined by the Act, and the text of the Act 
leaves other issues unresolved. For example, the Act does not say how 
soon a firm must report after it obtains reportable information. The 
Act is also silent as to what information must be reported. Applying 
the legislative history of the Act and the expertise developed over the 
last twenty years enforcing section 15(b) of the CPSA (15 U.S.C. 
2064(b)), the Commission proposes these regulations to implement the 
new reporting provision.
    The Act provides that ``[f]or purposes of section 19(a)(3) of the 
Consumer Product Safety Act (15 U.S.C. 2068(a)(3)), the requirement to 
report information under this subsection is deemed to be a requirement 
under such Act.'' Section 16(b) of the CPSA (15 U.S.C. 2065(b)) 
authorizes the Commission to require manufacturers, private labelers 
and distributors to make reports and provide information reasonably 
required for the purposes of implementing the CPSA. A failure to make 
reports or provide information under section 16(b) of the CPSA (15 
U.S.C. 2065(b)) is a prohibited act under section 190(a)(3) of the CPSA 
(15 U.S.C. 2068(a)(3)). The Commission proposes this rule under section 
102 of the Act and section 16(b) of the CPSA (15 U.S.C. 2065(b)). The 
proposed rule specifies the information that should trigger a report, 
the timeframe for reporting, and the content of reports. Violations of 
this rule are prohibited acts under the CPSA. Since the statutory 
reporting obligation became effective on June 17, 1994 when the bill 
was signed into law, subject firms may use this proposal for guidance 
as to how to comply with their reporting obligation in the statute.
    Section 30(d) of the CPSA (15 U.S.C. 2079(d)) provides that ``[a] 
risk of injury which is associated with a consumer product and which 
could be eliminated or reduced to a sufficient extent by action under 
the Federal Hazardous Substances Act, the Poison Prevention Packaging 
Act of 1970, or the Flammable Fabrics Act may be regulated under this 
Act only if the Commission by rule finds that it is in the public 
interest to regulate such risk of injury under this Act.'' Such a 
finding is unnecessary for this rule because it does not regulate a 
risk of injury, but merely requires firms to report information about 
consumer products.

B. Section by Section Discussion

    Section 1117.3 of the proposed rule emphasizes that subject firms 
must report whenever they obtain sufficient information to put a 
reasonable firm on notice of a reportable choking incident. The 
reporting provision originated in the Senate, and The Report of the 
Senate Committee on Commerce, Science and Transportation states this 
provision requires subject firms to ``report to the CPSC any 
information obtained that supports the conclusion that an incident 
occurred in which a child, regardless of age, choked on such a product 
and, as a result of such coking incident, the child died, suffered 
serious injury, ceased breathing for any length of time, or was treated 
by a medical professional.'' (S. Rep. No. 195, 103d Cong., 2d Sess. 10 
(1993).)
    The rule is intended to require firms to report incident 
information obtained after June 17, 1994, the effective date of the 
Child Safety Protection Act. The Commission has placed no limitations 
on the age of the child involved in the incident or on the intended 
ages for the toy or game involved. This approach is consistent with the 
Senate committee report which said ``reports are to be made regardless 
of the age of the child who chokes and regardless of the ages of the 
child for which the toy was intended.'' (S. Rep. No. 195, 103d Cong., 
2d Sess. 10 (1993)).
    Section 1117.4 of the proposal requires firms to report within 24 
hours of obtaining information about a reportable choking incident. 
Since the statute does not provide a time frame for reporting, the 
Commission believes the intent was that firms report as soon as they 
obtain ``information that supports the conclusion that an incident 
occurred.'' (S. Rep. No. 195, 103d Cong., 2d Sess. 10 (1993)). 
Moreover, immediate reporting is important to help the Commission 
prevent additional choking incidents to children.
    Proposed Sec. 1117.5 describes the information that firms must 
report. The Commission has limited the reporting requirements to 
information necessary to give the Commission staff sufficient 
information to understand the nature of, and the context for, the 
choking incident and to determine whether corrective measures may be 
necessary. Because these reports are limited to reduce the burden on 
reporting firms, the Commission anticipated that in some cases the 
staff may need to investigate further.
    Section 1117.6 of the proposed rule explains that this reporting 
provision is in addition to, but not a substitute for, the reporting 
requirements of section 15(b) of the CPSA (15 U.S.C. 2064(b)). Even if 
a report of a choking hazard is not required by the proposed rule, a 
report may be necessary under section 15(b) of the CPSA (15 U.S.C. 
2064(b)) and 16 CFR Part 1115.
    The remaining provisions of this proposed regulation set forth the 
confidentiality, liability ad penalty provisions that would apply to 
reporting in accordance with the proposed regulation published below.

C. 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. The proposed 
regulation simply implements 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.

D. Environmental Considerations

    The proposed rule fall 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 proposed below may produce such effects.
    For this reason, neither an environmental assessment nor an 
environmental impact statement is required.

E. Proposed Effective Date

    This regulation is proposed to become effective 30 days after 
publication of the final regulation in the Federal Register. Subject 
firms should be aware, however, that the Child Safety Protection Act 
required reporting as of June 17, 1994. Firms may use this proposal for 
guidance as to how to comply with the law.

List of Subjects in 16 CFR Part 1117

    Administrative practice and procedure, Business and industry, 
Consumer Protection, Toy Safety, Penalties, Reporting and recordkeeping 
requirements, and Small Parts.

Conclusion

    Therefore, pursuant to the authority of the Child Safety Protection 
Act [Pub. L. 103-267), section 16(b) of the CPSA (15 U.S.C. 2065(b)), 
and 5 U.S.C. 553, the CPSC proposes to amend Title 16 of the Code of 
Federal Regulations, Chapter II, Subchapter B by adding a new Part 1117 
to read as follows:

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

Sec.
1117.1  Purpose.
1117.2  Definitions.
1117.3  Reportable information.
1117.4  Time for filing a report.
1117.5  Information that must be reported and to whom.
1117.6  Relation to section 15(b) of the CPSA.
1117.7  Confidentiality of reports.
1117.8  Effect of reports on liability.
1117.9  Prohibited acts and sanctions.

Appendix to Part 1117--Sec. 102 of the Child Safety Reporting Act

    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.


Sec. 1117.1  Purpose.

    The purpose of this part is to set forth the Commission's 
regulations for reports of choking incidents required by the Child 
Safety Protection Act. The statute requires that each manufacturer, 
distributor, retailer, and importer of a marble, small ball, or latex 
balloon, or a toy or a game that contains a marble, small ball, latex 
balloon, or other small part, shall report to the Commission any 
information obtained by such manufacturer, distributor, retailer, or 
importer which reasonably supports the conclusion that an incident 
occurred in which a child (regardless of age) choked on such a marble, 
small ball, or latex balloon or on a marble, small ball, latex balloon, 
or other small part contained in such toy or game and, as a result of 
that incident the child died, suffered serious injury, ceased breathing 
for any length of time, or was treated by a medical professional.


Sec. 1117.2  Definitions.

    (a) Small part means any component 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.
    (b) Small ball means any ball with a diameter of 1.75 inches (4.445 
cm) or less when measured in the manner set forth in 16 CFR 
1500.18(a)(17)(iii) & (iv). For purposes of this designation, the term 
``ball'' includes any spherical, ovoid, or ellipsoidal object that is 
designed or intended to be thrown, hit, kicked, rolled, or bounced, and 
is either not permanently attached to another toy or article, or is 
attached to such toy or article by means of a string, elastic cord, or 
similar tether. The term ``ball'' includes any multi-sided object 
formed by connecting planes into a generally spherical, ovoid, or 
ellipsoidal shape that is designated or intended to be used as a ball, 
and any novelty item of a generally spherical, ovoid, or ellipsoidal 
shape that is designated or intended to be used as a ball.
    (c) Choked means suffered an obstruction of the airways.
    (d) A latex balloon is a toy or decorative item consisting of a 
latex bag that is designed to be inflated by air or gas. The term does 
not include inflatable children's toys that are used in aquatic 
activities, such as rafts, water wings, life rings, etc.
    (e) A marble is a ball made of a hard material, such as glass, 
agate, marble or plastic, that is used in various children's games, 
generally as a playing piece or marker.
    (f) Serious injury includes not only the concept of ``grievous 
bodily injury'' defined in the Commission's rule for Substantial Hazard 
Reports at 16 CFR 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 or more than one day are examples of situations in which the 
Commission shall presume that such a serious injury has occurred.
    (g) Subject firm means any manufacturer, distributor, retailer or 
importer of marbles, small balls, latex balloons, or a toy or game that 
contains a marble, small ball, latex balloon, or other small part.


Sec. 1117.3  Reportable information.

    A subject firm shall report any information it obtains which 
reasonably supports the conclusion that a reportable incident occurred. 
Generally, firms should report any information provided to the company, 
orally or in writing, which states that a child choked on a marble, 
small ball, latex balloon, or on a marble, small ball, latex balloon or 
other small part contained in a toy or game and, as a result of that 
incident the child died, suffered serious injury, ceased breathing for 
any length of time, or was treated by a medical professional. Subject 
firms must not wait until they have investigated the incident or 
conclusively resolved whether the information is accurate or whether 
their product was involved in the incident. Firms shall not wait to 
determine conclusively the cause of the death, injury, cessation of 
breathing or necessity for treatment. An allegation that such a result 
followed the choking incident is sufficient to require a report.


Sec. 1117.4  Time for filing a report.

    A subject firm must report within 24 hours of obtaining information 
which reasonably supports the conclusion that an incident occurred in 
which a child (regardless of age) choked on a marble, small ball, or 
latex balloon or on a marble, small ball, latex balloon, or other small 
part contained in a toy or game and, as a result of that incident the 
child died, suffered serious injury, ceased breathing for any length of 
time, or was treated by a medical professional. Section 1117.5 sets 
forth the information that must be reported.


Sec. 1117.5  Information that must be reported and to whom.

    (a) Reports shall be directed to the Division of Corrective 
Actions, Consumer Products Safety Commission, 4330 East West Highway, 
Bethesda, Maryland 20814 (Mailing Address: Washington, D.C. 20207) 
(Phone: 301-504-0608, facsimile: 301-504-0359).
    (b) Subject firms must report as much of the following information 
as is known when the report is made:
    (1) The name, address, and title of the person submitting the 
report to the Commission,
    (2) The name and address of the subject firm,
    (3) The name and address of the child who choked and the person(s) 
who notified the subject firm of the choking incident,
    (4) Identification of the product involved including the date(s) of 
distribution, model or style number, a description of the product 
(including any labeling and warnings), a description of the marble, 
small ball, latex balloon or other small part involved, and pictures or 
sample if available,
    (5) A description of the choking incident and any injuries that 
resulted or medical treatment that was necessary,
    (6) Copies of any information obtained about the choking incident,
    (7) Any information about changes made to the product or its 
labeling or warnings with the intention of avoiding such choking 
incidents, including, but no limited to, the date(s) of the change and 
its implementation, and a description of the change. Copies of any 
engineering drawings or product and label samples that depict the 
change(s).
    (8) The details of any public notice or other corrective action 
planned by the firm,
    (9) Such other information as appropriate.
    (c) Subject firms must immediately supplement their reports when 
they obtain further information specified in section (b).


Sec. 1117.6  Relation to section 15(b) of the CPSA.

    Section 15(b) of the CPSA requires subject firms to report when 
they obtain information which reasonably supports the conclusion that 
products they distributed in commerce fail to comply with an applicable 
consumer product safety rule or with a voluntary consumer product 
safety standard upon which the Commission has relied under section 9 of 
the CPSA, contain a defect which could create a substantial product 
hazard, or create an unreasonable risk of serious injury or death. The 
Commission's rules interpreting this provision are set forth at 16 CFR 
1115. The requirements of section 102 of the CPSA and this Part are in 
addition to, but not to the exclusion of, the requirements in section 
15(b) and Part 1115. To comply with section 15(b), subject firms must 
continue to evaluate safety information they obtain about their 
products. Subject firms may have an obligation to report under section 
15(b) of the CPSA whether or not they obtain information about choking 
incidents. Firms must also comply with the lawsuit reporting provisions 
of section 37 of the CPSA, interpreted at 16 CFR 1116.


Sec. 1117.7  Confidentiality of reports.

    The confidentiality provisions of section 6 of the CPSA, 15 U.S.C. 
2055, apply to reports submitted under this Part. The Commission shall 
afford information submitted under this Part the protection afforded to 
information submitted under section 15(b), in accordance with section 
6(b)(5) of the CPSA and subpart G of Part 1101 of Title 16 of the CFR.


Sec. 1117.8  Effect of reports on liability.

    A report by a manufacturer, distributor, retailer, or importer 
under this Part shall not be interpreted, for any purpose, as an 
admission of liability or of the truth of the information contained in 
the report.


Sec. 1117.9  Prohibited acts and sanctions.

    (a) Whoever knowingly and willfully falsifies or conceals a 
material fact in a report submitted under this Part is subject to 
criminal penalties under 18 U.S.C. 1001.
    (b) A failure to report to the Commission in a timely fashion as 
required by this Part is a prohibited act under section 19(a)(3) of the 
CPSA, 15 U.S.C. 2068(a)(3).
    (c) A subject firm that knowingly fails to report is subject to 
civil penalties under section 20 of the CPSA, 15 U.S.C. 2069. 
``Knowing'' means the having of actual knowledge or the presumed having 
of knowledge deemed to be possessed by a reasonable person who acts in 
the circumstances, including knowledge obtainable upon the exercise of 
due care to ascertain the truth of representations. Section 20(d) of 
the CPSA, 15 U.S.C. 2069(d).
    (d) Any person who knowingly and willfully violates section 19 of 
this Act after having received notice of noncompliance from the 
Commission may be subject to criminal penalties under section 21 of the 
CPSA, 15 U.S.C. 2070.

Appendix to Part 1117--Sec. 102 of the Child Safety Reporting Act


Sec. 102  Reporting Requirements.

    (a) Reports to Consumer Product Safety Commission.--
    (1) Requirement to Report.--Each manufacturer, distributor, 
retailer, and importer of a marble, small ball, or latex balloon, or a 
toy or game that contains a marble, small ball, latex balloon, or other 
small part, shall report to the Commission any information obtained by 
such manufacturer, distributor, retailer, or importer which reasonably 
supports the conclusion that--
    (A) an incident occurred in which a child (regardless of age) 
choked on such a marble, small ball, or latex balloon or on a marble, 
small ball, latex balloon, or other small part contained in such toy or 
game; and
    (B) as a result of that incident the child died, suffered serious 
injury, ceased breathing for any length of time, or was treated by a 
medical professional.
    (2) Treatment Under CPSA.--For purposes of section 19(a)(3) of the 
Consumer Product Safety Act (15 U.S.C. 2068(a)(3)), the requirement to 
report information under this subsection is deemed to be a requirement 
under such Act.
    (3) Effect on Liability.--A report by a manufacturer, distributor, 
retailer, or importer under paragraph (1) shall not be interpreted, for 
any purpose, as an admission of liability or of the truth of the 
information contained in the report.
    (b) Confidentiality Protections.--The confidentiality protections 
of section 6(b) of the Consumer Product Safety Act (15 U.S.C. 2055(b)) 
apply to any information reported to the Commission under subsection 
(a) of this section. For purposes of section 6(b)(5) of such Act, 
information so reported shall be treated as information submitted 
pursuant to section 15(b) of such Act respecting a consumer product.

    Dated: June 28, 1994.
Sadye E. Dunn,
Secretary, Consumer Product Safety Commission.
[FR Doc. 94-16083 Filed 6-30-94; 8:45 am]
BILLING CODE 6355-01-M