[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]
[[Page Unknown]]
[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
