[Federal Register Volume 60, Number 38 (Monday, February 27, 1995)]
[Rules and Regulations]
[Pages 10490-10495]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-4483]



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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1117


Interpretative Regulations for Reporting Choking Incidents to the 
Consumer Product Safety Commission Pursuant to the Child Safety 
Protection Act

AGENCY: Consumer Product Safety Commission (CPSC).

ACTION: Final 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 choking incidents 
involving such products. The Commission is issuing a rule to implement 
this reporting requirement.

DATES: This regulation becomes effective March 29, 1995.

FOR FURTHER INFORMATION CONTACT: Eric L. Stone, Office of Compliance 
and Enforcement, CPSC, 4440 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, (Pub. L. No. 103-
267 (June 17, 1994) (``the Act'' or the ``the CSPA'') requires:
    Each manufacturer, distributor, retailer and importer of 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.
    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 civil penalties under section 20 of the CPSA, 15 U.S.C. 
2069. The Act provides a high degree of confidentiality for choking 
reports. Reports shall not be interpreted as admissions of liability or 
of the truth of the information in the reports.
    On July 1, 1994, the Commission proposed a rule to define several 
terms and resolve ambiguities and uncertainties in the statutory 
reporting scheme. (59 F.R. 33927) The Commission received over 200 
comments from consumer groups, medical professionals, and individual 
consumers. Generally, these comments supported the proposed rule. 
Manufacturers, trade associations, testing labs, attorneys and others 
commented on behalf of industry. Generally, these groups sought to 
limit the reporting requirements and allow firms more time and 
discretion. In all, over 260 comments were received and analyzed.

B. Consideration of the Comments

1. Substantive Versus Interpretative

    Several manufacturers, trade associations and industry consultants 
objected to this rule being issued as a substantive rule. Generally, 
these commenters believed interpretative rules were more appropriate. 
Consumers and consumer groups supported issuance of substantive rules.
    The business commenters argued (1) a substantive rule would be 
binding and would eliminate the opportunity to challenge the 
Commission's interpretation of the reporting requirement on a case-by-
case basis; (2) the Commission did not issue other reporting rules 
under section 15(b) or 37 of the CPSA as substantive rules; (3) since, 
unlike the provisions of section 101(c) of the Child Safety Protection 
Act, Congress did not grant the Commission specific authority to issue 
this rule, the Commission should limit itself to an interpretative 
rule; (4) section 16(b) of the CPSA is a recordkeeping and inspection 
provision and was not intended to be used for reporting rules except 
those limited to inspections; and (5) given the tight timeframes for 
reporting, the rule should be interpretative.
    Section 102(a)(2) of the Child Safety Protection Act provides that 
``[f]or purposes of section 19(a)(3) of the Consumer Product Safety Act 
[15 U.S.C. 2068(a)(3), describing prohibited acts], the requirement to 
report information under this subsection is deemed to be a requirement 
under such Act.'' While the Act does not explicitly require the 
Commission to issue rules to implement it, the Commission believes that 
Congress intended the entire reporting section to be considered part of 
the CPSA. The Commission believes its general authority under section 
16(b) to issue rules concerning reporting applies.
    Section 102 left unanswered several questions about reporting 
procedures and the contents of the report. The Commission has an 
obligation to further define the reporting obligation outlined in the 
statute through rulemaking and it has the authority to do so.
    Section 16(b) of the CPSA (15 U.S.C. 2065(b)) authorizes the 
Commission to require manufacturers, private labelers and distributors 
to ``make such reports * * * as the Commission may, by rule, reasonably 
require for the purposes of implementing this Act.'' 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 19(a)(3) of the CPSA 
(15 U.S.C. 2068(a)(3)). The Commission proposed this rule under section 
102 of the Act and section 16(b) of the CPSA (15 U.S.C. 2065(b)).
    Although section 16(b) falls within a section titled ``Inspection 
and Recordkeeping,'' the language of the provision does not by its 
terms limit reporting solely to an inspectional context. The Commission 
has consistently taken this ``plain language'' view of section 16(b). 
The Commission cited section 16 as part of the authority for the 
section 15(b) reporting regulations codified in 16 CFR Part 1115. In 
addition , the Commission has relied on section 16(b) for authority to 
require reports in the certification [[Page 10491]] process for child 
resistant cigarette lighters (16 CFR Part 1210, Subpart B).
    The Commission carefully weighed the policy concerns raised by the 
commenters. A substantive rule would require firms to report the 
specified information and firms would be judged solely on whether they 
met the reporting requirements.
    An interpretative rule should provide adequate guidance to firms as 
to what should be reported and the timeframes for reporting. Since 
reports cannot be used against firms, there are few disincentives to 
reporting under the CSPA than under section 15(b) of the CPSA. 
Assembling the limited information to report should pose only minimal 
burden on reporting firms. The Commission, therefore, concludes that 
while a substantive rule could be legally justified, it is unnecessary 
for policy reasons.

2. Section-by-Section Analysis of the Comments

(a) Section 1117.2--Definitions
    Several industry commenters suggested that the Commission exempt 
from the choking hazard reporting requirement any products that are 
exempted from the small parts regulations at 16 CFR 1501.3 and small 
parts intended for adult assembly. Various consumer commenters opposed 
such changes. The Commission exempted certain items from the small 
parts ban because it believed that the risk of injury posed by the 
product was outweighed by some functional benefit of the product. 
Balloons, books, writing materials, clothing and other items were 
exempted.
    Unlike a ban, the requirement to report hazards does not interfere 
with the sale of the exempt product, and the choking hazard report does 
not place an extraordinary burden on the reporting firm. Congress did 
not limit the reporting obligation to only those products subject to 
the small parts regulation. In fact, it specifically included 
categories of products that were subject to the exceptions or not 
covered by the small parts ban at 16 CFR Part 1501 (balloons, toys and 
games intended for use by the children 3 and older). With the exception 
of balloons which are specifically mentioned in the reporting 
provision, the Commissioners could not agree as to whether the choking 
hazard reporting provision applies to products that would have been 
exempt from the small parts requirements. Accordingly, that issue will 
remain unresolved until such time as a majority of the Commission 
concurs on its resolution. Pending that resolution, reporting on these 
products exempt under section 1501.3 of Title 16 is not required.
(b) Section 1117.2(b)--Small Balls
    One comment suggested that manufacturers of items with inaccessible 
small balls, such as pinball machines, should not have to report 
choking hazards with those balls. The Commission disagrees. Since the 
purpose of this provision is to inform the agency of choking hazards, 
the only salient factor is whether someone choked on a ball. If the 
ball is incorporated in a pinball machine but somehow got out and 
caused a choking, that is the very kind of information firms should be 
reporting to the Commission. If a ball is truly inaccessible, then 
there will be no choking incidents to report.
    The Commission made a minor change to section 1117.2(b) spelling 
out the procedure for identifying small balls in this section rather 
than incorporating it by reference.
(c) Section 1117.2--Choked
    Several commenters suggested changes in the definition of the word 
``choked.'' Some manufacturers thought the definition of ``choked'' in 
the regulation as ``obstruction of the airways'' was too vague. Some 
suggested that under this provision a momentary cessation of breathing 
might be considered a choking. Another suggested that the definition be 
changed to the Red Cross description in First Aid & Safety, (American 
Red Cross 1993, pp. 44, 91). Various consumer groups supported the 
proposed definition.
    As Congress did not define the word ``choked,'' the Commission 
proposal gave a dictionary definition of ``choked'' that is commonly 
understood by the public and health professionals. The definition of 
``choked'' does not provide all the diagnostic guidance in the Red 
Cross document cited by one manufacturer. That document suggests ``[i]f 
a child is coughing weakly or is making a high-pitched sound or if the 
child cannot speak, breathe, or cough, the airway is completely 
blocked.'' [Emphasis added.] This statement recognizes that the 
blockage of the airway is the essence of choking. While this Red Cross 
diagnostic guidance may be useful to firms in determining whether an 
airway was in fact obstructed, it is not a definition of choking.
    Other commenters suggest that hiccuping or swallowing might be 
interpreted as obstructing the airway. The Commission does not intend 
that the definition cover such natural phenomena. ``Choked'' in this 
context refers only to obstruction of an airway by a small part, 
balloon, small ball or marble, not to a natural functions such as 
swallowing.
(d) Section 1117.2(f)--Serious Injury
    The proposal included a definition of serious injury drawn from the 
Commission's Substantial Product Hazard rule, 16 CFR at 1115.6(c). 
Although none of the commenters pointed it out, that definition 
includes various harms such as lacerations and fractures not likely to 
directly result from choking. The Commission has decided to amend the 
definition of serious injury to delete references to such inquries.
(e) Section 1117.3--Reportable Information
    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 choking incident, the child died, suffered 
serious injury, ceased breathing for any length of time, or was treated 
by a medical professional.'' [Emphasis added. (S. Rep. No. 195, 103d 
Cong., 2d Sess. 10 (1993).] Under the proposed rule, if the allegations 
received by the firm meet the statutory test (choking on one of the 
specified products or small parts leading to a cessation of breathing 
or other specified effects) then no further inquiry is necessary.
    Several industry commenters wanted time to investigate choking 
incidents. Many suggested 10 days. Essentially, they argue they should 
not be forced to take at face value the word of parents, physicians, 
attorneys, and others about an incident. They contend the Commission 
might be burdened with unreliable reports. They also argued that this 
provision could require them to report a choking incident involving 
someone else's product and objected to having to do so. Finally, at 
least one firm objected to the term ``ceased breathing for any length 
of time'' since it might require the report of a momentary cessation of 
breathing. Consumer group commenters approved of this provision, noting 
that it relieves firms of the obligation to investigate and 
[[Page 10492]] determine whether the incident was real. They contend 
this provision will lead to quicker reports. The consumer groups also 
argued that firms under-report under section 15(b) of the CPSA and 
argued against giving firms leeway to avoid reporting under this 
provision.
    The Commission is skeptical about how much additional information a 
firm might obtain in even a ten day period. If the person notifying the 
firm of an incident is unreliable, it is difficult to see how the firm 
would obtain useful information within that timeframe. Sometimes, firms 
do not learn the full details of such incidents until months or years 
later and then, only after extensive discovery in litigation. An 
additional 10 days is not likely to greatly assist a firm in 
determining whether the statement made to it by a parent, attorney, 
physician, or other person is true.
    Based on its experience with section 15(b) of the CPSA, the 
Commission believes an immediate report may save lives. As a report 
involves a minimal burden on the reporting firm and cannot be used 
against the firm as an admission, there is little reason not to provide 
an immediate report. Since this statutory reporting provision went into 
effect in June 1994, the Commission has received only a handful of 
reports. After examining these reports, the Commission does not share 
the concern of some industry commenters that the Commission will be 
deluged with spurious reports.
    This provision does not require manufacturers, distributors and 
retailers to report incidents which they know were not caused by their 
product. However, if they are informed of an incident which allegedly 
involved their product they should report unless a reasonable person 
would conclude their product was not involved. While it is conceivable 
a parent, attorney, physician or other party might mistakenly notify a 
firm that its product caused a reportable choking incident, that is not 
likely to be a common event. Moreover, if a firm's product is so 
similar to the object that caused the choking incident that it is 
mistakenly identified, it may present the same risk. The public 
benefits if firms err on the side of reporting. For the reasons 
enumerated above, the Commission has not changed this provision.
    Section 102 of the CSPA states that reports are due if the child 
choked and ``ceased breathing for any length of time.'' [Emphasis 
added.] This language suggests that whether the cessation of breathing 
was momentary or prolonged, a report must be filed. Whether a parent or 
child succeeds in dislodging the time within a second, a minute, or 
never, the incident is still reportable. The Commission staff has 
received questions about whether this requires firms to report a child 
swallowing something, sneezing, or hiccuping. As noted earlier, the 
intent of this provision is to obtain reports of choking incidents, not 
incidents where a child swallowed something, or hiccuped. The 
Commission believes the words ``ceased breathing for any length of 
time'' are unambiguous. It sees no reason to provide further definition 
than is provided by the statute.
(f) Sections 1117.3 and 1117.4--Time for Filing a Report
    A number of manufacturers, Members of Congress, trade associations, 
and industry consultants suggested the Commission give firms 10 days to 
route choking information to an appropriate corporate official, conduct 
a reasonable investigation, and assemble the information that must be 
reported. They point to the 10 day period for investigation of death 
and grievous bodily injury under 16 CFR 1115.12(d) and 1115.14(d) and 
the 30 days for law suit reporting allowed by section 37 of the CPSA as 
precedents. They also note that the statute did not specify a timeframe 
for reporting and, therefore, left the Commission with discretion to 
allow a longer time period. Many consumer groups and consumers 
supported the proposal's 24 hour requirement as an important lifesaving 
requirement.
    If Congress did not expect immediate reporting it could have 
specified a time frame, such as the 30 days it provided in section 37 
of the CPSA. It did not do so. Therefore, the Commission believes the 
legislative intent was to require immediate reporting. In the 
Commission's experience, immediate reporting may prevent additional 
choking incidents or deaths.
    The 24 hour reporting requirement in this rule is consistent with 
the 24 hour requirement in the Commission's section 15(b) rules. The 
section 15(b) rules require firms to immediately report once they have 
obtained reportable information. Firms are given ten days to analyze 
whether an obligation to report exists under section 15(b) only when 
the obligation to report is not immediately clear. (Firms must report a 
death allegedly caused by a defect in their product if they cannot 
within a reasonably expeditious--usually 10 day--investigation 
determine the defect that caused the death does not trip the ``could 
create a substantial hazard'' reporting trigger of Section 15(b).) 
Section 15(b) requires firms to evaluate a wide range of information to 
determine whether the product contains a defect which could create a 
substantial risk or presents an unreasonable risk of serious injury or 
death. In contrast, the CSPA's choking reporting requirement is simple. 
A firm has either learned of an incident that meets the statutory 
criteria, or it hasn't. In addition, the content of a choking hazard 
report is limited compared to a ``full report'' under section 15(b) of 
the CPSA. For the reasons set forth above, the Commission declines to 
change the twenty four hour requirement.
    In the event a firm obtains information indicating that a child 
choked, without any allegation of cessation of breathing, death or 
other triggering event, or without clear allegations that a small part, 
balloon, marble, or small ball was involved, the firm may investigate 
to determine whether a reportable incident has occurred. The firm does 
not have an obligation to report until it has learned that the choking 
incident did cause a death, cessation of breathing or other triggering 
incident.
    The Commission has modified the final rule to adopt an imputation 
of knowledge provision identical to the one in its section 15 rules. 
This new provision is found at section 1117.4(b). In evaluating whether 
or when a subject firm should have reported, the Commission will deem a 
subject firm to have obtained reportable information when the 
information has been received by an official or employee who may 
reasonably be expected to be capable of appreciating the significance 
of the information. Section 1117.4(b) notes the Commission believes 
this process should usually occur within five days. However, if firms 
are capable of transmitting choking hazard data to a responsible 
official within a shorter timeframe, they should not wait five days.
(g) Section 1117.5--Content of Reports
    Proposed section 1117.5 describes the information that firms must 
report. The Commission proposal attempted to limit the reporting 
requirements to information necessary to give the Commission staff 
sufficient information to understand the nature and content of the 
choking incident and to determine whether corrective measures may be 
necessary. Nevertheless, several manufacturers and trade associations 
had questions or concerns about the information that must be submitted.
    At the outset, it should be noted that much of the information that 
must be reported under section 1117.5(b) will be contained in the 
letter or other record of contact with the person notifying the 
[[Page 10493]] firm of the choking incident. A retailer or distributor 
may have no information other than the name and a sample of the 
product, its own distribution information, and the choking complaint. 
The rule has been modified to make it clear a retailer or distributor 
is not under any obligation to seek additional information from its 
supplier to complete a report. Section 1117.5(c). A manufacturer 
(including an importer) may have more information about the design 
iterations of the product and any corrective action taken.
    Several commenters stated that if their product was not involved in 
the choking incident it would be pointless to submit some of the 
information such as corrective action measures. Firms have no 
obligation to report on design changes or corrective action measures if 
none were undertaken. Therefore, these provisions pose no burden on 
firms.
    A trade association expressed uncertainty about the obligation in 
section 1117.5(b)(7) to report changes made in the design of the 
product and whether changes made before or after the incident need be 
reported. The Commission intentionally made this provision broad to 
include all changes made to address choking incidents similar to the 
one reported, whether made before or after the reported choking 
occurred.
    Several commenters expressed concern that the 24 hour reporting 
obligation would make supplemental reports necessary. They suggested 
that some timeframe be supplied for supplemental reports. The 
Commission agrees and has added language to subsection (c) of 1117.5 
requiring supplemental reports be submitted within ten days. Firms do 
not have to file a supplemental report if they have already provided 
all the information required by subsection (b) of section 1117.5.
    Section 1117.6 of the proposed rule explains this reporting 
provision is in addition to, but is 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. Several consumer groups said the agency 
should vigorously enforce the section 15(b) reporting obligation. The 
Commission plans to do so.
    The remaining provisions of the regulation set forth the 
confidentiality, liability and penalty provisions that would apply to 
reporting in accordance with the proposed regulation published below. 
These provisions were not controversial.

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. 103-267, June 17, 1994. The regulation 
simply implements the obligations imposed by that law. The regulation 
itself will not have a significant economic impact or small businesses, 
either beneficial or negative, beyond that which results from the 
statutory provisions.

D. Environmental Considerations

    The rule 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.

E. Effective Date

    This regulation will 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.

List of Subjects in 16 CFR Part 1117

    Administrative practice and procedure, Business and industry, 
Consumer protection, Toy safety, Penalties, Reporting and recordkeeping 
requirements, 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 amends 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

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.

    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 
interpretative regulations for reporting 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 part 1501.
    (b) Small ball means any ball that under the influence of its own 
weight, passes, in any orientation, entirely through a circular hole 
with a diameter of 1.75 inches (4.445 cm) in a rigid template .25 
inches (6 mm.) thick. 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 a 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 [[Page 10494]] 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 and injuries necessitating absence from school or 
work of 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) 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 of this part sets forth the information that must be reported.
    (b) The Commission will deem a subject firm to have obtained 
reportable information when the information has been received by an 
official or employee who may reasonably be expected to be capable of 
appreciating the significance of the information. Under ordinary 
circumstances, 5 days shall be the maximum reasonable time for 
information to reach such an employee, the Chief Executive Officer or 
the official or employee responsible for complying with the reporting 
requirements of section 102 of the Child Safety Protection Act.


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

    (a) Reports shall be directed to the Division of Corrective 
Actions, Consumer Product Safety Commission, 4330 East West Highway, 
Bethesda, Maryland 20815 (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 not 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) Retailers or distributors should supply as much of the 
information required in paragraph (b) of this section as is available 
to them but are not required to obtain information about product design 
changes or recall activities from the product manufacturer.
    (d) Within ten days of their initial report, subject firms must 
supplement their reports to supply any of the information required by 
paragraph (b) of this section that was not available at the time of the 
initial report.


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 
part 1115. The requirements of section 102 of the CSPA 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 part 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 [[Page 10495]] 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.

    Dated: February 17, 1995.
Sadye E. Dunn,
Secretary, Consumer Product Safety Commission.
[FR Doc. 95-4483 Filed 2-24-95; 8:45 am]
BILLING CODE 6355-01-M