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

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