Proposed Rule; Requirements 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

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