10490 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Rules and Regulations

recordkeeping requirements, United

States investments abroad.

Dated: February 2, 1995.

Carol S. Carson,

Director, Bureau of Economic Analysis.

For the reasons set forth in the

preamble, BEA amends 15 CFR Part 806

as follows:

PART 806—DIRECT INVESTMENT

SURVEYS

1. The authority citation for 15 CFR

Part 806 is revised to read as follows:

Authority: 5 U.S.C. 301; 22 U.S.C. 3101–

3108; and E.O. 11961 (3 CFR, 1977 Comp.,

p. 86), as amended by E.O. 12013 (3 CFR,

1977 Comp., p. 147), E.O. 12318 (3 CFR, 1981

Comp., p. 173), and E.O. 12518 (3 CFR, 1985

Comp., p. 348).

§ 806.14 [Amended]

2. Section 806.14(e) is amended by

removing ‘‘$15,000,000’’ and adding

‘‘$20,000,000’’ in its place.

[FR Doc. 95–4631 Filed 2–24–95; 8:45 am]

BILLING CODE 3510–EA–M

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.

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
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Rules and Regulations 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
10492 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Rules and Regulations

determine whether the incident was

real. They contend this provision will

lead to quicker reports. The consumer

groups also argued that firms underreport 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
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Rules and Regulations 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.

§ 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.

§ 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
10494 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Rules and Regulations

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.

§ 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.

§ 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.

§ 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.

§ 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.

§ 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
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Rules and Regulations 10495

CPSA and subpart G of part 1101 of title

16 of the CFR.

§ 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.

§ 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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. 93C–0380]

Listing of Color Additives for Coloring

Contact Lenses; 1,4-Bis[4-(2-

Methacryloxyethyl)

Phenylamino]Anthraquinone

Copolymers

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

color additive regulations to provide for

the safe use of the colored reaction

product formed by copolymerizing 1,4-

bis[4-(2-methacryloxyethyl)

phenylamino]anthraquinone with 3-

[tris(trimethylsiloxy)silyl]propyl vinyl

carbamate (CAS Reg. No. 134072–99–4)

and N-vinyl pyrrolidone to form contact

lenses. This action is in response to a

petition filed by Bausch & Lomb, Inc.

DATES: Effective on March 30, 1995,

except as to any provisions that may be

stayed by the filing of proper objections;

written objections and requests for a

hearing by March 29, 1995.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Helen R. Thorsheim, Center for Food

Safety and Applied Nutrition (HFS–

216), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3092.

SUPPLEMENTARY INFORMATION:

I. Introduction

In a notice published in the Federal

Register of November 3, 1993 (58 FR

58699), FDA announced that a color

additive petition (CAP 3C0242) had

been filed by Bausch & Lomb, Inc., 1400

North Goodman St., Rochester, NY

14692–0450. The petition proposed that

the color additive regulations be

amended in § 73.3106 1,4-Bis[4-(2-

methacryloxyethyl)

phenylamino]anthraquinone

copolymers (21 CFR 73.3106) to provide

for the safe use of 1,4-bis[4-(2-

methacryloxyethyl)

phenylamino]anthraquinone

copolymerized with N-vinyl

pyrrolidone and

3[tris(trimethylsiloxy)silyl] propyl vinyl

carbamate to form contact lenses. The

filing notice erroneously indicated that

the petition was filed under section

409(b)(5) of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C.

348(b)(5)). The correct section of the act

is 721(d)(1) (21 U.S.C. 379e(d)(1)).

II. Applicability of the Act

With the passage of the Medical

Device Amendments of 1976 (Pub. L.

94–295), Congress mandated the listing

of color additives for use in medical

devices when the color additive in the

device comes in direct contact with the

body for a significant period of time (21

U.S.C. 379e(a)). The use of the reaction

product of 1,4-bis[4-(2-

methacryloxyethyl)

phenylamino]anthraquinone

copolymerized with 3-

[tris(trimethylsiloxy)silyl]propyl vinyl

carbamate and N-vinyl pyrrolidone as a

color additive in manufacturing contact

lenses is subject to this listing

requirement. The color additive is

formed into contact lenses in such a

way that at least some of the color

additive will come in contact with the

eye when the lenses are worn. In

addition, the lenses are intended to be

placed on the eye for several hours a

day, each day, for 1 year or more. Thus,

the color additive will be in direct

contact with the body for a significant

period of time. Consequently, the use of

the color additive currently before the

agency is subject to the statutory listing

requirement.

III. Identity

The color additive, when used to

color contact lenses, is produced by

copolymerizing the dye 1,4-bis[4-(2-

methacryloxyethyl)

phenylamino]anthraquinone (CAS Reg.

No. 121888–69–5) with 3-

[tris(trimethylsiloxy)silyl]propyl vinyl

carbamate (CAS Reg. No. 134072–99–4)

and N-vinyl pyrrolidone monomers. The

dye 1,4-bis[4-(2-methacryloxyethyl)

phenylamino]anthraquinone covalently

bonds through two methacrylate groups

to the polymer matrix during

polymerization. The resulting

copolymeric product is formed into a

contact lens.

IV. Safety Evaluation

The agency believes that because 1,4-

bis[4-(2-methacryloxyethyl)

phenylamino]anthraquinone has a

significantly lower molecular weight

than the N-vinyl pyrrolidone/3-

[tris(trimethylsiloxy)silyl]propyl vinyl

carbamate/1,4-bis[4-(2-

methacryloxyethyl)

phenylamino]anthraquinone copolymer,

it would be more readily absorbed into

the body than the copolymeric color

additive and would thus be expected to

show a greater toxic effect. Therefore,

the safety evaluation of the subject color

additive focused primarily on 1,4-bis[4-

(2-methacryloxyethyl)

phenylamino]anthraquinone.

FDA concludes, from the data

submitted in the petition and from other

relevant information, that the maximum

daily exposure to 1,4-bis[4-(2-

methacryloxyethyl)

phenylamino]anthraquinone from this

petitioned use in contact lenses would

be no greater than 0.08 micrograms per

person per day (μg/p/d). The agencycalculated upper limit was based on two

factors. First, the maximum use level

anticipated by the petitioner is 300 parts

per million (ppm) of the lens material or

15 μg of 1,4-bis[4-(2-methacryloxyethyl)