Proposed Collection of Information Under OMB Review; Mouthing Behavior Study

CONSUMER PRODUCT SAFETY COMMISSION

Proposed Collection of Information Under OMB Review; Mouthing

Behavior Study

AGENCY: Consumer Product Safety Commission (CPSC).

ACTION: Notice.

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SUMMARY: As the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35)

requires, the U.S. Consumer Product Safety Commission (CPSC or

Commission) announces that the Information Collection Request (ICR)

described below has been forwarded to the Office of Management and

Budget (OMB) for review and comment. The proposed collection of

information consists of a study to observe 200 children ages 3 months

through 35 months to record what items they put in their mouths and for

how long. The study also includes a telephone survey of the parents of

about 400 children between 36 and 72 months old to estimate the

mouthing behavior of these children. The information will help the

Commission assess the risks associated with children mouthing products

containing potentially harmful substances. Comments on the study should

be submitted to OMB and CPSC.

DATES: Written comments must be received on or before August 30, 1999.

ADDRESSES: Written comments should be captioned ``Mouthing Behavior

Study'' and mailed to the Office of Information and Regulatory Affairs,

Office of Management and Budget, Attention: Desk Officer for CPSC, 725

17th Street, NW, Washington, DC 20503. Copies of comments also may be:

mailed to the Office of the Secretary, Consumer Product Safety

Commission, Washington, D.C. 20207; delivered to the Office of the

Secretary, Consumer Product Safety Commission, Room 502, 4330 East-West

Highway, Bethesda, Maryland, telephone (301) 504-0800; or filed by

telefacsimile to (301) 504-0127 or by email to [email protected].

FOR FURTHER INFORMATION OR A COPY CONTACT: Celestine T. Kiss,

Engineering Psychologist, Consumer Product Safety Commission,

Washington, D.C. 20207; 301-504-0468 ext. 1284 or by email to

[email protected].

SUPPLEMENTARY INFORMATION:

A. Background

The U.S. Consumer Product Safety Commission staff is investigating

the potential exposure and health risks to children from teethers,

rattles, and toys that are made of polyvinyl chloride (PVC) that

contains various dialkyl phthalate (DAP) plasticizers, especially

diisononyl phthalate (DINP). Manufacturers use plasticizers to soften

the PVC. Tests using animals exposed to high levels of certain DAP

plasticizers have caused concerns that PVC children's products might

present a risk of liver or other organ toxicity to children. Whether

DINP would cause toxic effects in humans depends on the amount of DINP

that is ingested. Thus, determining the amount of time children have

DINP-containing products in their mouths is one important component of

the risk assessment.

The CPSC staff recently released a report, The Risk of Chronic

Toxicity Associated with Exposure to Diisononyl Phthalate (DINP) in

Children's Products (Dec. 1998), which concluded that, based on the

best available information, few, if any, children are at risk of liver

or other organ toxicity from PVC toys that contain DINP. This was based

on estimates of the amount of DINP ingested, which indicated that DINP

exposure did not reach a potentially harmful level. However, the staff

believes that there are a number of uncertainties in this assessment,

particularly regarding the types of toys that children are mouthing and

how long they typically mouth these toys. In addition, the staff at

that time did not address the potential carcinogenic risk from DINP,

which is being investigated by a Chronic Hazard Advisory Panel (CHAP)

appointed by the Commission. After the CHAP provides advice on the

carcinogenic risk of DINP, accurate exposure data will be needed in

order to perform a risk assessment. Therefore, CPSC will perform this

study to gather better data on which to base the health-risk

assessment.

Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C 3501-

3520), Federal agencies must obtain approval from the Office of

Management and Budget (OMB) for each collection of information they

conduct or sponsor. ``Collection of information'' is defined in 44

U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or

requirements that members of the public submit reports, keep records,

or provide information to the agency or a third party. An agency may

not conduct or sponsor, and a person is not required to respond to a

collection of information

[[Page 41398]]

unless it displays a currently valid OMB control number.

Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires

Federal agencies to provide a 60-day notice in the Federal Register

concerning each proposed collection of information before submitting

the collection to OMB for approval. The Federal Register notice with a

60-day comment period soliciting comments on this collection of

information was published on March 11, 1999 (64 FR 12153) (corrected

comment submission date published March 22, 1999 (64 FR 13854)). One

comment was received, from the Toy Manufacturers of America, Inc.

(TMA). The points raised in that comment are addressed in the request

for approval of this collection of information that was submitted to

OMB.

B. Description of the Collection of Information

This extensive exposure study is intended to obtain a better

estimate of the amount of time children mouth products that could

contain phthalates. The CPSC is also interested in how mouthing time

varies with age, gender, and socioeconomic strata. The Commission also

can use information from this study to assess potential hazards

associated with other children's products, such as exposure to lead.

The title of this collection of information is ``Mouthing Behavior

Study.''

The observation portion of the study involves 200 children between

3 and 35 months old. The observations will be conducted over 2 days for

3 hours per day. For 20 continuous minutes out of each half-hour, the

child's mouthing activities will be recorded. This will include (1) the

specific object being mouthed, (2) the length of the mouthing episode

and (3) whether the object was placed to the lips, or put into the

mouth. Mouthing is defined, for purposes of this study, as placing any

item to the child's lips, tongue, and/or into the mouth.

In addition to the observations, a contractor will conduct a

telephone survey to determine mouthing behaviors of 400 children from

36 to 72 months old, as reported by the parent. This age group will not

be observed.

The Commission will use all this information to estimate the

frequency and duration of children's mouthing activities, by age.

Interested persons may obtain a copy of the request to OMB for

approval, containing a more detailed description of the intended study,

from the Commission's Office of the Secretary.

C. Burden on Respondents

Two hundred subjects will be used for the observation portion of

the study. Each subject's total participation time will be

approximately 13 hours. For most of this time, however, the child and

the caregiver will be engaged in their regular activities. (Time spent

in the normal course of a respondent's activities does not count as

part of the burden of a collection of information. 5 CFR 1320.3(b)(2).)

The Commission's staff estimates that each child in the observation

study, and the persons associated with that child (including parents

and other caregivers), will spend an average total of about 4.5 hours

among them in reacting specifically to the observer. This is calculated

by estimating 15 minutes for one person to participate in the telephone

interview, 1 hour for one person to observe the subject and fill out

the questionnaire, 15 minutes for that person to report the results to

the contractor, 1 hour each for two persons during the in-home

interview/habituation period (2 hours total), and an average of 30

person-minutes of interaction relating to the study for each of the 2

observation sessions (1 hour total). Therefore, the total burden hours

for these respondents will be about 900 hours (200 x 4.5 hours).

The number of subjects required for the older children telephone

survey portion of the study is 400. Each subject's total time will be

approximately 1.5 hours. This is calculated by estimating 15 minutes

for the initial phone interview, 1 hour observing the subject and

filling out the questionnaire, and 15 minutes for reporting the results

to the contractor by telephone. Therefore, the total burden hours for

the telephone survey will be about 600 hours. Thus, the estimated one-

time reporting burden for this collection is 1500 hours.

D. Requests for Comments

Send comments regarding the burden estimate, or any other aspect of

the information collection, including suggestions for reducing the

burden, to the addresses given at the beginning of this notice.

Dated: July 27, 1999.

Sadye E. Dunn,

Secretary, U.S. Consumer Product Safety Commission.

[FR Doc. 99-19624 Filed 7-29-99; 8:45 am]

BILLING CODE 6355-01-P