Proposed Collection of Information; Mouthing Behavior Study; Comment Request

CONSUMER PRODUCT SAFETY COMMISSION

Proposed Collection of Information; Mouthing Behavior Study;

Comment Request

AGENCY: Consumer Product Safety Commission.

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'') is announcing an opportunity for public comment on a

proposed study to determine the frequency and duration of children's

mouthing behaviors. The study will observe 200 children ages 3 months

through 36 months to record what items they put in their mouth and for

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

about 400 children between 37 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. The Commission will consider

all comments received in response to this notice before requesting

approval of this observational study from the Office of Management and

Budget.

DATES: Written comments must be received by the Office of the Secretary

on or before June 9, 1999.

ADDRESSES: Written comments should be captioned ``Mouthing Behavior

Study'' and mailed to the Office of the Secretary, Consumer Product

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

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

West Highway, Bethesda, Maryland; telephone (301) 504-0800. Comments

also may be filed by telefacsimile to (301) 504-0127 or by email to

[email protected].

FOR FURTHER INFORMATION CONTACT: For information about the proposed

collection of information, call or write 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 may be made from polyvinyl chloride (PVC) that

contains various dialkyl phthalate (DAP) plasticizers, especially

diisononyl phthalate (DINP). Manufacturers use plasticizers to soften

the PVC.

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. Staff will undertake

additional work to gather better data on which to base the health risk

assessment.

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 Commission also can use

information from this study to assess potential hazards associated with

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

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 a third party. 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.

B. Description of the Collection of Information

This additional work will include an extensive exposure study 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.

Subjects will be recruited by random digit dialing (RDD) in two

large metropolitan areas that are each diverse from a socioeconomic

viewpoint. RDD will be used to provide probability samples to ensure

that the estimates are representative of the metropolitan areas where

the study is conducted.

The observation portion of the study involves 200 children between

3 and 36 months old. The observations will be conducted over 2 days for

4 hours per day. The observer will keep a diary of the child's

activities during the observations. Examples of activities will include

eating, napping, or sleeping, play, and child-care. For 15 continuous

minutes out of each 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.

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In addition to the observations, a contractor will conduct a RDD

telephone survey to determine mouthing behaviors of 400 children

between 37 and 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 more detailed description of the

intended study from the Commission's Office of the Secretary.

C. Burden on Respondents

The Commission's staff estimates that 200 subjects are required 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 each child (including parents

and other caregivers), will spend an average total of about 3.5 hours

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

by estimating the time of interacting with one person for a 0.5 hour

phone interview, two persons for 1 hour 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 700 hours (200 x 3.5 hours).

The staff estimates that the number of subjects required for the

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

will be approximately 15 minutes. Therefore, the total burden hours for

the telephone survey will be about 100 hours.

Thus, the estimated one-time reporting burden for this collection

is 800 hours.

C. Requests for Comments

The Commission solicits written comments from all interested

persons about the proposed survey to determine children's mouthing

behaviors. The Commission specifically solicits information about the

hourly burden and about any monetary costs that may be imposed by this

collection of information. As required by the PRA, the Commission also

seeks information relevant to the following topics:

Whether the collection of information is necessary for the

proper performance of the Commission's functions;

Whether the information will have practical utility for

the Commission;

Evaluate the accuracy of the agency's estimate of the

burden on the proposed collection of information, including the

validity of the methodology and assumptions used;

Whether the quality, utility, and clarity of the

information to be collected could be enhanced; and

Whether the burden imposed by the collection of

information on those who are to respond could be minimized, including

by use of automated, electronic, mechanical or other technological

collection techniques, or other forms of information technology.

Dated: March 5, 1999.

Sadye E. Dunn,

Secretary, U.S. Consumer Product Safety Commission.

[FR Doc. 99-5980 Filed 3-10-99; 8:45 am]

BILLING CODE 6355-01-P