[Federal Register Volume 64, Number 47 (Thursday, March 11, 1999)]
[Notices]
[Pages 12153-12154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-5980]


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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.

[[Page 12154]]

    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