[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]
=======================================================================
-----------------------------------------------------------------------
CONSUMER PRODUCT SAFETY COMMISSION
Proposed Collection of Information; Mouthing Behavior Study;
Comment Request
AGENCY: Consumer Product Safety Commission.
ACTION: Notice.
-----------------------------------------------------------------------
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
cpsc-os@cpsc.gov.
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 ckiss@cpsc.gov.
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
