[Federal Register Volume 64, Number 146 (Friday, July 30, 1999)]
[Notices]
[Pages 41397-41398]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19624]
=======================================================================
-----------------------------------------------------------------------
CONSUMER PRODUCT SAFETY COMMISSION
Proposed Collection of Information Under OMB Review; Mouthing
Behavior Study
AGENCY: Consumer Product Safety Commission (CPSC).
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) 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 cpsc-os@cpsc.gov.
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
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 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
