[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]


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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