[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 [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