[Federal Register Volume 65, Number 104 (Tuesday, May 30, 2000)]
[Notices]
[Page 34446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-13466]



[[Page 34446]]

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CONSUMER PRODUCT SAFETY COMMISSION


Notice of Meeting of Chronic Hazard Advisory Panel on Diisononyl 
Phthalate (DINP) and Opportunity for Public Comment

AGENCY: Consumer Product Safety Commission.

ACTION: Notice of meeting.

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SUMMARY: The Commission announces the second meeting of the Chronic 
Hazard Advisory Panel (CHAP) on diisononyl phthalate (DINP). The 
Commission appointed this CHAP to advise the Commission on any chronic 
hazards of cancer, birth defects, and gene mutations associated with 
children's products containing DINP. The public may submit written or 
oral comments on the issues to be considered by the CHAP.

DATES: The opportunity for the presentation of oral comments will be on 
June 20 from 10 a.m. to 5 p.m. The remainder of the meeting will be 
held from 8:30 a.m. to 5 p.m. on June 21 and from 8:30 a.m. to 4 p.m. 
on June 22, 2000.
    Requests to present oral comments, and a written copy of the text 
of the oral comments, must be filed with the Office of the Secretary no 
later than June 13, 2000.
    Written comments must be received no later than June 13, 2000.

ADDRESSES: The meeting will be held in the fourth floor hearing room in 
the Commission's offices at 4330 East-West Highway, Bethesda, Maryland.
    Written comments, or requests to present oral comments and the 
written text of such comments, should be mailed, preferably in five 
copies, to the Office of the Secretary, Consumer Product Safety 
Commission, Washington, D.C. 20207-0001, or delivered to the Office of 
the Secretary, Consumer Product Safety Commission, Room 502, 4330 East-
West Highway, Bethesda, Maryland; telephone (301) 504-0800. These items 
also may be filed by telefacsimile to (301)504-0127 or by email to 
[email protected]. These items should be captioned ``CHAP on DINP.''

FOR FURTHER INFORMATION CONTACT: Concerning requests and procedures for 
oral presentations of comments: Rockelle Hammond, Docket Control and 
Communications Specialist, Consumer Product Safety Commission, 
Washington, DC 20207; telephone: (301) 504-0800 ext. 1232; email [email protected]. For all other matters: Marilyn Wind, Directorate for 
Health Sciences, Consumer Product Safety Commission, Washington, D.C. 
20207; telephone (301) 504-0477, ext. 1205; email [email protected].

SUPPLEMENTARY INFORMATION: The Commission has been concerned with 
potential risks posed to children under 3 years of age by the 
plasticizer diisononyl phthalate (DINP), which is used to soften some 
children's teethers, rattles, and toys made from polyvinyl chloride 
(PVC). DINP can leach from such products when they are mouthed or held 
by children, causing some DINP to be absorbed through skin and mucous 
membranes. DINP has been shown to cause liver and other organ toxicity 
in laboratory animals. Also, the Commission has received a petition 
(No. HP 99-1) from the National Environmental Trust and eleven other 
organizations asking that the Commission ban PVC in children's 
products.
    The Commission appointed a seven-member CHAP to evaluate the 
existing scientific information regarding the mechanism by which DINP 
may cause cancer and the implications of this on the potential cancer 
risk to children. The CHAP members were selected from scientists 
recommended by the National Academy of Sciences. See 15 U.S.C. 2077, 
2030(b). The first meeting of the CHAP was on May 10-11, 2000. The 
second meeting of the CHAP will be on June 20-22, 2000, in the fourth 
floor hearing room at the Commission's offices in Bethesda, MD (see 
address above).
    The CHAP is seeking public comment on issues relating to the 
hazard, exposure, and risk posed by DINP in children's products. It is 
interested in comments and data pertaining to: (a) What the appropriate 
Acceptable Daily Intake (ADI) of DINP would be; (b) which critical 
endpoint to use to determine the ADI; (c) the mechanism by which DINP 
causes cancer in rodents and the relevance of these induced neoplasms 
to human risk; (d) the appropriate risk assessment model or models to 
determine human risk; (e) the differential sensitivity/susceptibility 
of young children to the effects of DINP, if any, and how to 
incorporate that into an assessment of risk; and (f) age-dependent 
pharmacokinetic differences. In addition, it is particularly interested 
in the following:
    1. Are Diisononyl Phthalate (DINP) rodent cancer bioassay data 
inapplicable to human hazard identification?
    2. Is there convincing evidence that a linear extrapolation 
approach for risk assessment is not appropriate for DINP?
    3. What is the most appropriate measure of the biologically 
effective dose for DINP-induced liver cancer?
    4. Any data available on the percutaneous absorption of DINP. 
(Provide any data available on absorption of DINP from the oral 
mucosa.)
    5. Any available data on the pharmacokinetics of DINP including 
salivary metabolism.
    6. Any available data on DINP metabolites.
    7. Any available information on spongiosis hepatis.
    8. Total exposure to phthalates in adults and children.
    9. Toxicological interactions between phthalate esters.
    The CPSC would appreciate it if any suitable data are submitted in 
the form of an Excel Spread Sheet, a space delimited ASCII file, or a 
SAS (SD2 or SSD) dataset.
    There will be an opportunity for oral comments on June 20, from 10 
am to 5 pm. As explained at the beginning of this notice, persons 
wishing to present oral comments must file a request, and a written 
copy of the text of their comments, with the Commission's Office of the 
Secretary no later than June 13, 2000.
    Commenters should limit their presentations to approximately 15 
minutes, exclusive of any periods of questioning by the members of the 
CHAP or the CPSC staff. The CHAP reserves the right to further limit 
the time for any presentation and to impose restrictions to avoid 
excessive duplication of presentations.
    Interested persons may also file written comments with the CHAP. 
Written comments must be filed with the Office of the Secretary no 
later than June 13, 2000.
    The remainder of the CHAP meeting will be from 8:30 a.m. to 5 p.m. 
on June 21 and from 8:30 a.m. to 4 p.m. on June 22, 2000. During this 
part of the meeting, the CHAP will discuss issues and the report it 
will write.

    Dated: May 24, 2000.
Sadye E. Dunn,
Secretary, Consumer Product Safety Commission.
[FR Doc. 00-13466 Filed 5-26-00; 8:45 am]
BILLING CODE 6355-01-P