[Federal Register Volume 75, Number 106 (Thursday, June 3, 2010)]
[Notices]
[Pages 31426-31428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13389]


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CONSUMER PRODUCT SAFETY COMMISSION


Notice of Meeting of Chronic Hazard Advisory Panel on Phthalates 
and Phthalate Substitutes and Opportunity for Public Comment

AGENCY: Consumer Product Safety Commission.

ACTION: Notice of meeting.

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[[Page 31427]]

SUMMARY: The Consumer Product Safety Commission (``CPSC'' or 
``Commission'') announces the second meeting of the Chronic Hazard 
Advisory Panel (CHAP) on phthalates and phthalate substitutes. The 
Commission appointed this CHAP to study the effects on children's 
health of all phthalates and phthalate alternatives as used in 
children's toys and child care articles, pursuant to section 108 of the 
Consumer Product Safety Improvement Act of 2008 (CPSIA) (Pub. L. 110-
314). The public may submit written or oral comments on the issues to 
be considered by the CHAP.

DATES: The opportunity to present oral comments will be on July 26, 
2010, from 10 a.m. to 5 p.m. The remainder of the meeting will be from 
8:30 a.m. to 5 p.m. on July 27 and from 8:30 a.m. to 4 p.m. on July 28, 
2010. Requests to present oral comments must be filed with the Office 
of the Secretary no later than July 1, 2010. Written comments, and a 
written copy of the text of the oral comments, must be received no 
later than July 12, 2010. Commenters should limit their presentations 
to approximately 15 minutes, exclusive of any periods of questioning by 
the members of the CHAP or the Consumer Product Safety Commission 
(CPSC) staff. The CHAP may further limit the time for any presentation 
and to impose restrictions to avoid excessive duplication of 
presentations.

ADDRESSES: The meeting will be in the fourth floor hearing room on July 
26 and 27 and in room 410 on July 28, 2010, 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 captioned ``CHAP on Phthalates'' and sent by 
electronic mail (e-mail) to [email protected], or mailed or delivered to 
the Office of the Secretary, Consumer Product Safety Commission, 4330 
East-West Highway, Bethesda, Maryland 20814.
    Online Registration and Webcast: Members of the public who wish to 
attend the meeting are requested to preregister online at http://www.cpsc.gov/cgibin/chap.aspx. This meeting will also be available live 
via webcast on July 26 and July 27, and by prerecorded webcast on July 
28, 2010, at http://www.cpsc.gov/webcast. Registration is not necessary 
to view the webcast.

FOR FURTHER INFORMATION CONTACT: Concerning requests and procedures for 
oral presentations of comments: Rockelle Hammond, Consumer Product 
Safety Commission, Bethesda, MD 20814; telephone: (301) 504-6833; e-
mail [email protected]. For all other matters: Michael Babich, 
Directorate for Health Sciences, Consumer Product Safety Commission, 
Bethesda, MD 20814; telephone (301) 504-07253; e-mail [email protected].

SUPPLEMENTARY INFORMATION: The Commission has previously investigated 
potential risks posed to children from phthalate plasticizers, 
especially di (2-ethylhexyl) phthalate (DEHP) and diisononyl phthalate 
(DINP), which were used to soften some children's teethers, rattles, 
and toys made from polyvinyl chloride (PVC). Phthalates can leach from 
such products when they are mouthed by children, causing some 
phthalates to be ingested. In addition, children and adults can be 
exposed to phthalates from many sources, including consumer products, 
food, cosmetics, medical devices, and the environment. Certain 
phthalates have been shown to cause adverse health effects, including 
birth defects, in laboratory animals. Section 108 of the CPSIA 
permanently prohibits the sale of any ``children's toy or child care 
article'' containing more than 0.1 percent of each of three specified 
phthalates--di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate 
(DBP), and benzyl butyl phthalate (BBP). Section 108 of the CPSIA also 
prohibits on an interim basis the sale of any ``children's toy that can 
be placed in a child's mouth'' or ``child care articles'' containing 
more than 0.1 percent of each of three additional phthalates--
diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), and di-n-
octyl phthalate (DnOP).
    Section 108 of the CPSIA requires the Commission to convene a CHAP 
``to study the effects on children's health of all phthalates and 
phthalate alternatives as used in children's toys and child care 
articles.'' The CPSIA requires the CHAP to complete an examination of 
the full range of phthalates that are used in products for children and 
to: (i) Examine all of the potential health effects (including 
endocrine disrupting effects) of the full range of phthalates; (ii) 
consider the potential health effects of each of these phthalates both 
in isolation and in combination with other phthalates; (iii) examine 
the likely levels of children's, pregnant women's, and others' exposure 
to phthalates, based on a reasonable estimation of normal and 
foreseeable use and abuse of such products; (iv) consider the 
cumulative effect of total exposure to phthalates, both from children's 
products and from other sources, such as personal care products; (v) 
review all relevant data, including the most recent, best-available, 
peer-reviewed, scientific studies of these phthalates and phthalate 
alternatives that employ objective data collection practices or employ 
other objective methods; (vi) consider the health effects of phthalates 
not only from ingestion but also as a result of dermal, hand-to-mouth, 
or other exposure; (vii) consider the level at which there is a 
reasonable certainty of no harm to children, pregnant women, or other 
susceptible individuals and their offspring, considering the best 
available science, and using sufficient safety factors to account for 
uncertainties regarding exposure and susceptibility of children, 
pregnant women, and other potentially susceptible individuals; and 
(viii) consider possible similar health effects of phthalate 
alternatives used in children's toys and child care articles.
    The CHAP's examination must be conducted de novo, and the statute 
specifies completion of its examination within 18 months of appointment 
of the CHAP. The CHAP must review prior work on phthalates by the 
Commission, but the Commission's prior work is not to be considered 
determinative. Within 180 days after completing its examination, the 
CHAP shall report to the Commission the results of the examination and 
shall make recommendations to the Commission regarding any phthalates 
(or combinations of phthalates or alternatives to phthalates) in 
addition to those permanently banned by the CPSIA that the CHAP 
determines should be declared hazardous substances.
    The first meeting of the CHAP was on April 14-15, 2010. The second 
meeting of the CHAP will be on July 26-28, 2010, 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 phthalates and phthalate 
substitutes from all sources of exposure, and especially in children's 
products. The CHAP is especially interested in comments and data 
pertaining to:
    1. Information on current and anticipated future uses of phthalates 
and phthalate substitutes in products, including market data, 
production levels, and the range of uses of specific phthalates and 
phthalate substitutes in different product types.
    2. Data on the types and levels of phthalates and phthalate 
substitutes found in consumer products, cosmetics, pharmaceutical 
drugs, medical devices, food, food supplements, food packaging, and 
pesticides.
    3. Information on the relative importance of different sources, 
routes,

[[Page 31428]]

and pathways of exposure to phthalates in the general population, 
expectant mothers, and children. For example, what are the relative 
contributions of exposure from diet, consumer products, ambient air, 
and other sources, which may differ depending on the particular 
phthalate and the exposed population?
    4. Data on consumer use patterns including the use of cosmetics and 
consumer products that may contain phthalates.
    5. Data on children's activity patterns, including mouthing 
activity, exposure to household dust, dermal exposure to toys, and 
other potential child-specific exposure pathways.
    6. Information relating to human exposure to phthalates and 
phthalate substitutes, including migration data, levels in 
environmental media (ambient and indoor air, water, soil, household 
dust), dermal exposure, oral exposure, and bioavailability.
    7. New, unpublished, or soon-to-be published data on the types and 
levels of phthalates, phthalate substitutes, or their metabolites in 
human urine, blood, milk, or other biological media.
    8. Information relating to metabolism or pharmacokinetic modeling 
that could be used to estimate human exposure from biomonitoring 
studies.
    9. Toxicity data on the full range of phthalates and phthalate 
substitutes in commercial use, especially unpublished or soon-to-be-
published studies.
    10. Human data on the toxicity of phthalates, including 
epidemiological and clinical studies, especially unpublished or soon-
to-be published studies.
    11. Information on the relative sensitivity of potentially 
vulnerable populations, including the fetus, young children, and 
expectant mothers, and whether there are any other vulnerable 
populations that should be considered.
    12. Information relating to assessing the cumulative (combined) 
risk from multiple phthalates, including dose response data, 
methodology, which health endpoint (or endpoints) is the most relevant 
to human risk assessment, and which phthalate substitutes or other 
compounds may contribute to the combined risk.
    Any information submitted to CPSC in response to this request will 
become part of the public record. The CHAP is especially interested in 
unpublished studies relating to toxicity or exposure. However, the CHAP 
will not consider summaries of toxicological studies prepared by 
chemical manufacturers as substitutes for the complete studies.
    There will be an opportunity for oral comments on July 26, 2010, 
from 10 a.m. to 5 p.m. Persons wishing to present oral comments should 
file a request with the Commission's Office of the Secretary no later 
than July 1, 2010, and submit the text of their comments not later than 
July 12, 2010. 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 may 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 July 12, 2010. The 
remainder of the CHAP meeting will be from 8:30 a.m. to 5 p.m. on July 
27 and from 8:30 a.m. to 4 p.m. on July 28, 2010. During this part of 
the meeting, the CHAP will discuss issues and the report it will write.

    Dated: May 28, 2010
Alberta E. Mills,
Acting Secretary, Consumer Product Safety Commission.
[FR Doc. 2010-13389 Filed 6-2-10; 8:45 am]
BILLING CODE 6355-01-P