[Federal Register: June 3, 2010 (Volume 75, Number 106)]
[Notices]
[Page 31426-31428]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03jn10-51]
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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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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 cpsc-os@cpsc.gov, 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 cpscos@cpsc.gov. For all other matters: Michael Babich,
Directorate for Health Sciences, Consumer Product Safety Commission,
Bethesda, MD 20814; telephone (301) 504-07253; e-mail mbabich@cpsc.gov.
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