PPB April 2015

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to facilitate sleep or the feeding of children
age three and younger, or to help such chil-
dren with sucking or teething.”—Section 108
(g)(1)(C).
Children’s toys or child care articles that
violate CPSC regulations can be stopped at
U.S. ports and refused entry. Similarly, such
unlawful products cannot be sold or distributed
and could be subject to a “voluntary” recall.
The CPSIA And The CHAP
The CPSIA required the establishment
of a Chronic Hazard Advisory Panel
(CHAP) of scientists to study the potential
health effects of certain phthalates (and
alternatives). The CPSIA focused on phtha-
lates in products children can put in their
mouths and chew or suck. The basic concern
is that phthalates can have negative health
effects including so-called endocrine-dis-
rupting effects. The CHAP was required to
make recommendations to the CPSC
including whether to continue an interim
ban on specific phthalates and whether to
ban other phthalates.
The CHAP reported its findings and
recommendations to the commission in July
2014. In its report, the CHAP found expo-
sure to some phthalates was associated with
harmful changes to male reproductive devel-
opment (“antiandrogenic” effects). The
CHAP essentially recommended that cer-
tain phthalates be permanently banned,
other phthalates not be banned and others
studied further or banned on an interim
basis. The CPSC staff reviewed the CHAP
report extensively and used it to create the
pending rule.
Proposed CPSC Phthalate Rule
The CPSC’s proposed rule adopts almost
all of the CHAP’s recommendations con-
cerning phthalates and phthalate alternatives.
They include:
1. Three phthalates were already permanently
banned under the CPSIA in 2008: DEHP,
DBP and BBP. Those three phthalates
remain banned without any change under
the proposed rule.
2. The proposed rule makes changes to three
phthalates previously subject to the
CPSIA’s interim ban:
• First, the interim ban on DINP should
be made permanent and extended to all
children’s toys and child care articles—
no longer just for children’s toys that can
be mouthed.
• Second, the interim ban on DNOP and
DIDP should be lifted because they do
not appear to have antiandrogenic effects.
3. Four other phthalates should also be
banned: diisobutyl phthalate (DIBP), di-n-
pentyl phthalate (DPENP), di-n-hexyl
phthalate (DHEXP) and dicyclohexyl
phthalate (DCHP). These would be pro-
hibited for use in children’s toys and child
care articles.
4. The CHAP recommended an interim ban
on diisooctyl phthalate (DIOP) because it
found insufficient evidence to support a
permanent prohibition. However, the
CPSC took no action on this phthalate
because it could not prohibit DIOP on an
interim basis. As a result, DIOP is not
prohibited on any basis under the pro-
posed rule.
5. The CPSC did not take any action on
other phthalate alternatives that the
CHAP reviewed, but had insufficient
information on which to act. The CHAP
did not recommend any prohibitions on
dimenthyl phthalate (DMP), diethyl
phthalate (DEP) or di(2-propyl) heptyl
phthalate (DPHP). It did recommend
additional study on DEP and DPHP.
6. The CPSC is not recommending a change
to the 0.1 percent (1,000 parts per million)
concentration level. It agreed with the
CHAP that found no compelling reason to
support raising or lowering the limit. The
CPSC said, “The limit is based on practi-
cal considerations, that is, the desire to
prohibit intentional phthalate use while
allowing trace levels.”
Scope Of The Proposed Rule
Importantly, the CPSC decided not to
recommend expanding the scope of the pro-
posed rule to include “any children’s product”
containing any phthalates. Although the
CPSC had the authority to do so under the
CPSIA, it chose to limit the phthalate rule
only to “any children’s toy or child care arti-
cle.” This is significant because had the rule
been expanded, it would have limited phtha-
lates in children’s rainwear, footwear, back-
packs, certain school supplies, apparel con-
taining elastic waistbands, and printed
t-shirts and sweatshirts. As the rule stands
now, not all children’s products are barred
from containing phthalates― only “children’s
toys” or “child care articles” are included in
the proposed rule.
Current Status Of Proposed Rule
As mentioned earlier, the CPSC formally
approved the notice of proposed rule in mid-
December 2014 and issued it for publication
and comment. The rule has been subject to
strong criticism by several groups, including the
American Council on Science and Health, who
cited an earlier blue ribbon panel study that
contradicts certain key CHAP and CPSC rec-
ommendations. The American Chemistry
Council and Exxon Mobil also criticized the
CHAP report and its methodology. It seems
unlikely, however, that the CPSC commission-
ers will significantly change their positions. The
Commission’s 3-2 vote to publish the notice of
proposed rulemaking was along strict party
lines and most likely will not change apprecia-
bly at the time of the final vote on the rule.
Looking Ahead
If this proposed rule is finalized and made
into a formal regulation, manufacturers,
importers, distributors and sellers of children’s
toys and child care articles will need to make
sure their products are in compliance with this
final regulation. If a product contains the
wrong type and amount of a particular phtha-
late, it will be illegal to import it or sell it in
the U.S. Now is the time to review your prod-
uct specifications, testing and certification
procedures if you deal with children’s toys or
child care articles. Once the proposed rule is
finally adopted, businesses will have 180 days
to comply with the new requirements follow-
ing its formal publication in the Federal
Register. Getting ahead now will keep you
from being caught short later.
This article is for informational purposes only
and not for the purpose of providing legal advice.
You should contact your attorney to obtain advice
with respect to any particular issue or problem.
APRIL 2015 • PPB • 71
Charles Joern is the principal of
Joern Law Firm which is based
in the Chicago, Illinois, area. He
focuses his practice in the area
of consumer product safety laws
and product liability. He can be
reached at 630-288-2775 or