Federal Register, Volume 74, Number 46, March 11, 2009, Pages 10455-10672 Page: 10,476
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10476 Federal Register/Vol. 74, No. 46/Wednesday, March 11, 2009/Rules and Regulations
same issue of the Federal Register (74
FR 2433), the Commission published
another notice of proposed rulemaking
describing preliminary determinations
that specific materials including certain
natural materials and certain metal and
alloys do not and would not exceed the
lead limits.
For materials or products that
inherently do not contain lead or
contain lead at levels that would not
exceed the lead content limits under
section 101(a) of the CPSIA, the
Commission proposed procedures and
requirements by which requests for
determinations on materials or products
will be reviewed. The Commission
emphasized that it would concentrate
its efforts on evaluating those materials
that are commodity-like, are used across
industry in a number of applications,
and are subject to detailed consensus
standards related to lead content and
other pertinent properties and that
review of individual products of a single
manufacturer would be assigned a low
priority.
For materials or products that exceed
the lead content limits in section 101(a)
of the CPSIA, section 101(b) of the
CPSIA requires the Commission to
provide notice and a hearing to consider
and evaluate the best-available,
objective, peer-reviewed, scientific data
before promulgating a rule on
exclusions. Given the highly technical
nature of the information sought-peer-
reviewed, scientific data-the
Commission stated its intention to
provide notice and comment procedures
based on written submissions, rather
than an oral hearing. 74 FR 2430.
Accordingly, the Commission proposed
procedures and requirements which
required that a request for exclusion
must be supported by the best-available,
objective, peer-reviewed, scientific
evidence, such as test results indicating
how much lead is present in the
product, how much lead comes out of
the product and the conditions under
which that may happen, and
information relating to a child's
interaction, if any, with the product.
D. Discussion of Comments to the
Proposed Rule
Several comments were received in
response to the proposed rule.2 All of
the commenters generally express
support for the proposed procedures
and requirements. Additional comments
are addressed below.
2 There were other comments that were submittedbut that did not address any issues related to this
rule. Accordingly, they will not be addressed here.Standard for Exclusions
The ATV Companies 3 question the
Commission's statement regarding the
difficult standard that needs to be met
for exclusions under section 101(b)(1) of
the CPSIA, suggesting that possibly no
petition might qualify for an exclusion
and citing recent statements from a
Senate conferee suggesting that the
exclusion is appropriate for use in this
context. They assert that exclusions
provided for by Congress should not be
rendered meaningless and that Congress
must have intended to provide relief for
some accessible components when
evaluated in the context of a child's
reasonably foreseeable use and abuse of
a product, and that certain ATV
components fall within the scope of
such an exclusion.
The Commission believes that the
clear language of the statute which
provides that it must determine, on the
basis of the best-available, objective,
peer-reviewed, scientific evidence that
lead in such product or material will not
"result in the absorption of any lead
into the human body * * *" (emphasis
added) does not allow the Commission
any discretion to consider materials or
products whereby exposure to the lead-
containing elements under reasonably
foreseeable use and abuse conditions
would result in any absorption of lead,
including through swallowing,
mouthing, breaking, and the aging of the
product. While Congress focused on
ingestion by using the words
"swallowing, mouthing, and breaking,"
the use or abuse of a children's product
containing lead in excess of the lead
limits could lead to the absorption of
lead from hand to mouth contact, as the
Commission has recognized for many
years. Had Congress not included the
use of the word "any", the Commission,
relying, inter alia, on the advice of its
toxicologists, engineers and human
factors experts, would have had the
authority to have considered whether
the requirement could be met if there
were some low amount of absorption of
lead, resulting in "no meaningful
increase" in children's blood lead
levels, thereby constituting a negligible
risk. While there is no established
threshold for adverse effects of lead,
peer-reviewed scientific literature
suggests ways of assessing the risk to
children given child-specific exposure
routes, and taking into account the
current knowledge of lead toxicology.
Models for such assessments have been
3 The ATV Companies are American Honda
Motor Co., American Suzuki Motor Corp., Arctic
Cat Inc., Bombardier Recreational Products Inc.,Kawasaki Motors Corp., U.S.A., Polaris Industries
Inc., and Yamaha Motor Corp., U.S.A.advanced recently by other federal and
state agencies. See e.g., Development of
Health Criteria for School Site Risk
Assessment Pursuant To Health and
Safety Code Section 901(G): Child-
Specific Benchmark Change in Blood
Lead Concentration for School Site Risk
Assessment, Final Report April 2007,
Integrated Risk Assessment Branch,
Office of Environmental Health Hazard
Assessment, California Environmental
Protection Agency. Physiologically, if
there is absorption of lead into the
human body, blood lead levels will
increase, but whether that has
significance from a health standpoint
remains a question. However, the
addition of the word "any" made it
explicit that Congress had already made
this risk assessment and legislated that
any absorption of lead from products or
materials containing lead above the
content limits established by Congress,
no matter how insignificant, would be
deemed unacceptable. The exclusion is
not rendered meaningless, as
conceivably some product could be over
the lead limit but designed in a way to
avoid hand to mouth exposure or some
other absorption pathway in children of
a certain age. Accordingly, the
Commission must follow the clear
language of the statute and cannot grant
any exclusion that does not meet this
requirement.
Other Considerations for Exclusion
Requests
The United States Association of
Importers of Textiles and Apparel
(USA-ITA) supports the proposed
procedures for requesting exclusions or
determinations for other materials that
may be included in apparel, such as
rhinestone beads. The Fashion Jewelry
Trade Association (FJTA) agrees that an
oral hearing is not required for the
Commission to act on exclusions and
requests expedited action on crystals.
For proposed exclusions, it states that
only relevant exposure conditions
should be considered, including
consideration of the child's age. The
American Apparel & Footwear
Association (AAFA) et al. assert that the
Commission should rely on an
extractable lead test rather than the total
lead content in its evaluations for
proposed exclusions and requirements.
FJTA requests that, in the absence of
published best-available, objective,
peer-reviewed scientific evidence, test
data using accepted published test
methods should be considered reliable
information. It also opposes the
requirement that a request for exclusion
should include evidence that may be
unfavorable to the requestor, because itclaimed that the purpose of the public
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United States. Office of the Federal Register. Federal Register, Volume 74, Number 46, March 11, 2009, Pages 10455-10672, periodical, March 11, 2009; Washington D.C.. (https://digital.library.unt.edu/ark:/67531/metadc132908/m1/30/: accessed April 16, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.