20 August 2013

>-- c:: G') .::. N**~** Re: BIC USA Children's Pen request for exception from CPSlA lead di>otent'ff mit

_ Docket: CPSC-2013-0016 

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. {**~** J : '>:> (,) The following comments are offered in response to information provided to GBSa; by Dr. Greg W. Gorderofthe Technology Sciences Group on behalfofBIC t1SA Inc. dated 24 July 2013 in the above cited matter. Also added are comments on BIC's response to CPSC questions on lead (Pb) in the pen points ofthe children's pen http://www.regulations.gov/#!docketDetail;D=CPSC-2013-0016

Respectfully,

Brian C

. Lee, PhD DABT bclee@goodafternoontox.us Good Afternoon Toxicology Consulting, LLC 991 NE Kirsten Place Corvallis OR 97330-6822 USA

GATC, LLC page 1 of3 20August 2013 BIC Children's Pen Pb Docket CPSC-2013-0016II. Testing protocol

· The response given by Dr. Gorderseems rather circular. The testing protocol

cannot completely distinguish exhaustion ofthe wipe material from the depletion of Pb from the pen point surface because exhaustion ofthe wipe could be occurring with <15 rotations on a fixed location ofthe wipe material. One might see some depletion ofthe pen point surface with greater number oflocations, but ifthe wipe material becomes "saturated" after5 rotations, adding more rotations dilutes the ug Pb per rotation average. Also, ifone sees an x-fold decrease in ug Pb per rotation with a 4-fold increase in rotations, should not one see an x-fold increase in ug Pb per rotation iwth a 4-fold decrease in rotations (i.e. from 30 to 7.5 rotations)?

VI. Human factors Normally, the secondhand or "indirecf' exposure of Pb has not been considered for regulatory purposes. It is bothersome that the BIC Children's Pen is indicated by Dr. Gorder as a contaminating source ofthe child's clothing, hair, furniture, writing paper, and other objects or pets in a child's environment. These objects and petfurs become reservoirs to provide additional and future Pb exposure from object-to-hand-to-mouth and object-to-mouth activities even when the child is not interacting with the pen. Other children and adults who have not touched the pen would also receive unnecessary Pb exposure by handling or mouthing the contaminated objects.
I agree that a 50% factor for ("direct") hand to mouth transfer of Pb is a reasonable assumption. It is not particularly conservative in view of hand-to-food and hand-to-simulated lip transfer studies with Pb and other non-light metals I have seen.

GATC, LLC 20August2013 page 2 of3 BIC Children's Pen Pb Docket CPSC-2013-0016Although unrelated to product safety, one must wonder about the need for a children's pen for a child who is learning to write. In 9. ofthe BIC response to CPSC questions, the suggested retail price is $3.49

. Even ifdiscounted by a third, that is more costly than a regular BIC pen and certainly more than a pencil. Pencils have very little Pb and provide more resistance than a pen against the surface ofthe paper. The resistance provided by the pencil would allow a child who is learning to write to have better control. http://'N'NVV.target.com/p/bic-round-stic-60ct-ball-pen-black/-/ A-14133864http://'N'NVV.discountofficeitems.com/office-supplies/writing-correction/penspencils/wood-pencils/ticonderoga-wood-pencil/p21216.html One can also buy a variety of reusable grips that fit on regular pencils and pens to make them easierto grasp

. http://blogs.babycenter.com/products and prizes/5-tools-to-help-your-childlearn-the-pencil-grip/ http://'N'NVV.therapro.com/Writing-Tools-C4388.aspx

GATC, LLC page 3 of3 20August2013 BIC Children's Pen Pb Docket CPSC-2013-0016