20 August 2013 

>--

c:: 

G') 

.::. N ~ 

Re: BIC USA Children's Pen request for exception from CPS lA lead di>otent'ffmit _ 

Docket: CPSC-2013-0016 U ) . { ~ J 

: '>:> (,) 

The following comments are offered in response to information provided to GBSa; 

by Dr. Greg W. Gorder of the Technology Sciences Group on behalf ofBIC 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 of the 

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 

20 August 2013 

BIC Children's Pen Pb 

Docket CPSC-2013-0016 
II. Testing protocol 

· The response given by Dr. Gorder seems rather circular. The testing protocol 

cannot completely distinguish exhaustion of the wipe material from the depletion 

of Pb from the pen point surface because exhaustion of the wipe could be 

occurring with <15 rotations on a fixed location of the wipe material. One might 

see some depletion of the pen point surface with greater number of locations, but 

if the wipe material becomes "saturated" after 5 rotations, adding more rotations 

dilutes the ug Pb per rotation average. 

Also, if one 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 of the child's clothing, hair, furniture, 

writing paper, and other objects or pets in a child's environment. These objects 

and pet furs 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 

20 August 2013 

page 2 of 3 BIC Children's Pen Pb 

Docket CPSC-2013-0016 
Although 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. of the BIC response to 

CPSC questions, the suggested retail price is $3.49 . Even if discounted 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 of the 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-14133864 

http://'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 easier to 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 

20 August 2013 

BIC Children's Pen Pb 

Docket CPSC-2013-0016