From: Hatlelid, Kristina

To: David Baker (david.baker@dhbakerlaw.com)

Subject: Pen petition follow-up questions

Date: Monday, July 08, 2013 8:34:24 AM

Dear Mr. Baker:

The U.S. Consumer Product Safety Commission (CPSC) staff has follow-up questions for BIC USA

regarding the prototype children’s pen that is the subject of the request for a functional purpose

exception to the CPSIA lead content limits that was submitted by you on behalf of BIC USA. In

addition, we would like BIC USA to clarify some of the information presented in the exception request.

I have included below specific questions. Staff requests written responses to these questions.

Depending on the responses to our inquiries, we may have additional questions. If necessary, staff

may be available for a follow-up telephone call.

Please note that this letter and the responses to our questions will be included in the public record.

Any telephone conversations will be memorialized in the form of a log and any written submissions

made on behalf of BIC USA will be added to the public record. You may request to have specificallyidentified confidential business information withheld from public disclosure by identifying the specific

information sought to be withheld and articulating the basis for confidential treatment. Alternatively, you

may choose to decline to answer a question. In that case, staff will proceed with our evaluation based

only on the information that is available.

I look forward to your response.

Best Regards,

Kris Hatlelid, Ph.D., M.P.H.

Toxicologist

Directorate for Health Sciences

U.S. Consumer Product Safety Commission

5 Research Place, Rockville, MD 20850

301.987.2558

khatlelid@cpsc.gov

Nickel Silver

1. Which alloys of nickel silver are/will be used for the pen points for the children’s

pen?

2. What are the Unified Numbering System (UNS) numbers of the nickel silver alloys

that will be used in the children’s pen?

3. What are the composition and mechanical properties of the nickel silver alloys that

will be used in the children’s pen?

4. Why is nickel silver required for the pen points?

5. Is lead intentionally added into the alloys of nickel silver that will be used for this

product? For what purpose?

6. For the nickel silver alloys currently used in manufacturing BIC pens, what are the

actual minimum and maximum lead content levels (% or ppm) of each lot?

7. Please specify the form ( e.g. ingot, sheet, coil, other) of the nickel silver material that

will be used in manufacturing the pen points.

8. If the lead content of the nickel silver alloy that will be used is less than 100 ppm,

would the alloy still be functional for its manufacture and use as pen points? If yes,

could BIC contract with a metals supplier to obtain nickel silver with less than 100ppm lead? If no, please explain why not.

9. If more than 100 ppm lead is required to achieve the desired mechanical properties of

nickel silver, what is the lowest lead content that will achieve those properties? Why

can’t a nickel silver with less than 8,720 ppm of lead, like C74500, C75200, or

C75700, with between 500 and 1,000 ppm lead maximum be used in the children’s

pen?

10. What lead content limit would be acceptable as a maximum level for the BIC

children’s pen points; i.e.

, what would be a feasible alternate lead limit for these

products?

11. Could substitute materials for lead be used in the nickel silver (similar to the way

bismuth can replace lead in steels to improve machinability) to replace the lead while

maintaining the desirable alloy properties?

Stainless Steel

1. What properties of stainless steel make it acceptable for use in making pen points?

2. Does BIC use stainless steel for the points of any pens it manufactures? What are the

identity (UNS Number), composition, and mechanical properties of that stainless

steel?

3. Can stainless steel be formed into pen points on the same machinery used for nickel

silver pen points?

4. Could other steel alloys, such as ASTM A606 or A608 (cold-rolled steels), provide

acceptable performance for pen points? Please explain why or why not.

Other Materials

1. Could other copper alloys with less than 100 ppm lead provide acceptable

performance for pen points, such as C260 brass alloys, which are available now with

less than 100 ppm lead? Please explain why or why not.

2. Could other materials, like titanium or aluminum alloys or polymers, provide

acceptable performance for pen points? Please explain why or why not.

Miscellaneous Questions

1. What does “cycle its machines” mean, and how does a lower lead content affect

cycling?

2. What is the duration referred to for “cycle its machines once instead of twice,” e.g

., is

it cycles per hour?

3. How many samples are represented by the total lead content test result of 8,720 ppm?

How were samples selected for testing? How were the tested samples representative

of the alloy used to make the pen points?

4. What was the lead content of the samples subjected to wipe testing?

5. In the wipe testing, are the results given as the total micrograms of lead released per

test ( i.e., all 30 full rotations with the Palintest wipe material), or some other metric?

6. Why is it necessary to use solvent-based ink?

7. Explain how using a stainless steel pen point with solvent based ink is 78 percent

more costly than a nickel silver pen point with solvent based ink? How would the

use of a stainless steel point affect the total cost of the pen?

8. How would the use of other alloys with less than 100 ppm lead like copper, titanium,

aluminum alloys, or polymers affect the total cost of the pen?

9. What do you expect the manufacturer’s suggested retail price of the pen will be?