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3M Study 06-375 Substantiation Questions
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1. Is your company asserting this confidential business information (CBI) claim on its own behalf? If the answer is no, please provide company name, address and telephone number of entity asserting claim.
Yes, the CBI claim is on behalfo f 3M.
2. For what period do you assert your claim(s) of confidentiality? If the claim is to extend until a certain event or point in time, please indicate that event or time period. Explain why such information should remain confidential until such
point.
The period o f timefor confidentiality should be indefinite because 3M plans to manufacture the substancefor use in making 3M products for an indefinite period with continued reliance on the competitive advantage it has in the confidential nature o fsaid substance.
3. Has the information that you are claiming as confidential been disclosed to any other governmental agency, or to this Agency at any other time? Identify the Agency to which the information was disclosed and provide the date and circumstances of the same. Was the disclosure accompanied by a claim of confidentiality? If yes, attach a copy of said document reflecting the confidentiality agreement.
Yes, the confidential information, chemical identity, has been submitted to the [ ]
4. Briefly describe any physical or procedural restrictions within your company relating to the use and storage of the information you are claiming CBI.
The measures taken to prevent undesired disclosure include standard 3M security procedures, such as [ ]
5. If anyone outside your company has access to any of the information claimed CBI, are they restricted by confidentiality agreement(s). If so, explain the content of the agreement(s).
Yes, [ ]
6. Does the information claimed as confidential appear or is it referred to in any of the following: a. Advertising or promotional material for the chemical substance or the resulting and product;
No
b. Material safety data sheets or other similar materials (such as technical data sheets) for the substance or resulting end product (include copies of this information as it appears when accompanying the substance and/or product at the time of transfer or sale);
No
c. Professional or trade publications; or
No
d. Any other media or publications available to the public or to your competitors.
No
If you answered yes to any of the above, indicate where the information appears, include copies, and explain why it should nonetheless be treated as confidential.
Not applicable, the chemical identity appears as a masked name on the MSDS. The material is an internally used chemical and not sold outside o f 3M
7. Has EPA, another federal agency, or court made any confidentiality determination regarding information associated with this substance? If so,
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provide Copies of such determinations. [] 8. Describe the substantial harmful effects that would result to your competitive position if the CBI information is made available to the public? In your answer, explain the causal relationship between disclosure and any resulting substantial harmful effects. Consider in your answer such constraints as capital and marketing cost, specialized technical expertise, or unusual processes and your competitors' access to your customers. Address each piece of information claimed CBI separately. [] 9. Has the substance been patented in the U.S. or elsewhere? Is a patent for the substance currently pending?
Yes, [ ]
10. Is this substance/product commercially available and if so, for how long has it been available on the commercial market?
No
a. If on the commercial market, are your competitors aware that the substance is commercially available in the U.S.?
Not applicable, material is not available commercially
b. If not already commercially available, describe what stage of research and development (R&D) the substance is in, and estimate how soon a market will be established.
The substance is an internally used chemical and commercial sale has not been initiated at this time.
c. What is the substance used for and what type of product(s) does it appear in.
The substance is an emulsifierfor [ ]. It does not take part in the reaction, [ ]
11. Describe whether a competitor could employ reverse engineering to identically recreate the substance?
The substance does not leave the site o f manufacture controlled by 3M except as noted above. However, determining the exact chemical identity o f the substance as a trace residual would require the use o f very sophisticated analytical equipment and methods by highly skilled chemists and would require an extendedperiod of time.
12. Do you assert that disclosure of this information you are claiming CBI would reveal: a. confidential processes used in manufacturing the substance;
Disclosure o f the chemical identity would disclose processes used in the manufacture and processing o f the chemical substance, since the reaction process is comprised o fsimple multi step process which are known in the literature, a skilled chemist or chemical engineer would readily deduce the scheme.
b. if a mixture, the actual portions of the substance in the mixture; or
Not applicable
c. information unrelated to the effects of the substance on human health or the environment?
Disclosure o f the chemical identity o f the substance is not necessary to interpret any o f the health and safety studies submitted because the generic name providedfor the substance is sufficient to allow interpretation o f the studies.
If your answer to any of the above questions is yes, explain how such information would be revealed.
13. Provide the Chemical Abstract Service Registry Number for the product, if known. Is your company applying for a CAS number now or in the near future?
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provide copies of such determinations.
[]
..
8. Describe the substantial harmful effects that would result to your competitive
position if the CBI information is made available to the public? In your answer,
explain the causal relationship between disclosure and any resulting substantial
harmful effects. Consider in your answer such constraints as capital and
marketing cost, specialized technical expertise, or unusual processes and your
competitors' access to your customers. Address each piece of information claimed CBI separately.
[J 9. Has the substance been patented in the U.S. or elsewhere? Is a patent for the
substance currently pending?
'
Yes, [ ]
10. Is this substance/product commercially available and if so, for howrlong has it
been available on the commercial market?
No
a. If on the commercial market, are your competitors aware that the substance is
commercially available in the U.S.?
Not applicable, material is not available commercially
b. If not already commercially available, describe what stage of research and
development (R&D) the substance is in, and estimate how soon a market will be established.
The substance is an internally used chemical and commercial sale has not been initiated at this time.
c. What is the substance used for and what type of product(s) does it appear in.
The substance is an emulsifierfor [ ]. It does not take part in the reaction, [ ]
11. Describe whether a competitor could employ reverse engineering to identically recreate the substance?
The substance does not leave the site o f manufacture controlled by 3M except as noted above.
However, determining the exact chemical identity o f the substance as a trace residual would
require the use o f very sophisticated analytical equipment and methods by highly skilled chemists and would require an extendedperiod o f time.
12. Do you assert that disclosure of this information you are claiming CBI would reveal:
a. confidential processes used in manufacturing the substance;
Disclosure o f the chemical identity would disclose processes used in the manufacture and
processing o f the chemical substance, since the reaction process is comprised ofsimple multi
step process which are known in the literature, a skilled chemist or chemical engineer would readily deduce the scheme.
b. if a mixture, the actual portions of the substance in the mixture; or
Not applicable
c. information unrelated to the effects of the substance on human health or the environment?
Disclosure o f the chemical identity o f the substance is not necessary to interpret any o f the health and safety studies submitted because the generic name providedfor the substance is sufficient to allow interpretation o f the studies.
If your answer to any of the above questions is yes, explain how such
information would be revealed.
13. Provide the Chemical Abstract Service Registry Number for the product, if known. Is your company applying for a CAS number now or in the near future?
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If you have applied for a CAS number, include a copy of the contract with CAS.
The assigned Chemical Abstract Registry Number, [ ].
14. Is the substance or any information claimed CBI the subject of FIFRA regulation or reporting? If so, explain.
No
3M Contact: Deanna Luebker, PhD, 3M TSCA 8(e) Coordinator 3M Toxicology Assessment and Compliance Assurance 3M Center 220-06-E-03 St. Paul, MN 55144 651-737-1374 (office) 651-733-1773 (fax) diluebker@mmm.com
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