[Code of Federal Regulations]
[Title 40 Volume 25]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR350.7]

[Page 399-400]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
                     Subpart A--Trade Secrecy Claims
 
Sec. 350.7  Substantiating claims of trade secrecy.

    (a) Claims of trade secrecy must be substantiated by providing a 
specific answer including, where applicable, specific facts, to each of 
the following questions with the submission to which the trade secrecy 
claim pertains. Submitters must answer these questions on the form 
entitled ``Substantiation to Accompany Claims of Trade Secrecy'' in 
Sec. 350.27 of this subpart.
    (1) Describe the specific measures you have taken to safeguard the 
confidentiality of the chemical identity claimed as trade secret, and 
indicate whether these measures will continue in the future.
    (2) Have you disclosed the information claimed as trade secret to 
any other person (other than a member of a local emergency planning 
committee, officer or employee of the United States or a State or local 
government, or your employee) who is not bound by a confidentiality 
agreement to refrain from disclosing this trade secret information to 
others?
    (3) List all local, State, and Federal government entities to which 
you have disclosed the specific chemical identity. For each, indicate 
whether you asserted a confidentiality claim for the chemical identity 
and whether the government entity denied that claim.
    (4) In order to show the validity of a trade secrecy claim, you must 
identify your specific use of the chemical claimed as trade secret and 
explain why it is a secret of interest to competitors. Therefore:
    (i) Describe the specific use of the chemical claimed as trade 
secret, identifying the product or process in which it is used. (If you 
use the chemical other than as a component of a product or in a 
manufacturing process, identify the activity where the chemical is 
used.)
    (ii) Has your company or facility identity been linked to the 
specific chemical identity claimed as trade secret in a patent, or in 
publications or other information sources available to the public or 
your competitors (of which you are aware)? If so, explain why this 
knowledge does not eliminate the justification for trade secrecy.
    (iii) If this use of the chemical claimed as trade secret is unknown 
outside your company, explain how your competitors could deduce this use 
from disclosure of the chemical identity together with other information 
on the Title III submittal form.
    (iv) Explain why your use of the chemical claimed as trade secret 
would be valuable information to your competitors.
    (5) Indicate the nature of the harm to your competitive position 
that would likely result from disclosure of the specific chemical 
identity, and indicate why such harm would be substantial.
    (6)(i) To what extent is the chemical claimed as trade secret 
available to the public or your competitors in products, articles, or 
environmental releases?
    (ii) Describe the factors which influence the cost of determining 
the identity of the chemical claimed as trade secret by chemical 
analysis of the product, article, or waste which contains the chemical 
(e.g., whether the chemical is in pure form or is mixed with other 
substances).
    (b) The answers to the substantiation questions listed in paragraph 
(a) of this section are to be submitted on the form in Sec. 350.27 of 
this subpart, and included with a submitter's trade secret claim.
    (c) An owner, operator or senior official with management 
responsibility shall sign the certification at the end of the form 
contained in Sec. 350.27. The certification in both the sanitized and 
unsanitized versions of the substantiation must bear an original 
signature.
    (d) Claims of confidentiality in the substantiation. (1) The 
submitter may claim as confidential any trade secret or confidential 
business information contained in the substantiation. Such claims for 
material in the substantiation are not limited to claims of trade 
secrecy for specific chemical identity, but may also include claims of 
confidentiality for any confidential business information. To claim this 
material as confidential, the submitter shall clearly designate those 
portions of the substantiation to be claimed as confidential by marking 
those portions

[[Page 400]]

``Confidential,'' or ``Trade Secret.'' Information not so marked will be 
treated as public and may be disclosed without notice to the submitter.
    (2) An owner, operator, or senior official with management 
responsibility shall sign the certification stating that those portions 
of the substantiation claimed as confidential would, if disclosed, 
reveal the chemical identity being claimed as a trade secret, or would 
reveal other confidential business or trade secret information. This 
certification is combined on the substantiation form in Sec. 350.27 with 
the certification described in paragraph (c) of this section.
    (3) The submitter shall submit to EPA two copies of the 
substantiation, one of which shall be the unsanitized version, and the 
other shall be the sanitized version.
    (i) The unsanitized copy shall contain all of the information 
claimed as trade secret or business confidential, marked as indicated in 
paragraph (d)(1) of this section.
    (ii) The second copy shall be identical to the unsanitized 
substantiation except that it will be a sanitized version, in which all 
of the information claimed as trade secret or confidential shall be 
deleted. If any of the information claimed as trade secret in the 
substantiation is the chemical identity which is the subject of the 
substantiation, the submitter shall include the appropriate generic 
class or category of the chemical claimed as trade secret. This 
sanitized copy shall be submitted to the State emergency response 
commission, a designated State agency, the local emergency planning 
committee and the local fire department, as appropriate, and made 
publicly available.
    (e) Supplemental information. (1) EPA may request supplemental 
information from the submitter in support of its trade secret claim, 
pursuant to Sec. 350.11(a)(1). EPA may specify the kind of information 
to be submitted, or the submitter may submit any additional detailed 
information which further supports the truth of the information 
previously supplied to EPA in its initial substantiation, under this 
section.
    (2) The submitter may claim as confidential any trade secret or 
confidential business information contained in the supplemental 
information. To claim this material as confidential, the submitter shall 
clearly designate those portions of the supplemental information to be 
claimed as confidential by marking those portions ``Confidential,'' or 
``Trade Secret.'' Information not so marked will be treated as public 
and may be disclosed without notice to the submitter.
    (3) If portions of the supplementary information are claimed 
confidential, an owner, operator, or senior official with management 
responsibility of the submitter shall certify that those portions of the 
supplemental information claimed as confidential would, if disclosed, 
reveal the chemical identity being claimed as confidential or would 
reveal other confidential business or trade secret information.
    (4) If supplemental information is requested by EPA and the 
submitter claims portions of it as trade secret or confidential, then 
the submitter shall submit to EPA two copies of the supplemental 
information, an unsanitized and a sanitized version.
    (i) The unsanitized version shall contain all of the information 
claimed as trade secret or business confidential, marked as indicated 
above in paragraph (e)(2) of this section.
    (ii) The second copy shall be identical to the unsanitized 
substantiation except that it will be a sanitized version, in which all 
of the information claimed as trade secret or confidential shall be 
deleted. If any of the information claimed as trade secret in the 
supplemental information is the chemical identity which is the subject 
of the substantiation, the submitter shall include the appropriate 
generic class or category of the chemical claimed as trade secret.