[Code of Federal Regulations]

[Title 40, Volume 31]

[Revised as of July 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 40CFR790.7]



[Page 7]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 790_PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST RULES

--Table of Contents

 

                      Subpart A_General Provisions

 

Sec.  790.7  Confidentiality.



    (a) Any person subject to the requirements of a consent agreement or 

a test rule under section 4 of the Act may assert a claim of 

confidentiality for certain information submitted to EPA in response to 

the consent agreement or the test rule. Any information claimed as 

confidential will be treated in accordance with the procedures in part 2 

of this title and section 14 of the Act. Failure to assert a claim of 

confidentiality at the time the information is submitted will result in 

the information being made available to the public without further 

notice to the submitter.

    (b) A claim of confidentiality must be asserted by circling or 

otherwise marking the specific information claimed as confidential and 

designating it with the words ``confidential business information,'' 

``trade secret,'' or another appropriate phrase indicating its 

confidential character.

    (c) If a person asserts a claim of confidentiality for study plan 

information described in Sec. Sec.  790.50(c)(1)(iii)(D), (iv), (v), and 

(vi) and 790.62(b)(6), (7), (8), (9), and (10), the person must provide 

a detailed written substantiation of the claim by answering the 

questions in this paragraph. Failure to provide written substantiation 

at the time the study plan information is submitted will be considered a 

waiver of the claim of confidentiality, and the study plan information 

will be disclosed to the public without further notice.

    (1) Would disclosure of the study plan information disclose 

processes used in the manufacture or processing of a chemical substance 

or mixture? Describe how this would occur.

    (2) Would disclosure of the study plan information disclose the 

portion of a mixture comprised by any of the substances in the mixture? 

Describe how this would occur.

    (3) What harmful effects to your competitive position, if any, do 

you think would result from disclosure of this information? How would a 

competitor use such information? How substantial would the harmful 

effects be? What is the causal relationship between disclosure and the 

harmful effects?

    (4) For what period of time should confidential treatment be given? 

Until a specific date, the occurrence of a specific event, or 

permanently? Why?

    (5) What measures have you taken to guard against disclosure of this 

information to others?

    (6) To what extent has this information been disclosed to others? 

What precautions have been taken in connection with such disclosures?

    (7) Has this information been disclosed to the public in any forms? 

Describe the circumstances.

    (8) Has the information been disclosed in a patent?

    (9) Has EPA, another Federal agency, or any Federal court made any 

pertinent confidentiality determination regarding this information? If 

so, copies of such determinations must be included in the 

substantiation.

    (d) If the substantiation provided under paragraph (c) of this 

section contains information which the submitter considers confidential, 

the submitter must assert a separate claim of confidentiality for that 

information at the time of submission in accordance with paragraph (b) 

of this section.



[49 FR 39782, Oct. 10, 1984, as amended at 51 FR 23713, June 30, 1986]