[Code of Federal Regulations]
[Title 40, Volume 28]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR720.90]

[Page 134-135]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 720--PREMANUFACTURE NOTIFICATION--Table of Contents
 
       Subpart E--Confidentiality and Public Access to Information
 
Sec. 720.90  Data from health and safety studies.

    (a) Information other than specific chemical identity. Except as 
provided in paragraph (b) of this section, EPA will deny any claim of 
confidentiality with respect to information included in a health and 
safety study, unless the information would disclose confidential 
business information concerning:
    (1) Processes used in the manufacture or processing of a chemical 
substance or mixture.
    (2) In the case of a mixture, the portion of the mixture comprised 
by any of the chemical substances in the mixture.
    (3) Information which is not in any way related to the effects of a 
substance on human health or the environment, such as the name of the 
submitting company, cost or other financial data, product development or 
marketing plans, and advertising plans, for which the person submits a 
claim of confidentiality in accordance with Sec. 720.80.
    (b) Specific chemical identity--(1) Claims applicable to period 
prior to commencement of manufacture. A claim of confidentiality for the 
period prior to commencement of manufacture or import for the chemical 
identity of a chemical substance for which a health and safety study was 
submitted must be asserted in conjunction with a claim asserted under 
Sec. 720.85(a).
    (2) Claims applicable to period after commencement of manufacture or 
import for commercial purposes. To maintain the confidential status of 
the chemical identity of a chemical substance for which a health and 
safety study was submitted after commencement of manufacture or import, 
the claim must be reasserted and substantiated in conjunction with a 
claim under Sec. 720.85(b). In addition to the questions set forth in 
Sec. 720.85(b)(3)(iv) of this part, the submitter must answer the 
following questions:
    (i) Would disclosure of the chemical identity disclose processes 
used in the manufacture or processing of a chemical substance or 
mixture? Describe how this would occur. In responding to the question in 
Sec. 720.85(b)(3)(iv)(A), explain what harmful competitive effects would 
occur from disclosure of this process information.
    (ii) Would disclosure of the chemical identity disclose the portion 
of a mixture comprised by any of the substances in the mixture? Describe 
how this would occur. In responding to the question in 
Sec. 720.85(b)(3)(iv)(A), explain what harmful competitive effects would 
occur from disclosure of this information.

[[Page 135]]

    (iii) Do you assert that disclosure of the chemical identity is not 
necessary to interpret any of the health and safety studies you have 
submitted? If so, explain how a less specific identity would be 
sufficient to interpret the studies.
    (c) Denial of confidentiality claim. EPA will deny a claim of 
confidentiality for chemical identity under paragraph (b) of this 
section, unless:
    (1) The information would disclose processes used in the manufacture 
or processing of a chemical substance or mixture.
    (2) In the case of a mixture, the information would disclose the 
portion of the mixture comprised by any of the substances in the 
mixture.
    (3) The specific chemical identity is not necessary to interpret a 
health and safety study.
    (d) Use of generic names. When EPA discloses a health and safety 
study containing a specific chemical identity, which the submitter has 
claimed confidential, and if the Agency has not denied the claim under 
paragraph (c) of this section, EPA will identify the chemical substance 
by the generic name selected under Sec. 720.85.

[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993]