[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: 40CFR716.55]

[Page 82-83]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 716--HEALTH AND SAFETY DATA REPORTING--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 716.55  Confidentiality claims.

    (a)(1) Section 14(b) of TSCA provides that EPA may not withhold from 
disclosure, on the grounds that they are confidential business 
information, health and safety studies of any substance or mixture that 
has been offered for commercial distribution (including for test 
marketing purposes and for use in research and development), any 
substance or mixture for which testinq is required under TSCA section 4, 
or any substance for which notice is required under TSCA section 5, 
except to the extent that disclosure of data from such studies would 
reveal--
    (i) Processes used in the manufacturing, importing, or processing of 
the substance or mixture, or
    (ii) The portion of a mixture comprised by any of the substances in 
the mixture.
    (2) Any respondent who wishes to assert a claim that part of a study 
should be withheld from disclosure because disclosure would reveal a 
confidential process or quantitative mixture composition should briefly 
state the basis of the claim, e.g., by saying ``reveals confidential 
mixture proportion data,'' and clearly identify the material subject to 
the claim.
    (3) Any respondent may assert a confidentiality claim for company 
name or address, financial statistics, and product codes used by a 
company. This information will not be subject to the disclosure 
requirements of section 14(b) of TSCA.
    (4) Information other than company name or address, financial 
statistics, and product codes used by a company, which is contained in a 
study, the disclosure of which would clearly be an unwarranted invasion 
of personal privacy (such as individual medical records), will be 
considered confidential by EPA as provided in Title 5, United States 
Code, section 552(b)(6).
    (b) To assert a claim of confidentiality for data contained in a 
submitted document, the respondent must submit two copies of the 
document:
    (1) One copy must be complete. In that copy, the respondent must 
indicate what data, if any, are claimed as confidential by bracketing or 
underlining the specific information. Each page containing data claimed 
as confidential must also contain a brief statement for the basis of the 
claim as well as a label such as ``confidential,'' ``proprietary,'' or 
``trade secret.''
    (2) The second copy must be complete, except that all information 
claimed as confidential in the first copy must be deleted. The second 
copy will be immediately subject to public disclosure.
    (3) Failure to furnish a second copy when information is claimed as 
confidential in the first copy will be considered a presumptive waiver 
of the claim of confidentiality. EPA will notify the respondent by 
certified mail that a finding of a presumptive waiver of the claim of 
confidentiality has been made. The respondent will be given 30 days from 
the date of his or her receipt of this notification to submit the 
required second copy. If the respondent fails to submit the second copy 
within the 30 days, EPA will place the first copy in the public file.

[[Page 83]]

    (c) If no claim of confidentiality accompanies a document at the 
time it is submitted to EPA, the document will be placed in an open file 
available to the public without further notice to the respondent.