[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: 40CFR721.11]

[Page 152-153]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 721.11  Applicability determination when the specific chemical identity 
is confidential.

    (a) A person who intends to manufacture, import, or process a 
chemical substance which is described by a generic chemical name is 
subpart E of this part may ask EPA whether the substance is subject to 
the requirements of this part. EPA will answer such an inquiry only if 
EPA determines that the person has a bona fide intent to manufacture, 
import, or process the chemical substance for commercial purposes.
    (b) To establish a bona fide intent to manufacture, import, or 
process a chemical substance, the person who intends to manufacture, 
import, or process the chemical substance must submit the following 
information in writing to the Document Control Office (7407), Office of 
Pollution Prevention and Toxics, U.S. Environmental Protection Agency, 
Room G-099, 1200 Pennsylvania Ave., NW., Washington, DC 20460, ATTN: 
SNUR Bonafide submissions.
    (1) The specific chemical identity of the chemical substance that 
the person intends to manufacture, import, or process.
    (2) A signed statement that the person intends to manufacture, 
import, or process the chemical substance for commercial purposes.
    (3) A description of the research and development activities 
conducted to date, and the purpose for which the person will 
manufacture, import, or process the chemical substance.
    (4) An elemental analysis.
    (5) Either an X-ray diffraction pattern (for inorganic substances), 
a mass spectrum (for most other substances), or an infrared spectrum of 
the particular chemical substance, or, if such data do not resolve 
uncertainties with respect to the identity of the chemical substance, 
additional or alternative spectra or other data to identify the 
substance.
    (c) If an importer or processor cannot provide all the information 
required in paragraph (b) of this section because it is claimed as 
confidential business information by the importer's or processor's 
manufacturer or supplier, the manufacturer or supplier may supply the 
information directly to EPA.
    (d) EPA will review the information submitted by the manufacturer, 
importer, or processor under paragraph

[[Page 153]]

(b) of this section to determine whether than person has shown a bona 
fide intent to manufacture, import, or process the chemical substance. 
If necessary, EPA will compare this information either to the 
information requested for the confidential chemical substance under 
Sec. 710.7(e)(2)(v) of this chapter or the information requested under 
Sec. 720.85(b)(3)(iii) of this chapter.
    (e) If the manufacturer, importer, or processor has shown a bona 
fide intent to manufacture, import, or process the substance and has 
provided sufficient unambiguous chemical identity information to enable 
EPA to make a conclusive determination as to the identity of the 
substance, EPA will inform the manufacturer, importer, or processor 
whether the chemical substance is subject to this part and, if so, which 
section in subpart E of this part applies.
    (f) A disclosure to a person with a bona fide intent to manufacture, 
import, or process a particular chemical substance that the substance is 
subject to this part will not be considered public disclosure of 
confidential business information under section 14 of the Act.
    (g) EPA will answer an inquiry on whether a particular chemical 
substance is subject to this part within 30 days after receipt of a 
complete submission under paragraph (b) of this section.

[53 FR 28359, July 27, 1988, as amended at 60 FR 34464, July 3, 1995]