[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: 40CFR720.25]

[Page 116-118]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 720--PREMANUFACTURE NOTIFICATION--Table of Contents
 
                        Subpart B--Applicability
 
Sec. 720.25  Determining whether a chemical substance is on the Inventory.

    (a) A new chemical substance is any chemical substance that is not 
currently listed on the Inventory.
    (b)(1) A chemical substance is listed in the public portion of the 
Inventory by a specific chemical name (either a Chemical Abstracts (CA) 
Index Name or a CA Preferred Name) and a Chemical Abstracts Service 
(CAS) Registry Number if its identity is not confidential. If its 
identity is confidential, it is listed in the public portion of the 
Inventory by a TSCA Accession Number and a generic chemical name that 
masks the specific substance identity. The confidential substance is 
listed by its specific chemical name only in the confidential portion of 
the Inventory, which is not available to the public. A person who 
intends to manufacture or import a chemical substance not listed by 
specific chemical name in the public portion of the Inventory may ask 
EPA

[[Page 117]]

whether the substance is included in the confidential Inventory. EPA 
will answer such an inquiry only if EPA determines that the person has a 
bona fide intent to manufacture or import the chemical substance for 
commercial purposes.
    (2) To establish a bona fide intent to manufacture or import a 
chemical substance, the person who proposes to manufacture or import the 
substance must submit to EPA:
    (i) Except as provided in paragraphs (b)(3) (i) and (ii) of this 
section, the specific chemical identity of the substance that the person 
intends to manufacture or import, using the currently, correct CA name 
for the substance and the other correct chemical identity information in 
accordance with Secs. 720.45(a) (1), (2), and (3).
    (ii) A signed statement that the person intends to manufacture or 
import that chemical substance for commercial purposes.
    (iii)(A) A brief description of the research and development 
activities conducted to date related to the substance, including the 
year in which the person first started to conduct research or 
development activity on the substance, and the general types of research 
and development activities conducted thus far (e.g., synthesis, 
substance isolation/purification, formulating, product development, 
process development, end-use application, toxicity testing, etc.). The 
person must also indicate whether any pilot plant or production-scale 
plant evaluations have been conducted involving the manufacture or 
processing of the substance.
    (B) If an importer is unable to provide the information requested in 
paragraph (b)(2)(iii)(A) of this section from the foreign manufacturer 
or supplier, the following information shall be submitted:
    (1) A brief statement indicating how long the substance has been in 
commercial use outside of the United States.
    (2) The name of a country in which it has been commercially used.
    (3) Whether the importer believes that the substance has already 
been used commercially, in any country, for the same purpose or 
application that the importer is intending.
    (iv) A specific description of the major intended application or use 
of the substance.
    (v) An infrared spectrum of the substance, or alternative spectra or 
other data which identify the substance if infrared analysis is not 
suitable for the substance or does not yield a reasonable amount of 
structural information. When using alternative spectra or instrumental 
analysis, the person must submit a spectrum or instrumental readout for 
the substance.
    (vi) The estimated date (month/year) in which the person intends to 
submit a Premanufacture Notice (PMN) for this substance if EPA informs 
the notice submitter that the substance is not on the Inventory.
    (vii) The address of the facility under the control of the submitter 
at which the manufacture or processing of the substance would most 
likely occur. For an imported substance, the facility under the control 
of the importer at which processing of the substance would likely occur, 
if any.
    (viii)(A) For substances intended to be manufactured in the United 
States, a description of the most probable manufacturing process that 
would be used by the submitter to produce the substance for non-exempt 
commercial purposes.
    (B) For substances intended to be imported, a brief description of 
how the submitter is most likely to process or use the substance for a 
commercial purpose. If the substance is not expected to be processed or 
used at any facility under the importer's control, a statement to this 
effect must be included along with a description of how the substance 
will be processed or used at sites controlled by others, if this 
information is known or reasonably ascertainable.
    (3)(i) If an importer cannot provide the chemical identity 
information required by paragraph (b)(2) (i) and (v) of this section 
because it is claimed confidential by its foreign manufacturer or 
supplier, the foreign manufacturer or supplier must supply the required 
information directly to EPA in accordance with Sec. 720.45(a) (1), (2), 
and (3) and reference the importer's notice. If the

[[Page 118]]

appropriate supporting document from the foreign party is not received 
within 30 days after EPA receives the importer's notice, the notice will 
be considered incomplete.
    (ii) If a manufacturer cannot provide all of the required 
information in accordance with Sec. 720.45(a) (1), (2), and (3) because 
the new chemical substance is manufactured using a reactant that has a 
specific chemical identity claimed as confidential by its supplier, the 
notice must contain chemical identity information that is as complete as 
known by the manufacturer. In addition, a letter of support for the 
notice must then be sent to EPA by the chemical supplier of the 
confidential reactant, providing the specific chemical identity of the 
proprietary reactant. The letter of support must reference the 
manufacturer's notice. If the appropriate supporting document from the 
supplier is not received within 30 days after EPA receives the 
manufacturer's notice, the notice will be considered incomplete.
    (4) EPA will review the information submitted by the proposed 
manufacturer or importer under this paragraph to determine whether it 
has a bona fide intent to manufacture or import 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).
    (5) If the proposed manufacturer or importer has shown a bona fide 
intent to manufacture or import the substance, and provide sufficient 
unambiguous chemical identity information so EPA can make a conclusive 
determination of the chemical substance's Inventory status, EPA will 
search the confidential Inventory and inform the proposed manufacturer 
or importer whether the chemical substance is on the confidential 
Inventory.
    (6) If the chemical substance is found on the confidential 
Inventory, EPA will notify the person(s) who originally reported the 
chemical substance that another person has demonstrated a bona fide 
intent to manufacture or import the substance and therefore was told 
that the chemical substance is on the Inventory.
    (7) A disclosure of a confidential chemical identity to a person 
with a bona fide intent to manufacture or import the particular chemical 
substance will not be considered a public disclosure of confidential 
business information under section 14 of the Act.
    (8) EPA will answer an inquiry on whether a particular chemical 
substance is on the confidential Inventory within 30 days after receipt 
of a complete submission under paragraph (b)(2) of this section.
    (9) If the required chemical identity information has not been 
reported correctly or completely in the notice (except as provided under 
paragraph (b)(3)(ii) of this section) or if any other required data or 
information has been omitted or is incomplete, EPA will consider the 
whole notice to be incomplete. As soon as an incomplete notice is 
identified as such by EPA, the Agency will immediately return the notice 
directly to the submitter. The submitter must then resubmit the whole, 
completed bona fide notice to EPA in order to have the Agency perform 
the desired Inventory search and respond to the notice.

[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993; 60 
FR 16309, Mar. 29, 1995]