[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: 40CFR716.35]

[Page 80-81]
 
                   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. 716.35  Submission of lists of studies.

    (a) Except as provided in Secs. 716.5, 716.20, and 716.50, persons 
subject to this rule must send lists of studies to EPA for each of the 
listed substances or listed mixtures (including as a known byproduct) in 
Sec. 716.120 which they are manufacturing, importing, or processing, or 
which they propose to manufacture (including import) or process.
    (1) Ongoing studies. As of the date a person becomes subject to this 
part, a list of ongoing health and safety studies being conducted by or 
initiated for them, noting for each entry: The beginning date of the 
study, the purpose of the study, the types of data to be collected, the 
anticipated date of completion, and the name and address of the 
laboratory conducting the study.
    (2) Initiated studies. After the date a person becomes subject to 
this part, a list of studies initiated by or for them, noting for each 
entry: The beginning date of the study, the purpose of the study, the 
types of data to be collected, the anticipated date of completion, and 
the name and address of the laboratory conducting the study.
    (3) Studies which are known but without possession of copies. As of 
the date a person becomes subject to this part, a list of unpublished 
health and safety studies known to them of which they

[[Page 81]]

do not have copies. The name and address of any person known to them to 
possess a copy of the unpublished study must accompany each entry on the 
list. For purposes of this section only, an unpublished study will be 
considered to be ``known to'' a person, if the study can be discovered 
by a file search in accordance with Sec. 716.25.
    (4) Studies previously sent to Federal agencies without 
confidentiality claims. A list of unpublished studies which have been 
sent to a Federal Agency with no claims of confidentiality. The 
submission must for each study: Identify the study by title, state the 
name and address to whom the study was sent, and the month and year in 
which the study was submitted. Any study identified will be treated as 
if it were submitted under section 8(d) and will be available for public 
disclosure under section 14(b) of TSCA. Persons subject to this 
requirement may submit either a list of unpublished health and safety 
studies previously submitted to any Federal agency without claims of 
confidentiality in accordance with Sec. 716.35(a)(4), or copies of each 
such study in accordance with Sec. 716.30.
    (b) Submission under paragraph (a) of this section must be 
identified either on the face of the study or otherwise by the 
applicable chemical name and CAS number (if any) listed in 
Sec. 716.120(a) (1) and (2), and must be accompanied by a cover letter 
containing the name, job title, address and telephone numbers of the 
submitting official, and the name and address of the manufacturing or 
processing establishment on whose behalf the submission is made.
    (c) Lists of health and safety studies should be submitted, 
preferably by certified mail, 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: 8(d) Health and Safety Reporting Rule (Notification Reporting).

[51 FR 32726, Sept. 15, 1986, as amended at 52 FR 20084, May 29, 1987; 
52 FR 44828, Nov. 20, 1987; 53 FR 12523, Apr. 15, 1988; 53 FR 46746, 
Nov. 18, 1988; 60 FR 34463, July 3, 1995; 63 FR 15774, Apr. 1, 1998]