[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: 40CFR716.20]

[Page 78-79]
 
                   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. 716.20  Studies not subject to the reporting requirements.

    (a) Excluding paragraph (a)(3) of this section, the following types 
of studies are exempt from the copy and list submission requirements of 
Secs. 716.30 and 716.35.
    (1) Studies which have been published in the scientific literature.
    (2) Studies previously submitted to the EPA Office of Pollution 
Prevention and Toxics. These studies are limited to section 8(e) 
submissions, studies submitted during section 4 proceedings, studies 
submitted with premanufacture notices or significant new use notices, 
and studies submitted ``for your information'' (FYI submissions) in 
support of EPA's TSCA Existing Chemicals

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Program. Studies which have been initiated pursuant to a TSCA section 
4(a) test rule, for which the person has submitted a letter of intent to 
conduct testing in accordance with the provisions of Sec. 790.25 of part 
790 of this chapter, are exempt from the list submission requirements of 
Sec. 716.35.
    (3) Except for those studies described in paragraph (a)(2) of this 
section, studies previously submitted to any Federal agency with no 
claims of confidentiality are exempt only from the copy submission 
requirements of Sec. 716.30, and must be listed in accordance with the 
provisions of Sec. 716.35.
    (4) Studies conducted or initiated by or for another person who is 
subject to, and who will report the studies under Secs. 716.30 and 
716.35.
    (5) Studies of chemical substances which are not on the TSCA 
Chemical Substances Inventory. This exemption applies only to those 
substances within categories listed under Sec. 716.120(c).
    (6) The following types of studies when the subject of the study is 
a mixture known to contain a substance or listed mixture listed under 
Sec. 716.120.
    (i) Acute oral toxicity studies.
    (ii) Acute dermal toxicity studies.
    (iii) Acute inhalation toxicity studies.
    (iv) Primary eye irritation studies.
    (v) Primary dermal irritation studies.
    (vi) Dermal sensitization studies.
    (vii) Physical and chemical properties.

If the substance or listed mixture is an impurity, no reporting is 
required (see paragraph (a)(9) of this section).
    (7) Analyzed aggregations of monitoring data based on monitoring 
data acquired more than 5 years preceding the date the substance or 
listed mixture was added to the list under Sec. 716.120.
    (8) Analyzed aggregations of monitoring data on mixtures known to 
contain one or more substances or listed mixtures listed in 
Sec. 716.120, when the monitoring data are not analyzed to determine the 
exposure or concentration levels of the substances or listed mixture 
listed under Sec. 716.120.
    (9) Studies on a substance or listed mixture listed under 
Sec. 716.120 that the person who is reporting has manufactured, 
imported, or processed or proposed to manufacture, import, or process 
only as an impurity. When reporting of such studies is to be required, 
that reporting will be separately proposed in the Federal Register.
    (10) Studies of chemical substances or listed mixtures previously 
submitted by trade associations in accordance with the provisions of 
Sec. 716.30.
    (b) The following types of studies on substances or listed mixtures 
listed under Sec. 716.120 are exempt from the copy and list submission 
requirements of Secs. 716.30 and 716.35.
    (1) For the listed ureaformaldehyde resins (CAS Nos. 9011-05-6 and 
68611-64-3), studies on agronomic plant growth or damage which 
demonstrate only that the resins stimulate plant growth or cause plant 
damage when applied as a fertilizer.
    (2) For the specified chemicals in Sec. 716.120(d) under the 
category ``Siloxanes,'' acute oral, dermal, and inhalation toxicity 
studies and primary eye and dermal irritation studies.
    (3) For the listed chemicals under Sec. 716.120(d) in the category 
``OSHA Chemicals in Need of Dermal Absorption Testing,'' studies on 
ecological effects.
    (4) For the chemicals listed at Sec. 716.120 with a special 
exemption referencing this paragraph, studies on mixtures containing the 
listed substance at levels below 1 percent of the mixture, except when a 
purpose of the study includes the investigation of the effects of the 
listed substance at levels below 1 percent.
    (5) Rulemaking proceedings that add substances and mixtures to 
Sec. 716.120 will specify the types of health and/or environmental 
effects studies that must be reported and will specify the chemical 
grade/purity requirements that must be met or exceeded in individual 
studies. Chemical grade/purity requirements will be specified on a per 
chemical basis or for a category of chemicals for which reporting is 
required.

[51 FR 32726, Sept. 15, 1986, as amended at 58 FR 47649, Sept. 10, 1993; 
58 FR 68315, Dec. 27, 1993; 60 FR 34884, July 5, 1995; 63 FR 15773, Apr. 
1, 1998]

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