[Code of Federal Regulations]
[Title 40, Volume 29]
[Revised as of July 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR717.3]

[Page 113-114]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 717_RECORDS AND REPORTS OF ALLEGATIONS THAT CHEMICAL SUBSTANCES CAUSE 
SIGNIFICANT ADVERSE REACTIONS TO HEALTH OR THE ENVIRONMENT--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 717.3  Definitions.

    The definitions set forth in section 3 of TSCA and the following 
definitions apply to this part:
    (a) Allegation means a statement, made without formal proof or 
regard for evidence, that a chemical substance or mixture has caused a 
significant adverse reaction to health or the environment.
    (b) Firm or company means any person, that is subject to this part, 
as defined in Sec. 717.5.

[[Page 114]]

    (c)(1) Known human effects means a commonly recognized human health 
effect of a particular substance or mixture as described either in:
    (i) Scientific articles or publications abstracted in standard 
reference sources.
    (ii) The firm's product labeling or material safety data sheets 
(MSDS).
    (2) However, an effect is not a ``known human effect'' if it:
    (i) Was a significantly more severe toxic effect than previously 
described.
    (ii) Was a manifestation of a toxic effect after a significantly 
shorter exposure period or lower exposure level than described.
    (iii) Was a manifestation of a toxic effect by an exposure route 
different from that described.
    (d) Manufacture or process means to manufacture or process for 
commercial purposes.
    (e)(1) Manufacture for commercial purposes means to import, produce, 
or manufacture with the purpose of obtaining an immediate or eventual 
commercial advantage for the manufacturer, and includes, among other 
things, such ``manufacture'' of any amount of a chemical substance or 
mixture:
    (i) For distribution in commerce, including for test marketing.
    (ii) For use by the manufacturer, including use for product research 
and development, or as an intermediate.
    (2) Manufacture for commercial purposes also applies to substances 
that are produced coincidentally during the manufacture, processing, 
use, or disposal of another substance or mixture, including both 
byproducts that are separated from that other substances or mixture and 
impurities that remain in that substance or mixture. Such byproducts and 
impurities may, or may not, in themselves have commercial value. They 
are nonetheless produced for the purpose of obtaining a commercial 
advantage since they are part of the manufacture of a chemical product 
for a commercial purpose.
    (f) Person includes any individual, firm, company, corporation, 
joint venture, partnership, sole proprietorship, association, or any 
other business entity, any State or political subdivision thereof, and 
any department, agency, or instrumentally of the Federal Government.
    (g) Process for commercial purposes means the preparation of a 
chemical substance or mixture, after its manufacture, for distribution 
in commerce with the purpose of obtaining an immediate or eventual 
commercial advantage for the processor. Processing of any amount of a 
chemical substance or mixture is included. If a chemical substance or 
mixture containing impurities is processed for commercial purposes, then 
those impurities are also processed for commercial purposes.
    (h) Retailer means a person who distributes in commerce a chemical 
substance, mixture, or article to ultimate purchasers who are not 
commercial entities.
    (i) Significant adverse reactions are reactions that may indicate a 
substantial impairment of normal activities, or long-lasting or 
irreversible damage to health or the environment.
    (j) Site means a contiguous property unit. Property divided only by 
a public right-of-way is considered one site. There may be multiple 
manufacturing, processing, or distribution activities occurring within a 
single site.
    (k) Substance means a chemical substance or mixture unless otherwise 
indicated.