U.S. EPA, Draft Criteria Statement (A Working Paper) on Exclusion Provisions in §§710.4(d)(7) and 720.30(h)(7) (July 6, 1992) (ELR Order No. AD-474)

AuthorCarolyne R. Hathaway/William K. Rawson/Ann Claassen/Julia A. Hatcher
Pages531-531
Draft Criteria Statement on Exclusion Provisions in TSCA §§710.4(d)(7) and 720.30(h)(7) Page 531
Draft Criteria Statement (A Working
Paper) on Exclusion Provisions in
TSCA §§710.4(d)(7) and 720.30(h)(7)
EPA
7/6/92
Criteria Statement (A Working Paper)
Section 710.4(d)(7) of the Inventory Reporti ng Rule
and Section 720.30(h)(7) of the PMN Rule exclude
from the reporting requi rements certa in chemical
substances th at may form from chemical reactions that
involve other substances use d in manufacturing and
processing operations. Such subs tances are frequently
used to improve the conditions under which spec ic
chemical substa nces are manufactured, or to ensure
the optimal perform ance of a commercial product.
e basic principles governing the a forementioned
exclusion provisions can be found in t he introductory
paragraph of 40 CFR 710.4(d) which states:
“[hellip] Although they a re considered to be
manufacture d or processed for a commercia l
purpose [hellip], they are not manu factured or
processed for distr ibution in commerce as chem-
ical substanc es per se and have no commercial
purpose separate f rom the substance , mixture, or
article of which the y may be a part.”
e same basic principles can a lso be found in the
introductory parag raph of 720.30(h) of the PMN
Rule.
ese principles establish t he basis which determines
whether a chemical subst ance is reportable under
the Inventory Reporting Ru le or the PMN Rule. An
excluded substance must not be ma nufactu red or
processed for distr ibution in commerce as a chemic al
substance per se, and must h ave no commercial pur-
pose separate from the subst ance, mixture, article, or
formulation of which it may be a part. ere fore, in
determining whet her a certai n chemical substance is
excluded under the provisions of 40 CFR 710.7(d)(7)
or 720.30(h)(7), one must consider whether that sub-
stance ful ly satises these criteria.
While he term “chemical sub stance” is dened in the
Act and in the Inventory and PMN reg ulations, a
chemical substa nce per se is not specically dened.
EPA interprets this term to mean a subst ance that is
manufacture d for its own sake, i.e., the subs tance itself
is intended to provide the primary proper ties that
determine the commercia l use of the product or prod-
uct mixture of wh ich it is a part. Fur thermore, such a
substance ca n function independently as a commercial
product.
Whether a substa nce is formed from an incidenta l or
an intended reaction is not a factor th at determines
the reportability of t hat substance. In fact, many sub-
stances excluded under t he provisions of 710.4(d)(7)
or 720.30(h)(7) are actually ma nufactured from an
intended reaction.
For the purpose of 40 CFR 710.4(d)(7) and 40 CFR
720.30(h)(7), an excluded substance is one that meet s
the following conditions:
1. e substance is formed from a chem ical reac-
tion that involves the use of a substa nce of the
type describe d under 40 CFR 710.4(d)(7) or 40
CFR 720.30(h)(7);
2. e substance does not fu nction to provide the
primary propert ies that determ ine the use of
the product or product mixture d istributed in
commerce, even though it may impa rt certain
physicochemical cha racteristics to the product
or product mixture of which it is a pa rt; and
3. e substance is not itself t he one intended for
distribution in commerce. A lthough it may be
a component of the product mixture or for-
mulation actual ly distributed in commerce, it
has no commercial pur pose separate from the
product mixture or formulat ion of which it is a
component.
In certain c ases, the primary funct ion of the substance
distributed in commerce is provide d by its immediate
precursor, and the reaction that form s the substance
is intended solely to impart cert ain physicochemical
properties to the product or product mix ture rather
than to produce the substa nce itself. In such cases, the
substance is not considered to be ma nufactu red or pro-
cessed for distr ibution in commerce as a chem ical sub-
stance per se, even if it is t he product or the principal
component of the product mixture or formulat ion dis-
tributed in commerce. e immed iate precursor that
actually provide s the primary function is considered
to be distributed in commerce a s a chemical substance
per se.

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