Exemptions From TSCA §5 PMN Requirements

• Author: Carolyne R. Hathaway/William K. Rawson/Ann Claassen/Julia A. Hatcher
• Pages: 35-48

Page 35

Chapter V:

Exemptions From TSCA §5 PMN Requirements

A. Statutory Provisions

TSCA §5(h) authorizes a number of exemptions

from all or part of the PMN and SNU N require-

ments of TSCA §5.1 ese statutory exemptions

include specic exemptions for substances manu-

factured or processed only in small quantities solely

for R&D,2 substances manufactured or processed

for test marketing purposes,3 and intermediates

“which exist[] temporarily a s a result of a chemical

reaction in the manufacturing or processing of a

mixture or another chemical substance, and . . . to

which there is no, and will not be, human or envi-

ronmental exposure.”4

In addition, TSCA §5(h)(4) authorizes EPA to

promulgate rules exempting other new chemical

substances from all or part of the PMN require-

ments if the Agency determines that the sub-

stances’ manufacture, processing, distribution, use,

or disposa l “will not present an unreasonable risk

of injury to hea lth or the environment.”5 Pursuant

to this authority, EPA has promulgated ru les sub-

jecting to limited review or exempting entirely a

number of categories of substances, including cer-

tain polymers,6 substances produced in quantities

of less than 10,000 kg per year,7 and a number of

other substances including impurities and byprod-

ucts with “no commercial purpose separate from

the substance, mixture, or article of which they are

a part.”8

Finally, §12(a) exempts from many of the require-

ments of TSCA, including the PMN requirements

1. 15 U.S.C. §2604(h), ELR S. TSCA §5(h).

2. Id. §2604(h)(3), ELR S. TSCA §5(h)(3).

3. Id. §2604(h)(1), ELR S. TSCA §5(h)(1).

4. Id. §2604(h)(5), ELR S. TSCA §5(h)(5).

5. Id. §2604(h)(4), ELR S. TSCA §5(h)(4).

6. See 40 C.F.R. §723.250.

7. See id. §723.50.

8. See id. §720.30(h).

of §5, substances manufactured, processed, or dis-

tributed solely for export from the United States.9

e following sections address the scope and appli-

cation of the various PMN exemptions.

B. R&D Exemption

TSCA §5(h)(3) exempts f rom PMN requirements

those chemical substances manufactured or pro-

cessed only in small quantities solely for scientic

experimentation, research, or a nalysis on that sub-

stance or another substance, including for purposes

of product development.10

Unlike the test marketing, low volume, and

polymer exemptions discussed below, the R&D

exemption does not require the submission of an

exemption notice or application to EPA. EPA regu-

lations establish the scope, conditions, and limita-

tions of the R&D exemption.11

1. Def‌inition of R&D Activities

R&D activities a re those underta ken solely for

purposes of scientic experimentation, research, or

analysis. ey may include evaluation of the physi-

cal, chemical, production, and performance cha r-

acteristics of a new or existing substance to develop

a new commercial product. Examples of R&D

activities include the following: synthesis of a new

chemical; analysis of physical or chemica l prop-

9. 15 U.S.C. §2611(a), ELR S. TSCA §12(a). e §12(a) export

exemption does not apply to the requirements of §8, and EPA

may also require testing of export-only substances pursuant to

§4. See id. EPA has conrmed that under TSCA §12(a), persons

who manufacture a chemical on the TSCA Inventory solely for

purposes of export are subject to all requirements of the Inven-

tory Update Rule promulgated pursuant to TSCA §8(b). Partial

Updating of the TSCA Inventory Data Base, 59 Fed. Reg. 30652,

30653 (June 14, 1994).

10. 15 U.S.C. §2604(h)(3), ELR S. TSCA §5(h)(3).

11. See 40 C.F.R. §720.36.