TSCA §5-Premanufacture and Significant New Use Notification

• Author: Carolyne R. Hathaway/William K. Rawson/Ann Claassen/Julia A. Hatcher
• Pages: 21-33

Page 21

Chapter IV:

TSCA §5—Premanufacture and

Significant New Use Notification

A. Statutory Notice Requirements

TSCA §5(a) prohibits the manufacture of a “new

chemical substance” or the manufacture or pro-

cessing of an existing chemical substance for a “sig-

nicant new use” unless a PMN or signicant new

use notice (SNUN) is submitted to EPA at least

90 days before the commencement of such manu-

facture or processing.1 During the 90-day review

period, EPA evaluates t he new chemica l substance

or use to determine whether limitations, restric-

tions, testing requirements, or other actions are

necessary to protect against an unreasonable risk of

injury to health or the environment.

1. Def‌inition of New Chemical Substance

and Signif‌icant New Use

A substance is a “new chemical substance” subject

to the notication requirements of TSCA §5(a)

if it is not included in the Inventory of chemical

substances compiled and ma intained by EPA pur-

suant to TSCA §8(b).2 us, whenever a chemical

does not appear on either the public or the con-

dential TSCA Inventories, it must be treated as a

new chemical substance that cannot be ma nufac-

tured, processed, or distributed in commerce until

a PMN has been led.

Similarly, manufacturers or processors of exist-

ing chemical substances must notify EPA before

undertaking any “signicant new uses” of those

substances. e signicant new use requirements

apply to a limited universe of EPA-designated uses

of existing chemicals. Specically, use of an Inven-

tory-listed chemical is not a “signicant new use”

unless EPA promulgates a regulation that identies

1. 15 U.S.C. §2604(a), ELR S. TSCA §5(a).

2. Id. §2602(9), ELR S. TSCA §3(9).

with specicity such uses for a particular chemical

substance or category of chemical substances.3 In

identifying signicant new uses, EPA must con-

sider “all releva nt factors,” including the projected

volume of the substance that will be manufac-

tured or processed for t he new use, the extent to

which the new use w ill cha nge or increa se human

and environmental exposure to the substa nce, and

the anticipated manner and methods of manu-

facturing, processing, distributing, and disposing

of the substance for the new use.4 Substances to

which signicant new use rules (SNURs) apply are

identied on t he TSCA Inventory and in detailed

regulations.5

2. Content of Notice

TSCA §5(d)(1) species the information and data

that must be included in the PMN or SNUN

submitted pursuant to §5(a).6 is information

includes, to the extent ascertainable, the chemical

identity and structure of the substance, the catego-

ries of use, estimates of the amount ma nufactured

or processed for each categor y of use, a nticipated

byproducts, estimated employee exposure, and

expected method of disposal.7 In addition, avail-

able test data on the health or environmental

eects of the chemical substance must be submit-

ted or described.8

3. Id. §2604(a)(1)(B), (a)(2), ELR S. TSCA §5(a)(1)(B), (a)(2).

4. Id. §2604(a)(2), ELR S. TSCA §5(a)(2).

5. See Signicant New Uses for Specic Chemical Substances, 40

C.F.R. pt. 721, subpt. E.

6. See 15 U.S.C. §2604(d)(1), ELR S. TSCA §5(d)(1). is

section incorporates most of the information requirements

described in id. §2607(a)(2), ELR S. TSCA §8(a)(2).

7. Id. §2607(a)(2), ELR S. TSCA §8(a)(2).

8. Id. §2604(d)(1)(B)-(C), ELR S. TSCA §5(d)(1)(B)-(C).