Regulation of Chemical Substances Under TSCA §5(e) Consent Orders

• Author: Carolyne R. Hathaway/William K. Rawson/Ann Claassen/Julia A. Hatcher
• Pages: 49-53

Page 49

Chapter VI:

Regulation of Chemical Substances

Under TSCA §5(e) Consent Orders

A. Statutory Criteria

Under §5(e) of TSCA, EPA may issue a proposed

order prohibiting or limiting the manufacture, pro-

cessing, dist ribution in commerce, use, or disposal

of a new chemical substance that may present an

unreasonable risk to health or the environment.1

To regulate a chemical under §5(e), EPA must

determine (1) that the available information is

insucient to permit a reasoned eva luation of the

substance’s health a nd environmental eects; and

(2) either that in the absence of such information,

the manufacturing, processing, distribution, use,

or disposal of the substance may present an unrea-

sonable risk of injury to health or the environment

(referred to as a “risk-based” nding), or that the

substance will be produced in substantial quanti-

ties and may reasonably be expected to enter the

environment in substantial quantities or result in

signicant or substantial human exposure (referred

to as an “exposure-based”  nding).2

B. Application of Statutory Criteria

EPA has established guidelines and criteria to

facilitate implementation of the §5(e) statutory cri-

teria. ese guidelines identify chemical c ategories

of concern; summarize the bases for an exposure-

based nding; a nd evaluate persistent, bioaccumu-

lative, and toxic (PBT) chemicals.

1. Categories of Concern

To facilitate its “risk-based” review of chemicals

that may be subject to an order or other limitations

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

2. Id. §2604(e)(1)(A), ELR S. TSCA §5(e)(1)(A).

under TSCA §5(e)(1)(A)(ii)(I),3 EPA has identied

55 chemical categories considered of concern due to

their human health eects, ecotoxicity, or environ-

mental fate.4 ese include general chemical cat-

egories such as phenols, acid dyes, and esters.5 For

each of the identied categories, EPA has dened

the category and summariz ed the hazard concerns,

boundaries, and recommended testing strategies

based on avai lable data and SAR.6 According to

EPA, the c ategories of concern do not represent

a comprehensive list of a ll chemicals that may be

subject to further action in the New Chemicals

Program, but are intended to serve as a guide for

PMN submitters.7

2. Exposure-Based Findings

EPA has also developed guidelines to identify PMN

substances that meet the exposure-based nding of

3. Id. §2604(e)(1)(A)(ii)(I), ELR S. TSCA §5(e)(1)(A)(ii)(I).

4. U.S. EPA, TSCA N C P (NCP) C-

 C (2002), available at http://www.epa.gov/oppt/

newchems/pubs/cat02.pdf.

5. EPA identied the following chemical categories of concern: Acid

Chlorides; Acid Dyes and Amphoteric Dyes; Acrylamides; Acry-

lates/Methacrylates; Aliphatic Amines; Alkoxysilanes; Aluminum

Compounds; Aminobenzo thiazole Azo Dyes; Anhydrides;

Carboxylic Acid; Anilines, Dianilines; Anionic Surfactants;

Azides; Benzotriazoles; Benzotriazole-hindered phenols; Boron

Compounds; Cationic Dyes; Cationic (quaternary ammonium)

Surfactants; Cobalt; Dia zoniums; Dichlorobenzidine-based

Pigments; Dithiocarbamates; Epoxides; Esters; Ethylene Gly-

col Ethers; Hydrazines and Related Compounds; Hindered

Amines; Imides; Diisocyanates; B-Naphthylamines, Sulfonated;

Lanthanides or Rare Earth Metals; Neutral Organics; Nickel

Compounds; Nonionic Surfactants; Organotins; Peroxides; PBT

chemicals; Phenolphthaleins; Phenols; Phosphates, Inorganic;

Phosphinate Esters; Polyanionic Polymers (& Monomers);

Polycationic Polymers; Polynitroaromatics; Stilbene, Respirable,

Poorly Soluble Particulates; Rosin; Stilbene, Derivatives of 4,4-

bis (triazin-2-ylamino); iols; Substituted Triazines; Triaryl-

methane Pigments/Dyes with Non-Solubilizing Groups; Vinyl

Esters; Vinyl Sulfones; Soluble Complexes of Zinc; Zirconium

Compounds. Id.

6. Id.

7. Id.