TSCA §4-Test Rules

• Author: Carolyne R. Hathaway/William K. Rawson/Ann Claassen/Julia A. Hatcher
• Pages: 61-82

Page 61

Chapter VIII:

TSCA §4—Test Rules

A. Overview

TSCA §2 states that it is the policy of t he United

States that “adequate data should be developed

with respect to the eect of chemical substances

and mixtu res on health and the environment

and that the development of such d ata should be

the responsibility of those who manufacture and

those who process such chemical substa nces and

mixtures.”1 TSCA §4 provides EPA with author-

ity to implement this policy by imposing health

and environmental eects testing requirements on

chemical manufac turers and processors.2 Congress

anticipated that this authority to require testing

would play a centra l role in ad ministration of the

new law.3

Over t he rst 20 yea rs u nder TSCA, EPA

made signicant progress in developing testing

programs for existing chemicals under §4. EPA

issued detailed regulations governing development

of test rules, negotiation of enforceable testing

consent a greements, and compliance with testing

requirements under test rules and consent orders.

e A gency also developed regulations governing

laboratory practices, test methodologies, and t he

sharing of test costs for §4 rules. Several thousand

chemicals were screened for possible testing, and

considerable testing was conducted pursuant to test

rules or enforceable consent agreements, or volun-

tarily by industry in response to testing needs iden-

tied by EPA under TSCA.

Nonetheless, concerns were expressed about

the eectiveness of TSCA §4 in stimulating wide-

spread testing of existing chemicals, and also about

1. 15 U.S.C. §2601(b), ELR S. TSCA §2(b).

2. Id. §2603, ELR S. TSCA §4.

3. See H.R. R. N. 94-1679, at 55-56 (1976), reprinted in 1976

U.S.C.C.A.N. 4539, 4540.

the lack of public availability of health eects data

for many large volume commercial chemicals.

Emerging toxicological issues, such a s endocrine

disruption, intensied these concerns, prompt-

ing new EPA testing initiatives under TSCA a nd

related authorities. Since the mid-1990s, EPA has

promulgated relatively few test rules under TSCA

§4, but has expended signicant resources on devel-

opment of voluntary testing initiatives, such as its

HPV Challenge Program, which required chemical

manufacturers to develop and make public screen-

ing level health eects data on chemicals produced

at more than one million pounds per year.

is chapter explains EPA’s statutory authority

to require testing under §4, provides an overview

of EPA regulations governing t he conduct of such

testing and the Agency’s experience implement-

ing its testing authority, and concludes with a brief

summary of signicant voluntary testing initiatives

launched by EPA.

B. Statutory Authority to Require

Testing

TSCA §4 provides EPA with authority to require

testing of any chemical substance or mix ture for

which EPA makes the following ndings, specied

in §4(a):

either

(1)(A) “the manufac ture, distribution i n com-

merce, processi ng, use, or d isposal of a c hemical

substance or mix ture, or that any combination of

such activ ities, may present an unrea sonable risk

of injury to health or the environment” [a §4(a)(1)

(A)(i) nding or “A” nding];4

4. Id. §2603(a)(1)(A)(i), ELR S. TSCA §4(a)(1)(A)(i).

Page 62 TSCA Deskbook

or

(1)(B) “a chemical subst ance or mixture is or wi ll

be produce d in subs tantial quantitie s, and (I) it

enters or may reasonably be anticipated to enter

the environment i n substantia l quantitie s or

(II) there is or may be signicant or substantial

human exposure to such substance or mix ture” [a

§4(a)(1)(B)(i) nding or “B” nding ].5

and both

(2) “there are insucient data a nd experience

upon which the eec ts of the manufacture, dis-

tribution in c ommerce, proces sing, use , or dis-

posal of such substanc e or mixture or of any

combination of such activities on hea lth or the

environment can rea sonably be determined or

predicted,”6

and

(3) “testing of such substance or m ixture with

respect to such eects is necessary to develop such

data.”7

In the ca se of a mixture, EPA must make an

additional nding that the eects the mixture

may have on hea lth or the environment may not

be reasonably and more eciently determined or

predicted by testing the chemical substances that

form the mixture.8

When EPA has made the required ndings for

a chemical substance or mi xture, EPA “shall by

rule require t hat testing be conducted.”9 EPA has

authority, however, to require testing only with

respect to health and environmental e ects for

which there is an insuciency of data and experi-

ence, and only to the extent that the data are rel-

evant to a determination that the manufacture,

distribution in commerce, processing, use, or dis-

posal of the test substance or mixture does or does

not present an unreasonable risk of injury to health

or the environment.10

1. The “May Present an Unreasonable Risk”

Finding

e term “unreasonable risk ” is not dened in the

statute. Nor does the statute specify t he amount of

5. Id. §2603(a)(1)(B)(i), ELR S. TSCA §4(a)(1)(B)(i).

6. Id. §2603(a)(1)(A)(ii), (B)(ii), ELR S. TSCA §4(a)(1)(A)(ii),

(B)(ii).

7. Id. §2603(a)(1)(A)(iii), (B)(iii), ELR S. TSCA §4(a)(1)(A)

(iii), (B)(iii).

8. Id. §2603(a)(2), ELR S. TSCA §4(a)(2).

9. Id.

10. Id.

evidence needed to support a nding that a chemi-

cal “may present” such an unreasonable risk. e

legislative history also provides little guidance on

these points, although the House Report did state

that regulatory “costs a re not to be incurred unless

they are oset by benets of at least the same

magnitude.”11

EPA explained its approach to mak ing ndings

under §4(a)(1)(A)(i) in its earliest testing propos-

als.12 e Agency divided the statutory language

into three parts: (1) may present a hazard; (2) may

present a risk; and (3) may present an unreason-

able risk.13 e following summarizes the Agency’s

approach to each aspect of the nding.

May present a hazard. EPA identied several fac-

tors relevant to an evaluation of potential health

hazards of a substance, including physica l and

chemical properties; structural similarity to chemi-

cals with known adverse eects; resu lts from pre-

vious testing of the compound, even if equivocal

or unreliable; and anecdotal and clinical reports

of injury. EPA stated that a determination that a

chemical may present a hazard would not be based

on denitive scientic data, but of necessity would

involve reasonable scientic assumptions, ext rapo-

lations, and interpolations.14

May present a risk. EPA uses the term “risk ”

to include both hazard and exposu re potential.

Because toxicity is of little concern if there is no

human exposure to the chemical, EPA explained

that it would look at both toxicity and exposure

in determining whether to test chemicals. EPA

explained further that the more severe the poten-

tial hazard, the less exposure potential the A gency

would consider necessary to support a test rule.

e Agency also indicated that it did not consider

evidence of actual human exposure necessary to

support a nding under §4(a)(1)(A)(i). Rather, EPA

stated, it is sucient to show that there is a rea-

sonable likelihood that exposure may arise because

of activities associated with the ma nufacturing,

processing, distribution, use, or disposal of the

chemical.15

11. See H.R. R. N. 94-1341, at 13 (1976), reprinted in 1976

U.S.C.C.A.N. 4491, 4503.

12. See Dichloromethane, Nitrobenzene, and 1,1,1-Trichloroeth-

ane, Proposed Test Rule, 46 Fed. Reg. 30300 ( June 5, 1981);

Chloromethane and Chlorinated Benzenes Proposed Test Rule,

Amendments to Proposed Health Eects Standards, 45 Fed. Reg.

48524 (July 18, 1980).

13. See 45 Fed. Reg. at 48524.

14. Id.

15. Id.