U.S. EPA, New Chemicals Exposure-Based Environmental Fate Testing Program (1992) (ELR Order No. AD-4006)

• Author: Carolyne R. Hathaway/William K. Rawson/Ann Claassen/Julia A. Hatcher
• Pages: 541-544

New Chemicals Exposure-Based Environmental Fate Testing Program Page 541

New Chemicals Exposure-Based

Environmental Fate Testing Program

EPA

1/92

New Chemical s Exposure-Based Envi ronmental

Fate Testing Program

I. Overview

Section 5(e) of the Toxic Substa nces Control Act

(“TSCA”) requires the Environmenta l Protection

Agency (“EPA” or “the Agency”) to review new chemi-

cal substanc es and authorizes the Agency to regu late

these substance s based on either the potential risk of

the chemical to huma n health or the environment or

the potential for substant ial production and signicant

or substantial huma n exposure or substantial envi-

ronmental release. Prior to 1988, EPA predominantly

issued 5(e) orders based on a nding under TSCA

section 5(e)(1)(A)(ii)(I) that the substance may pres-

ent an unreasonable risk of i njury to hea lth or the

environment. is approach uses t he potentia l risk of

new chemical subst ances, identied through the use

of structure-ac tivity relationships and test data on the

new chemical subst ance, as the basis for identifying

new chemical subst ances for potential regulation under

section 5(e). Administrative Orders issued usi ng this

approach typical ly include human health protection

and/or environmental release c ontrols, and requi re

the submission of toxicity testin g to address concerns

raised by EPA technica l reviewers.

In February 1988, the Oce of Pollution Prevention

and Toxics (“OPPT,” formerly the Oce of Toxic

Substances) implemented an exposu re-based?? review

for certain new c hemica l substances based on a nding

under TSCA section 5(e)(1)(A)(ii)(II) that the sub-

stance may be produced in subs tantial quantities, that

there may be signica nt or substa ntia l huma n expo-

sure, or that such substa nce may enter the environ-

ment in substantial qua ntities. Sinc e that time, OPPT

routinely uses one or both (“risk-based” or “exposure -

based”) of its sect ion 5(e) authorities to select new

chemical substa nces for regulation and testing.

OPPT has developed internal g uidelines to assist in

identifying ne w chemical substances, received as pre-

manufacture notic es (“PMNs”), which would meet t he

“exposure-based ” nding. For this purpose, general

guidance for ma king routine judgements regard-

ing substantia l production, signi cant or substantial

human exposure, a nd substantial environmental

release have been prepared.  is approach includes

core testing program s which are considered for chemi-

cals meetin g these levels (see Appendix A for guidelines

and “core” testing recommendation). ese test ing rec-

ommendations, however, have typical ly only addressed

concerns for potential huma n healt h eects and toxic-

ity to aquatic organism s.

OPPT intends to add environmental fate tes ting rec-

ommendations to this “exposure -based ” regulatory

approach in order to obtain more information on the

relevant behavior of new chemica l substances in the

environment. OPPT sta members have de veloped a

strategy for recommend ing environmental fate testing

based on predicted annua l production volume, water

solubility (measured or esti mated), and expo sure-based

criterion met. e environmental fate stud ies requested

would be based on the par ticular environmental

medium to be exposed.

II. Objectives of this New Approach

One objective of this exposure -based fate testing

approach is to obtain more test data on t he environ-

mental fate of new chemica l substances submitted for

Agency review. Exper ience duri ng the past 13 years of

the New Chemicals Prog ram has shown that PMNs do

not always include test data , particularly data on envi-

ronmental fate. Test data obtained th rough t his new

approach would improve environmental fate est imates

for a broader class of new chemica l substances.

Secondly, data developed would aid OPPT in its ex po-

sure assessments. In t urn, more accurate environmental

exposure estim ates would improve the Agency’s risk

assessments for new chemic al substances, thereby

enhancing EPA’s risk management decisions.

Historically, the New Chemica ls Program has encour-

aged PMN submitters to develop proces ses and tech-

nologies which reduce or prevent releases of chem ical

substances to the envi ronment. Simil arly, an importa nt

goal of this new approach i s to encoura ge PMN sub-

mitters to investigate pos sible pollution prevention

strategies that c ould be employed th roughout the

PMN chemical’s life-c ycle to reduce releases to the

environment. However, the following considerations

should be stressed:

1. e criteria outlined below are mea nt to be

exible; OPPT may elect to chan ge these levels

(“triggers”) at a later date; and

2. EPA has not determined that relea ses to the

environment in quantities below thes e levels

are either “safe” or “acceptable.” Rather, EPA

continues to advocate that a ll chemical releases

be reduced to the max imum extent possible.