U.S. EPA, Office of Toxic Substances Existing Chemicals Program, Question and Answer Summary, EPA Seminar on Industry Obligations Under TSCA (May 5, 1987) (ELR Order No. AD-484)

• Author: Carolyne R. Hathaway/William K. Rawson/Ann Claassen/Julia A. Hatcher
• Pages: 607-613

Q&A Summary From EPA Seminar on Industry Obligations Under TSCA (May 5, 1987) Page 607

Question and Answer Summary From

EPA Seminar on Industry Obligations

Under TSCA (May 5, 1987)

EPA

undated

QUESTION A ND ANSWER SUM MARY EPA

SEMINA R ON INDUSTRY OBLIGATIONS

UNDER TSC A (MAY 5, 1987) OTS EXISTI NG

CHEMICA LS PROGRAM

I. CAIR

Q.1. At the Industry mee ting, a speaker stat ed

that the comment s received on the proposed CAI R

would be reviewed a fter the nal ru le is promul-

gated. Doesn’t thi s negate the extensive comment s

received?

A.1. e speaker actual ly said that the comments on

CAIR were bein g studied and serious consideration

would be given to them in preparin g the nal rule.

II. Chemical Testing

Q.2. What is E PA doing to prevent or lim it the

“unnecessa ry and cruel” use of a nimals in toxicity

testing prog rams?

A.2 EPA only requires testin g in cases that meet two

criteria: (1) existing data are ina dequate; and (2) test-

ing is necessar y to obtain the data. We do not use

direct anim al testing for all chemicals; we a lso use

other methods to evaluate a c hemical’s toxicity where

feasible. For example, the Age ncy uses a t ype of com-

puter modeling that employs data from chem icals that

are structu rally-related to certain classes of c hemicals

being investigated .

Computer modeling or computer simulation provides

a way to use all the dat a available on previous animal

tests. However, testing may sti ll be required to obtain

information not previously known a nd necessary for

evaluation of chemica l toxicity. Whenever possible,

EPA uses in vitro assays before requ iring whole animal

studies. Nevert heless, many e ects require the whole

organism to be stud ied.

EPA rmly supports the development of alternatives

to the use of anima ls in toxicity evaluation. Many of

these methods are s till in the early stages of develop-

ment. EPA has a research eort under way to develop

and validate a lternative test met hods that u se fewer

animals. e A gency is working on alternative tests for

mutagenicity, developmental and reproductive toxic-

ity, neurotoxicity, and dosimetry. ese tests could

reduce both the numbers of ani mals, as well as the

cost of toxicity testing a nd other research. e Oce

of Pesticides and Toxic Substances already u ses several

alternative test method s and will continue to incorpo-

rate new ones as they bec ome accepted by the scienti c

community.

Q.3. What did you mea n by a special consideration

for “chemicals found i n the Great Lakes” in ref er-

ence to the Expo sure Based Test Rule?

A.3. In evaluati ng candidates for its rst test rule bas ed

on environmental monitoring data to obta in data to

identify human hea lth and environmental hazards of

substances with k nown human or environmental expo-

sure, one of the principal groups of chemica ls EPA has

considered is a list of chemica ls reported to be found in

the Great Lakes. One or more of the Great L akes list

chemicals may be in t he rst environmental monitor-

ing based rule.

Q.4. Why are chem icals that have been produced or

imported for yea rs without any problems on the list

of 73 OSW chemica ls? Sodium Sacchar in is such a

chemical. W hy is it being tested for hydrolysi s?

A.4. In the example you cited, Sacc harin has been

listed as a carci nogen by the EPA Carcinogen A ssess-

ment Group (CAG) and other reviewers. e original

OSW hazardous w aste lists were compiled by com-

bining many list s (CAG, CWA “priority pollutants,”

RTECS, etc). All chemica ls listed in Appendix VIII of

40 CFR Part 261 are being looked at for “relisting”; the

same data set is needed for a ll chemicals. e data will

be used in the fate and t ransport model to determine

new “concentration-based” lis tings.

Q.5. What is the biodeg radation test that is bei ng

required of the 73 OS W Chemicals?

A.5. e proposed biodegradation procedure would

generate microbiological tra nsformation rate data for

organic chemica ls in saturated subsurface materia ls.

e data will be u sed as part of a chemical trans-

port and fate model for asse ssing the fate of organic

chemicals leach ing into ground water from waste

management facil ities. e anaerobic tra nsformation

of chemicals in selec ted subsurface samples will be

estimated from subsur face microcosm studies using

methods recently reported by Wi lson et al. (198 6). e

procedures will be u sed to determine the length of the

adaptation period before detect able degradation can be

observed and the ha lf-life of the compound following

the adaptation period. Supporti ng laboratory methods

will be applied to the mea surement of residual test

chemicals, level s of persistent intermediate s, biomass,

and other physical-chemic al parameters. A minimum

of six subsurface sa mpling sites will be identied on

the basis of two temperat ures and three pH values.