U.S. EPA, 1989 TSCA Industry Seminar Questions and Answers (undated) (ELR Order No. AD-510)

• Author: Carolyne R. Hathaway/William K. Rawson/Ann Claassen/Julia A. Hatcher
• Pages: 401-422

1989 TSCA Industry Seminar Questions and Answers Page 401

1989 TSCA Industry Seminar

Questions and Answers

EPA

2/1/90

UNITED S TATES ENV IRONMENTAL PROTEC-

TION AGENCY

WASHINGTON, D.C. 20460

FEB 1 1990

OFFICE OF PESTICIDES AND TOXIC

SUBSTANCES

Gordon Wood

Senior Vice President

Synthetic Organic Chemical Manufacturers Association

1330 Connecticut Avenue, NW

Suite 300

Washington, DC 20036-1702

Dear Mr. Wood:

Enclosed is a set of questions and a nswers that resulted

from a TSCA Industr y Seminar our oce held for

SOCMA in 1989. Cathy Marshal l has asked that we

send these Q’s and A’s to you for distribution to the

attendees of the semina r. If you have any questions

about distribution of the document, pleas e call Kathy

Tyson, Acting Chief of the Strategies Development

Section (382-3580), for assistance.

We consider the annual TSCA semi nars, and the

resulting Q and A docu ments, to be valuable in pro -

viding guida nce to industry. SOCMA was very helpful

to us in planning t he 1989 TSCA Industry Sem inar,

and we look forward to working w ith SOCMA again

in planning the upc oming 1990 TSCA Indust ry Semi-

nar. For your information, Rick Pica rdi, our Industry

Liaison, is expecte d to return from a leave of absence

on February 20.

Sincerely yours,

Charles L. El kins

Director

Oce of Toxic Substances

Enclosure

1989 TSCA Industry Seminar

Questions & Answers

Prepared by: USEPA

Oce of Toxic Substances

TS-799

401 M Street SW

Washington, DC 20460

Introduction

For each of the past severa l annual TSCA industry

seminars, the EPA Oce of Toxic Substances ha s col-

lected questions from those at tending the sem inar.

Answers to thes e questions were prepared by va rious

technical st a and, then, assembled by the Environ-

mental Assista nce Division (formerly the TSCA Assis-

tance Oce).

e Oce of Toxic Substances believes Q & A docu-

ments are an importa nt means of providing g uidance

to industry and have be en encouraging such docu-

ments in many areas. Q & A doc uments exist for the

Comprehensive Assessment Informat ion Rule (CAIR),

Community-Right-to-Know/Title II I, asbestos and

other subjects. Call t he Toxic Substances Control Act

(TSCA) Hotline at (202) 554-1404 for information on

these documents.

Table of Contents

I. Premanuf acture Notificat ion ( PMN) / New

Chemic al Rev iew

II. Signifi cant New Use Rule s (SN UR)

III. PMN TSCA Section 5(e) Consent Order s

IV. PMN Notices of Commenc ement

V. TSCA Invento ry

VI. CFC Substitu tes

VII. TSCA Section 4 Testin g

VIII. C omprehensiv e Ass essment Informat ion R ule

(CAIR)

IX. Commu nity-Right -to-Know / SARA Tit le II I

X. Biote chnology

XI. Expor t Noti fication

XII. Inter national Cooper ation

XIII. Compli ance/Enforc ement

XIV. Genera l

I. Premanufacture Notif‌ication (PMN)/

New Chemical Review

1. It appears that EPA is too d riven by hazard when

what they should be f ocusing on is risk. Since ris k

is a funct ion of hazard and exposure , if either of

these is hig h when the other is low so that the risk i s

minima l, why spend scarce resources on e xpensive

testing or cont rols?

In carry ing out its mandate to protect human health

and the environment, EPA is not driven by haza rd

alone when assessing t he potential ri sk of a new chemi-

cal substanc e. In general, low exposure may mitigate

the Agency’s concern for a high ha zard nding based

on a determination that there wou ld be no unreas on-

able risk to human health or t he environment.

However, TSCA Section 5 authorizes EPA to not only

consider risk but also to regu late based on the potential

Page 402 TSCA Deskbook

for substantial product ion volume and substantia l or

signicant huma n exposure or substantial environmen-

tal releases . Experience has shown that very few Pre-

manufacture Noti cations (PMNs) contain any health

or environmental eects d ata. EPA believes that the

data obtained usin g the exposure-based nding wil l

enable the Agency to bet ter characterize new chemi-

cal substanc es, and supplement and validate the use of

structure-ac tivity analysis in the new chemic als review

process.

2. Will you or a re you considering reinstati ng the

PMN acknowled gement letter? Please!

EPA resumed this serv ice on June 28, 1989. Acknowl-

edgement letters had been di scontinued due to OTS

Fiscal Year 1989 budget constraints.

3. EPA has issued a polic y to no longer notify PMN

submitters of rece ipt of their documents. ese

notications w ere very useful. How ca n such a posi-

tion be taken by E PA in view of 40 CF R 720.65(a)?

“EPA will acknow ledge receipt by sending the sub-

mitter a lette r[hellip]”

EPA resumed this serv ice on June 28, 1989. Acknowl-

edgement letters had been di scontinued due to OTS

Fiscal Year 1989 budget constraints.

4. Isn’t it time to revise t he PMN form? Some of the

questions ca n certainly be bett er worded or revised

and some of the boxes a re obviously too small. e

PMN review sta  must have a wish list. W hy not

work with a soft ware manufactu rer to provide a

exible format on a di skette with a built in word

processor to ma ke the job easier on both the pre-

parer and the r eviewer?

e PMN form may undergo revisions in a nticipa-

tion of the need to renew its cleara nce by the Oce of

Management and Budget du ring 1990. If you have any

comments on revising the form plea se forward those

comments in writing to La rry Culleen, Chief, Preman-

ufacture Notice Ma nagement Branch (TS-794), U.S.

EPA., 401 M Street, S.W., Washington, D.C. 20460.

5. For PMN submissions what t ypes/extent of

toxicology d ata would EPA like to see on a routine

basis?

EPA would like to routinely see a screening prole simi-

lar to the exposure-based core data set for health and

ecotoxicity: Health core testing would include the oral

acute LD50, a 28-day oral subchronic, an Ames assay,

and an in vivo mouse micronucleus assay. e ecotoxicity

screen would include the sh acute LD50, Daphnia acute

EC50, and the algae EC50. In addition, if widespread

human exposure is anticipated, EPA would like to see a

developmental toxicity study conducted in one species.

6. Does your oce wa nt testing data on simi lar

substance s when a company submits a PMN?

Yes, if no data exist on the new chem ical subst ance but

the PMN submitter has data on sim ilar chemicals, the

Agency would encoura ge that the data be submitted

along with notice. A lternatively, EPA encourages sub-

mitters to contact the Age ncy and negoti ate a testing

program for chemical c lasses if the company plans to

submit multiple notices on a chemical series .

7. Can alternative huma n and environmental sa fety

tests be submit ted for the exposure trigg ered test

requested by EPA for new PMN chem icals for valid

scientic rea sons?

Yes. In general however, EPA believes that the core

tests on the PMN substanc e are the preferred testing

and any request for deviat ion must be submitted to

the Agency with t he rationale for that deviation. e

Agency must subsequently approve the dev iation.

8. For a PMN substanc e with recognized low tox-

icity, what does EPA consider as a n insignicant

exposure popul ation? Is there a formula?

EPA’s exposure-based aut hority under Sect ion 5(e) of

TSCA does not require the A gency to consider such

factors as toxicity. However, potential toxicity is alw ays

a factor for the Agency’s risk-based act ions taken under

TSCA Section 5(e). EPA’s criteria for selecting cases f or

exposure-based ac tions was identied in a September

22, 1988 letter from the Director of the Oce of Toxic

Substances to Dr. Gerald ine Cox of the Chemical

Manufacturer s Association. is letter is also ava ilable

through EPA’s TSCA Hotline, (202) 554-1404.

9. Are low volume exemption PMN a mendments

eective on rec eipt or is an EPA response needed?

(We’ve gotten conic ting information from EPA on

this.)

Amendments which wi ll result in a change in site or

use require a submission of a new exemption. Such

submissions are subject to the 21-day review and may

not take eect unti l the review period expires.

10. In line with your conc ern on replacing existin g

chemicals w ith safer ones, why does EPA continue

to question liquid formu lations of existing produc ts

which reduce exp osure and metals in euent a nd

insist on more aquat ic tox data?

PMN submitters are encourage d to provide informa-

tion in their submissions which i ndicate how a new