United States

Environmental Protection Agency

Pollution Prevention and

Toxics (7407)

Fall 1998

EPA 747-N-98-001

CHEMICAL

TESTING

News and Information

Chemicals in Our Community

Welcome to Chemicals

in Our Community

Lynn R. Goldman, M.D.

Assistant Administrator for Pollution Prevention,

 Pesticides & Toxic Substances

At EPA we believe that giving people information on the chemicals to which

they are exposed is the right thing to do and the smart way to reduce pollution.

We know industrial facilities emit chemicals. But so does the local dry cleaner.

And we are exposed to chemicals used in our schools, grocery stores — and

homes. Chemicals are in thousands of consumer products we use every day, such

as household cleaners — even children’s toys. Every citizen has a right and need

to know the chemicals that are transported, stored, released and used in their

communities. Citizens now have some of that information, but they need more.

Citizens need information on chemicals’ toxicity and safe exposure levels, on

how the chemicals act in the environment: Do they persist? Do they accumulate

in our bodies? In other words, what are the risks?

Armed with this information, citizens could better decide for themselves

which household products to buy, whether to allow their children to play in the

school yard, or swim in a nearby lake or stream. They would be better able to

persuade owners of a small local business or a giant multi-national corporation to

switch to safer chemicals or reduce chemical use. Armed with good information

on chemicals in their communities, citizens could simply better protect themselves and their children and create a safer world.

(continued on page 2)
2 Chemicals in Our Community

(continued from page 1)

The Toxics Release Inventory and

other chemical right-to-know initiatives are

making this vision a reality. Since TRI

reporting began in 1988, industries required

to report reduced their emissions by almost

half, despite enormous growth in our

economy. And we have seen an explosion

in the public’s demand for information on

chemicals in their communities. Public

access to existing web sites with right-toknow information now averages over a

million “hits” or “visits” a day.

We are working hard to get all the

information citizens need to make decisions

to protect their health. This first issue of

Chemicals in Our Community focuses on an

important chemical right-to-know problem: a

complete lack of publicly available basic

toxicity data for 43 percent of the most

widely produced industrial chemicals, and

incomplete data for almost all the others. Not

knowing if many of the thousands of chemicals to which we are exposed are toxic means

that we cannot assess the health and environmental risks.

On the eve of Earth Day, Vice President

Gore once again championed citizens rightto-know by announcing that EPA was

challenging the chemical industry to provide

health and ecological testing data for 3,000

of the most widely used chemicals in this

country. EPA will issue a follow-up rule to

require industry to fill in any gaps. And for

the first time we will require TRI reporting

about persistent chemicals that are toxic at

very low levels and that build up in animal

and human tissue and breast milk. We will

direct special attention to those chemicals

that children are most likely to encounter.

EPA is committed to taking direct

actions to protect public health and the

environment from industrial chemicals, as

well as enabling citizens to better protect

themselves from these potential threats. In

the months and years ahead, we hope

Chemicals in Our Community will help you

to learn more about these efforts.

Welcome to Chemicals in

Our Community

EPA is

committed to

taking direct

actions to

protect public

health and the

environment

from industrial

chemicals,

as well as

enabling

citizens to

better protect

themselves

from these

potential

threats.

In This Issue

Chemicals in Our Community is published

by EPAs Office of Pollution Prevention &

Toxics (OPPT) to increase public awareness

of and access to news and information on

toxic chemicals and pollution prevention

available through OPPT. This resource is

also available on the Internet at: http://

www.epa.gov/opptintr/opptpub.htm.

Mailing address:

Chemicals in Our Community

US EPA (7407)

Office of Pollution Prevention & Toxics

401 M Street, SW

Washington, DC 20460

Advisory Board:

IAB Project Manager: Georgianne McDonald

EAD Project Manager: Mary Wigginton

Publisher: Marla Hendriksson

Senior Editors: Georgianne McDonald,

 Diane Sheridan, and Mary Wigginton

OPPT Divisional Representatives:

 Dan Fort (EETD), Odelia Funke (IMD),

 Patricia Grim (OPME), Leonard Kiefer

 (RAD), Chris Tirpak (CCD), and Chen

 Wen (PPD).

Welcome to Chemicals in

 Our Community

Chemical Right-to-Know

Chemical Hazard

 Availability Data

OECD Screening Informa-

 tion Data Set (SIDS)

Considering the Costs

 of Testing

Electronic Health & Safety

 Studies

Chemical Testing for

 Endocrine Disruptors

OECD Test Guidelines in

 Health & Env. Effects

Hazardous Air Pollutant

 Test Rule

Master Testing List

PMN Chemical Testing

 Issues

Dermal Absorption Rate

 Testing for OSHA

ChemAlliance: Compliance

 Assistance Centers

Whats New

Cover

3

5

7

8

9

11

12

13

14

15

16

17

18
Fall 1998 3

ChemRTK

arose from the

realization that,

even for the

most common

chemicals in

commerce,

there is very

little data

available on

health and

environmental

effects.

Chemical Right-to-Know

A New Era of Environmental Protection

William H. Sanders, III, Dr. P.H., P.E.

Director, Office of Pollution Prevention and Toxics

It’s not often one gets the chance to

hear the Vice President of the United States

explain bioaccumulation to a group of

fourth-graders. Not only did this unlikely

event take place during Earth Week, but he

did a terrific job. The kids were genuinely

interested and went back to their classes

with a lot to think over.

The occasion was the Vice President’s

announcement of the Chemical Right-toKnow Initiative, a major and important

undertaking for OPPT that will greatly

expand the information available on thousands of high-priority chemicals. ChemRTK

arose from the realization that, even for the

most common chemicals in commerce, there

is very little data available on health and

environmental effects. OPPT’s “Chemical

Hazard Data Availability Study” (see article

on page 5) revealed that fewer than 7% of

high-production volume (HPV) chemicals

have a full set of baseline testing data

publicly available, and almost half the

chemicals have no data available whatsoever!

The full study is available on OPPT’s home

page (www.epa.gov/opptintr/chemtest).

The Chemical Right-to-Know Initiative

will fill in these gaps, and provide the basis

for better and faster decisions on where

chemicals present hazards to human health

and the environment, and on steps to eliminate or manage these hazards. As such,

ChemRTK is fast becoming one of the most

visible and highest-priority efforts at OPPT.

It focuses, at the outset, on the three specific

actions identified by the Vice President:

Get baseline testing done on the 3,000

HPVs.

EPA will challenge industry to voluntarily undertake baseline testing on HPV

chemicals on a very rapid schedule, using

internationally-recognized testing protocols.

Chemicals that are not covered by the

voluntary challenge program will be subject

to test rule requirements. We expect to

publish a test rule proposal in early 1999.

Conduct extensive testing on chemicals to

which children are disproportionately

exposed.

Children can be especially sensitive to

chemical exposures. OPPT will work with

other offices, agencies and stakeholders to

identify the chemicals in consumer products

that lead to significant exposures in children,

and will identify a battery of health tests

needed to better screen the risks of these

chemicals. Voluntary agreements, such as

(continued on page 4)
4 Chemicals in Our Community

enforceable consent agreements (ECAs), will

be established with companies to test these

chemicals. The chemicals not covered by such

agreements will be included in a Children’s

Health Test Rule which EPA will propose by

the end of 1998 and make final in 1999.

Collect TRI release information on highpriority PBT chemicals.

Persistent, bioaccumulative, toxic

chemicals (PBTs) are of special concern due

to their environmental persistence and

tendency to concentrate in body tissues. Yet,

many PBTs are not covered under the Toxics

Release Inventory (TRI), the database which

contains information about potentially

hazardous chemicals and their use. We will

propose a rule to lower the threshold for

reporting of PBTs already on TRI, and to add

other PBTs (also at the lower thresholds) to

reporting requirements. EPA will propose the

PBT Rule by the end of 1998 and make it

final in 1999.

At the core of ChemRTK is EPA’s

commitment to making data available to the

public in a form that is easy to access, use

(continued from page 4)

and understand. Virtually all of the information generated from this initiative will be

made readily available through the Internet

and in other forms, so that the public can

access information about the chemicals in

use in their homes, schools, workplaces and

elsewhere.

Of particular importance to me as the

Director of OPPT is the development of a

comprehensive Chemical Right-to-Know

Strategy to put these activities into a larger

context. Data alone can be a powerful agent

for change, but OPPT clearly has a responsibility beyond simply providing new data.

We must be prepared to act in a timely and

decisive fashion when new information

suggests heretofore unrecognized risks. The

Chemical Right-to-Know Strategy will lay

out the approaches OPPT will use to assess

risks, establish priorities for testing and for

risk reduction, and to take actions so that

there are no industrial chemicals which pose

“unreasonable risks.”

This truly is the beginning of a new era

in environmental protection. Stay tuned to

this publication for more information.

For further information about EPA’s

Chemical Right-to-Know Testing Program, please contact:

Frank D. Kover, Chief - Chemical Information & Testing Branch

or Barbara Leczynski, Chief - Existing Chemical Branch

Chemical Control Division (7405)

Office of Pollution Prevention & Toxics

U.S. Environmental Protection Agency

401 M Street, S.W.,

Washington, D.C. 20460

Phone: (202) 260-8130 or (202) 260-3945

Fax: (202) 260-1096

E-mail: kover.frank@epa.gov or leczynski.barbara@epa.gov
Fall 1998 5

...the majority

of the HPV

chemicals not

listed on TRI

lack the basic

information

needed to

determine if

they should be

listed on TRI.

Chemical Hazard Data Availability Study

Charles Auer, Director

Chemical Control Division

EPA’s Chemical Hazard Data Availability Study finds major gaps in

the basic information that is readily available to the public on high

production volume chemicals.

In an Earth Day 1998 announcement,

Vice President Gore and Administrator

Browner committed EPA to three initiatives

aimed at strengthening the public’s right and

ability to know about the potential health and

environmental risks from toxic substances.

These initiatives build on OPPT’s work in our

Right-to-Know and TSCA programs. In the

near future, OPPT will be asking chemical

manufacturers to voluntarily increase critical

testing for 3000 high production volume

(HPV) chemicals, pursuing new rules to

guarantee that the chemicals children are

exposed to are fully tested for their health

effects, and proposing

new, lower reporting

thresholds for the most

persistent and

bioaccumulative chemicals on EPA’s Toxics

Release Inventory (TRI).

The announcement on

the testing of high

production volume

chemicals is a direct result

of OPPT recent analysis of

the public availability of

basic testing and screening

information on chemicals

produced or imported at

more than 1 million

pounds per year (HPV

chemicals). EPA/OPPT

recently released its analysis on the availability

of SIDS (Screening and Information Data Set)

test data on US HPV chemicals (see article on

page 7). SIDS is considered the minimum set

of tests that can allow an informed screeninglevel evaluation of a chemical’s hazards. A full

text of the EPA report, entitled “Chemical

Hazard Data Availability Study: What do we

really know about the safety of high production

volume chemicals?”, is available on the

Internet at www.epa.gov/opptintr/chemtest/

hazchem.htm.

The study found that of the 3,000 U.S.

HPV chemicals, a full set of SIDS testing was

publicly available for only 7% of the chemiCHEMICAL HAZARD

DATA AVAILABILITY

STUDY

What Do We Really

Know About the

Safety of High

Production Volume

Chemicals?

EPA’S 1998 Baseline of

Hazard Information That Is

Readily Available to the Public

(April 1998)

Office of Pollution Prevention & Toxics

cals and that no SIDS data were available for

43% of the chemicals. The report also

considers specific subsets of chemicals

including TRI-listed chemicals, those with

occupational exposure standards, and those

used in certain consumer products. In

addition, the report discusses the costs of

completing the tests needed to fill the data

gaps on these chemicals and offers a preliminary look at how individual companies who

produce HPV chemicals compare in terms of

the data available on their products.

Here are some of the highlights we found

when we analyzed the available data on these

subsets of chemicals of

special interest.

Chemicals reported

under TRI — 203 HPV

chemicals appear on the

TRI list. One would

expect TRI chemicals to

be relatively well tested,

and, in fact, over half of

these high-volume TRI

chemicals have all six of

the basic screening tests,

and all of the TRI HPV

chemicals have at least

some data available.

Clearly, there are more

test data available on the

TRI chemicals than on

the full set of all HPV

chemicals, but there are still data gaps —

about 20% of the HPV TRI chemicals were

missing 2 or more of the basic SIDS tests.

On the other hand, many of the HPV chemicals not listed on TRI lack the basic information needed to determine if they should be

listed on TRI — nearly half of the non-TRI

listed HPV chemicals have no data available

and fewer than 4% have the full set of basic

tests. (See Figure 1, next page.)

Chemicals in the products we use —

Chemicals contained in consumer products

are of concern due to the likelihood of their

exposure to children, as well as other

(continued on page 6)
6 Chemicals in Our Community

EPA is launching

a Chemical

Right-to-Know

Initiative aimed

at creating the

information base

that is needed

to accurately

assess the

potential risks

...of chemicals

in commercial

use today. sensitive populations. Fortunately, the

industry has completed basic testing for more

of these chemicals than is the case for other

HPV chemicals — of the 491 HPV chemicals

listed on EPA’s Indoor Air Source Ranking

Database, 25% have data publicly available

for all six SIDS tests, while only 7% have no

data available. Nonetheless, the great

exposure potential of consumer products and

the fact of children’s exposure suggests the

need for additional testing beyond the SIDS

level so that we can adequately assess the

risks of such chemicals.

Chemical companies need to do more to

deal with this problem: Our preliminary

analysis shows that, out of 830 companies

making HPV chemicals in the US, 148

companies have no SIDS data available for

any of their products. An additional 459

companies sell products for which, on

average, half or fewer of the SIDS tests are

available, while only 21 companies produce

chemicals that are fully tested. (See Figure 2)

Much remains to be done — While

these groups of chemicals are relatively

more fully tested than the bulk of HPV

chemicals, it is alarming that basic testing

on human health hazards and ecotoxicity

have been not completed on such large

numbers of HPV chemicals. EPA is

launching a Chemical Right-to-Know

Initiative aimed at creating the information

base that is needed to accurately assess the

potential risks posed by the trillions of

pounds of chemicals in commercial use

today. A key element in this initiative is

focused on engaging chemical manufacturers, interest groups, and other Federal

agencies in the US, along with government

and industry in other countries, in an

enlarged effort to rapidly complete SIDS

testing on all HPV chemicals.

(continued from page 5)

Figure 1

Figure 2
Fall 1998 7

OECD’s Screening Information

Data Set (SIDS)

Richard Hefter

Risk Assessment Division

The toxicity

testing is

designed to

measure how

potent the

chemical is

from acute

or one-time

exposures

such as from

accidental

ingestion or

skin contact.

Since the 1970’s, member countries of

the Organization for Economic Cooperation

and Development (OECD) have been working

together to address issues of chemical safety.

The OECD includes the U.S., Mexico,

Canada, European countries, Japan, Korea,

and Australia. One of the major problems is

that of evaluating the tens of thousands of

chemicals already in commerce - “existing

chemicals.” OECD members decided to

focus on the chemicals having the highest

worldwide production (over 2 million

pounds), and to collect for each one a

standard minimum set of data. OECD would

then use the data to screen these “highproduction-volume” (HPV) chemicals for

their potential risks to society. By 1990, the

United States and the other OECD member

countries were ready to start this voluntary

international testing program.

The basic level of testing and other

information gathered is called the Screening

Information Data Set, or SIDS. The SIDS

includes information on the identity of the

chemical, its physical and chemical properties, uses, sources and extent of exposure.

The testing required is designed to answer

basic questions about the chemical. For

instance, environmental fate testing can tell

us whether the chemical degrades quickly in

the environment and how it is distributed

throughout the environment.

The toxicity testing is designed to

measure how potent the chemical is from

acute or one-time exposures such as from

accidental ingestion or skin contact. Other

tests measure the effects from longer exposures as might be encountered in the workplace or in communities near production

facilities, such as mutagenicity tests which

could indicate a potential to cause cancer.

Tests are also required that measure the

chemical’s ability to interfere with reproduction (fertility) and fetal development. Finally,

a number of studies are required that indicate

the potential for environmental effects such as

to fish and aquatic plants should the chemical

be released to water from production and

wastewater treatment facilities. While all

these tests do not fully measure a chemical’s

toxicity they do provide a minimum set of

information that can be used to determine if

additional testing is necessary.

Once sponsor countries and their industries have selected chemicals to work on, they

collect data; prepare SIDS Dossiers (standardized summaries of the available information)

and Testing Plans (for chemicals lacking

some of the SIDS data); circulate SIDS

Dossiers and Testing Plans to other countries

for review and approval; review and comment

on the documents prepared by other countries; carry out SIDS testing and add the new

data to the Dossier; and prepare a SIDS Initial

Assessment Report (SIAR). OECD review of

SIARs (at SIDS Initial Assessment Meetings,

or SIAMs) determines whether chemicals

have a low priority for further work or

whether further (Post-SIDS) testing or

analysis of more detailed exposure information is needed.

The results of the SIDS program are

available to all countries through the International Registry of Potentially Toxic Chemicals (IRPTC) and the International Program

for Chemical Safety (IPCS). The program

also cooperates with other international

programs concerned with chemical safety,

such as the World Health Organization.
8 Chemicals in Our Community

Considering the Costs of Testing

Lynne Blake-Hedges

Economics, Exposure and Technology Division

The results

of EPA’s

analysis of

the costs can

be used to

help shape

the testing

requirements

put forth

by EPA.

$ $

$

$

$

$

$

Chemical toxicity testing is often

required by the EPA under Sections 4 and 5

of the Toxic Substances Control Act (TSCA).

Manufacturers of the chemicals are generally

responsible for paying the cost of testing.

Costs of testing can vary significantly, and

certain tests can be expensive. The Agency

estimates that many tests can exceed

$100,000 and some, such as cancer toxicity

tests, can exceed $100,000. A Screening

Information Data Set (SIDS), a typical battery

of testing, generally ranges from $200,000 to

$280,000. Recent Chemical Marketing

Reporter (June 29, 1998) estimates for

chemical industry value of shipments exceed

$391 billion, some percentage of which is

attributable to those chemicals with little

toxicity information.

Therefore, to balance the need to gather

information about chemical toxicity against

the desire to minimize costly regulatory

actions, the Agency considers testing costs in

its decisions about chemical testing. This

consideration of the costs of testing requirements is a relatively straightforward concept.

Agency economists carefully anticipate which

companies will be subject to the requirements

of the rule. They assess the value of sales

from a chemical, usually based upon the

estimated volume produced and/or processed

and the chemical sales price.

In cases where the chemical is new and

not yet commercialized, price and production projections from the manufacturer are

used. Judgments are then made about the

affordability of the testing when multiple

manufacturers produce a chemical, and

they might share testing costs. The Office

of Pollution Prevention & Toxics (OPPT)

generally considers that test costs exceeding 1 percent of sales value suggest a

possible adverse effect on the businesses

involved. In this case, the Agency will

more closely examine the testing requirements. Similarly, the Agency also evaluates the potential effects on small businesses of chemical testing.

For existing chemicals, the value of all

sales is compared with the costs of the testing

requirements to assess the industry’s ability to

afford the testing without adverse effects.

With new chemicals, the Agency considers

both the ability to afford testing and the time

at which testing costs are recovered based

upon projected production.

Estimates of the costs of testing include

laboratory costs (equipment, supplies, etc.)

and laboratory labor hours. Other costs

considered include costs of soliciting laboratory bids, selection of laboratories, preparing

test protocols, monitoring tests under

progress, and preparing reports to EPA on the

testing. The cost of testing requirements can

extend beyond the actual test itself and

include forming agreements with other

manufacturers for cost-sharing and export

notification. Further, if EPA requires

chemical testing, that chemical is automatically covered by export notification requirements. That is, if the chemical is exported,

the company must notify EPA, and EPA

notifies the destination country that they are

receiving this chemical.

The results of the EPA’s analysis of the

costs can be used to help shape the testing

requirements put forth by EPA. Frequently,

testing requirements may be tiered, such

that more expensive or advanced testing

may be required only if results of a screening test suggest a need for further testing.

For new chemicals, the time at which test

results are required is often related to the

estimated time for those costs to be recovered through sales.

Given the number of industrial chemicals available today that have little or no

toxicity data, toxicity testing will clearly

continue to be necessary. In meeting the

challenge to ensure the availability of such

information while minimizing the costs to

the businesses that provide it, the EPA will

continue to include costs as one of the

considerations in developing testing

requirements.
Fall 1998 9

Electronic Health and Safety Studies

John Nowlin

Information Management Division

Every year the

EPA reviews

thousands of

studies and

makes a

determination

as to the use

of the chemical

in question.

Chemical manufacturers have been

submitting health and safety studies to the

EPA since the inception of the Toxic Substances Control Act (TSCA) in 1976. These

studies, submitted under Sections 4 and 8 of

TSCA, include studies of chemicals or

mixtures that may present an “unreasonable”

(Section 4a) or a “substantial” (Section 8e)

“risk of injury to health or the environment.”

EPA also asks for studies (Section 8d) on

chemicals for which there are insufficient

data. Most of these studies were submitted in

response to chemical testing recommendations made by the TSCA Interagency Testing

Committee (ITC). Every year the ITC

reviews numerous Section 8(d) studies and

decides whether testing for health effects,

environmental fate, or ecological effects is

needed. To date there are over 100,000

studies covering over 9,000

chemicals in EPA’s TSCA test

submission database called

TSCATS.

Summary

information from

the TSCATS

database can be

accessed free of

charge through the

Right-to-Know

Network (RTKNET)

located at www.rtk.net.

RTKNET allows the user

to select the level of detail

they want in their report. There are

three levels of reports, the first of which

allows the user to chose a report that will

produce a description of each reference

matching the search criteria. The second

type of report provides the same information as well as a list of specific chemicals

and studies. The third report provides all

the information mentioned plus the full text

of abstracts.

Although the health and safety studies

themselves are not currently on-line, they are

available from the EPA’s Confidential

Business Information Center (CBIC) located

at 401 M Street SW, Room E-G099, Washington, DC 20460. A new EPA web site is

being developed to allow industry submission

of health and safety studies electronically.

This effort, started over two years ago, is part

of an Agency-wide initiative to improve

electronic commerce throughout the EPA.

In July 1996, as part of the EPA’s

electronic commerce initiative, the EPA’s

Office of Pollution Prevention and Toxics

(OPPT) invited industry, organizations,

public interest groups, laboratories, the press,

federal agencies and individuals to meet with

the EPA in an open session to discuss ways

to improve the timeliness, accessibility and

quality of information reported under TSCA.

The meeting generated tremendous energy,

and resulted in a commitment to the electronic submittal and dissemination of health

and safety data. The group agreed

that the best way to collect health

and safety data would be to

convert the existing paper-based

health and safety data (HaSD) form

into an electronic means of submitting the data. This electronic HaSD

form will allow for the direct

uploading of health and

safety summary data

directly into TSCATS

and to electronically

attach the full study.

Less than a year after

the first meeting, the

electronic HaSD form

was put into use.

The electronic HaSD form is

currently being used to collect health and

safety data for the ITC. To date, the ITC has

reviewed over 40,000 chemicals and will soon

be using TSCATS to post information on these

chemicals on their web site. To learn more

about the ITC, visit www.epa.gov/opptintr/itc.

OPPT’s new Chemical Right-to-Know

(CRTK) program will also use the electronic

HaSD form and TSCATS to post chemical

information on EPA’s web site. CRTK

includes collecting studies on almost 3,000

high production volume chemicals - chemicals that are produced or imported in quantities greater than a million pounds a year.

(continued on page 10)
10 Chemicals in Our Community

Data on these chemicals will be made

available to the public under Vice

President Gore’s Chemical Right-toKnow initiative, an initiative to allow the

public to easily access to information

about chemicals in their community (see

article on page 3).

OPPT plans to publish health and

safety information on the EPA web site.

The design of the web page includes a

user-friendly interface that will allow the

public easy access to information on

chemicals of interest. The new web site

will include the ability to access health

and safety information at various levels of

complexity (depending on the user’s

needs). OPPT will continue to improve its

ability to collect and disseminate information to fulfill the communities’ right to

know about chemicals. As part of this

commitment, OPPT holds regular open

sessions on the electronic submission and

dissemination of TSCA data.

To request information on the next

electronic open session meeting, write to:

John Nowlin (7407), US EPA, 401 M

Street, SW, Washington, DC 20460 or

send an e-mail to nowlin.john@epa.gov.

(continued from page 9)

Figure 2

Figure 1
Fall 1998 11

Outside Experts Recommend Chemical

Testing Process for Endocrine System Effects

Gary Timm

Chemical Control Division

In recent years, increasing scientific

and public attention has been focused on

the potential effects of synthetic chemicals on the hormone, or endocrine,

systems of people and wildlife.

The endocrine system consists of the

glands and the hormones they produce

that help guide the development, growth,

reproduction and behavior of animals

including human beings. The glands of

the endocrine system include the pituitary, thyroid, and adrenal, as well as the

ovaries and testes. The hormones produced by these glands travel through the

bloodstream and affect functions in other

parts of the body. For example, adrenaline

helps stimulate physical activity; estrogen

affects the female reproductive system;

and androgen affects the male reproductive system.

Chemicals that interfere with the

normal function of these complex systems

are known as “endocrine disruptors.” For

example, some chemicals may mimic a

natural hormone, “fooling” the body into

over responding to the hormone. Other

chemicals may block the effects of a

hormone in parts of the body normally

sensitive to it.

In response to the increasing concerns

about potential endocrine effects, Congress included provisions in the 1996

Food Quality Protection Act and amendments to the Safe Drinking Water Act that

require EPA to develop by August 1998 a

program for screening and testing chemicals for adverse effects to endocrine

systems. To meet this ambitious Congressional deadline and to include the latest

scientific thinking, EPA established the

Endocrine Disruptor Screening and Testing

Advisory Committee (EDSTAC) to provide

advice and recommendations.

The EDSTAC met nine times between

December 1996 and June 1998, and will

submit its final recommendations by September. The committee focused on screening

pesticides, contaminants, and commercial

chemicals for estrogenic, androgenic, and

thyroid hormone effects. With the universe of

chemicals to be prioritized for endocrine

screening and testing numbering more than

86,000, the committee has recommended a

tiered process to detect endocrine disrupting

chemicals and quantify their effects that

includes initial sorting of chemicals, priority

setting for chemicals to be tested, and a

battery of eight in vitro and in vivo screening

assays, and a battery of four multi-generation

(rodent, fish, invertebrate) tests.

Updates on OPPT and EDSTAC

activities can be found on the Internet at

www.epa.gov/opptintro/opptendo.

EPA established

an advisory

committee called

the Endocrine

Disruptor

Screening and

Testing Advisory

Committee

(EDSTAC)

to provide

advice and

recommendations
12 Chemicals in Our Community

Presently, 30

health effects

guidelines and

six ecotoxicity

test guidelines

have been

harmonized

between

EPA/OPPT

and OECD.

Differences in test guidelines between

offices of the U.S. Environmental Protection

Agency have the potential of leading to

confusion and to unnecessary testing of

chemicals. Similarly at the international

level, differences in test guidelines between

nations lead to unnecessary testing of

chemicals in world commerce. To avoid

duplication of testing, the Office of Pollution

Prevention and Toxics (OPPT) and the Office

of Pesticides Programs (OPP) have been in

the process of harmonizing their guidelines

for human health and ecotoxicity testing into

a single set of guidelines for the Office of

Prevention, Pesticides and Toxic Substances

(OPPTS), and in the process are harmonizing

these OPPTS guidelines with those of the

Organization for Economic Cooperation

and Development (OECD).

The OPPT/OPP project

was begun in 1990 and is

nearing completion. The

harmonization effort

between OPPT with OECD

had been ongoing since

the mid 1980’s.

International harmonization of test guidelines

has been a high priority for

Assistant Administrators of OPPTS since

1990. By cooperating closely with other

Federal agencies, states, tribes, and nongovernmental organizations, and with their

counterparts in other countries, the EPA is

reducing the burden to regulated industry,

increasing efficiency in collecting test data

and in assessing risk, avoiding duplication of

effort, saving animal lives and expense,

reducing non-tariff trade barriers and fostering the mutual acceptance of test data

between the U.S. and other countries.

OPPT has published 118 guidelines not

only in the areas of human health and

ecotoxicity, but also in environmental fate

and physical chemistry. OECD has published 55 guidelines in the same four areas.

OPP has a total of 97 test guidelines in these

areas, plus 129 additional guidelines for

other specific requirements for OPP’s

evaluation of pesticides (e.g., product

identity, performance, composition, application exposure).

Presently, 30 health effects guidelines

and six ecotoxicity test guidelines have been

harmonized between EPA/OPPT and OECD.

Ten health effects guidelines and 13

ecotoxicity guidelines have been harmonized

between OPPT and OPP to produce guidelines which are unique to OPPTS. Some of

these OPPTS test guidelines incorporate

recent and significant advances in the

scientific knowledge and methodologies,

particularly in the areas of neurotoxicity,

developmental neurotoxicity, developmental and reproductive biology,

aquatic plant toxicology and sediment

toxicology. OPPT is currently

leading many of the

efforts to harmonize these

improved guidelines with

OECD. These guidelines

are being revised in light of

OPP Science Advisory

Board (SAP) comments in

May and October 1996.

In July 1998, EPA

will publish 45 OPPT/OPP

harmonized guidelines in health effects for

key toxicity tests (acute toxicity, specific

organ/tissue toxicity, subchronic toxicity,

chronic toxicity, genetic toxicity, neurotoxicity, reproductive and developmental toxicity,

immunotoxicity and metabolism and

pharmokinetics) will be published in the

Federal Register. They will also be available

electronically in PDF (portable document

format) on the EPA World Wide Web site at

www.epa.gov/epahome/research/htm, or via

the U.S. Government Printing Office (GPO)

at ww.access.gpo.gov or in disk or paper

form (call GPO at 202-512-0132).

It is expected that at least 10 guidelines in

ecotoxicity (the 850 series) should be harmonized and finalized by the end of this year.

OECD Test Guidelines in Health and

Environmental Effects

Michael C. Cimino

Risk Assessment Division
Fall 1998 13

Hazardous Air Pollutant Test Rule

Richard Leukroth

Chemical Control Division

Since the Clean Air Act was amended in

1990, EPA’s Office of Air and Radiation

(OAR) has used a “technology-based” and

performance-based approach to significantly

reduce emissions of air toxics from major

sources of air pollution. Under this approach,

OAR develops standards for controlling the

routine emissions of air toxics from each

major type of facility within an industry

group. These standards — know as

“maximum achievable control technology”

(MACT) standards — are based on emission

levels that are already being achieved by the

better-controlled and lower-emitting sources

in an industry. To date, OAR’s Office of Air

Quality Planning and Standards has completed work on some 22 MACT standards.

Eight years after a MACT standard is issued,

OAR must assess the remaining health risk

(also called residual risk) from that source

category. If the residual risk assessment

indicates a continued concern about potential

health effects that may occur at MACT

standard exposure levels, then OAR may

implement additional standards that address

any significant remaining risk.

While OAR focuses efforts on developing MACT standards, they have asked EPA’s

Office of Research and Development to

develop an approach to assess residual risk

(see Residual Risk Report to Congress; 63 FR

19914; April 22, 1998) and to collaborate

with EPA’s Office of Pollution Prevention

and Toxics (OPPT) to use TSCA section 4(a)

as a means to obtain identified data needed

for this future assessment. The data obtained

through TSCA would be used to implement

several provisions of section 112 of the Clean

Air Act, including determination of residual

risk, estimation of the risks associated with

accidental releases of chemicals, and determinations regarding whether substances should

be removed from the Clean Air Act Section

112(b)(1) list of hazardous air pollutants. In

addition, the data will be important for EPA’s

Chemical Right-to-Know program as well as

for other Federal agencies—the Agency for

Toxic Substances and Disease Registry, the

National Institute for Occupational Safety and

Health, the Occupational Safety and Health

Administration, and the Consumer Product

Safety Commission—for assessing chemical

risks and taking appropriate actions within

their programs.

As an initial effort to build this database,

OPPT proposed the HAP Test Rule in June

1996. OPPT identified 21 High Production

Volume chemicals from the List of Hazardous

Air Pollutants that require additional data. The

proposed rule would require that industry test

these HAP chemicals for health effects from

inhalation exposures using the eleven OPPTS

harmonized test guidelines published in the

Federal Register (FR6243820, April 15, 1998).

This is the first TSCA chemical test rule

that gives industry the opportunity to submit

alternative testing proposals which, if

acceptable to EPA, would permit industry test

sponsors to enter into Enforceable Consent

Agreements (ECAs) with the Agency that

would use state of the art methods to perform

route-to-route extrapolations of health effects

of chemicals from existing data where the

route of exposure was not by inhalation.

These methods — pharmacokinetics and

mechanistic data—describe how the body

absorbs, distributes, metabolizes, and excretes

a chemical. OPPT has received alternative

test proposals for almost half of the chemicals

listed in the HAPs rulemaking.

On December 24, 1997, the proposed

rule was amended to cross-reference the

(continued on page 14)

The proposed

rule required

that industry

test HAP

chemicals for

health effects

from inhalation

exposures using

the 11 OPPTS

harmonized test

guidelines...
14 Chemicals in Our Community

Master Testing List (MTL)

Frank Kover

Chemical Control Division

Since 1990, EPA’s Office of Pollution

Prevention and Toxics (OPPT) has used the

Master Testing List (MTL) — a list of

industrial chemicals that are considered to

be the highest priority for its chemical

testing program under the mandates of

Sections 2 and 4 of TSCA. The MTL helps

EPA program managers focus limited

Agency resources on the highest priority

chemical testing needs, publicize OPPT’s

industrial chemical testing priorities,

obtain public input on program priorities,

and encourage voluntary industry initiatives to conduct needed testing. OPPT adds

individual chemicals and chemical categories to the MTL as a result of the TSCA

Interagency Testing Committee activities

and requests by other EPA program offices,

other Federal agencies, as well as OPPT’s

Existing Chemicals Program.

The MTL currently lists over 600

chemicals and more than 15 chemical

categories such as endocrine disruptors,

oxygenated fuel additives, paint stripping

products and chemicals, and hazardous air

pollutants. All of the chemicals and categories on the list are “active” in ongoing testing

programs, testing action development, or

testing needs development.

With Vice President Gore’s 1998 Earth

Day announcement, EPA anticipates the

size of the list to increase significantly

with the addition of chemicals that may

pose the greatest risks to children and the

3,000 chemicals, labeled High Production

Volume (HPV) chemicals, that are produced or imported in amounts over one

million pounds per year. EPA expects to

issue the next version of the MTL sometime in 1999. Given the expanded scope

from adding the HPV chemicals, it may be

necessary to reformat the list.

The current (1998) version of the MTL

is available in hard copy from OPPT’s

Public Docket and the TSCA Hotline, (202)

554-1404. The electronic version is on the

Internet at www.epa.gov/opptintr/chemtest/

index.htm.

EPA anticipates

the size of the

list to increase

significantly

with the

addition of

HPV chemicals

and chemicals

that may pose

the greatest

risks to

children.

proposed testing requirements to the new

eleven harmonized TSCA guidelines. In

this amendment, the Agency removed

certain testing requirements; revised the

economic assessment; proposed criteria

to help determine who is required to test

a HAP chemical that is a byproduct or

impurity; and described other changes

and clarifications to the proposed test

rule. To help meet requirements contained in the proposed amended rule,

EPA also solicited ECA proposals on

HAP chemicals for which proposals had

not been received.

Once again, on April 21, 1998, the

proposal was amended to modify the

provisions for identifying persons who are

required to test and to provide additional

guidance in determining what their

responsibilities would be under the rule.

With the close of the comment period,

June 22, 1998, OPPT staff is working to

complete the ECA negotiations and finalize

the rule as soon as possible. Comments and

support documents for the HAPs rulemaking

can be found, on the Internet at

www.epa.gov/fedrgstr/EPA-TOX/1997/

December/Day-24/s-t33451.htm.

(continued from page 13)
Fall 1998 15

PMN (Premanufacture Notice)

Chemical Testing Issues

David Schutz

Chemical Control Division

... anyone

wanting to

manufacture a

“new” chemical

must submit a

premanufacture

notice (PMN)

for Agency

approval.

(continued on page 16)

In implementing the Vice President’s call

to gather basic test data on the most widely

used chemicals, EPA will have the ability to

screen these chemicals for potential effects on

human health and the environment. EPA’s

ability to perform toxicity screening has been

substantially developed through its New

Chemicals Program. Under this Program, the

Agency routinely screens chemicals before

they are manufactured for commercial use.

EPA's New Chemicals Program sets the

pace for the chemical industry's testing of

new chemicals for potential health risks.

Section 5 of TSCA requires that anyone

wanting to manufacture a "new" chemical,

i.e., one that is not on EPA's list of chemicals in commerce known as the TSCA

Inventory, must submit a Premanufacture

Notice (PMN) for EPA approval. OPPT's

New Chemicals Program then assesses the

proposed chemical for its uses, benefits,

and its potential to harm human health and

the environment.

EPA's assessment of a chemical's

potential risk is based partly on test results

submitted its PMN and partly on existing

information on similarly structured chemicals. EPA has been collecting and evaluating

data on chemicals for

almost 20 years, and

as a result the

program has built an impressive storehouse of information

on the hazards such chemicals

can pose.

Although TSCA

requires that a manufacturer submit to the

Agency any toxicological or environmental test data it has

on a chemical at the

time of its PMN

application, there

is no defined

base data set of

hazard information, and TSCA does not require prior

testing of new chemicals. Less than half of

the PMN applications include toxicological

data. In evaluating PMNs for which no or

little data is provided, EPA scientists

predict toxicicity by assessing the

chemical's structural similarity to chemicals for which toxicological data are

available in a process called structureactivity relationship analysis (SAR).

The Agency's SAR knowledge base has

largely been accumulated through the New

Chemicals program and through testing

submitted under sections 4 and 8 of TSCA.

When data available to the New Chemicals

Program is not adequate to assess the

toxicity and risk of the new chemical, the

Agency often requires that additional data

be generated.

EPA toxicologists, chemists, biochemists,

engineers, and experts in other disciplines

work together to predict the potential risks to

human health or the environment from each

new substance. Most of the new chemicals

submitted to the program complete the review

process without being restricted or regulated

in any way. However, if the Agency determines that a new chemical substance may

pose an unreasonable risk or that production

volume and potential worker or environmental exposure is substantial, EPA can take

action to control the new chemical.

EPA uses a variety of

approaches in obtaining test

data needed to assess or

manage new chemicals

risks: (1) permit the

PMN submitter

to manufacture

or import the

new substance

under specified

conditions,

where deviation

from the conditions would require

submission of test data; (2) require

submission of test data before a speci-
16 Chemicals in Our Community

Dermal Absorption Rate Testing for OSHA

Keith Cronin

Chemical Control Division

EPA is developing a proposed Test

Rule under Section 4(a) of the Toxic

Substances Control Act (TSCA) that could

require manufacturers (including importers)

and processors of 47 chemical substances of

interest to the Occupational Safety and

Health Administration (OSHA) of the

Department of Labor to conduct dermal

absorption rate testing.

EPA was asked by the TSCA Interagency

Testing Committee (ITC) to require the

chemical industry to test about 80 chemicals

for dermal absorption rates. The request came

from OSHA, which needs absorption rate data

to determine whether workers need to wear

protective equipment when handling certain

chemicals. In anticipation of this request, the

Office of Pollution Prevention and Toxics

(OPPT) and ITC developed a method for in

vitro dermal absorption rate tests for screening workplace chemicals. On the basis of the

test method, EPA solicited Enforceable

Consent Agreement (ECA) testing proposals

from industry. Through an ECA, industry

agrees with EPA to conduct specific tests on a

specified schedule. The ECA is a more

flexible tool for all parties than rulemaking.

EPA received one offer from industry to test

one chemical via an ECA. OPPT is currently

preparing a proposed TSCA Section 4 Test

Rule for 47 chemicals with the highest

production volume and highest number of

workers exposed for which no adequate data

have been reviewed. At a later date, EPA

will propose testing for the remaining

chemical substances of interest to OSHA.

OPPT and ITC

developed a

method for

in vitro dermal

absorption

rate tests for

screening

workplace

chemicals.

(continued from page 15)

fied production volume or date is

reached (known as "triggered" testing);

or (3) permit the PMN submitter to

suspend the review period while developing additional test data (this approach

works best where the needed testing can

be completed relatively quickly). EPA

takes action to control new chemicals for

about 10% of the cases.

When the Agency specifies (using a

consent order under Section 5) conditions under which it will permit manufacture or import of a new substance

pending development of test data,

manufacture of the new substance can take

place under precautions for workers or

environmental safeguards (e.g., protective

equipment, use restrictions, methods of

waste disposal) which the Agency believes

provide a remedy for the possible risks. In

cases where the Agency determines that a

new substance will present an unreasonable

risk, EPA can prohibit the manufacture,

processing, or distribution in commerce of

the substance.

For more information on this program

visit the New Chemicals Program website at

www.epa.gov/opptintr/newchms.
Fall 1998 17

ChemAlliance is designed

to assist the chemical industry to

more efficiently achieve and

maintain compliance with

environmental regulations with an

emphasis on pollution prevention.

David Piantanida

Environmental Assistance Division

ChemAlliance

Compliance Assistance Center Coming Soon!

ChemAlliance is a compliance assistance

center designed for the chemical industry. It

was established in the fall of 1997 under a

cooperative agreement funded by EPA’s

Office of Enforcement and Compliance

Assurance (OECA). EPA has partnered with

the National Center for Clean Industrial and

Treatment Technologies (CennCITT), Pacific

Northwest National Laboratory (PNNL), and

the University of Wisconsin - Solid and

Hazardous Waste Education Center

(SHWEC) in this effort.

ChemAlliance is designed to assist the

chemical industry to more efficiently achieve

and maintain compliance with environmental

regulations with an emphasis on pollution

prevention. Specifically, ChemAlliance will:

• Provide information that addresses the

environmental compliance needs of the

chemical industry.

• Improve information transfer between

individual companies and EPA, and

among assistance providers.

• Provide practical information on how

chemical manufacturers can improve

compliance while reducing costs and

improving quality.

• Help chemical manufacturers decrease

the costs and increase the effectiveness

of compliance.

Information will soon be provided via

a World Wide Web site and will contain an

“expert help desk” function that will

enable users to locate important information quickly. The ChemAlliance web site

and toll-free hotline will be launched in

September 1998.

Who is ChemAlliance?

What is ChemAlliance?

ChemAlliance will help users to sort

through existing information and direct them

immediately to the best solution.

Why ChemAlliance?

• Individual company representatives

charged with compliance at one or

several facilities

• Individuals or organizations that

provide assistance to industry

Who are Expected to be the Primary Users

of this Center?

The Center’s objectives in serving each

of these markets are to assist the company

level individual in understanding and

maintaining compliance and to enhance the

capabilities of industry by providing useful

and accurate information.
18 Chemicals in Our Community

What’s New

New Standards and

Information Program Help

Protect Families and

Children from Lead Paint

Hazards

Through its Toxics Release

Inventory (TRI), the U.S. EPA

recently reported industrial

releases of toxic chemicals in

U.S. communities decreased

from 2.5 billion pounds in 1995

to 2.4 billion pounds during

1996, a decline of 4 percent or

100 million pounds. Since

industry first began reporting

releases in 1988, releases have

decreased by almost 46 percent.

The 1996 TRI report also

includes industry-specific analyses

of five major industry sectors that

are required to report their toxic

chemical releases. Over the past

10 years, all of these industries

have reduced the amount of toxic

pollution they report to EPA. Of

these five industry sectors,

declines in TRI chemical releases

were led by chemical manufacturing, followed by primary metals,

electrical equipment, pulp and

paper, and petroleum refining.

EPA will complete a report later

this summer containing analyses

of the additional 15 industries

that report to the TRI.

Information on TRI is

available in public libraries, or

on-line at www.epa. gov/

opptintr/tri, or by calling the TRI

User Support at (202) 260-l53l.

EPA has proposed new

standards and is issuing a final

rule, effective June 1999, that

addresses health hazards from

lead-based paint. The proposed

standards identify levels of lead

and provide consumers with

information about lead-based

paint hazards of renovating or

remodeling their homes. The new

rule will require renovators, who

are working for compensation, to

give homeowners and tenants

information on how to protect

themselves from lead hazards

before renovation begins.

The new rule and proposed

standards cover homes built

before 1978. There is an estimated

80 percent of all residences built

before 1978 which contain some

lead-based paint. Although it can

usually be safely managed, when

lead-based paint is disturbed

during renovation it can contaminate dust and soil and pose a

significant hazard, especially to

young children. Almost one

million children under the age of

six have unsafe levels of lead in

their bodies, making lead poisoning the number one environmental

health hazard for young children.

At a final meeting of EPA’s

Endocrine Disruptor Screening

and Testing Advisory Committee

(EDSTAC), committee members

provided final comments on the

draft report. This report recommends a strategy for screening and

testing chemicals to determine

whether they have potential to

affect endocrine function in

humans, fish, and wildlife.

The EDSTAC was established

to implement a provision of the

Food Quality Protection Act and

Safe Drinking Water Act amendments that require screening and

testing protocols for chemicals

suspected of endocrine disrupting

effects. More information on

EDSTAC can be found on the web

at www.epa.gov/opptintr/opptendo/

index.htm or by calling the Keystone Center at (970) 468-5822.

1996 TRI Data Release

Announced

Final Report on Endocrine

Disruptors Screening Due

in July

Copies of both the proposed

and final rules as well as a

pamphlet on lead hazards in the

home for renovators to use are

available on EPA’s web site at

www.epa.gov/lead or by calling

the hotline at (800) 424-LEAD.
Fall 1998 19

EPA completed guidelines for

doing ecological and neurotoxicity

risk assessments. Both guidelines

were developed to foster consistency across the Agency for

planning and conducting risk

assessments. The guidelines for

ecological risk assessment

describe three phases of the

process, general principles, and

examples of how the principles

can be applied to situations such

as hazardous waste clean-up, new

pesticide registration, or watershed management. The neurotoxicity risk assessment guidelines

are intended to guide the

Agency’s evaluation of chemicals

suspected of causing adverse

neurological effects, with a focus

on the vulnerability of infants’ and

children’s nervous systems. The

guidelines are available on EPA’s

web site at www.epa.gov/ncea.

EPA has established a new

network for pollution prevention

information and technical

assistance through a grant

program that is funding nine

regional pollution prevention

centers. In February 1998,

representatives from each of the

centers met to develop a decision

making process, standardize

bibliographies, establish quality

assurance protocols, and discuss

evaluation and measurement

issues.

 In addition to the grant

program, OPPT allocated an

additional one million dollars to

fund activities in each of these

centers that improve state

cooperation. Without the states’

investment of staff time and

resources, regional centers

cannot survive. The network,

called the Pollution Prevention

Resource Exchange (P2Rx)

provides information that is

readily accessible and updates

technical information. The

network is easy to search,

collect, synthesize, and identify

experts and other sources of

information. More information

about the network can be found

on EPA’s web site at

www.epa.gov/p2.

OPPTS has published an online version of Act Locally, a

compilation of OPPTS databases,

programs, funding opportunities,

hotlines, training opportunities,

and other pesticide/toxics related

activities that can be used by

communities to gather more

information for improving their

local environments. The listings

will be updated periodically and

nominations for new items are

welcome.

EPA Publishes Final

Guidelines for Ecological

and Neurotoxicity Risk

Assessment

New Software Identifies

Building Products for

Environmental Performance

As part of its Environmentally Preferable Purchasing

(EPP) Program, EPA has contributed to the development of a

Pollution Prevention

Centers Across US

Network for Better Service

OPPTS Assembles

Community-Based

“Tool” Box

software program that helps to

identify products that will reduce

energy use, improve air quality

and other conditions that can

improve the environmental

performance of buildings. The

software program, Building for

Economic and Environmental

Sustainability (BEES), was

developed under an Interagency

Agreement by the National

Institute of Standards and

Technology with funding from

EPA. The program will help

federal facility managers make

decisions about how to purchase

building products based on cost

and environmental considerations. For more information see

the web site at www.usgbc.org.

What’s New
United States

Environmental ProtectionAgency (7407)Washington, DC 20460Official BusinessPenalty for Private Use$300