U.S. GOVERNMENT PUBLISHING OFFICE

WASHINGTON : 

For sale by the Superintendent of Documents, U.S. Government Publishing Office

Internet: bookstore.gpo.gov Phone: toll free (866) 512–1800; DC area (202) 512–1800

Fax: (202) 512–2104 Mail: Stop IDCC, Washington, DC 20402–0001

24–968PDF 2017

S. HRG. 112–984 

LEGISLATIVE HEARING ON THE 

SAFE CHEMICALS ACT 

JOINT HEARING 

BEFORE THE

SUBCOMMITTEE ON SUPERFUND, TOXICS 

AND ENVIRONMENTAL HEALTH 

OF THE

COMMITTEE ON 

ENVIRONMENT AND PUBLIC WORKS 

UNITED STATES SENATE 

ONE HUNDRED TWELFTH CONGRESS 

FIRST SESSION 

NOVEMBER 17, 2011 

Printed for the use of the Committee on Environment and Public Works 

( 

Available via the World Wide Web: http://www.fdsys.gov 

(II) 

COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS 

ONE HUNDRED TWELFTH CONGRESS 

FIRST SESSION 

BARBARA BOXER, California, Chairman 

MAX BAUCUS, Montana 

THOMAS R. CARPER, Delaware 

FRANK R. LAUTENBERG, New Jersey 

BENJAMIN L. CARDIN, Maryland 

BERNARD SANDERS, Vermont 

SHELDON WHITEHOUSE, Rhode Island 

TOM UDALL, New Mexico 

JEFF MERKLEY, Oregon 

KIRSTEN GILLIBRAND, New York 

JAMES M. INHOFE, Oklahoma 

DAVID VITTER, Louisiana 

JOHN BARRASSO, Wyoming 

JEFF SESSIONS, Alabama 

MIKE CRAPO, Idaho 

LAMAR ALEXANDER, Tennessee 

MIKE JOHANNS, Nebraska 

JOHN BOOZMAN, Arkansas 

BETTINA POIRIER, Majority Staff Director and Chief Counsel 

RUTH VAN MARK, Minority Staff Director 

SUBCOMMITTEE ON SUPERFUND, TOXICS AND ENVIRONMENTAL HEALTH

FRANK R. LAUTENBERG, Chairman 

MAX BAUCUS, Montana 

THOMAS R. CARPER, Delaware 

JEFF MERKLEY, Oregon 

KIRSTEN GILLIBAND, New York 

BARBARA BOXER, California, (ex officio) 

MIKE CRAPO, Idaho 

LAMAR ALEXANDER, Tennessee 

MIKE JOHANNS, Nebraska 

JOHN BOOZMAN, Arkansas 

JAMES M. INHOFE, Oklahoma, (ex officio) 

(III) 

C O N T E N T S 

Page 

NOVEMBER 17, 2011 

OPENING STATEMENTS 

Lautenberg, Hon. Frank R., U.S. Senator from the State of New Jersey ........... 1 

Inhofe, Hon. James M., U.S. Senator from the State of Oklahoma .................... 3 

Carper, Hon. Thomas, U.S. Senator from the State of Delaware ........................ 5 

Gillibrand, Hon. Kristen, U.S. Senator from the State of New York .................. 6 

Merkley, Hon. Jeff, U.S. Senator from the State of Oregon ................................ 7 

Baucus, Hon. Max, U.S. Senator from the State of Montana, prepared statement ......................................................................................................................

WITNESSES 

Sturdevant, Ted, Director, Department Of Ecology, State Of Washington ....... 8 

Prepared statement .......................................................................................... 11 

Responses to additional questions from: 

Senator Boxer ................................................................................................... 24 

Senator Carper ................................................................................................. 28 

Senator Inhofe .................................................................................................. 29 

Brody, Charlotte, Director Of Chemicals, Public Health And Green Chemistry, 

Bluegreen Alliance ............................................................................................... 32 

Prepared statement .......................................................................................... 34 

Responses to additional questions from: 

Senator Boxer ................................................................................................... 37 

Senator Carper ................................................................................................. 39 

Senator Inhofe .................................................................................................. 40 

Dooley, Cal, President and Ceo, American Chemistry Council ........................... 42 

Prepared statement .......................................................................................... 44 

Responses to additional questions from: 

Senator Carper ................................................................................................. 65 

Senator Inhofe .................................................................................................. 68 

Matthews, Robert, Counsel, Consumer Specialty Products Association ............. 75 

Prepared statement .......................................................................................... 77 

Responses to additional questions from: 

Senator Carper ................................................................................................. 85 

Senator Inhofe .................................................................................................. 87 

Denison, Richard, Senior Scientist, Environmental Defense Fund; Safer 

Chemicals, Healthy Families Coalition .............................................................. 91 

Prepared statement .......................................................................................... 93 

Responses to additional questions from: 

Senator Boxer ................................................................................................... 107 

Senator Carper ................................................................................................. 110 

Senator Inhofe .................................................................................................. 113 

ADDITIONAL MATERIAL 

Statements: 

Business Alliance Committed to Finding the Right Approach to Updating 

TSCA .............................................................................................................. 153 

American Cleaning Institite ............................................................................ 156 

Edison Electric Institute .................................................................................. 158 

National Council of Churches .......................................................................... 160 

National Petrochemical & Refiners Association (NPRA) .............................. 161 

Page

IV 

—Continued 

Society of Chemical Manufactures & Affiliates ............................................. 166 

Dr. Paul A. Locke; Associate Professor at John Hopkins Bloomberg School 

of Public Health ............................................................................................ 170 

Physicians Committee for Responsible Medicine ........................................... 175 

S.C. Johnson & Son, Inc. ................................................................................. 182 

(1) 

OVERSIGHT HEARING ON THE 

BROWNSFIELD’S PROGRAM - CLEANING UP 

AND REBUILDONG COMMUNITIES 

WEDNESDAY, OCTOBER 19, 2011 

U.S. SENATE, 

COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS, 

SUBCOMMITTEE ON SUPERFUND, TOXICS AND

ENVIRONMENTAL HEALTH, 

Washington, DC. 

The committee and subcommittee met, pursuant to notice, at 10 

a.m. in room 406, Dirksen Senate Office Building, Hon. Frank Lautenberg [chairman of the subcommittee, presiding. 

Present: Senators Lautenberg, Inhofe, Crapo, Carper, Cardin, 

Whitehouse, Barrasso, Udall, Merkley, and Gillibrand. 

OPENING STATEMENT OF HON. FRANK LAUTENBERG, 

U.S. SENATOR FROM THE STATE OF NEW JERSEY 

Senator LAUTENBERG. We welcome the witnesses. Obviously, I 

guess we all think that when we have an issue before the public, 

that we all think it is very important. Needless to say, I am not 

going to differ with the usual routine here. 

I will start off on what I hope will be a good setting for the birthday of my colleague and friend, Senator Inhofe. He is younger than 

I by a few years. It is not noticeable, I know, but take my word 

for it. There is a degree of envy, and we wish him happy birthday. 

We have had I won’t say it is a unique relationship, but it is one 

that we don’t agree necessarily on all the subjects, but we agree on 

respect for one another and it is always great to work with Senator 

Inhofe. 

During the past 2 years, this Committee and the Subcommittee 

have held five hearings that identified serious problems with the 

Toxic Substance Control Act, known as TSCA. And today, we are 

starting to look for our solutions to those problems and discuss 

them publicly. 

In our previous hearings, we uncovered dangerous and costly deficiencies in TSCA and this Committee heard from CDC officials 

who told us their scientists found 212 industrial chemicals, including six carcinogens coursing through America’s bodies. Twice, we 

have heard from EPA Administrator Lisa Jackson, who told us 

under current law that her agency lacks the tools it needs to regulate high-risk chemicals. 

2 

And we heard from others who shared their anxiety about having 

no system for determining which everyday chemicals might hurt 

them or their children. 

TSCA is so severely flawed that the nonpartisan Government Accountability Office testified that it is a ‘‘high-risk area of the law.’‘ 

Our hearings also revealed the status quo does not work for the 

chemical industry either. In the hearing last February, executives 

from Dow and DuPont, two major chemical companies, testified in 

support of reform in part because of the difficulties their companies 

face operating under different rules and in different States. 

We heard similar messages earlier from the chemical maker 

BASF and S.C. Johnson, the global consumer product company. We 

heard from colleagues on both sides of the aisle who agree that 

TSCA must be revised to work better for businesses and the health 

of our citizens. 

Now, I first introduced legislation to address TSCA’s shortcomings in 2005. Since then, my legislation has evolved through 

scientific advances and feedback from various other sources, including the chemical industry. At a hearing nearly 2 years ago, I told 

this Committee the bill should be considered an invitation to all to 

play a part, and I meant it seriously. I invite colleagues with whom 

we might have some sharp differences, let’s sit down and talk 

about it. This is important enough that we want to keep the door 

open and we will listen to ideas or views that others have. 

Many Members on our side offered ideas that are included in the 

newest version of my bill and I am pleased that most of the Committee’s Democrats are now co-sponsored. We also heard from Senator Vitter, who said that TSCA reform legislation must be based 

on sound science and called for more input from the National Academy of Sciences on chemical risk assessment. 

So this year’s version of the Safe Chemicals Act mandates that 

EPA use the best available science, as defined by the ongoing work 

of the National Academies. Last summer, Senators Inhofe and 

Barrasso raised concerns about inadvertently depriving our economy of chemicals that are essential to daily life. And I mentioned 

something here that was, as they say, up front and personal. When 

I had six courses of chemotherapy last year and I was mighty glad 

to meet the chemicals, I can tell you, and they treated me nicely. 

So we know that there is lots of value that comes from chemicals, 

and we want to be sure that we don’t get in the way of availability 

of those products, but we do want to watch out for those that might 

bring harm instead. 

As a result, we have included provisions to ensure the continued 

availability of chemicals for critical or essential uses. Concerns 

were also raised about our proposal for prioritizing certain chemicals for safety review, so we completely overhauled that section of 

the bill. 

Earlier this year, Senator Inhofe and I met about trying to make 

this bill bipartisan. And he suggested a process for getting more 

ideas from industry and others on the table. Throughout the summer, our staffs held 10 meetings with representatives from industry, from labor and environmental groups on different sections of 

the Safe Chemicals Act. Those meetings increased understanding of 

the bill’s strengths, as well as areas that could be improved. 

3 

Today’s hearing is an opportunity for the witnesses and Members 

of the Committee to take the next step toward a bipartisan bill. 

And if there are concerns with something in the Safe Chemicals 

Act, I hope that you will either offer a suggestion for improving it 

or commit to working through the details with us in the next 2 

weeks. 

The bottom line is this: This legislation establishes a strong, but 

practical system for guaranteeing the safety of chemicals, many of 

which end up in our bodies and the bodies of our children and we 

remain open to other ways of achieving our shared goal of a system 

that improves safety and encourages continued innovation and 

growth in the chemical industry. 

But we have got to get going. We have to act soon. I plan to call 

for a vote in this Committee in the near future and I hope that we 

will be able to address any concerns that might be raised today so 

we can approve a bipartisan bill that encourages the use of chemicals that help and protect our children from the chemicals that 

harm. 

Senator LAUTENBERG. Is Senator Crapo going to be here shortly, 

do you know? 

Senator INHOFE. I am sitting in for him. 

Senator LAUTENBERG. Oh, OK, a birthday treat for Senator 

Inhofe. He can fill in. 

Senator INHOFE. Thank you. Thank you. 

As I understand it, Mr. Chairman, this is a joint full Committee 

and Subcommittee, so that would be appropriate. 

OPENING STATEMENT OF HON. JAMES INHOFE, 

U.S. SENATOR FROM THE STATE OF OKLAHOMA 

Senator INHOFE. I appreciate the comments you made, and I 

know that it isn’t only on my birthday that I get those comments 

because it surprises a lot of people that Senator Lautenberg and I 

are very good friends. We have a mutual respect, and we know the 

areas where we disagree. And I think it is appropriate the way he 

is doing this. 

The stakeholders meetings were very thoughtful. We learned a 

lot from the participants as efforts to modernize TSCA continue in 

the future. These discussions will undoubtedly help to build a foundation for eventual reforms. The participants were candid and 

forthcoming with their unique viewpoints and I look forward to 

building an agreement around that. And I think that is a good 

start, bringing the people in to talk about these things. 

While we often heard very conflicting ideas from stakeholders on 

how TSCA should be modernized, we also identified a few areas of 

potential common ground and I think that that warrants further 

discussion. Although our hearing today is on S. 847, which is not 

incorporated in what we have learned from the stakeholders process, it is a starting point, I recognize that. 

It is a battle, given the unemployment rate hovering around 9 

percent and numerous costly new regulations coming from this Administration that we make sure that any toxic reforms help to not 

only protect human health, but jobs and the economy. That has got 

to be part of the consideration as we develop this thing. 

4 

My interest in TSCA modernization, which I have said before, is 

in large part due to TSCA’s broad reach over chemical manufacturing and its potential and real impacts on the economy. TSCA 

regulates the manufacturing, the distribution, use and disposal of 

chemicals, authority that covers thousands of transactions and decisions by thousands of people every day, and I have consistently 

said that TSCA must be accomplished with a broad base of support, including industry up and down the value chain. It also must 

take into account the small-and medium-size businesses that could 

be affected the most if the law is updated improperly. 

Our witnesses today represent a few of the stakeholders we 

heard from in the course of our meetings that we had. They possess 

a wide range of perspectives on TSCA modernization and its implementation, but we must not forget that there are plenty of other 

groups that have strong interest in this, other stakeholders as well. 

At this time, I would like to ask unanimous consent to place into 

the record the statements from the American Cleaning Institute, 

the Grocers Manufacturers Association, the Society of Chemical 

Manufacturers and affiliates, and the National Petrochemical and 

Refiners Association. 

Senator LAUTENBERG. Without objection. 

[The referenced documents follow:] 

Senator INHOFE. While I believe it is time to bring this 35 year 

old statute into the 21st century, it is also important that we do 

it right, and I am sure that this is a good start in that, Mr. Chairman. 

Thank you. 

[The prepared statement of Senator Inhofe follows:] 

STATEMENT OF HON. JAMES M. INHOFE, 

U.S. SENATOR FROM THE STATE OF CALIFORNIA

I would like to begin by thanking Senator Lautenberg for scheduling a legislative 

hearing on S. 847 the Safe Chemicals Act of 2011. I would also like to thank him 

and his staff for inviting us to co-host a series of listening sessions, which included 

not only our staffs, but representatives from industry and the environmental community. 

The stakeholder meetings were very thoughtful and we learned a great deal from 

the participants. As efforts for modernizing TSCA continue in the future, these discussions will undoubtedly help to build a foundation for eventual reforms. The participants were candid and forthcoming with their unique viewpoints and I look forward to building agreement around some of the many challenges facing TSCA reform moving forward. 

While we often heard very conflicting ideas from stakeholders on how TSCA 

should be modernized, we also identified a few areas of potential common ground, 

and I think that warrants further discussions. Although our hearing today is on S. 

847—which has not incorporated what we learned in the stakeholder process or addressed many longstanding concerns—I am encouraged that this bill helped begin 

a constructive dialog that may help lead to a workable bill which down the road 

could pass both the House and Senate and become law. 

It is vital—given an unemployment rate hovering around 9 percent and numerous 

costly new regulations coming from this administration—that we make sure any 

TSCA reforms help to not only protect human health, but jobs and the economy. My 

interest in TSCA modernization—which I have said before—is in large part due to 

TSCA’s broad reach over chemical manufacturing and its potential, and real, impacts on the economy. TSCA regulates the manufacturing, distribution, use, and disposal of chemicals—authority that covers thousands of transactions and decisions by 

thousands of people every day. 

I have consistently said that TSCA modernization must be accomplished with a 

broad base of support, including industry up and down the value chain. It also must 

take into account the small and medium size businesses that could be affected the 

5 

most if the law is updated improperly. Our witnesses today represent a few of the 

stakeholders we heard from in our meetings. They possess a wide range of perspectives on TSCA modernization and its implementation but we must not forget that 

there are plenty of other groups that have a strong vested interest in this effort and 

need to be considered as well. 

At this time I would like to ask unanimous consent to have statements from the 

American Cleaning Institute, the Grocery Manufacturers Association, the Society of 

Chemical Manufacturers and Affiliates, and the National Petrochemical & Refiners 

Association—all of whom also participated in the stakeholder meetings—inserted 

into the record. 

While I believe it is time to bring this 35 year old statute into the 21st Century, 

it is equally as important that we do it the right way without harming American 

innovation or shipping jobs overseas. 

My principles for reform remain the same: any modernization of TSCA should be 

based on the best available science; use a risk-based standard for chemical reviews; 

include cost-benefit considerations; protect proprietary information; and must 

prioritize reviews for existing chemicals. 

These are principles I have stood by for many years and I think are vital to a 

successful TSCA modernization process that is appropriately protective, predictable, 

efficient, and revives confidence in our Federal chemical management system. 

Again, I appreciate Sen. Lautenberg’s work on this issue and his willingness to 

gather information in a constructive, bipartisan nature. I look forward to hearing 

from the witnesses today. 

Senator LAUTENBERG. Thanks very much. 

Senator Carper. 

OPENING STATEMENT OF HON. THOMAS CARPER, 

U.S. SENATOR FROM THE STATE OF DELAWARE 

Senator CARPER. Thank you, thank you. And I want to join all 

of our colleagues in wishing Jim happy birthday. It is a joy to here 

with you today. And I think a great gift that gets him out of the 

conversations between—of both our Chairman and Senator Inhofe 

on, and with your staffs, it would be a great gift for our Country. 

I just want to commend you for the time and energy that you and 

your staffs are putting into this. These are important issues that 

I care a lot about. I know others do as well. 

Every day in this Country, manufacturers use, as we know, various chemicals to make everything from carpets to cosmetics, cars, 

water bottles, dishwashing soap, and we need these chemicals to 

keep our manufacturing base strong. We also need to make sure 

that we are using and disposing of them safely. 

As others have said, it has been more than 30 years since we revisited the Toxic Substance Control Act, and that is far too long 

when we consider how much more we manufacture and use chemicals today and how much more we understand today about those 

chemicals. 

Industry, environmental and public health leaders, the Obama 

administration, several of our colleagues in Congress, including me, 

all agree that current law is not sufficient and it is time that the 

Toxic Substance Control Act is modernized. 

From what I understand, the principles for TSCA reform that 

have been outlined by the chemical industry, the NGO community 

and other stakeholders are remarkably similar, and that is encouraging. I believe that there is a path forward to reforming TSCA 

that we can address, that will enable us to address the needs of 

our diverse stakeholders on this issue, including our constituents. 

Senator Lautenberg has introduced, as we know, a bill to 

strengthen our chemical safety law that has gone through several 

6 

iterations. I think it is not just a good start, but it is a good process 

that is underway. And I just want to say to Senator Inhofe that 

I look forward to working with both of you and with our colleagues 

here in the Senate in our efforts to try to pass strong chemical 

safety legislation. 

I look forward to hearing from our witnesses today, especially the 

guy in the middle, with whom I was pleased to serve in the House 

lo those many years ago. Cal, it is especially nice to see you. Welcome one and all. 

Thanks so much. 

Senator LAUTENBERG. Thanks very much, Senator Carper. 

We will proceed with the witnesses. Welcome. Each of you brings 

experience and obviously a point of view. 

Oh, my goodness, surprise. 

Senator Gillibrand I think was the next arrival and we look forward to hearing from you. 

OPENING STATEMENT OF HON. KRISTEN GILLIBRAND, 

U.S. SENATOR FROM THE STATE OF NEW YORK 

Senator GILLIBRAND. Thank you, Senator Lautenberg, for your 

leadership on such an important issue, one that very deeply affects 

our constituencies and the whole Country. I appreciate that the 

Committee is going to examine the Safe Chemicals Act which aims 

to modernize TSCA. And I, too, have read the studies and reports 

that have found toxic chemicals in everyday products. 

Since TSCA became law more than 30 years ago, we have seen 

an unacceptable rise in childhood cancers, learning disabilities, 

birth defects, allergies, asthma, autism and infertility. Our children 

are being exposed to hundreds of chemicals before they are even 

born. Umbilical cord blood samples show exposure to over 200 

chemicals from BPA, which is found in plastic bottles, flame 

retardants which are used in electronics and in furniture, and 

PCBs, a known carcinogen that has remained in our soil and water 

decades after it has been banned. 

Congress can no longer afford to ignore the failures of TSCA to 

prevent public health any longer. The issue of the effectiveness of 

our Nation’s chemical regulations is extremely important to all 

Americans and in particular to mothers like me. We must stand 

with parents across the Country who have joined together to demand better from their elected leaders. 

It is just not good enough for the Federal Government to sit on 

the sidelines while States are forced to fill in the void and take 

matters into their own hands. In my home State of New York, the 

State legislature passed critically needed reforms, like protecting 

babies from toxic chemicals, BPA in baby bottles and other cancercausing chemicals found in nursing pillows and in baby carriers. In 

all, 25 States across the Country have passed 80 chemical safety 

laws in 9 years, with overwhelming majorities and strong bipartisan support. 

I applaud this action at the State level, but we need a national 

policy that ensures chemicals in products are safe in every State 

and for every family. 

The legislation we are examining today, the Safe Chemicals Act, 

changes the current paradigms to put the burden on proving a 

7 

chemical is safe on industry and provides that our regulators need 

to finally allow this law to work as it was intended. As the legislation moves forward, it is essential that the final product make 

meaningful reforms that will give comfort to consumers that the 

products that they purchase for their families are safe. 

Mr. Chairman, earlier this year, I heard the story of Mira 

Brouwer, a young girl from Ithaca, New York, who at the age of 

just 4 years old passed away as the result of complications in the 

treatment for brain cancer. Faced with the loss of her young 

daughter, her mother, Chistine Brouwer, founded Mira’s Movement. It is an organization to raise awareness of pediatric cancer. 

[Audience interruption.] 

Senator GILLIBRAND. I agree. I agree with you. 

[Laughter.] 

Senator GILLIBRAND. Mira’s mother shared her story and her 

questions and concerns about what could have contributed to her 

daughter’s cancer. She pored through study after study that identified the potential links between chemicals in our environment and 

such cancers, just like the one that took Mira’s life. We owe it to 

Mira and thousands of the children who are facing similar ailments 

to ensure that the products that we produce in this Country and 

that we purchase for our families are safe. 

Thank you, Mr. Chairman, for looking at this important issue. 

Senator LAUTENBERG. Thank you very much. 

Senator Merkley. 

OPENING STATEMENT OF HON. JEFF MERKLEY, 

U.S. SENATOR FROM THE STATE OF OREGON 

Senator MERKLEY. Thank you, Mr. Chair. Senator, your leadership on this issue has been extremely important, and your commitment to modernizing the Toxic Substance Control Act so we can 

protect our families from exposure to dangerous toxins is terrific. 

So thank you for doing that. 

Oregon has been a leader among the States in attempting to 

limit toxic chemicals, ranging from flame retardants to mercury, 

cyanide and so forth. But we are not satisfied. Our families are not 

satisfied with the protection from dangerous chemicals that exist 

currently. 

Oregon is among the top five in the Nation for adult asthma 

rates, the top 10 for breast cancer, near the top for autism, and 

these kinds of diseases are linked to toxic chemicals in our environment. 

The shocking part for me is that the Environmental Protection 

Agency has been unable to protect our families from exposure because the Toxic Substance Control Act does not provide EPA with 

the necessary tools to collect data on chemical risk and effectively 

regulate the most toxic chemicals. 

And who are most impacted by this? It is consumers and families 

across America who don’t know if they are using products that 

could be harmful to their health. 

Reforming TSCA makes common sense. We know that many 

American companies currently have to prepare to abide by the 

REACH law in Europe, which requires much higher control of 

chemical toxins. We know that many States, as my colleague just 

8 

referred to, have gone out on their own to try to pass laws, as New 

York has, as Oregon has, as so many have, because of the vacuum 

in Federal policy. It makes sense to have a Federal policy to regulate toxic substances that actually works. 

So I look forward to the hearing today and to doing all I can to 

help take this important bill forward to protect the health of Americans across this Nation. 

Senator LAUTENBERG. Thank you very much, Senator Merkley. 

And now we ask our witnesses to make their statements. Today, 

we are going to hear from a range of experts who have significant 

experience in chemical safety: Mr. Ted Sturdevant, Director of the 

Washington State Department of Ecology; Charlotte Brody, Director of Chemicals, Public Health and Green Chemistry for the 

BlueGreen Alliance, a national partnership of labor unions and environmental groups; and Mr. Cal Dooley, President and CEO of the 

American Chemistry Council; Mr. Robert Matthews, a partner in 

the law firm of McKenna Long & Aldridge, and counsel to the Consumer Specialty Products Association; and Dr. Richard Denison, 

Senior Scientist for the Environmental Defense Fund. 

And we welcome you. 

And Mr. Sturdevant, you are the first, and please give us your 

testimony. 

STATEMENT OF TED STURDEVANT, DIRECTOR, DEPARTMENT 

OF ECOLOGY, STATE OF WASHINGTON 

Mr. STURDEVANT. Thank you, Chairman Lautenberg, Ranking 

Member Inhofe and Members of the Committee for this opportunity 

to testify. I am Ted Sturdevant, the Director of the Washington 

State Department of Ecology. 

It is very significant that this Committee is willing to open the 

conversation on TSCA reform and I applaud you for the open and 

inclusive dialog that you have had to date. And I want to particularly recognize the leadership of Senator Lautenberg for offering 

this legislation, and to Senator Inhofe for supporting such an inclusive dialog. 

This is a critical issue for the States and I appreciate the chance 

to share our perspective. 

So today, what I would like to do is talk about why States care 

so much about TSCA reform; what we have had to do in the face 

of an outdated TSCA; and speak just a little bit about the preemption of States’ authority in this arena. 

So why do States care about TSCA? As State environmental 

agencies around the Country, part of our job is to protect people 

and the environment from harmful exposure to toxic chemicals. 

When those chemicals come from a pipe or a smokestack, we know 

what to do. We have the tools to deal with that. But when they 

come from ubiquitous products like foam and furniture or the plastic casings of a television or toys, we don’t have the tools to deal 

with those. 

We can’t intercept chemicals that leave products and get into our 

public waterways via wastewater or stormwater runoff with potential human exposure along the way. We are just not good at that. 

So as we grow concerned about a particular chemical or chemicals in our States, we face a very difficult choice. And that is, do 

9 

we tackle that chemical or chemicals with inadequate tools and resources or do we look the other way? And more and more, what you 

are seeing are States deciding to act and step up to this. So even 

with those inadequate tools, that is the pattern we are seeing in 

the States. 

But our preference is for a third option, and that is for a Federal 

system that works. So I want to share an example of what we face 

and really how ill-equipped we are to deal with this kind of thing. 

In Washington State, we are undertaking a massive effort to restore and protect Puget Sound, the Nation’s second-largest estuary. 

And in the city of Tacoma, which sits on Commencement Bay in 

the Sound, we have spent over $100 million cleaning up contaminated sediments in the bay. And last year, for the first time, we 

started to see improved health in those sediments, which was great 

news. 

But at the same time, we are seeing phthalates come in via 

stormwater runoff and settle on top of those sediments. Phthalates 

are plasticizer chemicals that are used in a wide variety of consumer products. And they are endocrine disrupters which can have 

harmful reproductive and development effects. 

So I don’t mean to open the debate about the science of 

phthalates, but we are concerned about these things getting into 

the food chain in Puget Sound and concerned about impacts on people that harvest food from Puget Sound. 

So the problem here is that we don’t know what to do about it. 

We don’t have the tools. We don’t have any means of really doing 

anything about that particular source of pollution. And we don’t 

have any means of protecting that investment that we have made 

in the bay. And I think that this is exactly the kind of problem that 

should be addressed by TSCA and don’t have confidence that it will 

be. 

So even without the right tools, as I said, States are tackling 

these challenges more and more. In the last 8 years, 18 States have 

passed chemical policy legislation and I think it is fair that we will 

continue to see those kinds of efforts in the upcoming legislative 

session. 

And it is important to note that this has not been a partisan 

issue at the State level. The votes on these things have been 

strongly bipartisan because it is a public health issue. 

Now, before I conclude, I want to speak briefly to the issue of 

preemption of States’ authority. Given the patchwork of regulations 

that is taking hold across the Country in States, some people believe that absolute preemption of States’ authority is necessary. I 

understand the concern, sympathize with the concern, but disagree 

with that approach for two reasons. 

First, as you said, TSCA has not been reformed for 35 years, so 

the States have been the folks that have filled that gap in the 

meantime and we need to have the authority to do our job, to deal 

with the unanticipated challenges of the future that TSCA may not 

address, even a reformed TSCA may not address. 

And second, we are not doing this because we don’t have anything better to do. We are doing this because we think we have to, 

because these challenges exist that are not getting addressed. 

10 

So I believe that if there is a national solution to this problem, 

preemption of States’ authority really becomes a non-issue because 

we will then direct, I think, our scant resources elsewhere. And we 

appreciate that the proposed bill preserves States’ authority. 

We also appreciate the sensible approach of requiring minimum 

data-sets on chemicals and showing that they meet safety standards. The bill’s provisions for sharing data with States, while maintaining confidentiality and enabling EPA to deal with the highestrisk chemicals are also appreciated. 

So TSCA reform is a big deal for the States. Last year, the Environmental Council of the States unanimously passed a resolution 

calling for TSCA reform, and that represents the environmental 

agencies of all the States across the Country. I don’t believe we 

have ever seen such broad agreement that TSCA needs to be fixed, 

whether your aim is to protect public health or the environment, 

or to have a more consistent, predictable playing field for businesses across the States. The solution to all these things I think 

is modernizing TSCA. 

Senator LAUTENBERG. Your full statement will be included in the 

record, so please forgive me because we want to move quickly. 

Mr. STURDEVANT. I was done and I appreciate the opportunity. 

Senator LAUTENBERG. Your testimony was excellent to this point. 

We look forward to having it in the record. 

[The prepared statement of Mr. Sturdevant follows:] 

11 


24968.001

Testimony of Ted Sturdevant 

Director 

Washington State Department of Ecology 

Before the Senate Committee on Environment and Public Works and 

Subcommittee on Superfund, Toxics and Environmental Health 

Legislative Hearing on the Safe Chemicals Act 

November 17,2011 

First I want to say thank you for the opportunity to testify on this very important 

issue. TSCA reform is an issue whose time has come, and it is very significant 

that this committee is willing to open this conversation. I applaud the committee 

for the open and inclusive effort to bring stakeholders together over the past year 

to inform this debate, and I want to particularly recognize the leadership of 

Senator Lautenberg for offering this bill, and of Senator lnhofe for supporting 

such an inclusive dialogue. This is a critical issue for the states and we 

appreciate the opportunity to share our perspective. 

Today, I'd like focus on why states care about modernizing TSCA, what we have 

had to do in the face of an outdated and ineffective federal chemical policy, and 

briefly address the issue of preemption of states' authority. 

So why do states care about TSCA? 

It is the job of state environmental agencies around the country, ours included, to 

protect people and the environment from harmful exposure to toxic chemicals. 

When those chemicals come from a pipe or a smokestack, we have the tools and 

the know-how to do our job. But when they come from ubiquitous products like 

the plastic casing of a television, or the foam in our furniture, we haven't had the 

tools or the know-how to do our job. We can regulate direct dischargers, we can 
12 


24968.002

clean up contaminated soils, but we can't intercept toxic chemicals that escape 

products and get into public waterways via wastewater or stormwater runoff, with 

potential human exposure along the way. 

As we better understand the consequences of human or environmental exposure 

to certain chemicals, we in the states face a tough choice: either tackle those 

chemicals with imperfect tools and inadequate resources, or look the other way. 

In Washington and in more and more states around the country, we have chosen 

to act. But our preference is for a third option: a federal system that works. 

Let me share an example of what we face, and how ill equipped we are to deal 

with it. 

In Washington State, we are undertaking a massive effort to restore the Puget 

Sound, the nation's second largest estuary, just behind Chesapeake Bay. In the 

city of Tacoma, we spent over $100 million to clean up contaminated sediments 

in Commencement Bay from its industrial past. Last year, we finally started 

seeing improved sediment and fish health in the Bay. But at the same time, we 

are now seeing phthalates pour into the bay in polluted stormwater runoff and 

settle on top of those clean sediments. Phthalates are used as plasticizers in a 

variety of everyday products such as flexible piping, soft plastic toys or packaging 

for consumer products, and they are considered endocrine disrupters. 

According to the National Institute of Environmental Health Sciences, many of 

these substances have been associated with developmental, reproductive and 

other health problems in wildlife and laboratory animals. Some research 

suggests that these substances are adversely affecting human health in similar 

ways. 
13 


24968.003

I am concerned about what phthalates might mean in the food chain in Puget 

Sound, and for the people that harvest its food. But I don't know what to do 

about it. We don't have any means of stopping or reducing this pollution stream, 

or protecting our investment in the Bay. I believe this is exactly the kind of 

problem that should be addressed by TSCA, but is not. 

States across the country are confronting similar problems, but more and more, 

we're developing our own solutions, state by state. 

Let me share another example. 

In 2008, Washington became the first state in the nation to ban all forms of 

PBDEs, a commonly used flame retardant used in foam and plastics that posed 

unacceptable neurological risks to children. This effort took significant time and 

resources at taxpayer expense, and it was strongly opposed by industry. Since 

then, several other states have banned PBDEs, and the EPA recently announced 

their phase-out nationally. 

But now we are learning about a chemical that was just listed on the California 

Office of Environmental Health Hazard Assessment's Proposition 65 list of 

chemicals as a known carcinogen. This chemical is known as Chlorinated Tris or 

"TDCPP," a flame retardant added to polyurethane foam in furniture. The 

challenge is that after a years-long effort to improve the safety of chemical flame 

retardants in furniture, we may now have to start over, but with a new chemical. 

There are three problems with this. First, it reveals that the system is not 

designed to move us toward safer chemicals. We have to wage long, bitter fights 

over controlling a specific chemical, but with no effective inducement to then shift 

to safer alternatives. 
14 


24968.004

Second, we have to recreate these efforts state by state, expending precious 

resources to do so. 

And third, this leads to a patchwork of chemical regulations that industry 

understandably fears. 

But this approach, however imperfect, is preferable to inaction. During the past 

eight years 18 states have passed legislation ranging from comprehensive 

chemical safety laws to bans on specific hazardous chemicals, and I'm sure we'll 

see many more such efforts in upcoming legislative sessions around the 

country. 

It's important to note that this is not a partisan issue at the state level. Most of 

these votes have been strongly bipartisan, because public health is at stake. 

The current system doesn't work for anyone. I shouldn't have to spend my 

resources on Washington-specific efforts that are better made at the national 

level. Citizens expect to be protected from harmful toxic exposures that could be 

avoided. And businesses shouldn't be subject to an increasingly complex maze 

of regulations across the country. 

For those reasons, I believe there is broad support for TSCA reform, and I think 

this is the right bill, at the right time. 

Let me briefly speak to the issue of preemption of states' authority before I 

conclude. 

Given the patchwork of regulations taking hold in the states, some believe that 

absolute preemption of states' authority is needed. I understand the concern, but 

disagree with this approach for two reasons. First, TSCA has not been updated 
15 


24968.005

in 35 years, even while our understanding of the human and environmental 

impacts of many chemicals has grown by leaps and bounds. 

In that time, the states have been the leaders and the innovators in protecting our 

citizens and their environment. Had states not been able to act, I don't believe 

we'd be having this conversation today, and we'd be stuck with an antiquated, 

ineffective system. Even if you pass strong TSCA reform today, we still need the 

authority to do our jobs and confront the unanticipated challenges of the future 

that TSCA may not address. 

And second, states are not undertaking these efforts because we want to. We're 

doing it because we have no other choice. If the federal system worked, we 

wouldn't have to do it ourselves. If you create a national solution to this problem, 

states can focus our scant resources elsewhere, and I believe preemption will 

become a non-issue. 

I think the proposed bill strikes a good balance on this issue. 

The second issue I'd like to address is information sharing. Better access to 

information would help us all -government, industry and consumers. We should 

build a system for sharing information about chemicals between EPA, the states, 

manufacturers and downstream users of chemicals. We can and should do this 

without asking companies to give away trade secrets. 

I'm confident we can figure that out. I see no reason that modernizing TSCA 

should conflict with industry's ability to innovate and create jobs. 

The comments I've made here reflect collective statements state leaders have 

made in recent years on the need for TSCA reform. Most recently this included a 

group of nine states submitting comments on this bill. In 2009, 13 states issued 
16 


24968.006

a set of principles for TSCA reform, and in August, 2010, the Environmental 

Council of the States, representing the leadership of all state environmental 

agency commissioners, unanimously passed a resolution urging Congressional 

reform of TSCA. 

I don't believe there has ever been such broad agreement that TSCA needs to 

be fixed. Whether your aim is to better protect the American people, or provide a 

more predictable, consistent playing field for business -or both- the answer is 

TSCA reform. Let me again offer my gratitude to you for inviting this 

conversation, for engaging the states in it, and for allowing me the privilege of 

testifying today. 

Attached are more detailed comments on the Safe Chemicals Act of 2011 that 

were submitted to Senator Lautenberg and Senator lnhofe on behalf of nine state 

environmental commissioners from California, Colorado, Delaware, 

Massachusetts, Maryland, Michigan, Oregon, Vermont, and Washington. 
17 


24968.007

Summary 

STATE ENVIRONMENTAL COMMISSIONERS 

COMMENTS ON THE 

SAFE CHEMICALS ACT OF 2011 

S. 847 (AprillS, 2011 Version) 

These comments were submitted to Sen. Lautenberg and Sen. Inhofe on August 23, 2011, 

by nine environmental commissioners from California, Colorado, Delaware, 

Massachusetts, Maryland, Michigan, Oregon, Vermont, and Washington. 

Reforming the Toxic Substances Control Act of 1976, (TSCA) is a key issue for states. 

In 2010, the Environmental Council of States (ECOS) passed a resolution calling for 

responsible TSCA reform to cover both new and in-use chemicals, and provide for quick 

action when needed, assessment of safer alternatives, and collaboration and informationsharing between federal and state programs. As of today, 30 states have passed chemical 

policy laws that include comprehensive chemical programs, bans on specific high-risk 

chemicals, and resolutions that call for TSCA reform. These arc overwhelmingly 

bipartisan efforts. Through our work, we have learned many lessons about what has 

worked and what has not in the Federal TSCA law. Our comments address the key issues 

for states, which are that TSCA reform should: 

• Preserve states' ability to protect public health and the environment. 

• Require minimum data for all chemicals and require manufacturers to show that chemicals 

meet safety standards. 

• Require United States Environmental Protection Agency (EPA) to define criteria for safer 

alternatives using a hazard and risk-based approach that considers the entire chemical life 

cycle, and encourage use of safer alternatives through market incentives and other means. 

• Give EPA authority to take immediate action to reduce threats from the most harmful 

chemicals, especially Persistent, Bioaccumulative and Toxic chemicals (PBTs) and other 

chemical substances determined to require immediate risk management, including chemical 

bans where needed. 

• Reward innovation and help safer chemicals and alternatives get to the marketplace faster. 

• Share information and coordinate between state and federal programs to maximize use of 

resources and ensure a predictable regulatory environment for all stakeholders. 

We appreciate the opportunity to submit these comments and respectfully ask for their 

consideration. We would welcome the opportunity provide additional information, 

answer questions, engage in discussion and provide suggested language on any or all of 

these issues. 

l. Preservation of State Authority. 

We support the express preservation of state authority in § 18 of Safe Chemicals Act of 

2011 (S. 847) and urge the bill's sponsors to retain this language. 
18 


24968.008

The retention of state authority as it is described in S. 847 is one of the most important 

issues in the TSCA reform debate. Many Federal environmental laws expressly preserve 

state authority. For example, many states have programs that contain requirements in 

addition to those specified in the Resource Conservation and Recovery Act (RCRA). 

Washington State has enacted toxic chemical cleanup legislation that is more restrictive 

than the Comprehensive Environmental Response, Compensation and Liability Act 

(CERCLA). States also have state cleanup programs in addition to CERCLA. The Clean 

Air Act authorizes California to establish more stringent vehicle emission standards, 

which can then be adopted by other states in lieu of the federal standards. These are only 

a few examples where state authority has been maintained without disruption of a federal 

program. Preservation of state authority is both workable and necessary. The states 

strongly recommend that this provision be retained in its current form. 

2. Enhanced State Coordination Role. 

Section 24 (State Programs) amends TSCA § 28 to require EPA to establish a state 

coordination process for data sharing and prioritization as it relates to management of 

chemical substances and mixtures. The language from last year's House discussion draft 

docs not appear inS. 847. Last year, the states worked with House Committee staff to 

strengthen federal coordination and cooperation with state programs and provide an 

enhanced consultative role in areas of particular importance to the states. At a minimum, 

the states request that §24 be revised to strengthen consultation and coordination with the 

states and local governments to: 

• Provide for advance consultation and coordination on the design and development of 

the electronic database established under§ 9(d). 

• Provide for advance consultation and coordination on the development of a 

streamlined process for sharing confidential business information with the states 

under§ 14. 

• Provide for consultation and coordination prior to: ( 1) establishing conditions on the 

manufacture, processing, use, distribution, or disposal of a chemical substance or 

mixture; and (2) granting an exemption or providing for public notice under§ 6(e) to 

determine if related states have taken a similar action under state law. 

• Provide for consultation and coordination before initiating any rulemaking and for 

meaningful opportunities for input throughout any rulemaking process under TSCA 

including efforts to define "safer alternatives" and establish criteria for alternatives 

assessment. 

• Provide for advance consultation and coordination on the development of Hot Spot 

action plans under § 34. 
19 


24968.009

• Provide for grant funding to the states to support activities related to§§ 5-9, 14, 18, 

23, 29, and 34, in addition to grant funding provided for states to promote and support 

activities in § 31. 

• Provide for state representation, appointed by ECOS, on the Interagency Science 

Advisory Board on alternative testing methods and the Interagency Prioritization and 

Testing Committee. 

3. Risk Based Safety Standards and the Role of Hazard Assessment. 

Section 3 (Findings, Policy and Goal) amends TSCA § 2(b) (3) to add new policy 

language related to meeting a risk-based safety standard that protects vulnerable 

populations and the environment. States recommend addition of the term hazard so that, 

consistent with the approach taken by many states, Federal policy is based on a hazard 

and risk-based approach to protect vulnerable populations and the environment. 

Chemical policy reform should shift chemical usc from chemicals that possess a high 

intrinsic hazard to chemicals with lower hazard. In many cases, there are equally 

effective and safer alternatives to hazardous chemicals. Manufacturers should be 

required to conduct safer chemical alternative assessments, as part of a safety standard 

determination, prior to implementing any other proposed risk control measures. In 

instances where safer alternatives are available, chemical policy should help shift uses 

towards these alternatives. When faced with a choice between implementing control 

measures and reducing intrinsic hazard, the states have often found that the cheapest and 

most effective option is reducing hazard. Protection of public health and the environment 

requires identification and substitution of safer alternatives, irrespective of current known 

risks. 

4. Minimum Data Set. 

Section 5 amends the Minimum Data Set and testing requirements ofTSCA §4. The 

states are concerned with the proposed language relating to the minimum data set, 

particularly the requirement that each minimum data set include the minimum amount of 

information necessary for the Administrator to conduct a screening-level risk assessment. 

This limitation appears to be open to a variety of interpretations, depending on the 

definition of screening level risk assessment. Many chemicals, particularly those 

produced at high volumes or chemicals with particular hazard traits, should receive a 

comprehensive risk assessment; the minimum data set should contain all of the data 

needed to conduct these types of assessments. The current language appears to limit the 

scope of the minimum data set in such a way as to preclude a thorough assessment of 

chemical substances without relying on additional testing orders. It is important to have a 

minimum data set that actually provides the information needed to make good decisions. 

When additional data may be needed beyond the minimum data set, there should be 

specific pre-established criteria and processes to quickly obtain this data without relying 

on additional testing orders. 
20 


24968.010

In addition, S. 847 requires that each minimum data set include information on the 

characteristics, toxicological properties, exposure, and use of chemical substances. States 

recommend that the following changes be made: characteristics changed to physical 

characteristics; exposure changed to potential exposure; and that information pertaining 

to environmental hazard be specitlcally added to this section. 

5. Chemical Substances in Priority Class 1. 

States support the detlnitions for Persistent and Bioaccumulative inS. 847. Section 7 

(Prioritization, Safety Standard Determination, and Risk Management) amends TSCA § 6 

to require the Administrator to assign a chemical substance to priority class 1 if it is 

detennined that the chemical substance is, or is degraded and metabolized into, a PBT 

with the potential for widespread exposure to humans or other organisms. 

In addition to PBTs that meet the above findings, the Administrator should be given the 

authority to add any other chemical substance that is determined to require immediate 

risk management to priority class 1. This should not be limited to PBTs. 

The term widespread should be replaced by the term significant. Significant exposure 

may occur even though that exposure may not be widespread. 

Additionally, the draft SCA requires the Administrator to determine, based on any more than 

theoretical concern, that there is uncertainty whether a chemical substance would satisfy the 

safety standard. The phrase more-than-theoretical is vague and unclear and should be refined or 

deleted. The States recommend that the language be made clear that the Administrator may ban 

PBTs and other chemicals in priority class I if, after an alternatives assessment, safer alternatives 

have been identified, regardless of whether measures are proposed to reduce exposure. 

6. Safety Standard Determination 

Section 7(b) places the burden of proof on the manufacturer and processor of a chemical 

substance to prove that a chemical substance meets the applicable safety standard. The 

EPA Administrator then determines whether the chemical substance meets the safety 

standard, using the best available science, which shall be based on the recommendations 

of a National Academy of Sciences (NAS) report entitled Science and Decisions. At a 

minimum, a timeframe should be established for the Administrator to develop guidance 

on the application of the NAS methodology to the data to be collected by the 

manufacturers for the purpose ofEPA's Safety Standard Determination, and for the 

manufacturer's requirement to indicate whether a chemical substance meets the safety 

standard. 

The requirements of the Safety Standard proposed for TSCA § 6(b) (I) (C) should be 

modified to include consideration of the most vulnerable ecosystems in addition to the 

health of vulnerable human populations. 

In addition, Section 7 amends TSCA § 6 to provide a process for determining whether 

chemicals of concern meet a safety standard and conditions under which chemicals may 

be exempted from the requirement to meet a safety standard. The public participation 
21 


24968.011

procedures as they relate to safety standard and exemption determinations are not 

adequate. While the bill authorizes a petition requesting EPA to reconsider a 

detennination that a chemical continues to meet the safety standard, it docs not provide 

for state input or public comment on initial safety standard determinations. A 

determination that a chemical meets the safety standard should be subject to a public 

notice and comment process. Similarly, while a determination to renew an exemption 

from the safety standard is subject to notice and public comment, initial determinations 

on such requests are not. Last year's House discussion draft provided for notice and 

comment on initial exemption requests. We submit that this is the better approach as it 

provides an opportunity for the broadest exchange of information on these two key 

determinations, which have public health and environmental impacts. 

7. Data Sharing-Confidential Business Information. 

Section 14 (Disclosure of Data) amends TSCA § 14 to provide for sharing of confidential 

information with states, tribes and local governments, upon request, for the purpose of 

administration or enforcement of a law and in accordance with one or more applicable 

agreements to ensure that confidentiality is maintained. We suggest two revisions to this 

section to facilitate a streamlined data sharing process and strengthen the state/federal 

partnership. First, access to confidential information should not be conditional on its use 

for administration or enforcement of an existing law. A growing number of states have 

taken, or are considering, action to regulate various toxic chemicals now in commerce. 

Unfettered state access to information on chemical substances is important, not only to 

administer and enforce existing laws, but also to inform state decision-making on the 

need for further regulation or restrictions on chemical substances. 

Second, the reference to applicable agreements in§ 14 is not clear. As an alternative, we 

suggest that state access to confidential information should be provided so long as the 

state agrees to safeguard the information under procedures that are equivalent to those 

utilized by EPA. We also suggest that EPA be required to coordinate and consult with 

the states in establishing a streamlined information sharing process. 

8. Green Chemistry, Safer Alternatives and Market Incentives. 

The development of safer alternatives to existing hazardous chemicals is an important 

tool to facilitate a shift away from the use of hazardous chemicals in commerce. S. 847 

should encourage manufacturers and processors to evaluate whether functionally 

equivalent alternatives are available, especially for those chemicals identified in priority 

class l, new chemical substances, or existing chemicals substances with new uses. EPA 

should be given the authority to ban these chemical substances to reduce the level of 

hazard posed by the chemical substance if a functionally equivalent alternative exists. 

Currently, the bill only requires a manufacturer or processor to evaluate whether feasible 

alternative exists if they are applying for an exemption to an EPA imposed prohibition. 

EPA, the States, formulators and the public should have access to identified safer 

alternatives to hazardous substances. The states strongly support the creation of market 

incentives for the development of safer alternatives, such as expedited EPA review of 
22 


24968.012

new chemicals that include a safer alternatives analysis, as provided in § 31, but this is 

not sufficient to ensure a systematic approach to determine if functionally equivalent, 

safer chemical substances are available. 

S. 847 is silent on criteria for evaluating chemicals and their alternatives. The bill should 

require that, within a year of enactment, EPA define and establish criteria for safer 

alternatives through rulemaking. At a minimum, safer alternatives should be identified 

based on risk assessment throughout the life cycle of a chemical substance. Other criteria 

that EPA might include are product function or performance, useful life, materials and 

resource consumption, water conservation, water quality and air emission impacts, 

transportation-related energy usage, greenhouse gas emissions, waste and end-of-life 

disposal impacts and public health, environmental and economic impacts. EPA could 

benefit from the states' experience in these areas and with these types of evaluations, and 

we have identified this as one of the recommended areas for enhanced state coordination. 

Public outreach and perhaps labeling explanation also will be needed to help people 

understand that safer alternatives mean less risk, not no risk. 

9. Development of Hot Spot Action Plans. 

Section 34 requires EPA to identify localities that arc disproportionately exposed to toxic 

chemicals and mixtures (the Hot Spot list), and after consultation with applicable state and local 

governments and elected officials. to publish the list. Subsection (f) further requires EPA to 

develop Hot Spot plans for EPA action to reduce disproportionate exposure in the identified 

localities. 

Addressing exposures using public health as the end rather than media-specific cleanup standards 

is strongly needed; however, this section does not provide for a state or local government role in 

developing or implementing such plans, a process for prioritizing the most severely impacted 

localities, or an identified source offunding to implement action plans. A collaborative 

relationship between the federal, state, and local governments in this regard, as well as adequate 

funding, is essential to successful implementation of these important environmental justice 

provisions. The States recommend that these additions be made to § 34. 

10. Coordination between Federal Agencies with Chemical Oversight Responsibilities. 

States support formal, ongoing and strong coordination between all federal agencies with 

responsibility for oversight of chemicals, including FDA, FIFRA, OSHA and CPSC. There also 

should be strong coordination within agencies, particularly EPA, so that decisions about chemical 

safety made in the TSCA program are considered in the media programs. 

11. Funding for Technical Assistance to Business through State Environmental 

Agencies. 

The bill does not currently provide any state funding to facilitate the usc of safer 

chemicals. Grant funding should be provided for State programs to reduce the use of and 
23 


24968.013

exposure to hazardous chemicals, including technical assistance to businesses seeking 

information on chemical use and exposure reduction strategies and pollution prevention 

and green chemistry, including onsite technical assistance to facilitate development of 

state and local toxic use reduction and pollution prevention plans; state chemicals 

clearinghouse data and information sharing to facilitate collaboration between state and 

local jurisdictions on chemicals information and data, product information, and safer 

alternatives outreach and education; training in chemical use and exposure reduction 

strategies and programs; reporting of state performance output and outcome measures; 

state recognition programs for reduction in toxic chemicals or implementation of 

voluntary programs; and monitoring of chemicals in the environment, animals, and 

humans to assess persistence and bioaccumulation. 

12. Regulation of PCB Waste and Residuals. 

TSCA Section 6 should be amended to provide for regulation of the management and 

disposal of polychlorinated biphenyl (PCB) waste and residuals under the appropriate 

provisions ofRCRA and CERCLA. Currently, the management and disposal of PCB 

wastes and residuals are subject to overlapping regulation under three separate federal 

environmental statutes-TSCA, RCRA, and CERCLA. PCBs are identified as a hazardous 

constituent under RCRA and as a hazardous substance regulated under CERCLA. The 

existing regulatory authority under RCRA and CERCLA governing the management and 

disposal of hazardous and toxic wastes and residuals is broader in scope than the 

authority under TSCA. The coordination of management of PCB wastes and residuals 

under these overlapping authorities often requires substantial time and effort between the 

three regulatory programs, resulting in a redundant, cumbersome approval process that 

impedes the timely and efficient remediation of contaminated properties and management 

of PCB wastes and residuals. 
24 


24968.014

Follow~up Questions Resulting from the November 17, 20ll, 

U.S. Senate Committee on the Environment & Public Works Hearing 

on the Safe Chemical Act of2011 

Questions from Senator Barbara Boxer: 

1. Mr. Sturdevant, can you describe the benefits to states from passage of federal legislation that 

reforms the Toxic Substances Control Act by creating strong standards to protect public health 

and the environment/rom dangerous chemicals? 

Response: The ultimate benefit to slates is reduced costs, improved public health and 

environmental protection. Passage of a TSCA reform bill that includes a preventative approach 

will put us on the path towards Jess chemical exposures that will improve public and 

environmental health, reduce the number of toxic chemical cleanup sites, and provide businesses 

with more regulatory certainty. Another benefit ofTSCA reform is the opportunity to enhance 

economic competitiveness and innovation for businesses and communities in our states. 

The benetlts to states from comprehensive TSCA refonn include: 

• A stronger, more protective federal system. 

Improved public health and environment by preventing harmful chemical exposures. 

Lower costs and risks to states. especially for states that do not have adequate tools or 

resources to tackle toxic chemical pollution. 

A more predictable regulatory system across all the states: less of a patchwork of regulation. 

Better data and infonnation on chemical toxicity. including improved transparency. 

States/federal partnership to address the most problematic chemicals on the market. 

Economic opportunity tor states through expanding markets tor safer chemicals and products. 

Sustaining the U.S. chemical industry and growing new jobs in our states. 

States action is growing in this area that can help inform a refonncd national system. Over the 

past nine years, there have been at least 81 state chemicals policies in 18 states related to 

chemicals of concern. Results from the states • experience can provide Congress with "on the 

ground" experiences and the practical aspects of running chemical management programs. 

One aspect of these states' actions is a concern from industry about the patchwork of state 

regulations. While I agree that a strong federal program is critical, the states will continue to 

respond to local problems and concerns as needed. 

2. Mr. Smrdeva/11, can you describe the difficulties that states may encounter by the lack of federal 

legislation reforming the Toxic Substances Control Act in a way that creates strong standard! to 

protect public health and the environment from dangerous chemicals? 

Response: Without a strong federal system, the states will continue to pursue legislative and 

administrative action on a state-by-state basis. This will cost states more in the future to 

implement our own chemical management programs. 
25 


24968.016

Lack of federal action on chemicals of concern will lead to future chemical contamination and 

cleanup sites. The cost of these sites is expensive and places a burden on taxpayers and 

businesses. 

It is difficult and expensive for states to take action on individual chemicals. Many states don't 

have the technical expertise or resources to address these challenges through a chemical-bychemical approach. 

Removing toxic chemicals from stormwater pollution, drinking water, and consumer products is 

expensive and sometimes impossible. Until we make the necessary reforms, our current pollution 

control practices force us to focus on detection and control, management methods, and treatment 

once the chemicals are in the environment. Without changes, our current regulatory system 

cannot prevent the creation of future contamination and cleanup sites, negative impacts on the 

economic vitality of local communities and expected increased healthcare costs. 

Another problem is interstate commerce. States don't have the authority to regulate commerce 

across our boundaries. Without TSCA reform, it's increasingly difficult for businesses in our 

states to harn1onize with other countries that are reforming their own chemicals management 

systems. This reduces our competitiveness in the states for chemical producers and formulators 

that are selling into international markets. 

States cannot adequately address the international nature of the global chemicals market. States 

do not have the authority to restrict the international use of chemicals that may end up in products 

that are produced in foreign markets, but re-enter through the states. One example is the 

production of perfluorinated chemicals (PFCs). These chemicals are used in global 

manufacturing and industrial applications, but are restricted on a voluntary basis in the U.S. 

Although the U.S. EPA and eight major companies established the 2010/15 PFOA Stewardship 

Program in 2006, there arc no international restrictions that prevent the use of these chemicals 

that may end up in products that re-enter through the states and into commerce. This is an 

example where EPA needs to have the tools to address this type of problem in a modernized 

TSCA. This is necessary to move away from the most problematic chemicals on the market. 

International harmonization is also necessary to effectively phase out or ban problematic 

chemicals, which will otherwise end up back in the U.S. 

3. Mr. Sturdevant, you are the Director of the State of Washington's Departme11f of Ecology. Could 

you please describe the importance of maintaining states ' authorily to address the threats to 

public health from dangerous chemicals, and the need to ensure That the federal TSCA reform 

legislation does not take this authorily away from states? 

Response: I support the express preservation of state authority in § 18 of the Safe Chemicals Act 

of2011 (S. 847) and urge Congress to retain this language. TSCA reform should set the floor, 

not the ceiling, on protecting public health. 

Many federal environmental laws expressly preserve state authority. For example, many states 

have programs that contain requirements in addition to those specified in the Resource 

Conservation and Recovery Act {RCRA). Washington State has enacted toxic chemical cleanup 

legislation that is more restrictive than the Comprehensive Environmental Response, 

Compensation and Liability Act (CERCLA). States also have state cleanup programs in addition 

to CERCLA. The Clean Air Act authorizes California to establish more stringent vehicle 

emission standards, which can then be adopted by other states in lieu of the federal standards. 
26 


24968.149

These are only a few examples where state authority has been maintained without disruption of a 

federal program. Preservation of state authority is both workable and necessary. 

However, if done correctly, a modernized TSCA will establish a strong federal chemical 

regulatory system that reduces the potential for individual states' action. 

Unfortunately, given that we cannot predict the future chemicals market, it is necessary that we 

expressively preserve the authorities of states to take action. Federal legislation will likely be a 

product of consensus, which means that it may not entirely fill the needs of states. As outlined in 

the Safe Chemicals Act of 20 II, priority I chemicals will be the initial focus, which will likely be 

a limited number of chemicals to be addressed by U.S. EPA. States may wish to augment this 

approach based on individual state needs. 

lt is now 2012, and most agree that TSCA reform is long overdue, For the past several years, as 

Americans became aware of shortcomings in federal protections, they have demanded change. It 

has been the states who have provided that change. Given industry's proven ability to block 

refonn, the American people should not be deprived of future protection in their home states. 

A reformed TSCA that allows states to bring forward chemicals of concern would provide 

additional safeguards for federal regulators. One new model is the approach currently authorized 

in the European Union's REACH regulations. REACH provides for identifying Substances of 

Very High Concern (SVHCs), meeting the criteria referred to in Article 57 and for establishing 

the "candidate list" for inclusion into the Authorization List. A key provision of this Article is 

that these substances are identified on the basis of proposals submitted by Member States or by 

the European Chemicals Agency {ECHA). Substances included on the candidate list are subject 

to information and notification requirements and can be prioritized and included in Annex XIV of 

REACH, which lists the substances subject to authorization. 

Reforming TSCA to allow states to bring forward the chemicals of concern in our states should 

be continued as a principle in TSCA reform. This will create additional accountability of the 

overall system and provide for an enhanced states/federal partnership on chemicals management. 

4. Mr. Swrdevant, do you believe that the bill establishes the right policy by ensuring that chemical 

manufacturers and processors have the duty to show that a chemical meets the safety standard? 

Whm benefits does this policy have for agencies that are charged with protecting public heaflh 

fi'om dangerous chemicals? 

Response: Yes, absolutely, but it all depends on getting the standard right- which is challenging, 

but can and must be done. Requiring chemical manufacturers and processors to show that a 

chemical meets the safety standard will improve consumer confidence with the industry's current 

practices. 

The Safe Chemicals Act of:ZOII should be amended to include the option of an alternatives 

assessment in the safety standard determination methodology. This would allow EPA to usc the 

best available science when conducting an assessment of risk. 

The benefits to agencies protecting public health include improved data and transparency, and 

fewer threats to public health. 
27 


24968.017

5. Mr. Swrdevant. do you believe that ir is Important for the federal government ro help promote 

innovarion in the development of safer alternatives to toxic chemicals through the development of 

a green chemistry program? 

If so, do you believe that S. 847 's provisions on green chemistry can help to promote such 

innovation? 

Response: The goal of green chemistry is to reduce or eliminate the use and/or generation of 

hazardous substances or processes. Green chemistry and TSCA reform go hand in hand, but they 

are not the same thing. TSCA reform will drive the demand for safer alternatives, but the science 

of green chemistry will ultimately provide the solutions and economic prosperity. 

The green chemistry provisions in S. 847 recognize the importance of incentives, research, 

education, and workforce development as the cornerstones for the advancement of green 

chemistry science. Additional green chemistry education provisions should be added to provide 

funding to k-12 and higher education academic institutions. This funding will enhance our state 

and private educational institutions' abilities to attract and teach green chemistry. Providing 

foundational funding will jumpstart innovation and economic development. 

I also recommend adding state "green chemistry research and development" grant programs to 

foster state, university and industry green chemistry pannership research and education programs. 

For example, Michigan has established a Green Chemistry Clearinghouse Program that brings 

together industry, government, and educators to advance the science of green chemistry. There 

are similar efforts in New England, Minnesota, Oregon and Washington State. Adding state 

grants for green chemistry economic development and commercialization will spur new business 

development. 

However, given that green chemistry is not going to happen overnight, it is critical that TSCA 

reform address the demand to identifY safer alternatives to existing hazardous chemicals. 

I believe that S. 847 should require manufacturers and processors to evaluate whether alternatives 

are available for problematic chemicals, especially those identified in priority class I. 

EPA should be given the authority to ban these chemical substances to reduce the level of hazard 

posed by the chemical substance if a safer and functionally-equivalent alternative exists. 

Currently, the bill only requires a manufacturer or processor to evaluate whether a feasible 

alternative exists if they are applying for an exemption to an EPA-imposed prohibition. EPA, the 

states, formulators and the public should have access to identified safer alternatives to hazardous 

substances. The states strongly support the creation of market incentives for the development of 

safer alternatives, such as expedited EPA review of new chemicals that include a safer 

alternatives analysis, as provided in § 31, but this is not sufficient to ensure a systematic approach 

to determine if functionally-equivalent, safer chemical substances are available. 

S. 847 is silent on criteria for evaluating chemicals and their alternatives. The bill should require 

that, within a year of enactment, EPA define and establish criteria for safer alternatives through 

rulemaking. At a minimum. safer alternatives should be identified based on risk assessment 

throughout the life cycle of a chemical substance. Other criteria that EPA might include are product function or performance, useful life, materials and resource consumption, water 

conservation, water quality and air emission impacts, transpor1ation-relatcd energy usage, 

greenhouse gas emissions, waste and end-of-life disposal impacts and public health, and 

environmental and economic impacts. EPA could benefit from the states' experience in these 
28 


24968.018

areas and with these types of evaluations, and we have identified this as one of the recommended 

areas for enhanced state coordination. Public education will be needed to help people understand 

that safer alternatives mean less risk, not zero risk. 

Questions from Senator Tom Carner: 

I. What do you believe is the biggest outstanding issue lhat the environmental and public health 

communities, the chemical industry, and others engaged in efforts 10 reform the Toxic Substances 

Control Act need to come closer together on In order to further strengthen the Safe Chemicals Act 

and gain even more support for reforming the country's chemical safety laws? 

Response: Addressing the data safety standard is probably the biggest outstanding issue at the 

moment, but confidential business information, state preemption, and the role of states are critical 

as well. I recommend that continued dialogue with all the stakeholders is needed to fun her refine 

the issues and to identil'y solutions. I am panicularly interested in hearing more specifics from 

industry representatives on concerns with S.847 and opponunities for improvement. 

2. Over the last several years. Europe. Canada, Australia, Korea, China, and other countries have 

tmderraken reforms of their nations· chemical safety laws. What can we learn from these 

countries' efforls to improve the safo use of chemicals? How can these lessons inform the work 

of the Senate Commillee on Environment and Public Works in proceeding willt the Safe 

Chemicals Act? 

Response: The most significant concept in the EU REACH Program is the concept of"no data, 

no market" for chemicals in commerce. This is the underpinning of the regulations that requires 

industry to provide chemical data information to the government. Another imponant lesson is the 

opponunity for global harmonization and sharing of data to improve efficiencies for government 

and industry. Canada and other jurisdictions have undenaken chemicals prioritization to address 

chemicals of concern. 

I recommend the Commi«ee staff reach out to these jurisdictions in order to inform the TSCA 

reform process, since chemicals are pan of a global market. Effons to harmonize, share toxicity 

information, identify and take action on high priority chemicals should be incorporated into 

TSCA reform. 

Another key provision in REACH Anicle 55 is the goal of authorization to ''ensure the good 

functioning of the internal market, while assuring that the risks from substances of very high 

concern (SVHS) are properly controlled, and that these substances are progressively replaced by 

suitable alternative substances or technologies where these arc economically and technically 

viable." 

The use of the "substitution principle" promotes the replacement or reduction of hazardous 

substances in products and processes by less hazardous or non-hazardous substances, or by 

achieving an equivalent functionality via technological or organizational measures. The 

substitution principle should be applied whenever safer alternatives are available at an acceptable 

socio-economic cost to replace persistent, bioaccumulative and toxic chemicals (PBTs) and other 

chemicals of concern. 
29 


24968.019

Japan issued updated regulations under its Chemical Substances Control Law (CSCL), 

Companies manufacturing and importing chemicals in Japan were required to submit 

notifications on June 30, 2011, for chemicals produced in volumes over one ton (metric ton), as 

well as for 88 "Priority Assessment Chemicals" (PACs) produced at any volume. PACs are those 

chemicals deemed to be of particular concern based on a combination of exposure and hazard 

information. 

The Japanese Ministry of Economy, Trade and Industry (MET!) will use information from the 

CSCL notifications to develop an expanded list of PACs. These chemicals will then undergo risk 

assessments. The prioritization process will ultimately allow METI to request hazard data on 

chemicals that raise significant concerns. The first list ofPACs was published on April!, 2011, 

and MET! forecasts the addition of approximately 1,000 PACs by March of2012. 

China recently unveiled its 12th Five-Year Plan for Environmental Protection. In the section that 

addresses chemicals management, the plan sets out to establish two priority chemical lists: one 

"Phase-out List of Hazardous Substances" under the 12th Five-Year Plan and one "List of Key 

Hazardous Substances for Priority Environmental Management, • under the recently released 

Measures for the Registration of Dangerous Chemicals for Environmental Management. 

Australia's National Industrial Chemicals Notification and Assessment Scheme (NlCNAS) and 

Environment Canada and Health Canada signed an agreement in December 20 II to enhance 

technical cooperation and share information on existing industrial chemicals. This replaces an 

earlier agreement between the counties that only covered new chemicals. 

Senator lnhofe's Questions: 

I. Mr. Sturdevant, in your testimony, you state that under the current TSCA. the "system is not 

designed to move us toward safer chemicals" and rhaf states have "to wage long, biller j/ghfs 

over controlling a specific chemical, but with no effective inducement to them to shifi to safer 

alternatives." One major concern that we have heard about this bill as written would be that it 

might stifle the ability to bring new chemicals to market. Even many crilics ofTSCAfeelthe 

current new chemicals program has been very successfiil and protected the public. Wouldn 'I 

putling additional barriers to bringing new chemicals to market equate to barriers to bringing 

less toxic chemicals to market? 

Response: S. 847 includes incentives to bring less toxic chemicals to market under Section 31 of 

the bill. This section requires EPA to establish a progrnm to create market incentives for the 

development of safer alternatives, including a provision for expedited reviews and recognition. 

One example is EPA's pesticide registration progrnm that places a high priority on registering 

new pesticides that are safer than pesticides currently on the market, those with public health 

benefits, and pesticides that are of particular economic importance to producers. This might be a 

potential model to review, or perhaps there are other good examples in other federal agencies. 

Providing the government with necessary data provides a "level playing field" for industry to 

compete in the growing market for safer chemical alternatives and green chemistry. Providing 

the right signals and incentives in TSCA reform will spur the development of safer chemicals and 

create a demand that businesses will jump to fill. Providing for market innovation that allows 

industry to embrace the principles of green chemistry at the design phase will create a market 

advantage for those companies seeking new market opportunities and growth. TSCA reform 
30 


24968.020

should provide an opportunity to move from the status quo where existing grandfathered toxic 

chemicals have a market advantage over new chemicals. 

2. In your testimony, you also mention that Washington was the "first state in the nation to ban all 

forms of P BDEs. " Was this a total ban or does your state recognize exemptions? If there are 

exemptions, why were they enacted ond do you supporttlrem? If there are exemptions. and EPA 

was to ban all forms of PBDEs under S. 847 authorities, what effects would losing tho.fe 

exemptions have on the state of Washington's economy? 

Response: The Washington ban (RCW 70.76)1 passed in 2007 encompassed most uses of the 

penta- and octa-BDE mixtures. The legislation also included a ban on the third PBDE mixture, 

deca-BDE, in mattresses and allowed a further ban in electronics and residential upholstered 

furniture if a safer alternative could be identified. We supported legislation that essentially 

banned all three forms of the chemical, but allowed for particular uses. 

A unique aspect of this legislation involved the creation of a lire safety committee to review the 

alternatives. ln November 2008, the agencies presented our recommendations to the Fire Safety 

Committee, made up of live lire safety experts, and they unanimously approved the alternatives 

presented. The State Fire Marshal determined that the alternative met applicable fire safety 

standards as required by the law. 

On January 20, 2009, Ecology submined a report to the Legislature describing how Ecology and 

Health evaluated alternatives for technical feasibility, toxicity and lire safety. lt also explains 

how the agencies were able to identitY safer alternatives. The report triggered the state ban on the 

manufacturing, sale and distribution of televisions, computers and residential upholstered 

furniture containing Deca-BDE by January 20 II. 

The banning of deca-BDE in electronics and residential upholstered furniture covered more than 

80% of the traditional deca-BDE use prior to the ban and has substantially restricted the use of 

this toxic flame retardant. Other uses of deca-BDE are not currently banned within Washington 

State. 

Specific exemptions were included by the Legislature in the original PBDE legislation. RCW 

70.76.020 identities a list of specific exemptions including military and space applications, FAA 

lire worthiness requirements and recommendations, transportation applications, sales by nonprofit organizations, etc. It is my understanding that these exemptions were included because 

specific industries were able to make a case to the Legislature that alternatives do not currently 

exist or that a ban was unreasonable in certain cases. The result is a ban on the most wide-spread 

uses, significantly reducing the risk of exposure, while exempting lower volume uses for which 

alternatives were not available, or where a ban was not feasible. I support this policy as a good, 

common sense solution. 

J You mention multiple forms of flame retardants in your testimony as examples of chemicals that 

are being regulated at a state level and in some instances pose "unacceptable" risks. If this 

legislation is enacted a11d EPA is unable to find a sllitable alternative which meets a 

"reasonable certainty of no harm "finding, is there any ··unacceptable" risk from products not 

protected from flammability? 

1 Chapter 70.76 RCW Polybromlnated dipheoyl ethen-flame retardants, avallabte at: 

htsp'l/apru.lftS.wa.gov(IU;W/dP.fault aspx 'citt>= 70.76&full=ttue,_7Q. 76 020 accessed 12/30/2011. 
31 


24968.021

Response: I support regulations that create an evaluation and approval process for continued use 

of a toxic chemical in certain situations. This would include a peer-reviewed scientific evaluation 

to determine, after a rigorous review and approval process, that no viable alternative exists or is 

likely to exist. The evaluation should also address if the risk posed from continued use of the 

toxic chemical is greater than the risk posed by its discontinued use. In some cases (perhaps 

many) it may make sense to continue such a chemical's use. 

I recommend that this process include a full life cycle assessment of the impacts upon human 

health and the environment and not just the impact from the use of a specific product. Our 

current risk management paradigm does not generally take into consideration the impacts from 

manufacture, transport, use, removal, disposal, etc. of a chemical throughout the entire value 

chain. The process should also recognize that non-chemical, product redesign and pollution 

prevention methods may be preferred to continued uses. For example, my staff and our partners 

at the Washington State Department of Health determined that, for residential upholstered 

furniture, the preferred alternative was to redesign the furniture using barriers that maintained fire 

safety. In this example, fire safety could be maintained through product redesign and toxic flame 

retardants such as deca-BDE were not needed. 

4. When you mentioned rhe PBDEs posed an "unacceptable" risk. how did you come to that 

ca/cularion? Should federal chemical managemem recognize an acceplable level of risk? Is 

rhere a way to calculare "unacceprable" risk as you have categorized it wirhoul some sort of 

cost·bemftt analysis? 

Response: The process Ecology used to determine risk is well documented in our report to the 

Washington Legislature: "Alternatives to Deca-BDE in Televisions and Computers and 

Residential Upholstered Furniture. "

2 Our approach can be summarized as an optimized risk 

reduction methodology. 

This approach allows us to identify a universe of chemicals that are potential replacements for a 

toxic chemical. As risk is a function ofhazard and exposure, these alternatives are reviewed for 

the hazard they pose to human health and the environment using principles established by the 

Environmental Protection Agency's Design for the Environment Program. Those chemicals that 

are identified as posing less of a hazard are subjected to additional filters including exposure, 

economic feasibility (including cost benefit review), functional feasibility, etc. At the end of this 

process, an alternative is identified that has both the lowest possible risk, as identified by 

optimizing hazard reduction and exposure concerns, while maintaining economic viability. 

Our approach includes chemical eliminalion and product redesign options. If no chemical 

avoidance and product redesign options are available, chemicals with significantly reduced 

hazard are identified for further evaluation. After evaluating exposure scenarios, chemicals that 

are optimized for risk reduction inherently include the lowest possible acceptable risk. Further 

evaluations and determinations may be necessary if no suitable alternatives can be met. 

Determining "acceptable" and "unacceptable" risk is ultimately a judgment call based on a 

careful weighing of costs and benefits. In the case ofPBDE's, the science showed significant 

cause for concern, particularly to young children. On the other hand, no one wants inadequate 

protection from fires. In the end, it was the fact that fire safety could be maintained without decaBDE that led to our conclusion that the risk was unacceptable. 

2 Ecology publication Number09·07-D4l~ Published Jan~ry 2009, ava!fabfe ..,t: http:/lwww ccy wa gcvfb,bhol9907041 hlml. accessed 

12/30/2011. 
32 

Senator LAUTENBERG. Ms. Brody, welcome. 

STATEMENT OF CHARLOTTE BRODY, DIRECTOR OF CHEMICALS, PUBLIC HEALTH AND GREEN CHEMISTRY, 

BLUEGREEN ALLIANCE 

Ms. BRODY. Chairman Lautenberg, Ranking Member Inhofe and 

Members of the Committee, thank you for the opportunity to appear before you. I am Charlotte Brody, a registered nurse, a mother, and the Director Chemicals, Public Health and Green Chemistry for the BlueGreen Alliance, a unique partnership of 11 labor 

unions and four environmental organizations. 

We bring together 15 million Americans in pursuit of good jobs, 

a clean environment, and a green economy. We support the passage 

of the Safe Chemicals Act because it can create some of the middleclass manufacturing jobs that our Country so desperately needs. 

Between 1992 and 2010, more than 300,000 chemical manufacturing jobs disappeared in the United States. Employment feel 38 

percent in the chemical industry at a time when all manufacturing 

declined by 24 percent. 

Among the union partners of the BlueGreen Alliance, the steelworkers represent the majority of organized workers in the chemical industry. Two other BlueGreen Alliance union partners also include some chemicals workers in their ranks. These unions and 

their members depend upon the existence of an American chemical 

industry. We need more Americans making chemicals and more 

people using chemicals made in America. 

We support the Safe Chemicals Act because we believe it will 

spur innovation and the invention of a new generation of safer 

chemicals that can be produced in the United States. 

I started practicing as a registered nurse around the time that 

TSCA became law. If I had practiced nursing the way I did then, 

I would be in prison for gross negligence and malpractice. That is 

how much as have learned about disease and treatment since then. 

What have we learned about human disease and chemicals? Let 

me just use the example of Agent Orange. Decades ago, I worked 

with young soldiers coming back from Vietnam. Those who had 

been exposed to Agent Orange were informed that their skin rash, 

core acne, was the only problem they would have from their exposure. That is what the science told us then. But over the last 40 

years, new knowledge keeps showing us how wrong we were. 

Now, Vietnam veterans who were exposed to Agent Orange, even 

those who didn’t have the skin rash, can be compensated for one 

kind of leukemia, two kinds of lymphoma, four other kinds of cancer, as well as diabetes, a type of heart disease and Parkinson’s 

disease. The V.A. also recognizes as compensable spina bifida, a defect of the developing fetus that results in incomplete closure of the 

spine in the children of Vietnam veterans born decades later. One 

chemical; so many diseases, including in children born decades 

later. 

Forty years ago, we simply didn’t understand that chemicals 

could do that. Allowing our Nation’s chemical management system 

to remain lost in the 1970’s is its own form of negligence. The punishment for this negligence is cancer, birth defects, infertility, asthma, and nervous system disorders. But the sentence is being doled 

33 

our indiscriminately to workers, babies in utero, the people who 

live at the fence-line of chemical plants, and millions of other 

chronically ill Americans, including people each of you were sent 

here to represent. 

The Safe Chemicals Act would modernize TSCA to reflect what 

we have learned about chemicals and human health since the 

1970’s. The bill’s safety standard of reasonable certainty of no 

harm from aggregate exposure captures the way good science 

works and underscores the legislation’s intent to make chemicals 

safe. 

Especially important for the members of the BlueGreen Alliance 

is that workers are identified as part of the vulnerable populations 

protected under that standard. The prioritization system and tiered 

use of data do a good job of tackling the huge problems created by 

decades of unregulated chemicals and starting to solve that problem with a worst-first approach. 

I represented the BlueGreen Alliance in the stakeholder process 

that Senators Inhofe and Lautenberg co-hosted this year and I 

comment both of you and your staffs for creating a careful, reasoned and reasonable dialog. 

I was trained as an OB/GYN nurse and I still think like a nurse. 

I know that the Senate has become a deeply partisan place and the 

proposal that would give the EPA more power to protect are not 

popular in every office. But the Safe Chemicals Act is fundamentally not about politics. It is about mercury in breast milk. It is 

about phthalates in newborn babies cord blood. And it is about the 

creation of new set of American manufacturing jobs making chemicals that are 21st century safe. Doing nothing is a negligent act. 

Thank you. 

[The prepared statement of Ms. Brody follows:] 

34 


24968.022

BLUEDREEN 

AlliANCE 

www.blueg reenallia nce.org 

Testimony of Charlotte Brody 

BlueGreen Alliance 

330 Townsend S:reel, Swte 205 

Sun FriJIKtSCO, CA 94107 

before the 

U.S. Senate Committee on Environment and Public Works and 

Subcommittee on Superfund, Toxics and Environmental Health 

joint Legislative Hearing on the Safe Chemicals Act 

November 17, 2011 

Washington, DC 

Chairman Boxer, Chairman Lautenberg, Ranking Members lnhofe and Crapo and members of 

the committee, thank you for the opportunity to appear before you this morning. I am 

Charlotte Brody, a registered nurse and the Director of Chemicals, Public Health and Green 

Chemistry for the BlueGreen Alliance. 

The BlueGreen Alliance is a unique partnership of 11labor unions and four environmental 

organizations. We bring together 15 million Americans in pursuit of good jobs, a clean 

environment and a green economy. We support the passage of the Safe Chemicals Act because 

it can create some of the middle class manufacturing jobs that our country desperately needs. 

Between 1992 and 2010 more than 300,000 chemical manufacturing jobs disappeared in the 

United States. Employment fell 38 percent in the chemical industry, at a time when all 

manufacturing jobs declined by 24 percent. 

I know I look more like the old nurse that I am than the typical image of a Steelworker. But I 

am a proud-dues paying member ofLocal2002-22 of the Steelworkers and a Safety and Health 

Advisor to the Steelworkers' Health, Safety and Environment Department. Among the union 

partners of the BlueGreen Alliance, the Steelworkers represent the majority of organized 

workers in the chemical industry, as well as hundreds of thousands of workers who use 

chemicals on the job. Two of the BlueGreen Alliance's other union partners, the United Food 

and Commercial Workers and the IUE-CWA also include some chemical workers in their ranks. 

These unions and their members depend upon the existence of an American chemical industry. 

We need more Americans making chemicals and more Americans using chemicals made in 

America. But we won't be able to achieve that vision if we're just producing and using the 

same chemicals that were in production 40 years ago. We support the Safe Chemicals Act 

because we believe it will spur innovation and the invention of a new generation of safer 

chemicals that can be produced in the United States. 

I started practicing as a registered nurse around the time that TSCA became law. If I practiced 

nursing the same way I did then, I would be in prison for gross negligence and malpractice. The 

science about disease and treatment has changed so much since then. 

CWA tr.-oc 
35 


24968.022

BLUEDREEN 

AlliANCE 

www.blueg reenallia nce.org 

Testimony of Charlotte Brody 

BlueGreen Alliance 

330 Townsend S:reel, Swte 205 

Sun FriJIKtSCO, CA 94107 

before the 

U.S. Senate Committee on Environment and Public Works and 

Subcommittee on Superfund, Toxics and Environmental Health 

joint Legislative Hearing on the Safe Chemicals Act 

November 17, 2011 

Washington, DC 

Chairman Boxer, Chairman Lautenberg, Ranking Members lnhofe and Crapo and members of 

the committee, thank you for the opportunity to appear before you this morning. I am 

Charlotte Brody, a registered nurse and the Director of Chemicals, Public Health and Green 

Chemistry for the BlueGreen Alliance. 

The BlueGreen Alliance is a unique partnership of 11labor unions and four environmental 

organizations. We bring together 15 million Americans in pursuit of good jobs, a clean 

environment and a green economy. We support the passage of the Safe Chemicals Act because 

it can create some of the middle class manufacturing jobs that our country desperately needs. 

Between 1992 and 2010 more than 300,000 chemical manufacturing jobs disappeared in the 

United States. Employment fell 38 percent in the chemical industry, at a time when all 

manufacturing jobs declined by 24 percent. 

I know I look more like the old nurse that I am than the typical image of a Steelworker. But I 

am a proud-dues paying member ofLocal2002-22 of the Steelworkers and a Safety and Health 

Advisor to the Steelworkers' Health, Safety and Environment Department. Among the union 

partners of the BlueGreen Alliance, the Steelworkers represent the majority of organized 

workers in the chemical industry, as well as hundreds of thousands of workers who use 

chemicals on the job. Two of the BlueGreen Alliance's other union partners, the United Food 

and Commercial Workers and the IUE-CWA also include some chemical workers in their ranks. 

These unions and their members depend upon the existence of an American chemical industry. 

We need more Americans making chemicals and more Americans using chemicals made in 

America. But we won't be able to achieve that vision if we're just producing and using the 

same chemicals that were in production 40 years ago. We support the Safe Chemicals Act 

because we believe it will spur innovation and the invention of a new generation of safer 

chemicals that can be produced in the United States. 

I started practicing as a registered nurse around the time that TSCA became law. If I practiced 

nursing the same way I did then, I would be in prison for gross negligence and malpractice. The 

science about disease and treatment has changed so much since then. 

CWA tr.-oc 
36 


24968.023

What have we learned about human disease and chemicals? It's hard to cram 40 years of 

science into 5 minutes of testimony. So let me just use the example of Agent Orange. Decades 

ago I worked with young soldiers just back from VietNam. Those who had been exposed to 

Agent Orange were informed that the skin rash, chloracne, was the only problem they would 

have from their exposure. 

That's what the science told us then. But over the last 40 years new knowledge keeps showing 

us how wrong we were. Every few years the Institute of Medicine looks at the new science and 

learns more about how this one chemical can cause multiple kinds of harm, even to people 

who had no acute effects. Now Vietnam veterans who were exposed to Agent Orange can be 

compensated one kind of leukemia, two kinds oflymphoma (Hodgkin's Disease, non-Hodgkin's 

lymphoma) and four other kinds of cancer as well as diabetes, a type of heart disease and 

Parkinson's Disease. The VA also recognizes as compensable spina bifida, a defect in the 

developing fetus that results in incomplete closing of the spine in the children of Vietnam 

veterans. One chemical. So many diseases, including in children born decades later. So many 

years after exposure. Four decades ago we simply didn't understand that chemicals could do 

that. 

Allowing our nation's chemicals management system to remain lost in the 1970s is its own 

form of negligence, especially when we have the opportunity to modernize the law. The 

punishment for this negligence is cancer, birth defects, infertility, asthma and nervous system 

disorders. But the sentence is being doled out indiscriminately to workers, babies in utero, the 

people who live at the fence line of chemical plants and millions of other chronically ill 

Americans, including people each of you were sent here to represent. 

The Safe Chemicals Act would modernize TSCA to reflect what we've learned about chemicals 

and human health since the 1970s. The bill's safety standard of reasonable certainty of no 

harm from aggregate exposure captures the way good science works and underscores the 

legislation's intent- to make chemicals safe. Especially important for the members of the 

BlueGreen Alliance is that workers are identified as part of the vulnerable populations 

protected under that standard. The prioritization system and tiered use of data do a good job 

of tackling the huge problem created by decades of unregulated chemicals and starting to solve 

that problem with a worst first approach .. I represented the BlueGreen Alliance in the 

stakeholder process that Senators Inhofe and Lautenberg co-hosted this year and I commend 

both of you and your staffs for creating a careful, reasoned and reasonable dialogue. 

I was trained as an OB-GYN nurse-- a baby nurse-- and while I've had lots of different jobs 

with different responsibilities over the years, I still think like a nurse. I know the Senate has 

become a deeply partisan place and that proposals that would give the EPA more power to 

protect are not popular in every office. But the Safe Chemicals Act is fundamentally not about 

politics. It's about mercury in breast milk. It's about phthalates in newborn babies' cord blood. 

And it's about the creation of a new set of American manufacturing jobs making chemicals that 

are 21st century safe. Doing nothing is a negligent act. Thank you. 
37 


24968.024

january 3, 

jonathan Aronchick 

Committee on Fnvir·on,m<'nt 

410 Dirksen Senate 

Washington DC 20510 

Dear Mr. Aronchick: 

Thank you the om)orturtitv 

Ranking Member 

Answers to Questions 

1. Can you describe 

that reforms the 

protect public 

The passage 

Boxer 

benefit workers in 

two critically important ways: 

of cancer and other diseases that 

anniversary of the Occupational 

Assistant Secretary of Labor for OSHA David Michael 

more than four million are seriously 

injured or sickened by exposure to agents," This is a conservative 

but sizable estimate of harm, 800 well-documented annual 

workplace will result in better 

identific<~tion occupational disease 

and to the creation limits and safer alternatives that will protect 
38 


24968.025

measures, 
39 


24968.026

Answers to Questions 

1. Whatdoyou 

and puh/ic 

efforts reform 

together on in 

more support for retorrnina 

Carper 

role of government and 

severely tilted by 

our air, food and 

water and products are under attack. That tilt difficult to come 

together on answers to complicated like the proper language for 

the Safe Chemicals safety standard to write legislation that will 

provide some for businesses but allow adaptation for the surprises 

that new science sometimes creates. 

What can we learn from 

countries efforts improve the 

inform work of the Senate 

proceeding Safe 

Korea, China and other 

rl''"mlrtlf</ How can these lessons 

Public Works 

states that have passed 80 chemical 

safety laws in the Chemistry Council did what they 

could to oppose and This experience suggests that the Senate 

Committee on Environment and Public should not wait for the 

support of all States before proceeding 

with its deliberations on 

The United States also turn the of being a laggard in 

chemical policy reform to good use crafting that harmonizes and 

builds upon earlier national reform efforts, efficiencies and costsavings for what is industry. There lessons to be learned from the 

implementation European Union's REACH and other efforts that can 

now used to strengthen the regulatory methodology of the Safe Chemicals 

Act. 
40 


24968.027

Senator 
41 


24968.028

Please let me know ifl help 

Sincerely, 
42 

Senator LAUTENBERG. Thanks very much. 

Mr. Dooley, we look forward to hearing your testimony. 

STATEMENT OF CAL DOOLEY, PRESIDENT AND CEO, 

AMERICAN CHEMISTRY COUNCIL 

Mr. DOOLEY. Thank you for the opportunity to testify on behalf 

of the American Chemistry Council, our member companies and 

their nearly 800,000 employees about the need to modernize the 

Federal system that regulates chemicals. We appreciate the efforts 

of Senators Lautenberg, Inhofe and other Members of this Committee, and we appreciate the chance to discuss our views about 

the Safe Chemicals Act. 

As I told this Committee in February, ACC strongly supports efforts to reform the 35 year old Toxic Substance Control Act. Over 

the years, public confidence in TSCA has diminished, contributing 

to misperceptions about the safety of chemicals, ill-conceived State 

laws, unnecessary product de-selections, and baseless litigation. 

Safety is a top priority of our Member companies. We need an effective and reliable chemical regulatory system that will instill in 

policymakers, our business partners, and the public the same level 

of confidence in the products that we have. 

Over 2 years ago, ACC released 10 principles for modernizing 

TSCA. These principles created a road map to a modern chemical 

regulatory system that will protect public health and the environment, while preserving the ability of American chemicals companies to drive innovation, grow jobs, and compete in the global marketplace. 

In recent months, ACC and other stakeholders have engaged 

with bipartisan Committee staff to discuss our respective positions 

about legislation to update TSCA. We appreciate and would like to 

commend Ben Dunham from Senator Lautenberg’s staff, and 

Dimitri Karakitsos from Senator Inhofe’s staff for their professional 

management of these discussions. 

Unfortunately, though, today we are discussing a bill that remains very similar to the bill that was introduced in 2010, which 

we consider unworkable. As we discussed during that process, 

there are several fundamental flaws in the legislation. 

No. 1, the safety standard. The bill’s standard for reasonable certainty of no harm from aggregate exposure for all chemicals would 

be virtually impossible to meet. If EPA were required by TSCA to 

consider the aggregate exposure to substances from every industrial, commercial and consumer product use of a chemical substance, regulatory paralysis would ensue. 

No. 2, new chemicals. There is a broad consensus even among 

TSCA critics that the program to evaluate new chemicals is working. In spite of this, the legislation would prescribe significant new 

data requirements for all new chemicals before they could come to 

market. It would also extend EPA’s time to evaluate this data, 

keeping these chemistries in a State of limbo. 

If EPA is unable to complete its work in a timely manner, and 

this is an agency that is known to struggle with deadlines, the 

chemical would effectively be barred from entering the market. 

Manufacturers are certain to seek more manageable regulatory environments and produce new chemicals, including green chemistry 

43 

developments and other potentially revolutionary new products, in 

other countries to avoid prohibitive costs and uncertainty. 

No. 3, minimum data-sets. The bill would create an enormous 

burden on EPA and on the manufacturers, with little benefit, by 

requiring a minimum data-set for all chemicals. Instead, EPA 

should collect data that is needed on specific types and classes of 

chemicals, as well as to take advantage of the massive amount of 

data that the agency already has access to. 

No. 4, prioritization. The bill’s prioritization proposal lacks rigorous criteria and makes no mention of integrating current knowledge about hazards, risk and exposure, three factors that are critical to informed regulatory decisions. ACC recently proposed a 

transparent and scientifically sound prioritization process to determine which chemicals should receive full safety assessments, so 

EPA can focus its resources where they are most needed. We believe our prioritization proposal would be more effective than what 

has been proposed in S. 847 and have the details in our written 

statement. 

Reform of TSCA is an important priority, but one that must be 

done right. Chemistry will be the source of clean energy, improved 

infrastructure, efficient transportation, medical advancement, and 

a strong defense, among a lot of other applications. An ill-conceived 

regulatory system such as that which would be created by S. 847 

would undermine America’s ability to develop and produce these 

transformational technologies and would put the jobs of today and 

tomorrow at risk. 

Even though S. 847 is not the answer, ACC and the industry remain fully committed to TSCA reform. We believe we can develop 

legislation that will give consumers confidence, that learns from 

the success and mis-steps of reforms undertaken by other countries, and that fosters innovation and job creation. 

Thank you for the chance to express our views on this critical 

subject and we look forward to continued collaboration on this 

issue. 

[The prepared statement of Mr. Dooley follows:] 

44 


24968.029

merican· 

Chemistry 

ouncil 

Testimony of 

The Honorable Cal Dooley 

President and CEO 

American Chemistry Council 

700 Second Street NE 

Washington, DC 20002 

Before the 

Senate Committee on Environment and Public Works and the 

Subcommittee on Superfund, Toxics & Environmental Health 

"Legislative Hearing on the Safe Chemicals Act" 

November 17, 2011 

americanchemistry. com"' 700 Second St., NE I Washington. DC 20002 11202) 249.7000 
45 


24968.029

merican· 

Chemistry 

ouncil 

Testimony of 

The Honorable Cal Dooley 

President and CEO 

American Chemistry Council 

700 Second Street NE 

Washington, DC 20002 

Before the 

Senate Committee on Environment and Public Works and the 

Subcommittee on Superfund, Toxics & Environmental Health 

"Legislative Hearing on the Safe Chemicals Act" 

November 17, 2011 

americanchemistry. com"' 700 Second St., NE I Washington. DC 20002 11202) 249.7000 
46 


24968.030

November 17,2011 

Page 2 

Thank you for the opportunity to testify on behalf of the American Chemistry Council, our 

member companies and their nearly 800,000 employees. We appreciate the efforts of Senators 

Lauten berg, Inhofe and other Members of this committee, and we appreciate the chance to 

discuss our views about S. 847, the "Safe Chemicals Act of2011." 

ACC strongly supports efforts to reform the 35-year old Toxic Substances Control Act (TSCA). 

Over the years, public confidence in TSCA has diminished, contributing to misperceptions about 

the safety of chemicals, ill-conceived state laws, unnecessary product de-selection, and baseless 

litigation. 

Safety is the top priority of our member companies. We need an effective and reliable chemical 

regulatory system that will instill in policymakers, our business partners and the public the same 

level of confidence in our products that we have. 

Over two years ago, ACC released 10 Principles for Modernizing TSCA. These principles create 

a roadmap to a modern chemical regulatory system that will protect public health and the 

environment, while preserving the ability of American chemical companies to drive innovation, 

grow jobs, and compete in the global marketplace. 

In recent months, ACC and other stakeholders have engaged with bipartisan committee staff to 

discuss our respective positions about legislation to update TSCA. We have appreciated the 

opportunity for our views to be heard and would like to commend Ben Dunham from Senator 

Lauten berg's staff and Dimitri Karakitsos from Senator lnhofe' s staff for their professional 

management of the discussions. Unfortunately, though, today we are discussing a bill that 

remains very similar to the bill introduced in 2010, which we consider unworkable. 

There are fundamental flaws in the legislation, including: 

Safety Standard: The bill's standard of"reasonable certainty of no harm ... from aggregate 

exposure" for all chemicals would be virtually impossible to meet. If the U.S. Environmental 

Protection Agency (EPA) were required by TSCA to consider the aggregate exposures to a 

substance from every industrial, commercial, and consumer product use of a chemical substance, 

regulatory paralysis would ensue. 

americanchemistry. com® 700 Second St., NE I Washington, DC 20002 I (202)249.7000 
47 


24968.031

November 17,2011 

Page 3 

New Chemicals: There is broad consensus, even among TSCA critics, that the current program 

to evaluate new chemicals is working. In spite of this, the legislation would prescribe significant 

new data requirements before new chemicals could come to market, as well as extend EPA's 

time to evaluate this data, potentially keeping these chemistries in a state of limbo. 

Manufacturers are certain to seek more manageable regulatory environments and produce new 

chemicals, including "green" chemistry developments and potentially revolutionary new 

products, in other countries to avoid prohibitive costs and uncertainty. 

Minimum Data Set: The bill would create an enormous burden on EPA and on manufacturers 

with little benefit by requiring a minimum data set for all chemicals. Instead, EPA should take 

advantage of the massive amounts of data and information that the Agency already has access to. 

Prioritization: The bill's prioritization proposal lacks rigorous criteria and makes no mention of 

integrating current knowledge about hazard, use, and exposure- three factors that are critical to 

an informed regulatory decision. ACC recently proposed a transparent and scientifically-sound 

prioritization process to determine which chemicals should receive full safety assessments so 

EPA can focus its resources where they arc most needed. We believe our prioritization proposal 

would be more effective than what has been proposed inS. 847, and have attached the details for 

your review. 

We also believe that S. 847 would compromise the protection of confidential business 

information, inappropriately expand EPA's authority into the jurisdiction of other federal 

agencies such as the U.S. Food and Drug Administration (FDA), further complicate issues 

surrounding national uniformity of standards, and fail to adequately consider animal welfare. 

Reform ofTSCA is an important priority, but one that must be done right. Chemistry will be the 

source of clean energy, improved infrastructure, efficient transportation, medical advancements, 

and of a strong national defense. An ill-conceived regulatory system, like that which would be 

created by S. 847, would undermine America's ability to develop and produce these 

transformational technologies and would put jobs of today and of tomorrow at risk. 

Even though S. 847 is not the answer, we remain fully committed to TSCA reform. We believe 

we can develop legislation that will give consumers confidence, learns from the success and 

missteps of reforms undertaken by other countries, and fosters innovation and job creation. 

Thank you for the chance to express our views on this critical subject, and !look forward to 

answering your questions. 

americanchemistry.com@ 700 Second St., NE I Washington, DC 20002 I (202)249.7000 
48 


24968.032

merican' 

Chemistry 

ouncil 

10 Principles for Modernizing TSCA 

The American Chemistry Council and its members support Congress' effort to modernize our 

nation's chemical management system. Such a system should place protecting the public health all' its 

highest priority, and should include strict government oversight. It should also preserve America's 

role as the world's leading innovator and employer in the creation ~[safe and environmentally 

sound technologies and products of the business f!f chemistty. 

The current chemical management law, the Toxic Substances Control Act (TSCA), is more than 30 

years old. It should be modernized to keep pace with advances in science and technology. Moreover, 

the law must provide the Environmental Protection Agency wUh the resources and the authority to do 

its job ef}ixtively. 

We have previously Q[(ered general concepts on lt:hich to base a modern chemical management 

system. This document expands upon those concepts and begins to provide more detail, which we 

hope will be useful to policy makers. We will continue to refine the details ofour principles/or 

modernizing TSCA and are committed to working with all stakeholders toward enactment C?f effective 

legislation. 

I. Chemicals should be safe for their intended use. 

Ensuring chemical safety is a shared responsibility of industry and EPA. 

Industry should have the responsibility for providing sufficient information for EPA to 

make timely decisions about safety. 

EPA should have the responsibility for making safe use detcnninations for high priority 

chemicals, focusing on their most significant uses and exposures. 

Safe use determinations should integrate hazard, use, and exposure information, and 

incorporate appropriate safety factors. 

Consideration of the benefits of chemicals being evaluated, the cost of methods to control 

their risks, and the benefits and costs ofaltematives should be part of EPA's risk 

management decision making, but should not be part of its safe use determinations. 

Other agencies, such as FDA and CPSC, should continue to make safety decisions for 

products within their own jurisdictions. 

2. EPA should systematically prioritize chemicals for purposes of safe use determinations. 

Government and industry resources should be focused on chemicals of highest concern. 

americanchemistry.com® 700 Second St., NE! Washington, DC 20002 I (202) 249.7000 
49 


24968.033

Page2 

The priorities should reflect considerations such as the volume of a chemical in 

commerce; its uses, including whether it is fonnulated in products for children; its 

detection in biomonitoring programs; its persistent or bioaccumulative properties; and the 

adequacy of available infonnation. 

3. EPA should act expeditiously and efficiently in making safe use detenninations. 

Since a chemical may have a variety of uses, resulting in different exposure potentials, 

EPA should consider the various uses and focus on those resulting in the most significant 

exposures. 

4. EPA should complete safe use determinations within set time frames. Companies that 

manufacture, import, process, distribute, or usc chemicals should be required to provide EPA 

with relevant information to the extent necessary for EPA to make safe usc determinations. 

Companies throughout the chain of commerce should be responsible for providing 

necessary hazard, use, and exposure information. 

EPA should be authorized to require companies, as appropriate. to generate relevant new 

data and information to the extent reasonably necessary to make safe use determinations 

without having to prove risk as a prerequisite or engaging in protracted rulcmaking. 

Testing of chemicals should progress to more complex and expensive tests through a 

tiered approach as needed to identify hazards and exposures of specific concern. 

To minimize animal testing, existing data should be considered prior to new testing, and 

validated alternatives to animal testing should be used wherever feasible. 

Existing data and information should be leveraged in EPA's safe use determinations, 

including data and information from other mandatory and voluntary programs such as 

REACH and the U.S. High Production Volume challenge. 

5. Potential risks faced by children should be an important factor in safe usc determinations. 

Safe use dctcnninations should consider the effects of a chemical on children and their 

exposure to the chemical. 

Safe usc determinations should consider whether an extra margin of safety is needed to 

protect children. 

6. EPA should be empowered to impose a range of controls to ensure that chemicals are safe for 

their intended usc. 

• The controls could range from actions such as labeling, handling instructions, exposure 

limits and engineering controls to use restrictions and product bans. 

americanchemistry .com® 700 Second St., NE I Washington, DC 20002 ! {202) 249.7000 
50 


24968.034

Page 3 

The controls should be appropriate for managing the risk, taking into account 

alternatives, benefits, costs, and uncertainty. 

7. Companies and EPA should work together to enhance public access to chemical health and 

safety information. 

EPA should make chemical hazard. use, and exposure information available to the public 

in electronic databases. 

• Other governments should have access to confidential information submitted under 

TSCA, subject to appropriate and reliable protections. 

Companies claiming confidentiality in information submittals should have to justify those 

claims on a periodic basis. 

Reasonable protections for confidential as well as proprietary information should be 

provided. 

8. EPA should rely on scientifically valid data and information, regardless of its source, 

including data and infonnation reflecting modern advances in science and technology. 

EPA should establish transparent and scientifically sound criteria for evaluating all of the 

infonnation on which it makes decisions to ensure that it is valid, using a framework that 

addresses the strengths and limitations of the study design, the reliability of the test methods, 

and the quality of the data. 

EPA should encourage use of good laboratory practices, peer review. standardized protocols, 

and other methods to ensure scientific quality. 

9. EPA should have the staff, resources, and regulatory tools it needs to ensure the safety of 

chemicals. 

EPA's budget for TSCA activities should be commensurate with its chemical management 

responsibilities. 

10. A modernized TSCA should encourage technological i1movation and a globally competitive 

industry in the United States. 

• A new chemical management system should preserve and enhance the jobs and 

innovative products and technologies contributed by the business of American chemistry. 

Implementation of TSCA should encourage product and technology innovation by 

providing industry certainty about the usc of chemicals. 

americanchemistry .com® 700 Second St., N£! Washington, DC 20002! (202) 249.7000 
51 


24968.035

ACC Prioritization Screening Approach 

I. Introduction 

This document provides background on ACC's approach to chemical prioritization 

screening. The approach is based on the following general principles: 

• The purpose of this approach is to identify substances as priority to receive more 

detailed evaluation and assessment which, when conducted, could possibly lead to 

risk management measures. 

• Apply a science- and risk-based approach, considering both the degree of hazard and 

extent of exposure potential in setting priorities. 

• Include criteria applicable to the range of chemicals being screened. Apply this 

principle through a two-step process rather than just those information elements 

available only for subsets of chemicals. 

• Leverage available data and existing hazard classification frameworks already in use 

across industry and agreed by regulators. 

• Incorporate relevant science advances where there is broad acceptance in the 

scientific community, e.g. improvements in how persistence and bioaccumulation 

considerations are addressed. 

• Allow for the incorporation of significant new information to ensure prioritization 

decisions remain current. 

• Adopt a simple, transparent screening method. 

• Include opportunity for public review and comment to ensure the best available data 

and information is used in prioritization decisions. 

• Allow professional judgment to be applied where appropriate, e.g. in hazard 

classification and second-tier ranking. 

II. Applying Initial Screening Step in ACC's Prioritization Approach 

The first step in applying ACC's prioritization approach is to apply criteria on human 

health and environmental toxicity potential to chemical substances. 

A. Hazard Potential 

The U.N. Globally Harmonized System of Classification and Labeling (GHS) was 

developed and internationally agreed to by many governments to provide criteria and a 

consistent approach for hazard classification of chemicals. It can also provide a 

recognized and generally accepted method for sorting chemicals in a prioritization 

process. The GHS framework has been used by international bodies, such as the OECD 

and WHO, and was endorsed by EPA's National Pollution Prevention and Toxics 

Advisory Committee (NPPT A C) to support prioritization. 

The GHS system applies to both human health and ecological endpoints. It includes 

criteria for both human and ecological health. For human health, criteria are available 

for both acute and chronic classifications, as well as CMR categorization. For ecological 

August 29, 2011 Page 1 
52 


24968.036

endpoints, criteria are similarly available for both acute and chronic classification. The 

use of one common system allows for appropriate assessment of all substances. GHS 

classification information is readily available for all substances, as U.S. manufacturers 

have developed GHS classifications for their products to meet international requirements. 

ACC's support of the GHS criteria for purposes of this prioritization tool is not a 

categorical endorsement of the GHS criteria for any other purpose. ACC has been an 

active participant in the development ofGHS and supports the system in principle. The 

GHS has not been broadly implemented to date in the U.S., although the Occupational 

Safety and Health Administration (OSHA) has indicated an intent to publish a regulation 

applying GHS in the workplace. ACC's December 29,2009, comments on OSHA's 

proposed rule to modify the existing Hazard Communication Standard (HCS) to reflect 

the GHS urged that implementation of the GHS adhere to certain principles (e.g., 

continued application of the "Building Block Approach" of the Purple Book). ACC 

made specific recommendations conceming details of the Hazard Classification 

definitions, cut-off values, among others. ACC stands behind those comments. In 

ACC's view, the use of GHS criteria in a screening-level prioritization of chemicals can 

materially assist in dctennining which chemicals receive additional evaluation by the 

Environmental Protection Agency, but does not necessarily preclude the use of other 

appropriate, applicable criteria developed under other systems. 

To classify a chemical in a hazard based priority ranking where there is not direct data on 

the chemical, EPA can employ the full range of approaches, such as QSAR, SAR, readacross and other modeling tools in which EPA has confidence based on molecular 

structure. In those situations where there still remains insufficient information on either 

environmental or human health hazards, the chemical would be classified as "high" for its 

environmental or health ranking. 

I. Environmental Ranking 

Table 1 provides a summary of how GHS criteria could be logically used for chemical 

management prioritization. 

Table l. Environmental Safety - Hazard Ranking 

GHS Classification - Ranking Environmental Rank 

Environmental Score 

Acute I or Chronic I or 

Insufficient Information to High 4 

Classify 

Acute II or Chronic II Medium High 3 

Acute Ill or Chronic III/IV or Medium 2 none 

Not classified Low 1 

August 29, 2011 Page 2 
53 


24968.037

2. Human Health Ranking 

Table 2. Human Health - Hazard Ranking 

Health 

Rank 

GHS Classification - Human Health Rankin~ Score 

GHSCMRCat Ia, Jb;OR 

Repeat Dose </= I 0 mg/kg/day (oral); 

</= 20 mg/kg/day (dermal); 

</=50 ppm/6hr/day (gas inhalation); High 4 

</= 0.2 mg/l/6h/day (vapour inhalation); 

</= 0.02 mg/l/6h/day (dust mist fume inhal). 

OR insufficient information to classify 

GHS CMR Cat 2; OR 

Repeat Dose I 0 - I 00 mg/kg/day (oral); 

20- 200 mg/kg/day (dermal); Medium High 50- 250 ppm/6hr/day (gas inhalation); 3 

0.2 - 1.0 mg/l/6hlday (vapour inhalation); 

0.02- 0.2 mg/l/6h/day (dust mist fume inhal). 

Not carcinogenlmutagenlrepro/develop;OR 

Repeat Dose 100 1000 mg/kg/day (oral); 

200 - 2000 mg/kg/day (dermal); Medium 250 - I 000 ppm/6hr/day (gas inhalation); 2 

1.0- 5.0 mg/l/6h/day (vapour inhalation); 

0.2- 1.0 mg/l/6h/day (dust mist fume inhal). 

Not carcinogen/mutagen/repro/develop; OR 

Repeat Dose> 1000 mg/kg/day (oral); 

> 2000 mg/kg/day (dermal); Low > 1000 ppm/6hr/day (gas inhalation); I 

>5.0 mg/l/6h/day (vapour inhalation); 

> 1.0 mg/l/6h/day (dust mist fume inhal). 

It is important to note that specific concerns about children's health (specifically potential 

hazards and adverse effects on the nervous system) and those caused by endocrine 

disruption mechanisms are addressed in this prioritization process: 

• The GHS CMR "R" classification includes specific evaluation of effects on 

development in utero and upon growth, maturation and reproduction. ("R" stands 

for reproductive toxicity and includes adverse effects on sexual function and 

fertility, as well as developmental toxicity in offspring). 

• Endocrine activity is not a distinct toxicological hazard per se, but rather a 

measure of a compound's ability to interact with components of the endocrine 

system. The prioritization process evaluates data and information on relevant 

apical tests, including tests for reproduction and developmental toxicity (potential 

August 29, 2011 Page 3 
54 


24968.038

effects, which can be mediated by endocrine pathways). Thus, even if specific 

screening for potential endocrine activity has not yet been conducted on certain 

compounds, hazard identification based on observable outcomes from apical 

toxicity tests (e.g., outcomes such as pathologic states indicative of disease 

conditions) covers all modes of action, including endocrine pathways. 

• The toxicity information evaluated (CMR and repeat dose toxicity) is directly 

relevant to evaluating potential hazards to all individuals, including children. Such 

data typically includes: I) identification and definition of possible hazards upon 

all major organ systems from both acute and repeated exposures, including the 

nervous system; 2) detection of potential hazards arising from in utero exposures, 

including possible effects on the nervous system; 3) evaluation of potential of a 

substance to affect reproduction; and 4) evaluation of the potential of a substance 

to damage DNA. 

Integration of Hazard Elements: 

Each of the environmental and human health classifications is assigned a numeric value 

based upon its ranking, with 1 being the lowest value and 4 the highest. The greatest 

ranking (highest hazard potential score) of either Environmental or Human Health is used 

in a substance-specific priority ranking. The numeric value does not imply relative 

weighting, but rather a numerical order of priority. 

B. Exposure Potential Ranking 

The screening method allows for an initial indication of the extent of exposure potential 

by considering: 

1. The chemical's uses and use pattem(s). 

2. Production volume as a first pass indicator of relative emission/release potential 

since magnitude and route (i.e. air, water, soil) of emissions is not available for all 

substances. 

3. Persistence and bioaccumulation characteristics of the substance. 

Together the 3 elements are used to rank exposure potential. 

1. Use Patterns 

The proposed approach applies the most current 2006 TSCA Inventory Update Reporting 

rule (IUR, now called the Chemical Data Reporting rule (CDR) data. To keep the initial 

prioritization simple and transparent, the approach "bins" different use patterns to align 

with general exposure potential intermediates, industrial use, commercial use and 

consumer use. These patterns are the same as those reported in the IUR and are 

consistent with REACH exposure categories (intermediates, worker, professional, 

consumer). Chemicals with consumer product use are likely to have widespread potential 

for general population exposures and are given high priority ranking within the approach. 

For the initial prioritization approach, child specific products are captured under general 

consumer products and all consumer products are weighted equally (see additional 

August 29, 2011 Page 4 
55 


24968.039

discussion below under Second Tier Considerations). Intermediates will have low 

general population exposures, since these substances are consumed, by definition, within 

the workplace. Therefore, they are given the lowest priority ranking within the approach. 

In the context ofthe proposed approach, the intermediates category includes both 

intermediates and non-isolated intermediates. A chemical used in multiple use patterns is 

assigned the priority of the highest use, e.g., a chemical in both industrial and commercial 

uses would be assigned the commercial Medium-High rank. 

T a e bl 3 U se P a tt erns- E xposure R an k' mg 

Use Pattern Ranking Use Pattern Score 

Consumer High 4 

Commercial Medium-High 3 

Industrial Medium 2 

Intermediates Low I 

The IUR Definitions of these terms are (40 CFR 710.3, 710.43): 

• "consumer use" means the use of a chemical substance or a mixture 

containing a chemical substance (including as part of article) when sold to 

or made available to consumers for their use. 

• "commercial use" means the use of a chemical substance or a mixture 

containing a chemical substance (including as part of an article) in a 

commercial enterprise providing saleable goods or services. 

• "industrial use" means use at a site at which one or more chemical 

substances or mixtures are manufactured (including imported). 

• "intermediate" means any chemical substance: 

o which is intentionally removed from the equipment in which it is 

manufactured, and 

o which either is consumed in whole or in part in chemical 

reaction(s) used for the intentional manufacture of other chemical 

substance(s) or mixture(s), or is intentionally present for the 

purpose of altering the rate of such chemical reaction( s) 

• "non-isolated intermediate" means any intermediate that is not 

intentionally removed from the equipment in which is it manufactured, 

including the reaction vessel in which it is manufactured, equipment 

which is ancillary to the reaction vessel, and any equipment through which 

the substance passes during a continuous flow process, but not including 

tanks or other vessels in which the substance is stored after its 

manufacture. 

2. Production Volume 

Recognizing that detailed exposure information will not be available for all substances to 

be screened, the proposed approach uses production volume as an indicator of exposure, 

which is widely used in many prioritization schemes. As production volume is just a 

rough surrogate of emissions, ACC suggests only very broad categories, covering about 

August 29, 2011 Page 5 
56 


24968.040

two orders of magnitude each. It may be useful to consider how additional exposure 

estimates may be applied in the second tier assessment. 

T a bl e 4 P ro d uctwn VI o ume as E . . miSSIOn S urrogate - Exposure Rankmg 

Production Volume as Emission Surrogate Ranking Volume Score 

>= 100,000,000 lbs national aggregate High 4 

1,000,000 lbs to < I 00,000,000 lbs national Medium - High 3 aggregate 

>= 25,000 lbs to< 1,000,000 lbs national Medium 2 aggregate 

< 25,000 lbs (below IUR site reporting limit) Low 1 

3. Persistence and Bioaccumulation 

Persistence and bioaccumulation are viewed as indicators of exposure, and therefore are 

considered under the exposure axis of the approach. A persistent substance that is 

emitted to the environment at the same rate as a non-persistent substance with similar 

partitioning properties will result in higher exposure to humans and the environment. In 

fact, multimedia modeling clearly indicates that environmental persistence in the 

compartment to which a substance partitions is a good indicator of human exposure 

potential (MacLeod & McKone et al. 2004). Similarly, substances that are not subject to 

biotransformation by higher organisms will exhibit a high bioaccumulation potential that 

results in higher exposures via the food chain (Arnot et al. 20 I 0). Therefore, it is 

recommended to apply the proposed persistence and bioaccumulation criteria in 

assessment of exposure potential as described below. 

The persistent and bioaccumulative (P&B) criteria of the proposed approach are targeted 

toward organic chemicals. Separate assessment criteria are likely needed for P&B 

evaluation for inorganics/metals, as in the approach taken by Canada's Chemical 

Management Program (CMP). 

For assessing persistence, based upon recent expert consensus (Boethling et al., 2009) it 

is recommended to distinguish persistent from non-persistent chemicals using the 

following criteria: 

• Volatile chemicals can be defined using a vapor pressure cut-off (i.e.,> I 000 Pa) 

o For volatile chemicals, persistent versus non-persistent chemicals are 

differentiated using a half-life cut-offin air (e.g., a substance is not 

persistent if air halflife is < 2 days). 

o For non-volatile chemicals, non-persistent substances can be defined as 

substances that are deemed: 

August 29, 2011 

readily or inherently biodegradable using standard biodegradation 

tests (OECD 301, 302, 306 test guidelines) or SAR or read across 

from measured data on a related substance, 

• show an equivalent degree of degradation (i.e. >20% in 28 days) 

via an abiotic degradation mechanism such as photolysis (OECD 

316) or hydrolysis (OECD 111 ), 

Page 6 
57 


24968.041

• evaluation of simulation data from transfonnation in soil, marine 

water/sediment, brackish water/sediment, surface water/sediment, 

oceanic water die away (e.g. OECD 308/309) have halflives 

below 180 days, OR 

if data are lacking, evaluation via BIOWIN model (EPIWEB 4) 

o Non-volatile substances that are not biodegradable or subject to abiotic 

losses based on the above criteria would be considered persistent. 

For assessing bioaccumulation, the key question for screening is the potential for 

biomagnification based on recent expert consensus (Gobas et al. 2009). To determine if 

a substance has the potential to biomagnify the following metrics have been agreed: 

• Trophic Magnification Factor (TMF)> l, fish Biomagnification Factor (BMF)> 1, 

fish Bioaccumulation Factor (BAF)/Bioconcentration Factor (BCF) > 5000. These 

metrics can be derived using lab or field measurements (where available) or recently 

improved computational models that are included in EPA's EPIWEB model that 

can be freely downloaded at www.cpa.gov/oppt/exposure/pubs/episuite.btm. 

This approach allows all organics to be addressed and is a scientifically updated version 

of the approach used in Canada's CMP. 

Based on the above recommendations, substances can be grouped with regard to 

persistence and bioaccumulation as follows: 

Table 5. Persistence and Bioaccumulation - Exposure Ranking 

Persistence and P&B Ranking P&B Score 

Bioaccumulation 

Persistent and High 5 

Bioaccumulative 

Persistent and Not Medium 3 

Bioaccumulative OR 

Not Persistent and 

Bioaccumulative 

Not Persistent and Not Low I 

Bioaccumulative 

integration of Exposure Elements: 

As demonstrated in the tables, each factor (use pattern, P&B, and production volume) 

would be assigned a numeric score based upon its ranking. All 3 factors are added to 

arrive at an overall value. These values are then separated into categories from low to 

high exposure potential. A proposed "banding" approach is illustrated in Table 6. 

August 29, 2011 Page 7 
58 


24968.042

Table 6. Integration of Exposure Rankings 

Combined Score- All 3 Exposure Rank Exposure Ranking 

elements Score 

II- 13 High 5 

9 10 Medium High 4 

7-8 Medium 3 

5-6 Medium Low 2 

3-4 Low I 

Overall Priority Grouping: 

In the overall approach, both hazard and exposure elements are considered when placing 

a substance in a risk-based prioritization ranking. The overall prioritization score for 

priority grouping and risk evaluation is based on the combined consideration of the 

hazard and exposure rankings. Priority Groups 7, 8, and 9 are deemed High Priority; 

Priority Groups 4, 5, and 6 are Medium Priority; and Priority Groups 2 and 3 are Low 

Priority. 

Review and Comment: 

It is important that screening be done in an open and transparent way and that the best 

available information be used. When screening for thousands of chemicals, EPA may not 

have access to all available information. The process should provide an opportunity for 

review and comment on initial rankings and an opportunity to submit additional relevant 

data and information to update proposed rankings with improved information. 

III. Second Tier Considerations: 

After the initial screening, some substances within individual priority groupings may 

require further rank ordering, particularly where a large number of chemicals are in the 

same priority group. Listed below are the types of information that will be useful to 

consider in this Second Tier rank ordering: 

Biomonitoring/Environmental Monitoring Data: 

Mere detection of chemicals in humans or the environment, i.e., "found in biomonitoring 

(CDC), found in water (NCOD), and found in air", while providing an indication of 

exposure, does not provide a useful criterion for exposure potential because almost any 

industrial or commercial chemical could be detected at trace levels, given increasingly 

sensitive analytical methods. Therefore, detection alone primarily reflects only the fact 

that a specific chemical was included in a measurement program. This criterion will also 

tend to bias the prioritization of chemicals for which well-established analytical methods 

are available. Consequently, this criterion is not used in the initial prioritization scheme. 

However, within a particular priority grouping, reliable monitoring information should be 

considered for Second Tier rank ordering within a quantitative process that assesses if the 

data is above a level of concern (i.e., places it in a risk context). 

August 29, 2011 Page8 
59 


24968.043

Use in Children's Products: 

Protection of childrens' health is a top priority and, in the initial ranking, child-specific 

products are captured under general consumer products and all consumer products are 

weighted equally. The specific IUR reporting of information on chemical use in products 

intended for children would be considered further within a particular priority grouping for 

Second Tier rank ordering, noting the following points: 

• the IUR definition is based upon use in a child specific product rather than child 

specific exposure potential 1 (see below). Without knowing a specific product type, it 

is difficult to understand if potential child exposure is greater than for a non-child 

specific product. For example, how does child exposure to a general usc cleaner 

compare to exposure from use in a child's raincoat. In the VCCEP assessments, there 

arc examples for inhalation exposures where estimates of passive child exposure 

during adult product use exceeded conservative estimates of child exposure during 

active use of a child-specific product (such as a hobby product)- differences were 

related to the amount of product used and substance concentration within the product 

(MEK VCCEP Submission). 

• the IUR definition targets children age 14 and younger. Younger children may be 

exposed to a variety of non-child specific products that are in general household use. 

Older children may be exposed to a variety of additional products. 

• the IUR information request is targeted to manufacturers, which may not have direct 

knowledge of all uses, particularly the presence in products for specific 

subpopulations, such as children. Therefore, it is not clear that the information 

requested for the IUR information would be consistently available across all 

substances being screened. Ideally, this information should be requested from 

formulators of child-specific products. 

Therefore, tor the initial prioritization approach, which represents a broad, unrefined 

categorization, child specific products arc captured under general consumer products and 

all consumer products are weighted equally. The IUR information on child specific use 

would be utilized within a particular priority grouping for Second Tier rank ordering. If 

the IUR information is utilized, it is important that the limitations above be considered in 

its application. 

1 IUR definition (Federal Register Volume 75, Number 156, Friday August 30, 2010, p. 49686): 

Intended for use by children means the chemical substance or mixture is used in or on a product 

that is specifically intended for use by children age 14 or younger. A chemical substance or 

mixture is intended for use by children when the submitter answers "yes" to at least on of the 

following questions for the product into which the submitter's chemical substance or mixture is 

incorporated: 

(1) Is the product commonly recognized (i.e., by a reasonable person) as being intended for 

children age 14 or younger? 

(2) Docs the manufacturer of the product state through product labeling or other written materials 

that the product is intended for or will be used by children age 14 or younger? 

(3) Is the advertising, promotion, or marketing of the product aimed at children age 14 or 

younger? 

August 29, 2011 Page 9 
60 


24968.044

Emissions Data: 

Production volume, which is readily available for substances, is used in this proposed 

approach, but only serves as a surrogate for environmental emissions. For further 

prioritization, data or estimates of environmental emissions can be used to refine 

prioritization. Estimates of environmental emissions will be available for some 

substances (e.g., TRI data). When TRI data are utilized it should be recognized that it 

addresses only emissions that result from industrial and not wide dispersive uses. In 

other cases, emissions estimates can be developed as a percentage of production volume 

based upon consideration of use categories. Within a particular priority grouping, 

available emissions information can be considered for Second Tier rank ordering, with 

the understanding that emissions information is not an indicator of actual exposure. 

Similarly, non-isolated system intermediates, by definition, would have de minimis 

exposure potential. Therefore, this IUR information could be considered within a 

particular priority grouping for Second Tier rank ordering. 

International Risk Management Actions: 

An initial screening approach for chemical prioritization should be based upon consistent 

application of specific hazard and exposure science elements that define risk potential. 

The hazard and exposure elements should be applicable across all substances being 

evaluated. For initial screening, existence of international risk management action plans 

should not be a factor that determines priority grouping. Risk management plans may be 

based upon many factors, including political drivers. It is unclear how factors, their 

relative weighting, and the rigor of the evaluation may vary across agencies and 

substances. For initial screening purposes, the same science-based criteria should be used 

to rank all substances. Consideration of existing international risk management plans 

could be utilized to check the functioning of the approach and could be considered within 

a particular priority grouping for Second Tier rank ordering with the possible effect of 

moving a chemical up in a grouping if actions are being taken internationally. 

IV. Summary 

ACC's prioritization approach is an example of a risk-based screening prioritization 

process that implements the general principles outlined at the outset of this document. It 

is based upon widely available information that can be utilized to understand the relative 

priority of chemicals for further evaluation from a risk perspective, i.e., integrating both 

hazard and exposure elements. Implementation of the screening framework will be most 

effective when utilizing the best available information. When conducting screening for 

thousands of chemicals, EPA may not have access to all available information. An open 

and iterative process that includes an opportunity for review and comment on initial 

rankings, together with the information that led to the result, and an opportunity to update 

the ranking with improved information will create a transparent and scientifically sound 

process. 

V. References 

August 29, 2011 Page 10 
61 


24968.045

Arnot, J.A., D. Mackay, T. F. Parkerton, R. T. Zaleski, C. S. Warren (2010), Multimedia 

modeling of human exposure to chemical substances: The roles of food web 

biomagnification and biotransformation, Environmental Toxicology and Chemistry 

29( l ):45-55. 

Boethling, R., K. Fenner, P. Howard, G. Klecka, T. Madsen, J.R. Snape, M.J. Whelan 

(2009). Environmental persistence of organic pollutants: guidance for development and 

review of POP risk profiles. Integrated Environmental Assessment and Management 

5(4): 539 556. 

Gobas, F.A.P.C, W. de Wolf, L. P Burkhard, E. Verbruggen, K. Plotzke (2009). 

Revisiting Bioaceumulation Criteria for POPs and PBT Assessments Integrated 

Environmental Assessment and Management, 5(4):624-637. 

MacLeod, M., T. E. McKone (2004). Multimedia persistence as an indicator of potential 

for population-level intake of environmental contaminants, Environmental Toxicology 

and Chemistry 23(10):2465-2472. 

van Wijk,D., R. Chenier, T. Henry, M. D Hernando, C. Schulte (2009). Integrated 

Approach to PBT and POP Prioritization and Risk Assessment' Integrated Environmental 

Assessment and Management, 5(4):697-71 1. 

August 29, 2011 Page 11 

24968.046

Proposed Prioritization Approach 

l>ftAFT lloy .. 2ll11 

U$E Pattern 

oerm;ence · t>l8: 

:oe Go:Jre 

Tt:lnnaoe !;core 

.SUIII fUM • P6 + Tonni!SJe I 

PRIORflY GROUPING= Hazard + Exposure Rankin95 

... = r 

H\llllllll tleatlhHilanl 

Not carcln39Ef\'ITIUtlgenlreprokle\leklp. OR 

' -llOtClalioltlerl >2000m!;'t!;'<laYI<I<!rma); 10CC (9§ tntl.illaUorlj; 

Not carctnogenrmutagenln!proJdeYetop;OR 

OR Chronic IIII'IV; {not acu'!efy Repe-at 006e 100-1000 mg!lli!;Vda) (Cir.ll.J: 2 .......... 200 - 21XK11!9-'k9'diiy (dermal): toxic and no <::flrnnlc d<t.a] 251)- 1000 ppmf61Tfday ('!Pfi 

GHS CMR cat 2; OR GHS Repeat 0\.16e" Cit 2 

Repeat OO&e 10 - 100 (tnl); 

3 ...... 1gb Acute 11 Cf'Cnronlc It 20 - 200 (Gern'lal); 50 - 250 (gali tntlalatlon); 

GHS Ct.IR Cat ta. 10; OR GHS Repeat Do6e cat 1 

Repe-at 006e -:1• 10 mg.•l!)llSay (oral); 

Acute I OR Ctvonlc I OR Jn&!I'TirjEfl'l ""'•20 • hlg • lnfOimatkln 1D cta&f.ll'y 50 pprnl61'f.'day 

... -. 6.2 ffl!JIV6M:Iay (VapOUr lrttalatlon 1; 

..,,. .. fHJ2 (d:U&tmtfit Une OR. 

ln&1611dentln'fDmla!Jontoda661f'Y 

August 29,2011 

fXDOBUnl a.m.nbl 

---,-

net: P, r016 

!b6 (below 

lnd!Jiiitltal-not 

ln!lem'IE!<llale -2- """"""""' 3 

'o!.llOttl ( 

B & "lct:P 

4 

,.., 

I'J"! &r.e. reporttngl25,000- <1MM <100MM 11:161 :,. 1001/M tl& IUR 

umr1 h..IR aggreg;;u liJR aggregate aggreqa!ft 

2 

ranc.3 -1S 

EllpOIUN Ranlllng = Baeed on sum CUM • PB • 'RIInlgl ICO«M) 

3-4 .... , .. .... 

-

m .. 

_ 

modum ........ 

1 2 • • 

1/ 4 

/. • // •I// • /

• 

v/ 

• • v /

./< v IV / 

Page 10 

24968.047

Hazard and Exposure Criteria for Prioritization Approach 

1HAZARD 

Environment and Human Health Classifications based upon GHS 

Environmental: 

From GHS classification gu:dance document 

Tobit>J.l.2:0milicaiioa..-f•Silbst....,lwllrdomm11oe"4'1liD<-

A<W"hiiiif 

.:.\\wi) C.u:-y:~J L(!!)C, o. LOO C-~u~ Laac..tna lt.uard /,N«l) .........-~du..-fas:irityd.su ,;~ ~ ·- -~~~ (.~-t.J) (nepry.: Clarot~H:l :so:EC or ZC..:... 0.1 X.piollr .......... w.,.,.._, (."r.V,t 3) Cttteeory::Cllntllittl OO!.C«EC • .:.-oo: .A.ecqut~tdlroUc:t«DciryUm.,.. ·-(.W.u: {) c .. _.,., C1arooir 1 loJ;)C~o.I.OO.mdlackofnpkl 

~.U.ccBClf.:.!«·ot 

liabMDtJ.osK.,....:.4 

C.&w:-y: Atwfl' I C:ttfl'liY- Clmt.ic l I C:aupry: CllruU.C! 

1.00 · L._"'l);:..,:... HU) 0: ·· N'Of:C :ar EC.. :...1 O.Ct ., :SOEC « EC,:.. 0: <.~:auo.ir-1 : 00 ., L(E):,. 10 0 .... - d npld~OIUUtcr Csu:-r:~J 1o.o., UEJC •• Ioo 

Human Health: (,~ry:(kollicl ll t ·. NOE.C a<Ec~ :... l 

BCf !OOcr.lfabwatLoJK-..:.4 

c .. ~~J lOO·:~;,..lOOmdlad.o! ,..,.~~ .... "" 

lKf..:. !•XI «. J£ abwat q ~ ... 4 C~r,-: (JinlaK -t •M~ .t .• ~;;;.·c,re:O~ N.:>acu.to:tmX~·--bi.:;koft;tpt.ddrt~bility a::d:&...'r.:. ~00 ;xr.tfahWICtlo! Ko# .,:.4, 

mleuNOZc, : q:l 

As above, based upon GHS 

August 29, 2011 

EXPOSURE 

Use Elements~ based upon IUR 

intermediate consumed during industrial processing 

industrial (not intermediate)· used in an industrial setting 

commercial occupational use in nonindustrial setting 

consumer general population residential use 

Persistence: 

Volatile substance iVP > 1000 Pa) Nm Pers1stent 1f a1r half l1fe < 2 days 

Nonvolatlle (VP < 1000 Pa ). Not Pers1slent 1f 

a) ready (OECD 301) 

b) 1nherent (OECD 301.302. 306) 

cl read across from measured data on a related substance 

d) eqUivalent degree of degradation (1 e >20(1(, 1n 28 v.a an abiOtiC degradat1o

!OECD:l16) IOECD 111! 

e) evaluation of s1mulat1on data from transformation 1n so1L manne waterrsed1ment. 

water/sediment. swiace water/sediment, ocean1c water die away (e g .. OECD 308

nave half lives oelow 180 days 

OR 1f data are 

f) evaluat1on v1a 

Bioaccumulation: 

model (EPlWEB 4/ 

A substance not bloaccumulatlve 1f 

a) measured TMF < 1 (field study) 

b) measured f1sh BMF < 1 (Jab study) 

c) measured f1sh BCF < 5000 (lab study) 

d; pred1cted BCF < 5000 usmg the BCFBAF model included 1n EPtWIN 4 

The above order reflects the preference for use 1n declSion-makmg 

NOTE P&B CRITERIA ARE FOR ORGANICS 

Tonnage· based upon IUR reporting ranges 

< 25,000 lbs (below IUR s1te reporting hm!t) 

25,000 <1 MM lbs national aggregate 

1MM • <100 MM lbs national aggregate ~100 MM lbs natiOnal aggregate 

Page 11 
64 


24968.048
65 


24968.049

RESPONSES OF CAL DOOLEY 

PRESII)ENT ANI) CEO, AMERICAN CHEMISTRY COUNCIL 

TO QllESTIONS FROM SENATORS CARPER AND INHOFE 

Questions from Senator Carper: 

I. What do you believe is the biggest outstanding issue that the environmental and 

public health communities, the chemical industry, and others engaged in efforts to 

reform the Toxic Substances Control Act need to come closer together on in order to 

further strengthen the Safe Chemicals Act and gain even more support for 

reforming our country's chemical safety laws'! 

ACC strongly supp01is the modernization ofTSCA consistent with the principles we first 

announced in 2009. We appreciate the Committee's eJTorts to modernize the Act and we are 

committed to working on a bipartisan basis to find a solution that protects health and the 

environment. enhances public confidence in the chemical management system, and protects jobs, 

innovation and U.S. cDmpetitivcness. 

Unl~1nunately, as l stated in my oral and "'Tilten statements for the November 17, 2011 hearing. 

Senator Lauten berg's San~ Chemicals Act (S. 847) raises numerous serious concerns, calling into 

question. if it were enacted, EPA's ability to in1plement the program, industry's ability to comply 

with it, and the: continued ability of the business of chemistry to innovate and create jobs in the 

United States. We have discussed many of these concerns in detail. and offered specific 

solutions. during the stakeholder dialogue process convened by Senators Lautenberg and Inhofe 

in mid-201 J. Our chief concems include the bill's ill-conceived safety standard, its approach to 

regulating new chemicals that is divorced from the realities of the marketplace, its poorly defined 

process fin· prioritizing cbcrnicals for review. its unprecedented expansion of EPA's scope of 

authority under TSCA to areas regulated by other federal agencies, and its failure to adequately 

protect confidential business infonnation. 

Perhaps lht' most fundamental Jlaw inS. 847 is the safety standard. That standard is based on the 

Food Quality Protection Act of 1996 (fQPA), which was designed to regulate pesticides that 

have a limited number of uses, specific applications. and nan·ow exposure pathways. 

Furthermore. pesticides are desirned to be biologically active~· that is. to kill pests. Industrial 

chemicals regulated under TSCA, by contrast, are designed for a myriad of industrial, 

commercial, and consumer product functions and uses and are not designed to be biologically 

active. Requiring "reasonable certainty of no harm .. .!rom aggregate exposure'' to such 

chemicals. as set forth inS. 847, is unworkable and disproportionate to the risks suggested by the 

nature of these chemicals and their potential exposures. 

Further. the S. 84 7 safety standard requires an examination of the aggregate exposure to all 

existing and new TSCA chemicals. This means that every possible exposure scenario from all 

uses would have to be determined to quantify estimates of total human exposure to a chemical. 

The time and resources required to evaluate all potentia! uses and exposures of all new and 

existing chemicals wnuld be owrwhdming ami wasteful !i:lr both govcrnmem and the regulated 

community. [t would also dramatically impede the innoYation and joh growth that is taking 
66 


24968.050

place today in the American chemical industry, which is experiencing resurgence in the United 

States due to the emergence of shale gas and other emerging energy sources. 

As stated in previous testimony before the Committee, ACC supports establishing a new 

standard as part of a modernized TSCA program, but it must be one designed to regulate 

industrial chemicals, not pesticides. As discussed in detail with Committee staff in the 

stakeholder dialogue, we recommend a "negligible risk" type of standard similar to that in the 

Occupational Safety and Health Act. Such an approach would ensure a strong level of 

protection, place the burden on manufacturers to demonstrate the safety of their products, and 

provide EPA with 11cxibility to detennine appropriate risk levels and risk assessment approaches 

fix the numerous am\ varying types of risks and exposures associated with industrial chemicals. 

2. Ove1· the last several :rears, Europe, Cauada, Australia, Korea, China, and other 

countries have undcraken reforms of their nations' chemical safety laws. What can 

we learn from these coutries' efforts to improve the sa fl.' use of chemicals'! How can 

these lessons inform the work of the Senate Committee on Environment and Public 

Works in proceeding with the Safe Chemicals Act? 

There arc two key areas that Congress could benefit !!·om when examining the regulatory efforts 

of other countries the importance of prioritization and the value of information sharing. 

AC:C believes there is much the U.S. can learn !rom Canada's Chemical l'v!anagcment Plan 

(CMP), particularly in the area of prioritization of chemicals fi:lr safety reviews. Canada's 

program to prioritize, its review of chemicals in commerce was comprehensive, science-based 

and transparent. Canada completed the entire prioritization process before it began performing 

risk assessments. Canada used an iterative process, engaging industry and other stakeholder 

input and feedback at muhiple stages, making further prioritization refinements along the way. 

At each stage of the process, rankings were shared publicly together with supporting 

information. Health Canada and Environment Canada were open to accepting data and updating 

the rankings (e.g .. replacing modeled information with study data). 

The result of this process was a data-driven and scientifically-based Jist of priorities presenting 

the greatest hazard and exp(>sun: potentiaL a result that the United States should drive for in a 

modernized TSCA program. Of the approximately 23.000 substanccs c>n Canada's Domestic 

Substances List (an inventory of substances manutiJcturcd in. imported into or used in Canada on 

a commercial scale. similar to the U.S. TSCA Inventory). H..:alth Canada and Environment 

Canada ultimately set aside 1 8, 700 chemicals as not requiring further assessmt,nt and are now 

engaged in a systematic process to assess the risks of 4.300 high. medium and low priority 

substances. 

[nthe stakeholder dialogue process cml\'cned by Senators Lautenbcrg and lnhofc. ACT put 

t(msard a detailed proposal fi.Jr prioritizing chemicals H.n· safety determinations. similar in nmny 

key respects to the one: used in Canada. We also provided our proposal to EPA as part of the 

Agency's stakeholder dialogue on chemical prioritization, and we appended it to our written 

statement for the Novcmkr 17 Suheommitke hearing. 
67 


24968.051

In contrast to the Canadian approach to chemicals management, ACC believes that Europe's 

program on Registration. Evaluation, and Authorization of Chemicals (REACH) is far too slow. 

inefficient and bureaucratic. Under REACH, the European Chemicals Agency (ECHA) will 

receive dossiers on new and existing chemicals, but to elate the registration deadlines have only 

applied to new chemicals, very high volume substances. and substances that have particular 

hazard characteristics. Registrations for the remaining substances in European commerce are 

due in .June 2013 and .June 2018, depending on production or import volume. Perhaps the most 

significant problem with REAC!! is that it prioritizes substances for regulatory action based only 

on hazard. According tn the European Commission, only some so;;, of all REACH dossiers will 

be reviewed. despite the signilicunt expense and burden of compiling these data-intensive 

registrations. 

Australia. Korea and China are also looking at ways to strengthen how they evaluate and assess 

chemicals. Australia is considering an approach to addressing existing chemicals similar to that 

used by Canada. Korea has proposed changes to its chemicals program but progress appears to 

have slowed. while China recently revised its new chemicals program. 

Importantly, any chemical regulatory system adopted in the U.S. should leverage the data, 

information and assessments on chemicals that have been generated by the chemical safety laws 

of other jurisdictions to the full extent allowed. Everyone will be well served by ensuring that a 

modernized U.S. TSCA law does not impose duplicative and unnecessary testing and data 

generation requirements. 

3. How do you suggest we improve the treatment of new chemicals coming onto the 

market in the Safe Chemicals Act so that the concerns of consumers around safety 

and companies around efficiency arc met'? 

ACC believes that the new chemicals program already in place in TSCA is fundamentally sound. 

We are not avvarc of any chemicals that have come through the existing PMN process that have 

later been found to cause significant hcalth/enviromncntal concerns, nor are we aware of any 

problems EPA has had in exercising appropriate regulatory control and oversight over chemicals 

reviewed in the new chemicals program. 

Moreover. TSCA.'s new chemicals program docs not inhibit American innov8tion. More new 

chemical applications have been tiled in the United States than in any other country or region of 

the world. That fact. and the significant number of new U.S. patents granted every year in 

chemistry. is evidence of the innovation that TSCA has allowed. It is critical that a modernized 

TSCA program continue to allow the U.S. chemical industry to innovate. compete and create 

jobs. 

In contrast with the current program. the provisions ofS. 847would impose a significant burden 

on new chemical development that would stifle innovation. Ironically. the burdensome 

requirements of S. 84 7 (including its heavy data burden and ilkonceived safety st<mdard) would 

likely hamper the very innovations in ·•greener" chemisuy its proponents believe should be 

promoted in the U.S. and that arc making their way into commerce today through the forces of 

the marketplace. 
68 


24968.052

When l testitled before the Committee in February of201 l. I stated that .1\CC believes that 

TSCA 's new chemicals program is already working and does not require an overhaul. I was 

joined by former EPA Assistant Administrator. Dr. Lynn Goldman, in that belief. She stated: 

"Over the years. the new chemicals program has made \\ondcrful efforts to inl(mn the chemical 

industry about the criteria used to assess chemicals. These d't(ms have encouraged development 

of safer chemicals, and I believe have caused the industry to screen out ·bad actors· before 

presenting them to EPA in the lirst instance ... 

ACC has long held the view that the initial pre-manufacturing notice ( Ptv1N) submissions for 

new chemicals under TSC'A should he tailored to the inf(>rmation ne\:ds of a substance. 

consistent with its physical characteristics. potential hazards and the usc nnd exposure patterns of 

anticipated markets. It is generally not well understood that the typical approach ll1r EPA's 

evaluation of a I'M\! includes review of all existing relevant inftmnation/data wuplcd with usc 

of both FPA 's "Chemical Categories·· read-across process and Ll'i\ ·s Sustainable Futures 

models and methods. 

The Sustainable Futures models are not traditional toxicity tests that rely on laboratory animals. 

but instead arc modern-day computerized tools developed to be able to predict the potential or u 

chemical to cause systemic toxicity. cancer and ccotoxicity with an adequate degree of scientific 

certainty. These models arc designed to be very conservative. \Vhen critics ofTSCA's new 

chemicals program claim that new chemicals arc being approved by Ll'A without toxicity tests. 

they fail to either acknowledge or umkrstand the true and full extent of EPA's evaluation 

process. which by design is built upon usc of advanced screening techniques that can reliably 

predict toxicities without requiring extensive animal testing. Such advanced approaches arc 

cnicient. cost-cC!ccti-,c and scientifically sound decision making tools f(>r evaluating ncv, 

chemkals to assure that PMN decisions arc protective of both human health and the 

environment. They also minimize the need for animal tests. 

Questions t!·om Senator lnhofc: 

I. Mr. Dooley, testimony was presented at the hearing that the way to grow American 

jobs in yuur industry is to enact Sen. Lautenberg's bilL What are your thoughts on 

that'? 

We disagree with that statcmcm in the strongest terms. In i\CC's vic\\, the concerns we 

have identitlcd vvith S. 84 7 would severely and perhaps irrcparahl;. damage American 

innovation and job growth in the U.S. chemical industry. Further. this n<:gativ·c impact on 

our industry would produce a ripple effect throughout the liS economy as other 

manufacturing sectors arc dependent on tht' business of chemistry. Any new TSC'i\ program 

must be workabk for consumers. workers, the regulated community. and EPA Restoring 

the public's confidence in the U.S. chemical regulatory system must be about efficient. costcl'fcctive and smart regulation that prioritizes chemicals !(1r review. provides t(n· satety. and 

allows l(>r innovation in new technologies and products and docs not impede job growth. 

ACCs numerous sugg.:stions llli TSCc\ mcxkrni/.atiun put l(m\ard in the- ~takcholdcr 

dialogue conn'ncd by Senators Lauten berg and lnhol~ try to strike a necessary balance 
69 


24968.053

between protecting public health and the environment and allowing for innovation and job 

growth. In our view. S. 847 misses that mark by a wide margin. 

2. It appeared at the hearing a coordinated effort was made to discredit ACC's 

sincerity and meaningful participation in TSCA efforts that have been undenvay. 

Would you like to comment on not only the discussion at the hearing but also ACC's 

level of engagement in efforts to modernize TSCA'! 

/\CC appreciates the opportunity to clarify for the record the extent of our engagement and 

leadership in TSC A modernization efforts. 

Despite the tone of the November 17 hearing. ACC remains committed to working on a 

bipartisan basis to lind a solution to modernizing TSCA to provide for safety, innovation and 

jobs. We rcspectf\.tlty encourage the Committee to begin afi·esh with a clean slate. 

The American business of chemistry- both the manufacturers of chemicals and our upstream 

and downstream value chain that touches virtually all of the technologies and products of our 

society- is unit]ed in the goal of modernizing TSC/\ and providing constructive solutions that 

will create a program that provides for safety, innovation and jobs. In AugllSl 2009, ACC made 

the first public declaration of basic principles for TSCA modernization even before the 

Environmental Protection Agency, which followed a few months later. Even before that we 

were active in discussing TSC.A with President Obama's transition team, and we have followed 

that discussion with periodic meetings with hPA, encouraging scientifically-bused positions 

from the Administration to help promote thoughtfuL effective reform. 

In 2010, ACC was fully engaged in the discussion the House Energy and Commerce Committee 

hosted on its discussion draft of legislation very similar to Senator Lautenberg's. We not only 

participated in every one of the eight individual discussion sessions, we submitted over 40 pages 

of written comments on concepts in the draft and suggestions for appropriate revisions. Because 

our comments on the House discussion draft are relevant to much ofS. 847, we have attached a 

copy of that submission for the Committee's infi:mnation. 

ln addition. we engaged fully in the stakeholder dialogue sessions convened by Senators 

Lauten berg and lnhofe in mid-2011, and met ·"'pnrately and periodically with the Senators' staff. 

The dialogue sessions fbcuscd on particular provisions in S. 84 7, via a schedule and order 

cstablisht~d by the Committee. The Committee also set ground mlcs of confidentiality to 

encourage constructiYc and trvnsparcnt dialogue by both industry and NGO stakeholders. We 

brought experts in toxicology. risk assessment and TSCA law and policy to those meetings and 

to meetings with other Congressional offkes in an attempt to educate staff and Members about 

our views of the complexities of chemical assessment, regulation and commerce. We also put 

forward in detail in the dialogue sessions both our concerns with S. 847 and proposed solutions 

(for example, see our response to Senator Carper's first question. summarizing our sarety 

standard recommendation put forward in the stakeholder dialogue). 

Frnrn A·1ay through November 20 ll, ACC was also engaged in an ongoing confidential dialogue 

directly with public interest representatives on details concerning TSCA modernization. /\CC 
70 


24968.054

believes those discussions were especially usdl.1l bccuuse they uccurred omside th~ context of S. 

847. 

ACC categorically rejects the repeated suggestion by certain Senators during the hearing that our 

reluctance to provide the Committee with specific legislative text has contributed in any way to 

delays in the consideration ofS. 847. As noted elsewhere in this response. despite a continuing 

series of discussions on concerns and problems inS. 847 and offers of solutions. we have yet to 

have any indication of how those concerns will be addressed in modifications to the bill, nor 

have we seen any meaningful changes to the bill or its earlier version dating back to the previous 

Congress. 

Finally. several suggestions were made in the hearing and especially afterwards that the business 

of American chemistry docs not share a unitied view ofS. 847, and that one segment of the 

industry in particular has a different view of the legislation. ACC points to the response of the 

Consumer Specialty Products Association (CSPA) to the Committce·s additional questions to 

that group. When answering a question about whether a divide exits. CSPA clearly stated. "'We 

do not believe that there is a ·divide' between CSPA and ACC .... IWJc arc strongly aligned on 

the principles \-\e have set fo11h for TSCA modernization and on a continued process of working 

jointly as an industry collation to support and work toward bringing TSCA in the 21st Century." 

Furthermore, when asked if they could suppori S. S47, CSPA expressed concerns about the bill 

similar to those put forward by ACC. "CSPA could not support S.847 if the only changes made 

to the bill were the provisions worked out with the "\JGOs as part of our discussions. There arc 

other sections of the bill that are importtml to us. including the adoption of a workable safety 

standard and data requirement, the provisions relating to new chemical review, and. very 

importantly. how a chemical will be screened and idemitied for priority review." 

3. During the hearing you had a ve11· interesting visual analogy about how risk would 

he treated under S. 847. Could you please explain that in more detail? 

The analogy was used in my demonstration of the so-called "risk cup." using the chemical 

chlorine as the example. a key component in implementation ofS. 84Ts safety standard. Under 

that standard, a TSCA substance would be t(nmd to meet the safety :;tandard Q.!!h: if EPA finds 

"there is a reasonable certainty that no harm will result to human health or the environment from 

aggregate exposure to the chen1ical substance.·· 

That standard. by its terms. suggests zero risk and is \cry similar to the salety standard for 

setting tolerances for food-usc pesticides under the FQPA, as discussed earlier. While it may be 

an appropriate standard for food-use pesticides. it is not a correct standard l(lr protecting human 

health/environment l!·om exposure to industrial chemicals under TSCA. More to the point: it is 

a standard that is not feasible for industrial chemicals rej!ulatcd under TSCA. 

fhc "reasonable certainty" standard is not necessary to protect human health/environment from 

TSCA chemicals because TSC/\ chemicals are not designed to be biologically a<:tive. as 

pesticides arc. Instead. TSCA chemicals are gcncrallv designed t\1r \<CrY broad industrial. 

commercial and cunsumer product functions and uses. Industrial uses include things like 

reactants to make other chemicals; commercial uses include things like fuel additives and 
71 


24968.055

lubricants: and consumer product uses include things such as household glues. So the FQPA 's 

"no hann·· standard is misaligned with TSCA chemicals which arc designed t(>r industrial. 

commercial and consumer applications. not for biological activity. 

In addition. the FQPA standard is not feasible to apply to TSCA chemicals. The reason for that 

is grounded in both the number ofTSCA chemicals in commerce and the number of uses of 

thos<:: chemicals. There arc about 600 pesticide active ingredients regulated under FIFRA and the 

FQP A. In contrast. TSCA chemicals in commerce range in mnnbt:r between 15,000 and 30.000 

chemicals (depending on how you count chemicals. based on volume). ln comrast to pesticide 

chemicals with specific uses and applications. there can be hundreds if not thousands of different 

uses ofTSCA chemicals. 

For example. the TSCA chemical chlorine has hundreds of uses. These range from 

pharmaceuticals to disinfectants for public water supplies to plastic manufacturing. Requiring a 

determination of·'no harm" based on consideration of the aggregate <:xposure to chlorine. from 

its hundreds of diflcrcnt uses. would impose a virtually impossible requirement. The S. 847 

safety standard's aggregate exposure requirement means every possible exposure scenario from 

all of these uses would have to be determined to quantity estimates of total human exposure to 

the chemical. The time and energy required to evaluate all these potential uses and exposures 

would be incredibly inefficient and a waste of resources. 

There arc also important questions about how EPA would implement an ''aggregate exposure" 

approach. I used tlll' "risk cup .. analogy in my testimony to describe how EPA determines 

whether aggregate exposure to a pesticide t!·om its specific uses and applications would cause 

harm. 

If the ·'risk cup" represents the total risk from aggregate exposures to a pesticide chemical. then 

additional exposures to that pesticide chemical from additional uses of it might cause the risk cup 

to "overflow''. In the more limited universe of pesticide chemicals and applications. EPA has 

been able to usc this sort of analysis to restrict <:erwin uses of certain pesticide chemicals. 

Applying the "risk cup .. approach in the TSCA context, however, would require an 

understanding of all of the exposures ti·m11 use of the chemical in all of its multiple 

(hundreds/thousands) functions and products. as well as from all natural sources, e.g.. natural 

sources, ambient air. and how much exposure a person might have over an entire lifetime. For a 

single chemical. such as chlorine. this 1vould involve gathering data on thousands of uses and 

products and would require EPA to conduct an aggregate exposure assessment from every 

industrial. commercial and consumer product use of the chemical subswnce. 

Assuming EPA could even conduct such an aggregate exposure assessment of chlorine. then how 

would EPA enforce a finding that the aggregate exposure to chlorine posed harm? !low would 

EP i\ determine which uses were acceptable and could continue. and those that could not'' 

Would EPA simply impose a moratorium on any new uses of chlorine. at the risk of hindering 

innovation in untold new technologies or lite-saving drugs? How would EPA identify "winners 

and losers" in the llhlli<:tplw.:e li.>r chlorine chemistry? Should EPA even have this authority? 
72 


24968.056

Setting aside that policy question. it is certain that if EPA were required by TSCA to consider the 

aggregate exposure to a substance from every industrial, commercial and consumer product usc 

of a chemical substance. the TSCA chemical management system would quickly break down. 

Paralysis in regulation would result. Public contidence in federal regulation of chemicals would 

be even less than it is today. 

lnstead of the FQPA standard, the TSCA safety standard must be one that is both protective of 

hmmm health and the environment and one that can be applied in a practical way. Aggregate 

exposure assessments should only he required in a modernized TSCA on a case hy case basis for 

substances when the need is indicated by certain triggers, such as a small margin of exposure. 

4. Do you feel that S. 847 is the proper starting point for a bipartisan TSCA 

modernization'! 

ACC strongly supports efforts to modernh:e TSCA and appreciates the cft(Jrts of Senators 

Lautcnbcrg, Inhofe and other Members of the Committee to address TSCA rd(mn. However. 

throughout our engagement with Senator Lautenberg's office on S. 847. and particularly through 

ACC's participation in the dialogue Senators Lautenberg and Inhofe convened on the bilL we 

have made clear that we do not believe the proposal is the basis for a bipartisan agreement on 

TSCA modernization. We expressed similar views to the House Energy and Commerce 

Committee when it considered a related proposal in :ZO l 0 (sec the attachment appended to this 

response). At this point in time. we respectfully encourage the Committee to begin with a fresh 

slate in an effort to craft a modernized TSCA program that provides f{H· safety. innovation and 

jobs. 

TSCA is a complicated statute. Chemistry, and the appropriat.: regulation of the business of 

chemistry to ensnrc that health and the environment is protected, is similarly complicated. 

Europe's new chemical regulatory system. REACH. was the subject of considerable discussion 

before it became final, and even then. we believe the result was flawed in many respects. 

Further, REACH is only now in the initial implementation stages. 

ACC has been a constructive participant and industry leader in the discussion of S. 847 and 

similar proposals. We have made clear our industry's commitment to TSCA modernization and 

to appropriate statutory and regulatory measures designed to pr01eet health and the environment 

as well as the competitiveness of U.S. industry. Although the proptmcnts ofS. 847 have 

acknowledged some of our concerns with the hilL we haw yet to see any indication of what 

changes, if any. will be made to address those concerns. 

5. The National A eadem)· of Sciences Report "Toxicity Testing in the 21" Century" 

discussed methods of evaluating chemicals including in vitro testing and 

computational toxicology. Do you think this legislation provides a clear path 

forward for development, validation and usc of these rapidly emerging tools within 

a tiered testing framework'! 

Certain set:tions or S. 847 speak to "varied or tiered data .. and encourage "the usc of alternativt: 

testing methods and testing strategies." Although on tlH:ir f~tcc these concepts appear to be 
73 


24968.057

consistent with certain aspects of the report from the National A~ademy of Sciences '·Toxicity 

Testing in the 21 '' Century.·· greater clarity is needed. 

Adequate characterization of advanced approaches for hazard pro!11ing is key to their practical 

application. S. 847 does not clearly articulate how. when or by whom the performance attributes 

of these methods. including relevance. reliability, sensitivity. and specificity, will be assessed. 

Presumably, the bill's proposed Interagency Science Advisory Board on Altemative Testing 

Methods (!SABATM) would play an important role. but the bill does not include specific 

provisions to ensure that these advanced profiling tools are adequately characterized in terms of 

pcrlbrmancc (the ability of a method to predict ''true" positives and '•true" negatives and its 

reliability in labs over time). applicability (the range of chemical structures that can be reliability 

evaluated by a method. and those that cannot) and mechanistic relevance (the step in the 

sequence of the process of induction of toxicity that is being measured by a given method). 

In addition. certain activities of the proposed lSABATM appear to overlap the existing 

Interagency Coordinating Committee for Alternatives to Animal Testing (lCCVAM, established 

by the !CCV AM Authorization Act of2000 ((P.l.. No. 106-545 (Dec. 19, 2000). codified at 42 

l ;.S.C. § 2851-3 ). As a result, S. 847 does not provide a clear path forward for the development. 

validation and usc of these tools or methods within an appropriately tiered integrated testing and 

assessment framework. These advanced toob and methods have to be appropriately 

characterized in terms of performance and biological context. and then an infl1rmed decision can 

be made whether the level of uncertainty associated with the results of a patiicular tool/suite of 

tools is sufficient for its intended use. If these tools are not appropriately characterized prior to 

being used it will convey a false sense that the data have a demonstrated ability to predict 

downstream events of concern for human health. 

S. 847's reference to the NAS Report also raises questions about some of the practical 

applications of its recommendations. for example, many of the high throughput ~HT) and high 

content (HC) advanced screening techniques that arc currently being applied in programs such as 

ToxCastTM and Tox 21 have been taken directly from the pharmaceutical field. In that arena, 

screening agents with potent biological activities is a routine part of the drug candidate 

development process. 

By contrast. commodity chemicals arc typically orders of magnitude less active than 

pharmaceutical agents since commodity chemicals arc designed to impart physicochemical 

etlccts (not biological effects) that cause or improve the specific performance of a product. This 

begs the question of whether such assays arc even capable of delivering meaningful information 

to inform risk-based decision making in the TSCA commodity chemical context. Obviously 

testing commodity chemicals at artificially high concentrations in HTiHC assay systems simply 

to elicit measureable responses will have little real world significance. A critical element will be 

to "anchor" the test systems with sutlicient knowledge a) of the biologieal context within its 

associated mode of action and key biological events, and b) to enable a translation between test 

dose concentrations and real lite exposures. 

In this regard, the National Academy of Sciences ·'Toxicity Testing in the 21st Century" report 

concludes that a coordinated effort and significant resources over the next several decades will 
74 


24968.058

be required. The report specitkally recommends that a new institution be created to "l()ster the 

kind of cross-disciplinary research that will be required to achieve the vision .. that will involve 

'·government, industry, universities, consulting laboratories. and the public interest community ... 

S. 847 does not address these findings and recommendations of the NAS Committee. 

ACC fully supports utilization of tiered integrative testing and assessment approaches to 

determine potential hazards and risk of chemicals in a modernized TSCA. Testing of chemicals 

should progress to more complex and expensive tests through a tiered approach as needed to 

identify hazards ami exposures of specific concern. To minimize animal testing, existing data 

should be considered prior to new testing. and validated altcrnatin:s to animal testing should he 

used vvhcrewr feasible. 

Importantly. a modernized TSCA needs to leverage the use of existing data and information in 

EPA's safe use determinations, including data and information from other mandatory and 

voluntary programs such as Canada's CMP. Europe's REACH and th.: U.S. lligh Production 

Volume challenge program. 

As ACC has testified before the Committee. AC:C is firmly committed to minimizing the usc of 

laboratory animals for testing and is equally commitled to assuring that animals used J()r testing 

arc treated humanely. ACC has supported the development and validation of alternative and 

non-animal methods. We have participated in a number of new/revised and alternative methods 

l'alidation efforts, including participation in studies and serving nn expert peer review panels. 

ACC has. and will continue to t::ncouragc the use of altcmatives to animal testing when these 

alternatives arc scientitically valid and predictive and acceptable to regulatory bodies. 
75 

Senator LAUTENBERG. Thanks very much, Mr. Dooley. 

Mr. Matthews, I’d like to hear from you. 

STATEMENT OF ROBERT MATTHEWS, COUNSEL, CONSUMER 

SPECIALTY PRODUCTS ASSOCIATION 

Mr. MATTHEWS. Thank you, Senator. My name is Bob Matthews. 

I am with McKenna Long & Aldridge, where I have the privilege 

to serve as counsel for CSPA. Indeed, it is a privilege to testify on 

their behalf before this Committee. 

I want to make it clear, I think it already is, that CSPA supports 

TSCA modernization and it does so for several reasons. I will list 

three of them. 

First, as has been echoed by several of the Senators in their comments, there is an erosion of public confidence, and that comes 

back to CSPA more than most industries because we are the 

branded companies. It is our products that are on retail shelves. It 

is our products which are in all of our homes, in our kitchens in 

our bathrooms and so on. And so when consumers are not confident 

about chemicals in their products, we feel that directly. 

Second, we think that the Federal Government should reestablish its role as the primary source of chemical management regulation in this Country. I echo comments previously stated in that regard. 

Third, we think there is an opportunity for the United States to 

reestablish its global leadership in chemical management. A chemical management system should be based on risk-based analysis of 

chemicals and establishing standards on the basis of risk should 

not be limited to considerations only of hazard, as we have seen in 

other jurisdictions. 

I do want to say a word about the process that we have been involved in, and we have been involved in multiple stakeholder discussions, including not the least of which is the process that Senators Lautenberg and Inhofe have led and directed. We appreciate 

that. We think those discussions have been positive and constructive. We salute your staffs who have done an excellent job in moving that process along. They are very good at what they do. 

And we have had similar processes with the NGO’s. Richard 

Denison to my left and others from the NGO community have 

reached out to us and we to them and productive discussions are 

going on there as well. 

We aren’t there, Senator, I must say. We are trying hard. We 

have moved. They have moved. And the key to those discussions 

has been, and I think it is a word, I apologize if I forgot who used 

it, but one of the Senators used it this morning. The key is to find 

solutions. And to do that, we have to understand what is the Safe 

Chemicals Act? What are its goals? And are there, where we have 

problems or we have concerns about the way it is written, are there 

alternative approaches that can solve those same problems and 

achieve those same goals? 

In that spirit, those discussions have been productive and I believe we have made progress. We still have a ways to go, and that 

is clear. 

I want to talk about two issues that our trade association, our 

member companies have focused on in particular. And the first 

76 

falls directly out of the notion that this should be a risk-based system. Well, if you are going to do risk analysis, you need more than 

just hazard data. You need to understand how those chemicals are 

being used, where they are being used, and what exposures are 

being created by those uses. That information comes right back to 

our industry because we are the companies who are placing those 

products with those substances on the marketplace. 

So the issue of use and exposure information is one that CSPA 

understands must be part of a modern TSCA, and indeed, we have 

for several years promoted the idea that this industry should come 

forward with additional information. And we have said so in our 

position papers and in the discussions with the stakeholders and 

with Senate Staff, we made clear that we are prepared to step forward under new legislation. And indeed, we have very specific proposals in that regard that we have placed on the table. 

And the last issue I want to briefly address, Senators, is sort of 

the natural fallout from that last point, which is we understand we 

need to come forward with substantial additional information 

under a modern TSCA. Inevitably, however, when we do that, some 

of that information will be confidential. And the protection of confidential information is critical to this industry. 

The examples we typically throw around, I am not smarter than 

these examples, so I will just use them: Coke and its formula; WD– 

40; PostIt Notes. Those formulas have been held proprietary by 

those companies who developed those formulas for decades. In the 

case of Coke, I think it is probably a century by now. It is just as 

important to those companies today as it was then to protect those 

interests. 

So we are concerned that there are not enough rigorous protections in the proposed legislation. Here again, however, we think 

there are ways to come at that issue where we can find solutions 

and provide the right balance on both the submission of information to the agency and the protection of that information to protect 

the interests of our member companies. 

I will be pleased to discuss any of those issues further during 

question and answer. 

Thank you. 

[The prepared statement of Mr. Matthews follows:] 

77 


24968.059

Testimony of 

Robert A. Matthews, Esq. 

McKenna, Long & Aldridge 

Of Counsel to, and on behalf of, 

The Consumer Specialty Products Association 

Before 

The Committee on the Environment and Public Works 

and 

Subcommittee on Superfund, Toxics and Environmental 

Health 

Joint Legislative Hearing on the Safe Chemicals Act 

United States Senate 

Washington, D.C. 

November 17,2011 

1667 K Street NW, Suite 300 I Washington, DC 20006 I www.cspa.org I 202-872-8110 
78 


24968.059

Testimony of 

Robert A. Matthews, Esq. 

McKenna, Long & Aldridge 

Of Counsel to, and on behalf of, 

The Consumer Specialty Products Association 

Before 

The Committee on the Environment and Public Works 

and 

Subcommittee on Superfund, Toxics and Environmental 

Health 

Joint Legislative Hearing on the Safe Chemicals Act 

United States Senate 

Washington, D.C. 

November 17,2011 

1667 K Street NW, Suite 300 I Washington, DC 20006 I www.cspa.org I 202-872-8110 
79 


24968.060

The Consumer Specialty Products Association {CSPA) greatly appreciates the 

opportunity to provide input at this legislative hearing on behalf of our approximately 

235 "consumer-facing" companies who are engaged in the manufacture, formulation, 

distribution and sales of approximately $80 billion annually in the U.S. of hundreds of 

popular brand name formulated products. CSPA members are committed to 

manufacturing and marketing safe, innovative and sustainable products that provide 

essential benefits to consumers while protecting human health and the environment. 

My name is Bob Matthews, and I serve as counsel to the CSPA. I am an environmental 

attorney with almost forty years of experience representing clients in counseling and 

litigation matters across a broad spectrum of international environmental laws and 

regulations. 

The products we represent are in every home and institution around the country. Our 

company names are on every one of their products. Product safety is the foundation of 

consumer trust and that the consumer products industry devotes substantial resources 

to achieving this goal. 

like EPA, ACC and other stakeholders, CSPA has previously introduced principles for 

TSCA modernization. Some common ground put forth by these diverse groups includes: 

• The U.S. needs a modern chemical regulatory law that reflects more than 

three decades of scientific and technological advances since TSCA was 

enacted. 

• The system needs to be risk-based, and must allow EPA to review and assess 

the safety of chemicals in commerce through a process of prioritization, with 

the chemicals of highest concern for immediate agency review. 

• The system must include a means by which EPA can obtain reasonable and 

appropriate use and exposure data from companies like those CSPA 

represents to better assess safety. 

• The system must protect public health and the environment while also 

protecting confidential business information {CBI), thereby preserving the 

ability of American companies to drive innovation, grow jobs and compete in 

the global marketplace. 

Establishing a Process for Dialogue 

Senate stakeholder discussions 

Senator Lauten berg and Senator lnhofe, we want to thank you for initiating the recent 

series of Senate staff meetings with key stakeholder groups to discuss in detail views on 

whether and how the TSCA statute should be changed. As one of six trade associations 

invited to participate in these sessions, CSPA is committed to the process of engaging in 
80 


24968.061

dialogue with all stakeholders to work through questions and issues in an effort to 

narrow our differences on TSCA issues. We commend the productive and professional 

approach undertaken both by your staff in organizing and directing these sessions, and 

by all of the stakeholders whose contributions were substantive and meaningful. Your 

leadership in this process is greatly appreciated. 

Industry dialogue 

Senator Lauten berg, you have noted the positive input which has been provided by 

TSCA-regulated companies, including Procter & Gamble, SC Johnson and others. 

Notably, P&G and SC Johnson serve as co-chairs of the CSPA Chemical Policy 

Management Team (CMPT), which operates as a leadership team of member company 

representatives within the association, and a group with which I am closely engaged as 

counsel to CSPA, particularly as it relates to our discussions about modernizing TSCA. 

Also notably, these works groups include representatives from the Downstream 

Coalition of trade associations that includes the CSPA, American Cleaning Institute (ACI) 

and Grocery Manufacturers Association (GMA). 

Under the guidance of the CMPT, the Downstream Coalition has been working now for 

more than three years on TSCA modernization issues. Six TSCA work groups that involve 

a committed group of technical and regulatory experts have taken on the task of 

reviewing key program issues to, first, understand their impacts on our industry, and 

second, to develop recommendations on how TSCA might be modernized to better 

address critical shared concerns in these key areas. 

Our approach in these discussions continues to seek a balance to ensure-

• EPA's ability to review and assess chemical safety in the protection of public 

health and the environment; 

• Companies can continue to innovate and that CBI is protected; and 

• Consumer confidence in the protection of human health and the environment. 

EPA dialogue 

CSPA is committed to TSCA modernization. We understand and accept our role in 

providing use information which may be needed to better inform EPA's prioritization 

and safety assessment decisions in the years ahead. To this end, the Downstream 

Coalition is also working with the EPA in an effort to better understand the types of 

information the agency needs to prioritize chemical review and to evaluate chemical 

use, exposure and risk. This dialogue will also include looking at how this information 

can be submitted to the Agency in a timely and meaningful way. 
81 


24968.062

NGO dialogue 

Two years ago, CSPA was asked by representatives in the NGO community to meet in an 

effort to better understand their priority concerns and calls for legislative reform of 

TSCA. A goal was to reach consensus to try to make progress on some of the 

challenging areas of TSCA modernization that most impact the downstream formulators. 

Over the past six months, CSPA has participated in several meetings with the Safer 

Chemicals Healthy Families Coalition and Environmental Defense Fund. In these 

sessions, we have provided ideas and recommendations developed by the TSCA Work 

Groups. We believe this process has succeeded in narrowing our differences in several 

critical areas, for example, on the timing, process, and content of reporting use and 

exposure information. 

As we have worked through this process, we have identified some common ground on 

two key TSCA elements of significance to CSPA: providing a system for EPA to receive 

more robust information on how chemicals are used for the purposes of both 

prioritizing and assessing the safety of chemicals; and balancing the need for more 

information with the need to protect proprietary and confidential business information. 

Both sides have come to the table with proposed solutions, and while we are not there 

yet, we are making progress. 

The bipartisan approach established by this Committee has served well to motivate that 

dialogue. 

Motivators for TSCA reform 

Enhancing consumer confidence on chemical safety 

Developing reasonable and necessary revisions to update the TSCA statute is 

tremendously important for CSPA member companies, who are, in many respects, the 

public face of the U.S. chemical industry. The products we produce are in every home 

and institution around the country. Our company names are on every one of their 

products. Therefore, maintaining a high level of consumer confidence in the safety of 

the chemicals used in their products is a responsibility that all CSPA member companies 

take very seriously. 

Consistent Regulation of Commerce in AliSO States 

Companies in the chemical industry face a multiplicity of regulations at the state level, 

as legislative and regulatory entities seek to develop and implement their own chemical 

management programs in the absence of action at the federal level. These various state 

actions have created a patchwork of requirements for evaluating, assessing and 

managing chemical use-making it extremely difficult and costly for companies to 
82 


24968.063

market products in aliSO states. Fifteen states have introduced resolutions asking 

Congress to reform TSCA. A modernized federal TSCA statute will reduce the need for 

regulation of chemicals by states, while providing assurances and assistance in 

partnership with state regulators in their efforts to address specific and priority needs in 

their communities. 

Supporting Global leadership for a Risk-based Approach to Chemical Review and 

Assessment 

Chemical regulation is changing rapidly and significantly around the globe. Many of our 

member companies operate in the international marketplace-and are facing costly and 

burdensome requirements to comply with the rigorous hazard-based approach taken 

under Europe's REACH regulation. It is essential for the U.S. chemical management 

system to keep pace with global developments and that our government resume its role 

as a global leader in chemical regulatory policy on behalf of all U.S. citizens and U.S. 

industry. The U.S. chemical industry is unified in its support for the adoption of a riskbased system under TSCA-which means the EPA will consider both hazard and 

exposure criteria in its assessment of a chemical's safety for its intended uses. 

Examining the provisions of S. 847 

CSPA acknowledged in April that the new bill, S. 847, has started to move in the right 

direction in several key areas, such as prioritization and minimum data set. CSPA 

recognizes the need for EPA to obtain additional reasonable and appropriate 

information on consumer product exposures to refine the categorization of those 

chemicals for further assessment. Such an approach needs to be based on sound 

science and must be practical, objective, and predictable in order to quickly and 

efficiently narrow the large chemical universe to a smaller, more meaningful, subset of 

chemicals that would receive further assessment. 

However, CSPA has serious concerns about sections of the bill, including, but not limited 

to, provisions that would: 

• Significantly expand requirements for Reporting, including through a 

burdensome Declarations section; and 

• Restrict and limit the protection of CBI. 

With regard to Reporting and Declarations, it is very important to ensure that 

information is collected as needed and does not impose an across-the-board 

requirement for every chemical user to identify every chemical use. We believe that it 

is neither necessary nor productive to require that the same amount of information be 

generated for low priority chemicals as that which may be needed for a high priority 

chemical. We also believe that EPA should focus their limited resources on chemicals 
83 


24968.064

which represent the highest hazards and highest potential for exposure and risk to 

human health and/or the environment. 

Providing Use and Exposure Information in Support of a Risk-based Approach 

CSPA recognizes that our companies are in a unique position to provide use and 

exposure information and are committed to undertaking a new reporting requirement 

to provide this information. This type of information is needed to better inform EPA's 

decisions in the prioritization and assessment of chemical safety. 

Therefore, CSPA supports the involvement of our chemical users in providing EPA 

certain use information with which the Agency can make well informed screening-level 

prioritizations. This reporting would include an indication of use in products intended 

for children and information about the concentration range of the chemical in the 

product. Reporting under these provisions can provide EPA with a current 

understanding of the use and exposure of chemicals in commerce without resorting to 

an inflexible use registration/declaration requirement for every chemical user to report 

every chemical use. This reporting must be tied directly into the overall framework of 

priority setting which will consider existing and available information to screen 

chemicals to identify chemicals for further review. 

Finally, while downstream users are committed to providing use and exposure 

information as needed by the Agency, it must be recognized that this may include 

information on chemicals in our products that is proprietary CBI. Intellectual property is 

a company's most valuable intangible asset, and represents a substantial investment of 

time and dollars that result more sustainable and innovative products entering the 

market. It must be carefully safeguarded from competitors. CSPA has indicated our 

support for revisions under the Safe Chemicals Act to require upfront substantiation of 

claims and appropriate sharing of CBI with state governments, and other appropriate 

authorities, but Q!1/y_ with assurances of appropriate safeguards. 

The updated TSCA, which can only be enacted with bi-partisan support, will touch 

thousands of companies in the U.S. and around the globe. If done right, a modern TSCA 

can drive innovation and sustainable products. 

Mr. Chairman and Members of the Committee, while there is still much work to be done 

to reach bipartisan consensus on updating the TSCA law, CSPA is committed to this 

process. Along with other stakeholders, our industry can help to provide 

recommendation on these and other issues a part of a modern chemical regulatory 

framework. 
84 


24968.065

AboutCSPA 

The Consumer Specialty Products Association (CSPA) is the premier trade association 

representing the interests of companies engaged in the manufacture, formulation, 

distribution and sale of more than $80 billion annually in the U.S. of familiar consumer 

products that help household and institutional customers create cleaner and healthier 

environments. CSPA member companies employ hundreds of thousands of people 

globally. Products CSPA represents include disinfectants that kill germs in homes, 

hospitals and restaurants; candles, and fragrances and air fresheners that eliminate 

odors; pest management products for home, garden and pets; cleaning products and 

polishes for use throughout the home and institutions; products used to protect and 

improve the performance and appearance of automobiles; aerosol products and a host 

of other products used every day. Through its product stewardship program, Product 

Care·, and scientific and business-to-business endeavors, CSPA provides its members a 

platform to effectively address issues regarding the health, safety and sustainability of 

their products. For more information, please visit www.cspa.org. 
85 


24968.066

January 3, 2012 

The Honorable James lnhofe, Ranking Member 

The Honorable Tom Carper 

United States Senate 

Washington, DC 20510 

Attn: Jonathan Aronchcik 

Jonathan Aronchick@epw.senate.gov 

Representing Household & ln5tltutlonal Products 

Clu""n • l'l>fWHit 

"""""•'KIWi C.,.. Atotl"'"'"'*"o.l • PeuM~~~ 

Via electronic transmission 

Subject: Response to Questions Related to Testimony Presented at a Joint legislative Hearing 

on the Safe Chemicals Act (Nov. 17, 2011) 

Dear Senators lnhofe and Carper: 

On behalf of the Consumer Specialty Products Association (CSPA), and of Mr. Robert Matthews 

who appeared for CSPA at the hearing before the Committee on Environment and Public Works 

on November 17, 2011, we are pleased to respond to the follow-up questions you have posed. 

Our responses, set forth below, provide further support for the bipartisan efforts to develop a 

modernized TSCA that provides EPA with the tools it needs to implement a sound, risk-based 

chemicals management system while at the same time meeting the needs of industry that new 

legislation facilitate, rather than impede, innovation. We look forward to continuing to work 

with the Committee members and their staffs towards achieving these goals. 

Questions from Senator Tom Carper: 

1. What do you believe is the biggest outstanding issue that the environmental and public 

health communities, the chemical industry and others engaged in efforts to reform the TSCA 

need to come closer together on in order to further strengthen the Safe Chemicals Act and gain 

even more support for reforming our country's chemical safety laws? 

Answer: For industry as a whole, the most significant outstanding issue is the definition 

of the safety standard. It is difficult to see how industry can support reforming our 

chemical safety laws without resolving this most fundamental issue. 

For the consumer products industry, it is vitally important that a modernized TSCA 

provide adequate protection for companies' trade secrets and confidential business 

information (CBI). CSPA believes that a reasonable balance can be developed to achieve 

the parallel goals of: (1) providing EPA with the information it requires to make 

informed, risk-based chemical safety and management decisions; and (2) protecting CBI, 

1667 K Street NW, Suite 300 I Washington, DC 20006 I www.cspa.org I 202-872-8110 
86 


24968.067

The Honorable James lnhofe 

The Honorable Tom Carper 

January 3, 2012 

Page 2 of6 

which is necessary to ensure continued innovation and is essential for American 

businesses to continue to compete successfully in a highly competitive global economy. 

CSPA member companies believe that all stakeholders are aligned around the shared 

goal of chemical safety, and that this principle should be the foundation for modernizing 

TSCA. Part of that process is improving the information provided to EPA by companies 

that use TSCA regulated chemicals in products and, to the maximum extent possible, 

sharing appropriate information with the public. Consumer product manufacturers 

agree that certain information provided to EPA must be afforded protection from 

disclosure to the public and business competitors in order to protect innovation. 

In conclusion, while CSPA believes that there are major outstanding issues related to 

modernizing TSCA, we believe that these concerns can be solved through a bipartisan 

effort. 

2. Over the last several years, Europe, Canada, Australia, Korea, China and other countries have 

undertaken reform oftheir nation's chemical safety laws. What can we learn from these 

countries' efforts to improve the safe use of chemicals? How can these lessons inform the work 

of the Senate Committee on EPW in proceeding with the Safe Chemicals Act? 

Answer: The Canadian program has sought to develop a regulatory review of chemicals 

based on prioritization of chemicals for further review and assessment. This process has 

involved stakeholder input and generally, has been widely viewed as an effective and 

productive approach to focus attention first on highest priority chemicals. Canada is 

now moving into a next phase of the process to begin to review a list of the next 

identified priorities. 

In contrast, the European approach is based on the collection of enormous amounts of 

data on large numbers of chemicals and chemical mixtures in phase 1, with a goal of the 

regulators then taking that information to review and identify chemicals for further 

action. The end result is an overload of data, much of which is unnecessary for a 

chemical safety review; this has only served to delay the process and increase the level 

of uncertainty for both consumers and industry with regard to chemicals used in 

products. Another lesson learned from the European approach is the need to rely upon 

a risk-based review of chemicals versus a hazard based approach. Again, the purpose is 

to identify the chemicals that may present a risk to human health and/or the 

environment. Exposure is a necessary part of this review. The European approach is 

also unnecessarily complex, creating obligations on data generation and sharing that are 

burdensome and ineffective. CSPA's approach to modernizing TSCA, which would 

require that the consumer product manufacturers provide meaningful use and exposure 

information on chemicals as they become prioritized, is a much more direct and efficient 

approach. 
87 


24968.068

The Honorable James lnhofe 

The Honprable Tom Carper 

January 3, 2012 

Page 3 of6 

3. Are there improvements to the Safe Chemicals Act that could better ensure that the 

processes the bill would put in place for bringing newer, greener chemicals to market support 

advancements in green chemistry and innovation? 

Answer: The chemical industry is highly innovative in the development of newer, more 

effective formulations for use in millions of products worldwide. Again, we believe that 

the most important part of this equation is to dearly and affirmatively provide direction 

to the EPA on the need to recognize and support the protection of CBI related to new 

chemicals, as well as formulations as they are developed and introduced in the 

marketplace Even before they commit to investment in a new chemical or process, a 

company needs to know they can adequately protect their investment from disclosure 

to their competitors. Strong protections of confidential and proprietary information as 

part of TSCA will not only assure that this information is provided to the EPA, but, in 

combination with a meaningful risk-based process for prioritization of chemicals, will 

also serve to encourage and support innovation. 

The following CSPA member companies have won the Presidential Green Chemistry 

Challenge Award: 

• BASF Corporation 

• Bayer Corporation 

• The Dow Chemical Company 

• E. I. du Pont de Nemours and Company 

• Eastman Chemical Company 

• Nalco Chemical Co. (now Ecolab, Inc.) 

• Novozymes North America, Inc. 

• The Procter & Gamble Company 

• Rohm and Haas Company (now The Dow Chemical Company) 

• S.C. Johnson & Son, Inc. 

• The Sherwin-Williams Company 

These companies expended a tremendous amount of time, money and effort to 

develop groundbreaking new technologies. The practical reality is that no company will 

invest in future Green Chemistry breakthroughs unless there is adequate protection for 

their investment in these new technologies. Thus, CSPA believes that it is essential that 

a modernized TSCA ensure continued innovation by providing necessary and 

appropriate protection for these companies' intellectual property. 

Questions from Senator James lnhofe: 

1. During the hearing we heard testimony that states are "ill equipped" to deal with chemical 

regulation and that regulating chemicals is an unnecessary drain on state resources. We also 

heard that state regulation of chemicals creates a "complex maze of regulations across the 
88 


24968.069

The Honorable James lnhofe 

The Honorable Tom Carper 

January 3, 2012 

Page 4 of6 

country." If TSCA is modernized to strengthen federal protections, how important is it from a 

business standpoint to at a minimum maintain the current levels of preemption in TSCA? 

Answer: We believe chemical regulation should be a federal responsibility largely 

because of this costly and duplicative regulation at the state government level. 

Chemicals and products are produced, marketed and sold in multiple jurisdictions--and 

a federal system will ensure that customers--both commercial and consumer--are 

assured the same level of access to chemicals and products, as well as assurance of 

safety in aliSO states. The United States should provide leadership on chemical safety 

as our companies represent the global leaders in innovation and productivity. The 

federal approach will also serve to reduce costs on manufacturers by eliminating 

duplicative and/or conflicting compliance under parallel regulatory systems. We agree 

that, at minimum, the Congress should ensure that current TSCA provisions that provide 

that, if the federal government has reviewed a chemical for safety, a state cannot take 

separate action that would conflict with the federal regulation. In the absence of 

regulation on a chemical, as appropriate, a state may take action. However, we believe 

it would be reasonable and practical to impose some period of moratorium on State 

action as part of TSCA to provide time for the EPA to update and implement their 

program. 

We appreciated the comments of the State of Washington at the Senate hearing that it 

was the preference of state governments for a federal regulatory system for TSCA 

versus a 50-state approach. During the 201llegislative session, 15 states introduced 

resolutions asking Congress to reform TSCA. A modernized federal TSCA statute will 

reduce the need for states to regulate chemicals, while providing assurances and 

assistance in partnership with state regulators in their efforts to address specific and 

priority needs in their communities. 

In conclusion, the distribution and sale of consumer products (e.g., electronics, 

household products) through our Nation's retail marketplace is extremely complex; 

thus, it is nearly impossible to manufacture products that comply with differing state 

statutory and regulatory requirements. That is why CSPA believes that a bipartisan 

comprehensive federal chemical management policy is vitally important. 

2. A major interest of industry in modernizing TSCA is to create regulatory certainty and not 

force businesses to deal with a patchwork of regulation on their products. Does modernization 

of TSCA without preemption properly address the issue of creating certainty? 

Answer: WhHe we appreciated the comments of the State of Washington that states 

would be unlikely to take additional action on chemical regulation if an effective federal 

program was established, this is not sufficient to create the level of certainty necessary 

to encourage research and development of innovative new products. We believe a 

better approach is to include preemption, with appropriate provision for additional 

state actions where the federal government has not made a safety determination. 
89 


24968.070

The Honorable James lnhofe 

The Honorable Tom Carper 

January 3, 2012 

Page 5 of6 

3. Since the hearing, there have been efforts to highlight a perceived divide between industry 

groups such as CSPA and ACC. Could you speak to your organizations view of that "divide?" 

Answer: We do not believe that there is a "divide" between CSPA and ACC. We 

understand that the final details of the law may impact our industry segments 

differently, and agree that it is incumbent on all of us to be engaged to ensure our 

interests are protected. But we are strongly aligned on the principles we have set forth 

for TSCA modernization and on a continued process of working jointly as an industry 

coalition to support and work toward bringing TSCA into the 21st century. 

4. You mentioned the efforts of CSPA and others in industry to try and find common ground 

around major TSCA modernization issues with environmental groups. Could you describe to me 

where you see CSPA's role in this effort and how that fits into the bigger picture of overall TSCA 

modernization? 

Answer: CSPA, as well as other members of the consumer products industry, has 

worked in parallel with manufacturers, most notably ACC, in seeking common ground 

with NGOs on the modernization of TSCA. For example, while ACC has focused on the 

safety standard and new chemical issues, CSPA, as explained above, has focused on the 

provisions of a modern TSCA under which consumer product formulators will be 

required to provide information to EPA on use and exposure of chemicals prioritized 

under TSCA. This is a new burden on our industry that we have accepted in order to 

ensure that the EPA adopts a risk-based approach for the review i!nd assessment of 

chemicals. It is incumbent on us to protect the interests of our companies in these 

discussions. Our discussions with the NGOs were initiated to provide us a better 

understanding of their goals and objectives and, in turn, to improve their understanding 

of how these objectives could be met in a workable process without imposing 

unnecessary burdens on industry and to protect trade secrets and confidential business 

information. Again, providing meaningful information on use and exposure of 

chemicals under TSCA is the only way to support a risk-based approach--which is a 

priority for all industry stakeholders. 

5. Absent any other major substantive changes to S. 847, if CSPA's negotiations with 

environmental groups yielded a compromise, would CSPA be supportive ofthe bill? 

Answer: No, CSPA could not support 5. 847 if the only changes made to the bill were 

the provisions worked out with NGOs as part of our discussions. There are other 

sections of the bill that are important to us, including the adoption of a workable safety 

standard and data requirement, the provisions relating to new chemical review, and, 

very importantly, how a chemical will be screened and identified for priority review. 

We look forward to engaging with all stakeholders on further discussions in these areas. 

In conclusion, CSPA would like to thank you for the opportunity to present input at the 

legislative hearing on behalf of our approximately 235 "consumer-facing" companies who are 
90 


24968.071

The Honorable James lnhofe 

The Honorable Tom Carper 

January 3, 2012 

Page 6 of6 

engaged in the manufacture, formulation, distribution and sales of approximately $80 billion 

annually in the U.S. of hundreds of popular brand name formulated products. 

Respectfully submitted, 

Robert A. Matthews 

McKenna long & Aldridge LLP 

Of Counsel to, and on behalf of, 

The Consumer Specialty Products Association 

cc: Ben Dunham, Ben Dunham@lautenberg.senate.gov 

Dimitri Karakitsos, Dimitri Karakitsos@epw.senate.gov 

Phil Klein, PKiein@cspa.org 
91 

Senator LAUTENBERG. Thanks very much. 

Mr. Denison, we look forward to hearing from you now. 

STATEMENT OF RICHARD DENISON, SENIOR SCIENTIST, ENVIRONMENTAL DEFENSE FUND; SAFER CHEMICALS, HEALTHY 

FAMILIES COALITION 

Mr. DENISON. Thank you, Mr. Chairman, Ranking Member 

Inhofe. I am testifying today on behalf of both Environmental Defense Fund and the Safer Chemicals Healthy Families Coalition, a 

broad coalition of over 300 health, environmental and environmental justice organizations and leading businesses that represent 

more than 11 million Americans, including the very young voices 

you heard in the back of the room a bit earlier. 

Mounting evidence of problems calls into question the safety of 

thousands of chemicals that we encounter in our everyday lives. 

Here are but a few examples of these problems. 

Scientific researchers increasingly link chemical exposures to serious diseases that are become more prevalent, including childhood 

leukemia and brain cancers, which have risen more than 20 percent since 1975; and fertility problems, which now affect 40 percent 

more women than they did in 1982. 

Eighty percent of all new chemicals reviewed by EPA are reviewed without access to any health or environmental information. 

That is because the U.S. is virtually the only developed Country in 

the world that does not require a minimum set of safety information to accompany a new chemical. 

Residents in low-income communities and communities of color 

like Mossville, Louisiana, which is surrounded by 14 different 

chemicals plants, are routinely exposed to far higher levels of deadly chemicals like dioxin, vinyl chloride and benzine than is the general population. And yet such disproportionate impacts are not required to be accounted for when the government assesses the risks 

of those chemicals. 

These problems can be ascribed to the failures of TSCA. They 

would also be ameliorated by the adoption of the Safe Chemicals 

Act. It provides a framework for a systematic solution to a set of 

problems that will only be addressed, if at all, through piecemeal 

actions. We support the legislation because it strike a balance between the need to fully protect public health, including the most 

vulnerable among us, with the need to encourage innovation and 

safer chemicals, and the needs of the chemicals marketplace and 

consumers and the public for better information, with the need to 

protect legitimate confidential information. 

Since the Act was first introduced in 2010, it has evolved substantially to reflect input from a variety of stakeholders. Changes 

have been made that both boost its health protections and make it 

more workable and ease its implementation. I give a number of examples of those positive changes in my written testimony. I also 

detail how the reforms of the Safe Chemicals Act would fix the 

major flaws of TSCA. 

But let me now turn and emphasize in my oral statement the opportunity we see to capitalize on what is a truly remarkable consensus among a broad array of stakeholders that Congress must reform this law. The need is urgent because it is not only failing to 

92 

provide health protections, it is failing to provide industry with a 

stable environment in which to conduct its business, and its customers with confidence in the safety of its products. 

We recognize that reform must meet the needs of a variety of 

stakeholders, and that is why our coalition has been deeply engaged in dialog with the industry. We have ongoing dialogs with 

the American Chemistry Council, with the Consumer Specialty 

Products Association and its members. We have met for many days 

over the past 6 months to narrow our differences. Eight members 

of our coalition traveled to the headquarters of both the Dow 

Chemical Company and Procter and Gamble to hear first-hand 

about their businesses and understand their perspectives for TSCA 

reform. 

We strongly have endorsed and support the bipartisan leadership 

shown by Chairman Lautenberg and Ranking Member Inhofe to 

convene a process of stakeholders to explore how we can move this 

bill forward in a way that is truly bipartisan. 

Let me say that while the details of many of the dialogs we are 

involved in are confidential, we have made substantial progress. In 

our dialog with CSPA, we are on the cusp of agreeing to recommendations for legislation to deal with the issues that Bob just 

mentioned: confidential business information and reporting of robust information on the use of chemicals. 

Based on my deep involvement in these dialogs, I believe there 

is not a single issue that we cannot find the solution to. EDF and 

our Coalition would welcome the opportunity to share the bridging 

concepts we have identified, along with the companies with whom 

we have engaged. 

We urge the Members of this Committee to act now to forge and 

advance bipartisan reform legislation in this Congress. It represents a once-in-a-generation opportunity to create a new chemical 

management system that sustains our health, our environment and 

our economy. 

Thank you very much. 

[The prepared statement of Mr. Denison follows:] 

93 


24968.072

Finding the ways that worK. 

STATEMENT OF 

RICHARD A. DENISON, Ph.D. 

SENIOR SCIENTIST 

ENVIRONMENTAL DEFENSE FUND 

BEFORE 

THE U.S SENATE 

COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS AND 

SUBCOMMITTEE ON SUPERFUND, TOXICS AND ENVIRONMENTAL HEALTH 

AT A LEGISLATIVE HEARING ON 

S. 847, THE SAFE CHEMICALS ACT OF 2011 

17 NOVEMBER 2011 

1875 Connecticut Avenue, NW T 202 387 3500 New York, NY I Austin, TX I BentonviUe. AR f Boston, MA I Boulder, CO I Raleigh, NC 

Washington, DC 20009 F 202 234 6049 Sacramento, CAt San Francisco, CA I Washington, DC 1 Be1)1ng. China I La Paz, Nlexico 

edf.org Tolally chlorme free 100% posH:onsumer recycled paper 
94 


24968.073

I am testifying today on behalf of both the Environmental Defense Fund (EDF) and Safer 

Chemicals, Healthy Families, a coalition of over 300 organizations that speak for more than 11 

million Americans. The coalition includes groups representing health professionals and healthaffected populations and communities, environmental justice organizations, leading businesses, 

and state and national environmental groups- all of whom came together to urge Congress to 

fundamentally reform the Toxic Substances Control Act of 1976. A list of members of the 

coalition is attached to my written testimony. 

THE PROBLEM 

Over the past decade, a litany of serious concerns has emerged that calls into question the 

safety of the thousands of chemicals we use and encounter in our everyday lives: 

• lead has shown up in a host of children's products, imported and domestic, finally 

prompting Congress to impose a ban- only to see another toxic heavy metal, cadmium, 

immediately take its place, in a most deadly version of the kids' game "whack-a-mole." 

• The science of biomonitoring has revealed that virtually all Americans, including newborns, 

carry in our bodies hundreds of toxic synthetic chemicals, many derived from everyday 

products- yet no one can tell us how they got there or what effects such a mixture of 

chemicals is having on our and our children's health, because they have not been 

adequately tested or assessed for safety. 

• Persistent, bioaccumulative and toxic (PBT) chemicals that we were told we would never be 

exposed to- such as those used as flame retardants in furniture and TV casings, in stainresistant coatings on textiles and food packaging, and as plastics additives- are now 

routinely detected in the dust in our homes, in our environment, in marine mammals, and 

even in people living in the remotest parts of the globe. 

• Our scientific understanding of how chemicals affect our biology has grown dramatically 

over the last decade. We now know that the timing of exposures, especially during early 

development, is critical; that even very low doses of certain chemicals can have adverse 

effects; and that it is the cumulative effects of long- as well as short-term, real-world 

exposures to multiple chemicals that matter most. 

• A large and growing body of scientific evidence' is linking chemical exposures to several 

serious chronic diseases and disorders that are becoming more prevalent, including: 

o leukemia, brain and other childhood cancers, which have increased more than 20% 

since 1975; 

o breast cancer, which went up by 40% from 1973 to 1998; 

o asthma, which almost doubled in prevalence from 1980 to 1995; 

o autism, diagnoses of which have increased 10-fold in the last 15 years; and 

o difficulty in conceiving and maintaining a pregnancy, which affected 40% more 

women in 2002 than in 1982. 

• EPA is forced to perform Google searches to try to identify all uses of chemicals like the 

hormone-disrupting bisphenol A. That is because it lacks authority to ensure accurate 

1 Summarized in The Health Case for Reforming the Toxic Substances Control Act, 2010, available at 

h_ttRJ~ltl:!rgQ_Qrt.sa_f~b-"-'1lli:E.l2'-'1Igf. 
95 


24968.074

reporting of chemical uses. And even though people are exposed to such chemicals from 

many different sources, EPA lacks a mandate to assess the aggregate risks. 

• EPA cannot provide even a rough approximation of the actual number of chemicals in 

commerce today or how and where they are used. That is because EPA is severely 

constrained in collecting even the most basic information from companies that make and 

use chemicals. Many companies are not even required to notify EPA when they begin to 

produce a chemical or use it in a new way. 

• 80% of all new chemical notices submitted to EPA include no health or environmental data. 

That is because the U.S. is virtually alone among all developed countries in not requiring a 

minimum data set to be submitted for new chemicals. While EPA can in theory require 

subsequent testing, the burdens are so high that it has done so for only a few percent of 

new chemicals. 

• Residents in low-income communities of color like Mossville, Louisiana (which is surrounded 

by 14 chemical plants) are routinely exposed to deadly chemicals like dioxin, benzene and 

vinyl chloride in amounts that far exceed general population exposures. Yet such 

disproportionate impacts need not be accounted for when the government conducts risk 

assessments on such chemicals, and actions to reduce the exposures are few and far 

between. 

• The public, state governments and even workers who may be directly exposed to chemicals 

are denied access to the great majority of chemical information that companies submit to 

EPA. That is because the companies have been given wide latitude to claim it as 

confidential, and EPA lacks resources to review the claims to determine if they are 

legitimate. 

All of the problems I just described can be attributed, in whole or in part, to the failures of our 

country's main chemical safety law, the Toxic Substances Control Act (TSCA). 

THE SOLUTION 

All of these problems would be largely or entirely ameliorated by adoption of legislation 

introduced this year, S. 847, the Safe Chemicals Act of 2011. It provides the framework for a 

comprehensive, systematic solution to a set of problems that until now have only been 

addressed -if at all- through reactive, piecemeal actions. 

EDF and the Safer Chemicals, Healthy Families coalition supportS. 847 because it strikes the 

right balance: It fully protects human health and the environment (including the most 

vulnerable among us), while also encouraging and rewarding innovation toward safer chemicals 

and products; and it informs the chemicals marketplace as well as consumers and the public, 

while protecting legitimate confidential business information. 

The Safe Chemicals Act would: 

promptly reduce exposure to the "worst of the worst" toxic chemicals, those that persist 

and build up in the food chain; 

ensure basic health and safety information is available for all chemicals as a condition 

for entering or remaining on the market; 
96 


24968.075

reduce the high burden of toxic chemical exposures on people of color and low-income 

and indigenous communities; 

upgrade methods used to test and evaluate chemical risks to reflect the best available 

science, based on recommendations of the National Academy of Sciences; and 

provide the tools and resources needed to identify and address those chemicals posing 

significant health and environmental concerns. 

Attached to my written testimony is a more detailed description of the many ways in which the 

Safe Chemicals Act would make vitally important reforms to TSCA. 

Since first introduced in 2010, the Act has incorporated many significant changes that reflect 

input from a broad range of stakeholders. Another attachment to my written testimony lists 

the many improvements made in the 2011 bill. Here are a few highlights of changes that both 

boost health protections and ease implementation and workability: 

An orderly process is set forth that categorizes chemicals into high-, some- and lowconcern classes and directs those chemicals toward specific actions or to be set aside. 

Action is to be taken to immediately reduce exposure to chemicals of high concernthose that are persistent, bioaccumulative and toxic (PBT) to which people are exposed. 

Chemicals would be prioritized and for those requiring safety determinations, the pace 

of that activity would be matched to EPA's capacity and resources. 

Minimum information requirements would be tailored to different types or classes of 

chemicals, while still ensuring that basic safety information is provided in a timely 

manner for all chemicals. 

THE OPPORTUNITY 

At this moment, there is a truly remarkable consensus among the full range of stakeholders 

that Congress needs to reform the Toxic Substances Control Act. TSCA is not only failing to 

provide the health protections that Americans need and expect, it is also not providing industry 

with a stable environment in which to do business, nor its customers at home and abroad with 

confidence in the safety of its products. 

We recognize a reformed TSCA must meet the needs of a diverse set of stakeholders, including 

the regulated community. That is why our coalition is directly engaging with a broad range of 

companies that produce, use, buy and sell chemicals and chemical products, to understand 

their perspectives and identify the best ways to deliver better information and critical health 

protections effectively and efficiently. 

We have ongoing dialogues with the American Chemistry Council (ACC) and the Consumer 

Specialty Products Association (CSPA) and more than a dozen of their member companies; 

these have involved many days of substantive meetings on key issues in TSCA reform over the 

past six months. Eight members of our coalition traveled to the Headquarters of both The Dow 

Chemical Company and Procter & Gamble, meeting for two full days with each company to 

learn about their businesses and approaches to chemical safety, and to share perspectives on 
97 


24968.076

TSCA reform. And we have met with dozens of other companies from all levels in the chemicals 

supply chain to understand their needs for information about chemicals in the products they 

make, buy and sell. 

We have also been extremely encouraged by the leadership of Chairman Lauten berg and 

Ranking Member lnhofe in convening a series of meetings of key stakeholders to explore ways 

in which TSCA reform could be advanced in a bipartisan manner. Our coalition enthusiastically 

participated in all ofthose meetings. 

All of these exchanges have convinced us that we have a huge opportunity to forge a legislative 

path forward that is truly bipartisan and meets the needs of both industry and the health and 

environmental communities. In our dialogues with industry, enormous progress has been 

made due to efforts made by both sides to gain a better understanding of each other's needs 

and perspectives, to narrow differences, and to find creative solutions that are both practical 

and effective. 

While confidentiality agreements preclude me from discussing details, let me say that in our 

dialogue with CSPA we are on the cusp of agreement on recommendations to consider in the 

legislation that would address two key needs in TSCA reform: balancing public access to 

chemical information with the need to protect legitimate confidential business information; 

and designing a system to provide EPA with more robust information on how chemicals are 

used for purposes of both prioritizing and assessing the safety of chemicals. 

I have come away from my deep involvement in these dialogues with the belief that there is not 

a single major issue in TSCA reform for which, working together, we cannot find a solution. EDF 

and the Safer Chemicals, Healthy Families coalition would welcome the opportunity to share 

these bridging concepts, along with companies with whom we have been engaged. We urge 

the members of the Committee to act on this major opportunity to forge and advance a 

legislative vehicle that is bipartisan. 

Public opinion research consistently shows that Americans do not see this issue in partisan 

terms, and that, whatever their political persuasions, they want a system that gives them 

confidence that the products and materials they buy and use every day are safe for their 

families and their environment and good for business and the economy. 

I strongly urge the Committee to advance TSCA reform legislation in this Congress. It 

represents a once-in-a-generation opportunity to create a chemicals management system that 

sustains our health, our environment, and our economy. 

Thank you for the opportunity to testify today at this important legislative hearing. 
98 


24968.077

MEMBERS OF THE SAFER CHEMICALS, HEALTHY FAMILIES COALITION 

Public Health Organizations 

Agent Orange legacy Children of Vietnam Veterans 

American Public Health Association- Public Health 

Nursing Section 

Asbestos Disease Awareness Organization 

Association of State and Territorial Directors of 

Nursing 

Bladder Cancer Advocacy Network 

Breast Cancer Action 

Breast Cancer Fund 

Citizens for Health 

Consumers Union 

The Endometriosis Association 

First Focus 

Institute for Agriculture and Trade Policy 

Lung Cancer Alliance 

Massachusetts Breast Cancer Coalition 

National Center for Environmental Health Strategies 

National Disease Clusters Alliance 

National Healthy Nail Salon Alliance 

National Pediculosis Association 

Partners in Healthy Communities 

Oregon Public Health Association 

Rachel's Friends Breast Cancer Coalition 

Women's Cancer Action 

Women's Community Cancer Project 

Women's Health & Environmental Network 

Women's Voices for the Earth 

Health Care Providers/Research Institutions 

Alliance of Nurses for Healthy Environments 

American Nurses Association 

Birth Defect Research for Children 

The CRS Institute 

Delaware Nurses Association 

DrGreene.com 

Health Care Without Harm 

Marine Environmental Research Institute 

Mount Sinai Children's Environmental Health Center 

National Medical Association 

Nurses for Global Health 

North Carolina Chapter of the American Academy of 

Pediatrics 

Ohio Nurses Association 

Physicians for Social Responsibility 

Physicians for Social Responsibility- Austin 

Physicians for Social Responsibility- Chicago 

Physicians for Social Responsibility- Colorado 

Physicians for Social Responsibility- Greater Boston 

Physicians for Social Responsibility- Los Angeles 

Physicians for Social Responsibility- Maine 

Physicians for Social Responsibility Oregon 

Physicians for Social Responsibility- Sacramento 

Physicians for Social Responsibility- San Francisco 

Bay Area 

Physicians for Social Responsibility- Tampa Bay 

Science & Environmental Health Network 

Washington Physicians for Social Responsibility 

Washington State Association of Occupational 

Health Nurses 

Washington State Nurses Association 

Yale School of Medicine, Environmental Health 

Group 

learning/Developmental Disabilities Organizations 

American Association on Intellectual and 

Developmental Disabilities 

American Network of Community Options and 

Resources 

Association for Children's Mental Health 

The Arc of Massachusetts 

The Arc of the U.S. 

The Autism Society 

CHADD- Children and Adults with Attention 

Deficit/Hyperactivity Disorder 

Developmental Disabilities Nurses Association 

Institute of Neurotoxicology & Neurological 

Disorders 

Learning Disabilities Association of America 

learning Disabilities Association of Maine 

Learning Disabilities Association of Michigan 

Learning Disabilities Association of Minnesota 

learning Disabilities Association of New York State 

Minnesota Association for Children's Mental Health 

Safe Minds 
99 


24968.078

National Environmental Organizations 

American Bird Conservancy 

Center for Health, Environment & Justice 

Center for International Environmental Law 

Clean Water Action 

Commonweal 

Earth justice 

Emerald Coastkeeper, Inc. 

Environmental Defense Fund 

Environmental Health Fund 

Environmental Law & Policy Center 

Grassroots Environmental Education 

Green America 

Greenguard Environmental Institute 

Greenpeace 

Jean-Michel Cousteau Ocean Futures Society 

League of Conservation Voters 

Natural Resources Defense Council 

North American Hazardous Materials Management 

Association 

Pesticide Action Network of North America 

Rachel's Network 

Sierra Club National Toxics Committee 

Teens Turning Green 

Union of Concerned Scientists 

US Public Interest Research Group 

Environmental Justice Organizations 

Advocates for Environmental Human Rights 

Air Alliance Houston (TX) 

Alaska Community Action on Taxies (AK) 

Black Women for Well ness 

BURNT (TN) 

Connecticut Coalition for Environmental Justice (CT) 

Don't Waste Arizona (AZ) 

The Earth Cause Organization (AR) 

Environmental Community Action Inc. (ECO-Action) 

(GA) 

Environmental Justice Action Group (AZ) 

Environmental Justice Advocates of Minnesota (MN) 

For a Better Bronx (NY) 

Galveston Baykeeper (TX) 

Indigenous Environmental Network (MN) 

Just Transition Alliance (CA) 

The JustGreen Partnership (NY) 

Kalpulli lzkalli 

Kentucky Resources Council, Inc. (KY) 

REACT- Rubbertown Emergency ACTion (KY) 

Rural-Coalition (DC) 

Safer Pest Control Project (ll) 

Southwest Worker's Union (TX) 

T.E.J.A.S. (Texas Environmental Justice Advocacy 

Services) 

UPROSE (United Puerto Rican Organization of 

Sunset Park) (NY) 

Voices for Earth Justice (MI) 

WE ACT for Environmental Justice (NY) 

Mom Bloggers for Safer Chemicals 

Alexandra Zissu at Alexandrazissu.com 

Anna Hackman at Green Talk 

Deanna Duke at Crunchy Chicken 

Diane MacEachern at Big Green Purse 

Donielle Baker at Natural Living Moms 

Jeanne Blaisdell at The Green Samaritan 

Kathy Scoleri at The Safe Mama 

Katy Farber at Non-Toxic Kids 

Linda Anderson at Citizen Green 

Lori Alper at Groovy Green Livin 

Sommer Poquette at Green & Clean Mom 

Tracy Himes at Verde Mom 

Parent Organizations 

EcoMom Alliance 

Growing Green Child Development Center 

Healthy Child Healthy World 

healthy-kids. info 

Holistic Moms Network 

Moms Rising 

Making Our Milk Safe 

National Green School Coalition 

Parents for Nontoxic Alternatives 

Styrofoam Out of Schooi/Fllnd for City of New York 

Reproductive Health Organizations 

The American Fertility Association 

Asian Communities for Reproductive Justice 

Association of Reproductive Health Professionals 

National Asian Pacific American Women's Forum 

Physicians for Reproductive Health and Choice 

Planned Parenthood Federation of America 

Reproductive Health Technologies Project 
100 


24968.079

State Advocacy and Community Organizations 

Action for Children North Carolina (NC). 

Alaska Community Action on Toxics (AK) 

Allergy Kids Foundation (CO) 

Alliance for a Clean and Healthy Maine (ME) 

Alliance for a Clean and Healthy Vermont (VT) 

Alliance for Sustainability (MN) 

Anti Uranium Coalition (CO) 

Arkansas Community Organizations (AR) 

Basel Action Network (WA) 

Bay Area Healthy 880 Communities (CA) 

Berkshire Environmental Action Team (BEAT) (MA) 

Buckeye Environmental Network 

Butte Environmental Council (CA) 

California Healthy Nail Salon Collaborative (CA) 

Californians for Pesticide Reform (CA) 

Cancer Prevention Coalition los Angeles 

Center for Environmental Health (CA) 

Chehalis River Council (WA) 

Citizens' Environmental Coalition (NY) 

Citizens for the Chuckwalla Valley (CA) 

Clean New York (NY) 

Coalition for a Safe & Healthy Connecticut (CT) 

Delawareans for Social and Economic Justice (DE) 

Duwamish River Cleanup Coalition (WA) 

Earth Ministry (WA) 

Earthology Institute (WI) 

Earth rose Institute (Fl) 

East Michigan Environmental Action Council {MI) 

Ecology Center (MI) 

Environment California (CA) 

Environment Illinois {IL) 

Environment North Carolina (NC) 

Environmental Health Strategy Center (ME) 

Families Against Cancer & Toxics (AZ) 

Florida Public Interest Research Group (FL) 

Glynn Environmental Coalition (GA) 

Great Lakes United (NY) 

GreenCAPE (MA) 

Green Cleaning Network (IN) 

Healthy legacy (MN) 

Hilltown Anti-Herbicide Coalition (MA) 

Huntington Breast Cancer Action Coalition, Inc. (NY) 

Indiana Toxics Action Project (IN) 

Kentucky Environmental Foundation (KY) 

Kids for Saving Earth (MN) 

locaiMotionGreen (MI) 

Lutheran Public Policy Office of Washington State 

(WA) 

Maine Association of Certified Professional 

Midwives (ME) 

Maine Children's Alliance (ME) 

Maine league of Conservation Voters (ME) 

Maine League of Young Voters (ME) 

Maine Organic Farmers and Gardeners Association 

(ME) 

Maine Parent Teacher Association (ME) 

Maine People's Alliance (ME) 

Maine Women's Lobby (ME) 

Mainely Girls (ME) 

Maryland Public Interest Research Group (MD) 

Massachusetts Breast Cancer Coalition 

Massachusetts Parent Teacher Association (P\A) 

(MA) 

Mercury Awareness Team of Washington (WA) 

Michigan Environmental Council (MI) 

Minnesota Center for Environmental Advocacy (MN) 

Minnesota Pesticide Awareness (MN) 

Minnesota Public Interest Research Group (MN) 

Natural Resources Council of Maine (ME) 

Neighbors for Clean Air (OR) 

New Jersey Environmental Federation 

New Jersey Environmental Justice Alliance 

New York City Environmental Justice Alliance (NY) 

New York Lawyers for the Public Interest (NY) 

North Carolina Conservation Network (NC) 

Northwest Coalition for Alternatives to Pesticides 

(OR) 

Ohio Conference on Fair Trade (OH) 

Ohio Environmental Council (OH) 

Ohioans for Health, Environment, and Justice (OH) 

Olympic Environmental Council (WA) 

Omaha Healthy Kids Alliance (NE) 

Oregon Center for Environmental Health (OR) 

Oregon Environmental Council (OR) 

Oregon Toxics Alliance (OR) 

PAWS(WA) 

Pesticide Watch Education Fund (CA) 

Preventing Harm Minnesota (MN) 

Project Safe Yard (NC) 

Projects for Environmental Health, Knowledge, & 

Action, Inc. (NJ) 
101 


24968.080

Audubon (WA) 

Restaurant Opportunities 

Task Force 

Spokane Riverkeeper (WA) ' 

Foster Neighborhood 

Sustainable Sudbury (MA) 

(MN) 

Texas 

Free North Carolina (NC) 

Center (ME) 

(ME) 

Group 

(TX) 

Washington Public Interest Research (WA) 

Washington Coalition (WA) 

Women for a Environment (PA) 

Women's Environmental {MN) 

Businesses/ Analysts 

Council 

Dapple Baby 

Debra Dadd 

DNP Technology 

Dream2Ciean, Ltd, 
102 


24968.081

How the Safe Chemicals Act of 2011 

would fix the 

Prepared 

flaws of the Toxic Substances Control Act 

Environmental Defense Fund 

develop and apply 

chemicals to which people 

and build up in 

(PBTs). "Hot spots" 

to disproportionately high 

be specifically identified 
103 


24968.082

assessments often drag 

conclusion or decision. 
104 


24968.083
105 


24968.084
106 


24968.085
107 


24968.086

Responses prepared by 

Environment and Public Works Committee Hearing 

November 17,2011 

Follow-Up Questions for Written Submission 

Dr. Richard A. Denison. Senior Scientist. Environmental Defense Fund 

Submitted in January 2012 

Questions from: 

Senator Barbara Boxer 

I. Mr. Denison, S. 847 prioritizes actions to address threats to chemicals that persist in the 

environment. can accumulate in people's bodies, are toxic and that people are exposed to in their 

everyday lives. 

Could you describe the public health need for focusing on these types of dangerous chemicals? 

RESPONSE: Urgent attention is needed to address the class of chemicals known as Persistent, 

Bioaccumulative, and Toxic Chemicals, or PBTs. This class includes many of the most notorious 

chemicals ever studied- chemicals such as dioxins, mercury, lead, cadmium and polychlorinated 

biphenyls (PCBs ), the dangers of which we have known for some time, as well as relative newcomers 

such as polybrominated diphenyl ethers (PBDEs) widely used as flame retardants and a variety of 

perfluorinated chemicals (PFCs) used to impart stain or moisture resistance to textiles and paper 

packaging or to produce nonstick cookware. 

PBTs are uniquely dangerous because they pose a triple threat. They persist in the environment for long 

periods of time and can be transported long distances; they accumulate in living organisms and increase in 

concentration as they move up the food chain; and, they are highly toxic, often at very low levels of 

exposure. 

Because they exhibit all three of these hazardous properties, PBTs are inherently unsafe. And because 

releases of even small amounts of PBTs will eventually lead them to build up to very high levels and in 

locations often far removed from their point of use or release, traditional risk assessment methods cannot 

be used to effectively support regulatory action on PBTs. Because risk assessments require a 

quantification of exposure levels, they cannot adequately evaluate the hann posed by PBTs, the levels of 

which will continue to rise in people or other organisms, even after the contaminant ceases being released 

into the environment. 

The special nature of the risks posed by PBTs has been noted by EPA: "These PBT chemicals are of 

particular concern not only because they are toxic but also because they remain in the environment for 

long periods of time, are not readily destroyed, and build up or accumulate in body tissue. Relatively 

small releases ofPBT chemicals can pose human and environmental health threats."' 

S. 847 appropriately requires evidence of actual or potential exposure to a PBT as a basis for its 

identification and targeting for expedited action to reduce exposure; this avoids targeting PBT chemicals 

to which there is no likelihood of exposure. S. 847 also appropriately provides for time-limited, 

1 Environmental Protection Agency. "Fact Sheet on EPCRA Section 313 Rulemaking: Persistent Bioaccumulative 

Toxic Chemicals." ( www .epa.govitriih)WSJl.Jlt!rcgslpbt!p..b.tnJl_Q:f>,.ruji) 
108 


24968.087

renewable exemptions for specific uses of targeted PBTs that serve critical or essential uses for which 

there are not available alternatives or which provide net health, environmental or safety benefits relative 

to available alternatives. Even for such exempted uses, S. 847 requires disclosure of such uses so that 

consumers and the public are aware of and can act to protect themselves from exposures to such 

chemicals. 

Can you also describe your viel1'S on S. 847 's process for prioriti=ing the assessment of 

chemicals? 

RESPONSE: The prioritization process inS. 847 represents a substantial improvement over that in 

earlier versions of the bill by providing an orderly, transparent procedure EPA is to use to place chemicals 

in different priority classes for which different subsequent actions are prescribed. Among the changes are 

the ability for EPA to identify chemicals of very low concern where sufficient data exist to do so- which 

is responsive to industry concerns that some chemicals can be set aside based on existing information and 

need not be subject to any further action unless new warranting information arises. 

S. 847 also ensures that the pace of safety determinations for chemicals that EPA determines require them 

is set so as to match available EPA resources, and the order of conduct of such determinations is 

prioritized based on relative risk. These provisions are also responsive to concerns of industry as well as 

other stakeholders that EPA be able to efficiently and effectively assess chemicals for which safety 

determinations are needed, and use risk as the basis for deciding which chemicals most need safety 

determinations. 

2. Mr. Denison, S. 847 tiers the amount of information that indus/ly must be provided on the safety 

of chemicals in order to demonstrate that the chemical is in fact safe. 

Could you please describe the benefits of this type of tiered information requirement and the 

importance of ensuring that adequate information is provided on all chemicals to ensure that they 

are safe? 

RESPONSE: A major deficiency in TSCA has been that it has failed to generate the health and 

environmental infonnation needed for EPA, the market and the public to make well-informed decisions 

on chemicals, even those in widespread use. Legal and procedural barriers have severely constrained 

EPA's authority and practical ability to require adequate testing of chemicals, both those already on the 

market and new chemicals prior to their market entry. (The U.S. is virtually the only developed country 

in the world that does not require a minimum set of safety information to be provided on a new chemical 

as a condition for entering the market.) 

Hence, a requirement that such information be developed for all chemicals by their manufacturers is a 

critical need for TSCA reform. Indeed, the stated policy established under the language ofTSCA itself in 

1976, unfortunately not realized, states just that: 

"It is the policy of the United States that adequate data should be developed with respect to the effect 

of chemical substances and mixtures on health and the environment and that the development of such 

data should be the responsibility of those who manufacture and those who process such chemical 

substances and mixtures."' 

2 TSCA §2(b)(1). Emphasis added. 
109 


24968.088

In implementing that policy, however, it should be recognized that not all chemicals require the same 

level or extent of information to determine their safety. For example, information needed to show the 

safety of a chemical used solely in industrial settings as an intermediate to make other chemicals is likely 

to be less than that needed for a chemical used in a widely sold, dispersive consumer product such as a 

householder cleaner. For this reason, S. 847 appropriately mandates that EPA develop tiered information 

requirements for different chemicals and groups of chemicals. 

Another significant departure ofS. 847 from a "one-size-fits-all" approach is that it provides for various 

types of information to be used to meet information requirements, a~ long as such information is 

scientifically reliable and sufficient to effectively screen chemicals for safety. The allowable information 

types extend well beyond traditional test methods to include "the use of alternative testing methods and 

testing strategies to generate information quickly, at low cost, and without the use of animal-based testing, 

including toxicity pathway-based risk assessment, in vitro studies, systems biology, computational 

toxicology, bioinformatics, and high-throughput screening." 

3. Mr. Denison, S. 847 references a National Academy of Sciences report, "Science and Decisions," 

to establish the best currently available science for determining the risks fi'om chemicals. 

Can you please describe the benefits of using the methods presented in this report and the 

strength ofS. 847 's overall approach to assessing a chemical's risks. compared to the way such 

risks are current(v assessed under TSCA? 

RESPONSE: The primary means by which chemical risks are to be judged under S. 847 is through risk 

assessment- a key demand of industry. Traditional risk assessments have often fallen short of protecting 

public health and have sometimes taken decades to identify a "safe'' level to certain chemicals. As a 

result, public and community confidence in risk assessment is very low. There are also major technical 

deficiencies in current risk assessment methodologies that must be addressed if it is to serve as a credible 

basis for determining chemical risks. For example, we now know that there are many chemicals for 

which any level of exposure poses some risk, yet traditional risk assessment assumes a safe level exists 

for nearly all chemicals. 

S. 847 therefore includes provisions to ensure that EPA's use of risk assessment incorporates the best 

available science, initially by being required to rely on the recent recommendations of the nation's 

foremost scientific body, the National Academy of Sciences, as to how EPA can improve its practice of 

risk assessment. The recommendations, many of which are already being implemented by EPA and other 

federal agencies, are critical to restoring the credibility of and public confidence in risk assessment. 

A key recommendation of the NAS is to reverse the common practice used by EPA of assuming that there 

is a level of exposure to a chemical below which there is no risk. Science tells us that many chemicals 

have effects even at very low doses; moreover, even where such a "threshold" may be seen for a chemical 

in a highly controlled study of genetically homogeneous laboratory animals, the extent of variability in 

the human population as a whole effectively erases such a threshold. Hence NAS recommends that only 

if EPA has strong affirmative evidence for a threshold in the human population should it assume there is a 

wholly "safe" level of exposure. A second key recommendation is that EPA needs to assess risk so as to 

ensure protection of vulnerable populations, including developing fetuses and children that are typically 

more susceptible to the effects of chemical exposures. Third, EPA needs to assess "aggregate" exposures 

to a chemical, accounting for the often multiple sources of exposure to a given chemical. Finally, where 

science allows, EPA risk assessments would need to identify groups of chemicals to which people may be 

exposed that act similarly or produce the same or similar health effects, and assess the "cumulative" 

exposures to all of those chemicals. 
110 


24968.089

Senator Tom Carper 

1. What do you believe is the biggest outstanding issue that the environmental and public health 

communities, the chemical industry, and others engaged in efforts to reform the Toxic Substances 

Control Act need to come closer together on in order to further strengthen the Safe Chemicals Act 

and gain even more support for reforming our country's chemical safety laws? 

RESPONSE: Recent dialogues among stakeholders has significantly narrowed substantive differences 

and identified considerable common ground, to the point where I was able to state in my written 

testimony that I believe there is not a single major issue in TSCA reform for which, working together, we 

cannot find a solution. 

The most difficult issue in my view is how to ensure the safety of new chemicals before they become 

ensconced in our economy, but do so in a manner that does not overly impede the ability of American 

industry to innovate and meet market demands. Even here, I think an appropriate balance can be struck 

by tailoring initial data and assessment requirements applicable to most new chemicals to reflect their 

likely limited initial production and use, and providing an effective means whereby those requirements 

can be increased as such a chemical's production and use expands. 

I must say I also believe that policies that place too much emphasis on speed-to-market considerations 

and the like are short-sighted and risk putting U.S. industry at a competitive disadvantage by failing to 

ensure they will be able to meet what is arguably the primary market driver for innovation today: 

demonstrated health and environmental safety and sustainability. Any consideration of arguments about 

innovation and competitiveness needs to be viewed from this starting point: All too often, a chemical's 

safety has been at best a tangential consideration. A major goal ofTSCA reform should be to ensure that 

innovation toward safety is an integral part of how chemicals are produced and used in this country. That 

necessarily means imposing some data and safety assessment requirements on new chemicals, before they 

are so embedded in our economy that the costs to industry, consumers and society to dislodge them are so 

high. 

I have written extensively on this topic; see, for example, "Raising the bar for chemical safety will spur, 

not stitle, innovation. "

3 

2. Over the last several years, Europe, Canada, Australia, Korea, China, and other countries have 

undertaken r~forms of their nations' chemical safety laws. What can we learn ]rom these 

countries' efforts to improve the safe use qf chemicals.? How can these lessons inform the work of 

the Senate Commitlee on Environment and Public Works in proceeding with the Safe Chemicals 

Act? 

RESPONSE: The scope of this question is huge, so I will provide a very brief response and provide 

some references for more information. The bottom-line Jesson to be learned from the efforts of other 

countries is that they have acted to address a problem that we are not acting to address, and hence they are 

well ahead of us in moving their chemical and related industries toward a more sustainable footing in 

today's global economy. 

Another observation is that the policies of these nations have a great deal in common and seek to address 

the very same problems that have plagued chemical safety efforts in the U.S. under TSCA: the lack of 
111 


24968.090

sufficient information on both new and existing chemicals, which impedes prioritization and 

identification of chemicals of concern; the slow pace of assessment of existing chemicals; the need to 

provide greater access to information within chemical supply chains, in the marketplace and to the 

broader public; and the need to ensure sufficient governmental authority to efficiently and expeditiously 

identify and restrict production and use of the most dangerous chemicals. 

Finally, most of these policies mirror all or substantial parts of the European Union's REACH Regulation, 

which is increasingly becoming a de facto global standard. Much of the chemical industry is already 

complying and learning to live with REACH. While REACH is not perfect and it is only at the early 

stages of implementation, it can and must serve as a critical reference point for TSCA reform. 

For more information, see: 

my 2007 report, Not That Innocent, comparing in detail the chemicals policies of the U.S., Canada 

and the European Union; 4 

my 2009 paper, published in Environmental Law Reporter, titled "Ten Essential Elements in TSCA 

Reform;"' and 

our numerous analyses of policy developments in other countries, posted on our Chemicals and 

Nanomaterials blog_6 

3. In reforming the Toxic Substances Control Act, how do you think Congress can strike the right 

balance between ensuring that the public has adequate information related to the safety of 

chemicals and chemical products and ensuring that American companies are not required to 

submit public information to the Environmental Protection Agency that might put them at a 

competitive disadvantaf(e in a global market? Do you think the S(l{e Chemicals Act in its current 

form strikes this balance? How might the bill be improved to ensure that the confidential business 

information of US. companies is sufficiently protected so that the US. maintains its position as 

an innovator and job-creator in the chemical industry? 

RESPONSE: There is clearly a need to balance the legitimate claims of companies to protect certain 

confidential business information (CBI) from public disclosure with the legitimate need for the market, 

consumers and the public to have access to infonnation they need to make sound decisions about 

chemicals that are in commerce. Unfortunately, TSCA 's provisions and their implementation by EPA 

have skewed this balance radically in the direction of denying the public's right to know and creating an 

ill-informed chemicals marketplace. 

The core problem is two-fold, constituting a vicious circle: Too many CBI claims are made, and each of 

the infrequent examinations of such claims done by EPA has found a large fraction to be illegitimate, i.e., 

not meeting the well-established criteria for what constitutes a legitimate trade secret. And because of the 

large number of claims made, EPA has lost the ability to review claims to ensure they are in fact 

legitimate and remain so over time; this lack of review has led directly to more claims being made, 

thereby completing the vicious circle. 

Under TSCA companies are free to claim, often without providing any justification, most information 

they submit to EPA to be CBI, denying access to the public and even to state and local governments. 

4 Available at h.\!J;2;i www.cnvironmcntaldcfensc.org/article.cfm'?contcntid=6147. 

5 Available at http: iwww.cdf.org/documents/9279 Denison 10 Elements TSC'A Rcli,rm.pdf. 
112 


24968.091

Even the identity of chemicals that are the subject of health and safety studies- which TSCA expressly 

forbids from being claimed CBI except in very limited circumstances- has been routinely masked under 

policies in place at EPA until recently. CBI claims remain in place until and unless challenged by EPA, 

yet EPA is not required to review the claims, and they never expire. 

S. 847 would go far to restore the right balance. All CBI claims would have to be justified up front. EPA 

would be required to review them, and only approved claims would stand. Approved claims would expire 

after no more than five years, except for types of claims for which EPA determines the five-year term 

would not apply. Other levels of government would have access to CBI. 

Many in industry have acknowledged the need for substantial reform ofTSCA's policies toward 

information disclosure. There is widespread agreement, for example, on the need for up-front 

substantiation both to reduce the number of claims asserted and better ensure the legitimacy of those 

claims that are made. 

One key to striking the right balance is to recognize that it is often information that links a specific 

chemical to a specific company or product that is most sensitive. Many disclosures, for example of a 

health and safety study on a chemical which in my view is information for which the public has a right to 

know, can be done in a manner that does not disclose such linkages and hence avoids the concern. 

The most difficult area is with new chemicals, where companies understandably have a greater need to 

protect the identity of the chemicals in which they've invested. Here, I think a viable approach may be to 

provide a time-limited allowance for some types of protections on infonnation concerning new chemicals, 

but with clear exceptions made for such chemicals where a potential hazard has been identified. 

One specific improvement to S. 847 would be to amend the provision limiting CBI claims to a single fiveyear period, to allow such claims to be extended upon a showing by the claimant that the conditions for 

granting CB! status in the first place remain. Another would be to specify up front certain types of 

information that are always eligible for CBI protection, such as a company's list of customers or detailed 

information about the precise process it uses to make a chemical. 
113 


24968.092

Senator James lnhofe 

I. Dr. Denison, in your view, what kind of additional resources would EPA require in order to 

implementS. 847 in a way that is sufficiently protective while not compromising speed to market 

or industry's innovative abilities? 

RESPONSE: The key kinds of additional resources needed include expanded and more modern 

information technology capabilities to manage and share information received from industry and other 

stakeholders; and increased staff resources to develop implementing regulations, policies and procedures, 

to ensure efficient processing of received information, to conduct safety determinations, and to review 

claims for protection of confidential business information claims. 

One of the key drivers for the chemical industry in wanting TSCA reform is to ensure that EPA has the 

ability to assess the safety of their chemicals, and where they are found to be safe, vouch for their safety 

so as to restore market and public confidence. That is why many companies support measures, and have 

expressed a willingness to provide resources themselves, to ensure EPA has sufficient resources and 

authority to get the information it needs, make decisions and take needed actions as efficiently as 

possible. 

ACC's principles for TSCA modernization, in particular #s 3 and 9, encompass these points: 

3. EPA should act expeditiously and efficiently in making safe use determinations. 

Since a chemical may have a variety of uses, resulting in different exposure potentials, EPA 

should consider the various uses and focus on those resulting in the most significant 

exposures. 

EPA should complete safe use determinations within set timeframes. 

9. EPA should have the staff, resources, and regulatory tools it needs to ensure the safety of 

chemicals. 

EPA's budget for TSCA activities should be commensurate with its chemical management 

responsibilities. 7 

Given the extremely limited extent of activity that has taken place under TSCA over the past several 

decades, and the enormity of the task of addressing the tens of thousands of chemicals that were 

grandfathered in under TSCA that have not been adequately tested or assessed for safety, a substantial 

increase in resources will be needed. That in my view is in everyone's interest, given how vital it is to 

both our economy and our health that the public, consumers, the domestic market, our trading partners 

and the global market all have confidence in the safety of the products of the U.S. chemical industry and 

related industries. 

2. What has been the effect of EPA's Chemical Data Reporting Rule on the level of information on 

chemicals available to the agency? 

RESPONSE: The short answer is that it is too early to tell, because the rule was only finalized late last 

year, the first reporting cycle will start in February of this year (with data not available until the second 

half of the year at the earliest), and many of the key enhancements will not be introduced until the next 

cycle of reporting that doesn't occur until 2016. 

EDF strongly supports the enhancements made in the CDR, although we are disappointed that their full 

implementation will not be realized for an additional four years. The CDR goes far to address a key 
114 


24968.093

deficiency in the Inventory Update Reporting Rule (IUR) it replaced: The infrequent reporting (once 

every five years) of only a single year's manufacturing data. Both EPA and our own analyses of data 

from past fUR reporting cycles demonstrates that, because of major year-to-year fluctuations in chemical 

production and import, such infrequent reporting has led to a highly inaccurate picture of what chemicals 

are actually in U.S. commerce and in what quantities. Unfortunately, we will have to wait until late 2016 

to get annual production data because implementation of that feature of the CDR was delayed until then. 

Another key improvement in the CDR is to require reporting of available information on chemical use for 

a larger number of chemicals than was the case under the fUR. Especially in a risk-based system for 

assessing chemical safety, good use information is essential to predicting exposure, and the lack of such 

information has been an Achilles heel ofTSCA. 

Unfortunately, a key deficiency of the fUR was retained in the CDR: The restriction of reporting 

obligations only to those chemicals produced at 25,000 pounds or more per year per site. Evidence 

indicates that the use of such a high threshold means that many, likely a signitlcant majority ot: chemicals 

actually in commerce will not be required to be reported and hence that EPA, the public and the market 

will not have any access to needed information on them. When EPA raised the fUR threshold from 

10,000 to 25,000 pounds per year per site a number of years ago, the number of organic chemicals 

reported fell by about two-thirds. In comparison, the thresholds for reporting information under REACH 

and other global chemicals management systems are much lower, approximately 2,200 pounds per year. 

Another deficiency is the lack of any requirement under the CDR for companies to promptly report 

significant changes in the production or use of a chemical, changes that could dramatically affect 

exposure and risk. 

By requiring declarations for all chemicals produced, S. 84 7 would go a significant way to address these 

deficiencies and ensure that, at the outset, EPA is able to get a full picture of chemicals in commerce, and 

better prioritize those chemicals and the resources it needs to devote to assessment of their safety. And by 

calling on companies to promptly inform EPA of major changes in a chemical's production or use, S. 847 

would ensure EPA has a current picture and is able to adjust the priority of a chemical, whether up or 

down, to reflect its actual production or use. 

3. We have heardfrom multiple witnesses in numerous TSCA hearings before the committee that 

EPA's New Chemicals program is working effectively and not in need of any major overhaul. If 

EPA had a greater ability to review existing chemicals that were grondfathered into the inventm:v 

or after they went through the PMN process, do youfeel EPA could still appropriately work 

within the current framework of the new chemicals program? 

RESPONSE: I would agree only that EPA's new chemicals program works better than its existing 

chemicals program, because TSCA gave EPA the authority and mandate to review such chemicals prior 

to their market entry. 

I do not believe that EPA receives adequate health and safety data to conduct a safety assessment of new 

chemicals that is robust and protective of health and the environment EPA lacks adequate authority to do 

so under TSCA, and the compensatory approaches it has developed, while in many ways representing a 

valiant etTort driven by necessity, are insufficient, especially with respect to predicting impacts on human 

health and long-term impacts on both human health and the environment. 
115 


24968.094

I will note all of the following deficiencies in EPA's new chemicals program, about which I have written 

in detail.8 

No dota, no problem: No up-front testing requirement or minimum data set applies to new chemicals, 

in contrast to the requirements of virtually every other developed country in the world. 

Guessing game: EPA is forced to heavily rely on limited models and methods to predict the toxicity 

or behavior of a new chemical. 

Catch-22: While EPA can require testing of a new chemical on a case-by-case basis, it must first 

show the chemical may pose a risk not an easy task without any data in the first place! 

One bite at the apple: EPA typically gets only a single opportunity to review a new chemical. 

Crystal-ball gazing: EPA has to try to anticipate a new chemical's for-all-time future production and 

use. 

Black box: New chemical reviews lack transparency. 

Anti-precaution: In deciding whether to require testing or controls for a new chemical, EPA equates 

lack of evidence of harm with evidence of no harm, largely owing to its limited authority under 

TSCA. 

Many of these same conclusions have been drawn by both the Government Accountability Office9 and the 

EPA's Office of Inspector General. 10 

4. Do you think that screening level testing is appropriate for new chemicals or should all new 

chemicals be required to go through a safety standard determination? 

RESPONSE: I think that the bar for data requirements and for assessing a new chemical does not 

necessarily need to he set as high as for an existing chemical, depending of course on its level and nature 

of production and use. I think an appropriate balance can be struck by tailoring initial data and 

assessment requirements applicable to most new chemicals to reflect their likely limited initial production 

and use, and providing an effective means whereby those requirements can be increased as such a 

chemical's production and use expands. 

5. Would you agree that most !f not all safety standard determinations will require more 

information than simply a "minimum data set"? 

RESPONSE: I think it will depend to some extent on the level of assessment EPA decides is needed to 

inform the safety determinations for particular chemicals or groups of chemicals. S. 84 7 specifies that the 

various minimum data sets EPA is to develop are to "include the minimum amount of information 

necessary for the Administrator to conduct a screening-level risk-assessment of the chemical substance or 

category of chemical substances" (Sec. 4(a)(l)(B)(iii)). Certain chemicals such as those used only in 

relatively closed industrial settings- may require no more than a screening-level risk assessment to serve 

as the basis for their safety determinations, in which case the applicable minimum data set should suffice. 

8 See my extensive analysis included in a blog post on EDF's Chemicals & Nanomaterials blog: 

http://blngs.edf.org/nanotechnology/2009/04rl6iepas-ncw~chcmicals-program-tsca-dealt-epa-a-vcry-poor-handl. 

9 See Government Accountability Office, Report GA0-05-458, Chemical Regulation-Options Exist to Improve 

EPA's Ability to Assess Health Risks and Manage fts Chemical Review Program, 2005, p. 5, available at 

www.gao.gov/new.items/d06l 03]JJllif. 

10 See USEPA Office of inspector General, "EPA Needs a Coordinated Plan to Oversee Its Toxic Substances 

Control Act Responsibilities," Report No. 1 0-P-0066, February 17, 2010, available online at 

http:i/w\y-,y,epa.gov'oigircports:201 Oi2Q 100217-1 0-P-0066.pdf. 
116 


24968.095

My expectation and desire would be that EPA establishes minimum data sets for specific types or groups 

of chemicals that it expects will be sufficient to conduct safety determinations; that approach will be more 

efficient and provide a more predictable business climate in which companies can operate with clear 

expectations of what data they will be required to provide. Nonetheless, there will be circumstances 

where closer examination of a chemical will lead EPA to conclude more data are needed; in those cases, 

EPA needs to have authority it can readily apply to get the additional data it needs for the safety 

determination. 

6. The National Academy of Sciences Report, "Toxicity Testing in the 21st Century," discussed 

methods of evaluating chemicals including in vitro testing and computational toxicology. Do you 

think this legislation pays enough attention to using these rapidly emerging and ~ffective tools? 

RESPONSE: I do thinkS. 847 sufficiently provides for and encourages use of such methods. A 

requirement EPA must meet in establishing minimum data sets is to "encourage and facilitate the use of 

alternative testing methods and testing strategies to generate information quickly, at low cost, and without 

the use of animal-based testing, including toxicity pathway-based risk assessment, in vitro studies, 

systems biology. computational toxicology, bioinformatics, and high-throughput screening" (Sec. 

4(a)(l)(B)(iv)). These are precisely the types of methods described in the NAS report to which your 

question refers. 

Moreover, an entire section of the bill (Section 30) is specifically designed to spur the use of such tools 

where they provide information of sutlicient scientific quality. 

It is important to note that the approaches identified by the NAS are for the most part still under 

development, and that report notes it will take many years and a major increased research investment to 

realize its vision of a new toxicology that largely or exclusively relies on such approaches. 

I am optimistic about the potential capabilities of emerging methods in understanding the effects of 

chemicals. They offer a number of potential benefits: They are efficient; geared toward understanding 

the biological activities of chemicals at a mechanistic level; potentially allow for the testing of chemicals 

in different cell types and over a wide range of doses; offer an innovative potential approach for 

evaluating the effect of a chemical at early stages of development; and may have particular relevance to 

humans because of the ability to use human cell cultures and human enzymes in the assays. Additionally, 

new assays may aid in understanding and evaluating the effects of chemical mixtures. 

However. there are also cautions at present concerning the accuracy of the new methods at this early 

stage. First, the current battery of tests only targets a subset of adverse effects on biological pathways, 

and hence will not assess the full range of potential adverse effects. Second, most HTS assays lack the 

ability to generate and therefore assess the toxicity of--- potential metabolites of chemical substances. 

Third, these assays typically use immortalized cell lines and consequently may give results that are not 

truly reflective of cellular behaviors in living organisms. Fourth, the potential for false positives and false 

negatives is worrisome and raises concerns for all stakeholders. Fifth. there are challenges in 

extrapolation between outcomes observed in vitro and in vivo. 

If the new methods are not validated prior to reliance on them as substitutes for conventional tests, EPA 

may improperly exonerate hazardous chemicals or penalize low-risk chemicals. These are only a few of 

the many issues that must be addressed before EPA relies exclusively on them for decisions with potential 

or actual regulatory consequences. 
117 


24968.096

My view is that EPA can and should allow for the integration of such methods at this point primarily as a 

supplement, not a wholesale replacement for, conventional testing methods. This will have the added 

benefit of yielding data that will aid in the validation of the newer testing methods. 
118 


24968.097

Senator David Vitter 

1. Low DQ:;s:.;. Analysis of human data has so far failed to provide firm evidence of direct causal 

associations between low level exposure to chemicals with endocrine disrupting properties and 

adverse health outcomes. The World Health Organization and the Imernational Union for Pure 

and Applied Chemisll:v have both concluded this. EPA also concluded in 2003 that until there is 

improved scientific understanding of the low dose hypothesis, it was ''premature" to require 

routine testing of substances for low-dose effects in the Endocrine Disruptor Screening Program. 

Yet, your testimony levels the charge that it is matter of fact even very low doses of certain 

chemicals can have adverse effects. It appears that this is not scientific fact. That being the case, 

shouldn't the issue of low doses(>{ chemicals having adverse ~[feels be an issue for scientific 

research and not legislation? 

RESPONSE: My testimony stated as follows: "We now know ... that even very low doses of certain 

chemicals can have adverse effects." It made no reference in this context to endocrine-disrupting or any 

other specific group or type of chemical, in contrast to your question. 

Many chemicals are well-established to have adverse effects at very low doses. Examples include lead, 

mercury, cadmium, benzene and many others. Just this month, the CDC's Advisory Committee on 

Childhood Lead Poisoning Prevention, the expert committee that advises the Department of Health and 

Human Services and the Centers for Disease Control on lead affirmed that the latest and best science 

demonstrates there is no safe level of exposure to lead. 11 

2. Biomo.rz.j[.orin_g:_ We have heard your concern that the science of biomonitoring has revealed that 

virtually all Americans, including newborns, carry in our bodies hundreds of toxic synthetic 

chemicals, yet no one can tell us how they got there or what effects such a mixture of chemicals is 

having on our and our children's health, because they have not been adequately tested or 

assessed for safety. 

However, the CDC's 2009 Fourth National Report on Human Exposure to Environmental 

Chemicals states that "The presence of an environmental chemical in people's blood or urine 

does not mean that it will cause effects or disease ... Small amounts may be of no health 

consequence, whereas larger amounts may cause adverse effects, Research studies ... are 

required to determine the levels of a chemical that may cause health effects and the levels that 

are not a significant health concern." 

As the CDC notes, scientific research and interpretation tools are key to understanding whether 

the detection of chemicals in our body is a problem. But the mere presence of a chemical does not 

by itself mean that there is any problem. Science is what is needed to address this issue -not 

legislation. Why does EPA need to address biomonitoring data any differently than any other 

piece ()[hazard or environmental data or information? 

RESPONSE: The converse of the statements you cite is equally true: The presence of an environmental 

chemical in people's blood or urine does not mean that it will not cause effects or disease. The facts that 

we now know that people are exposed to chemicals to which we were told we would never be exposed, 

that many hundreds of such chemicals have been identified, and that the more we look for, the more we 

find, should in my view flip any presumption of safety or lack of effect. 

11 See report titled "Low Level Lead Exposure Harms Children: A Renewed Call for Primary Prevention," approved 

at January 4, 2012 meeting, p. 16, lines 19-20, available at http: '\nyw.q].£,gov/ncch'I>Cilll:ACC'1.P.Piactivities.htm. 
119 


24968.098

In order to assess risk, EPA needs to understand whether and to what extent people are exposed to 

chemicals in commerce; the science ofbiomonitoring can help enormously in that regard by directly 

measuring chemicals in people. In contrast to predictive models or assumptions about release, 

environmental fate and the like that are often used to estimate exposure, biomonitoring provides direct, 

empirical data and can usefully serve as a means of"ground-truthing" models and assumptions. 

Recent biomonitoring data on both phthalates and poly-brominated diphenyl ethers amply illustrate this 

point. Phthalates are very widely used in products ranging from plastics to cosmetics and other personal 

care products. They exhibit a range of toxicity, including to the liver, kidney, and male reproductive 

system. The first CDC National Report demonstrated surprisingly high levels of di-butyl phthalate (DBP) 

and di-ethyl phthalate (DEP) in U.S. residents in general, and for DBP, in women of child-bearing age in 

particular. Indeed, these data demonstrated high-end levels of DBP that were an order of magnitude 

higher than a prior estimate that had been developed based on industry-provided use data and expert 

judgment." In part as the result of these biomonitoring data, the CDC has placed a high priority on 

investigating potential phthalate exposure routes in more detai!. 13 

Polybrominated diphenyl ethers (PBDEs) are widely used flame retardants. Different species ofPBDEs 

are used in products ranging from plastics (such as computer cases) to upholstery foam. Toxicological 

studies indicate that they can disrupt thyroid metabolism and may have effects on other organs, including 

the liver. Because PBDEs are not very volatile or water soluble, they were assumed to more or less stay 

in place in products, and were not believed to have a high potential for exposure. However, 

biomonitoring studies from around the world have demonstrated that levels ofPBDEs in peoples' bodies 

have been dramatically increasing over the past two decades, with the highest levels currently reported in 

the United States." This finding has prompted a number of responses, including the voluntary 

withdrawal of two types ofPBDE (penta- and octa-bromo diphenyl ethers) and a ramped-up research 

effort to characterize the toxicity, metabolism, kinetics and environmental fate and transport of these 

substances. 

I believe biomonitoring data should be one key source of information EPA considers, alongside "other 

pieces of hazard or environmental data or information" to which your question refers. Far more research 

and testing are needed to understand the effects of both individual chemicals and combinations of 

chemicals to which people are potentially or actually exposed; these are the kinds of data that S. 84 7 

would required be developed and assessed. 

I note that S. 847 requires EPA to rely upon the recommendations of the NAS Science and 

Decisions report in determining the "best available science" that EPA must use in making a 

12 National Toxicology Program Center for the Evaluation of Risk to Human Reproduction (CERHR). (2000) NTPCERHR Expert Panel Report on Di-n-Butyl Phthalate. Available at 

c<:rl]r,;lichs.tLib.,gsl_yi<:lll'.!!lic;ale:'Qh)ILall!t.9§/dj;lp_,l<;llm-li_naJ:J!!lli!!&DS1D Accessed on January 12,2006. 

David RM. (2000) Exposure to phthalate esters. Environ. Health Perspect. I 08( I 0)979-982. 

Kohn MC, Parham F, Masten SA, et al. (2000) Human exposure estimates for phthalates. Environ. Health Perspect. 

108(11) A495. 

13 Agency for Toxic Substances and Disease Registry. "ATSDR's Substance-Specific Priority Data Needs (PDNs)." 

Available at www.atsdr.cd_~vlpdnslunfilled.html. Accessed January 10, 2006. 

14 Petreas M, She J, Brown FR, Winkler J, Windham G, Rogers E, Zhao G, Bhatia R, Charles MJ. (2003) High body 

burdens of2,2',4,4'-tetrabromodiphenyl ether (BDE-47) in California women. Environ. Health Perspect. 

111(9):1175-1179. 
120 


24968.099

wfety determination. Don't you think it would be a mistake for Congress to "lock in" the science 

of2008 in a modernized TSCA.? Also, being that it setsforth a recommendation ta assume "no 

threshold"for all toxic ~ffects induced by chemicals- one that is highly controversial, and that 

does not follow the standards of professional practice used to assess the safety of chemicals, 

consumer products, food contact materials and pharmaceuticals under a variety of US laws and 

regulations, why should this radical departure from best risk assessment practices be applied in 

regulatory decision-making? 

RESPONSE: The recommendations presented in a fully documented and reviewed report of a 

prestigious, highly qualified panel of scientists convened by nation's foremost scientific body, the 

National Academy of Sciences, can hardly be described as "radical." Your own initiatives in recent 

months have demanded far greater involvement of the NAS as a source of objective, independent review 

of EPA's scientific methods and practices. 

The report you cite was commissioned precisely to address long-standing det1ciencies in the practice of 

risk assessment by EPA and other federal agencies- and, far from locking in old science, to modernize it. 

What has been locked in for decades are the "standards of practice" to which your question refers, namely 

the state of risk assessment science that dates back to the 1984 NAS Red Book; the NAS' 2009 "Science 

and Decisions" report, called the Silver Book, was specifically intended to break the lock and bring the 

practice of risk assessment into the 21" century. 

Of course, science will continue to evolve, and we should not "lock in'' even the most up-to-date science 

in a law in a manner that does not allow practices and regulatory decision-making to evolve along with 

advances in science. I would strongly support a requirement under a reformed TSCA that EPA 

periodically. no less often than once every five years, be required to review its methodology in light of 

advancements and to make needed enhancements in its risk assessment methodologies and practices. 

3. We have heard your testimony that EPA is forced to perform Google searches to try to identify all 

uses C!f chemical because it lacks authority to ensure accurate reporting of chemical uses. 

Furthermore, we have heard from you that EPA cannot provide even a rough approximation of 

the actual number of chemicals in commerce today or how and where they are used. 

1m 't this a gross overstateme111 at best.? Just visiting the EPA's own website one can learn 

about how much il?formation EPA has at its fingertips. Under TSCA authority as it exists today, 

EPA, through the Inventory Update Rule, received reports on 6,200 chemicals, from a total of 

3,827 sites, representing 1,541 companies in 2006. More than 95 percent of the total production 

volume reported is mam!factured in the United States. }or organic chemicals manufactured in 

quantities of 300,000 pounds or greater at a given Site, submitters also reported downstream 

uses. These submitters reported nearly 1 trillion pounds of organic chemicals. The 2006 fUR data 

contained industrial processing and use information that accounted for 72 percent and 

commercial and consumer use iijformation that accounted for 22 percent of the nearly 1 trillion 

pounds. 

While the 2006IUR data does not include chemical substances manufactured or imported in 

amounts of less than 25,000 lbs. per site, it surely captures by far most of the chemicals in 

commercial production today. EPA will hove more use information in the 2012 CDR reports as it 

has dropped the use reporting threshold to 100,000 lbs, and will drop it to 25,000 beginning in 

2016. 
121 


24968.100

Also, EPA does have external resources available OECD 's eChemPortal provides access 

to reports and datasets maintained by some 30 member countries, the US among them, 

containing 657,802 chemicals and 560,920 endpoints. 

And, changes to TSCA are not needed for EPA to get use information. Section 8(a) ofTSCA 

authorizes EPA to require reporting by manufacturers (including importers) and processors 

(other than small manufacturers and processors) of the categories or proposed categories of use 

for each such substance or mixture. EPA does collect use information through the former 

Inventory Update Rule and the new Chemical Data Reporting Rule. The new CDR Rule has 

reporting codes for 48 industrial sectors, 35 industrial function categories, and 33 consumer and 

commercial product categories. Furthermore, EPA has authority to ask processors to submit use 

information, but has chosen not to do so. 

Section 8(a) authorizes EPA to collect numerous pieces of information ji-om manufacturers 

(including importers) and processors (other than small manufacturers and processors, such as: 

the common or trade name, the chemical identity, and the molecular structure of each chemical 

substance or mixture for which such a report is required; the categories or proposed categories 

of use of each such substance or mixture; the total amount of each such substance and mixture 

manufactured or processed, and reasonable estimates of the total amount to be manufactured or 

processed; a description of the b)products resultingfi·om the mam!facture, processing, use, or 

disposal of each such substance or mixture; all existing data concerning the environmental and 

health effects of such substance or mixture; and the number of individuals exposed, and 

reasonable estimates of the number who will be exposed, to such substance or mixture in their 

places of employment and the duration of such exposure. To get this information, there is no 

requirement that EPA make any showing of unreasonable risk or findings beyond that the 

information is "reasonably required". 

So, in sum, EPA does not need Google, or the provisions of this bill to get the chemical 

information it need<. So where are the actual gaps you claim exist? 

RESPONSE: Your statement that the IUR (now CDR) "surely captures by far most of the chemicals in 

commercial production today" is simply not the case. Unfortunately, a key deficiency of the IUR was 

retained in the CDR: The restriction of reporting obligations only to those chemicals produced at 25,000 

pounds or more per year per site. Evidence indicates that the use of such a high threshold means that 

many, likely a significant majority of, chemicals actually in commerce will not be required to be reported 

at all, and hence that EPA, the public and the market will not have any access to needed information on 

them. Consider the following: 

When EPA raised the fUR threshold from I 0,000 to 25,000 pounds per year per site a number of 

years ago, the number of organic chemicals reported fell by about two-thirds. 

The former, long-time Director of EPA's Office of Pollution Prevention and Taxies, which 

administers TSCA, has estimated that on the order of 50,000 chemicals are presently in U.S. 

commerce. 15 

The European Commission estimated that 30,000 chemicals would need to be registered under its 

REACH Regulation, which has a threshold of one metric ton, or 2,200 pounds per year per 

producer. Moreover, when they estimated how many chemicals would be subject to each of 

REACH's four tiers of data requirements, they found that the number of chemicals per tonnage 

15 Testimony of Charles M. Auer, President, Charles Auer & Associates, LLC, Submitted on August 3, 2010 to 

Subcommittee on Commerce, Trade and Consumer Protection, U.S. House of Representatives, Committee on 

Energy and Commerce, for a Hearing On H.R. 5820- The Toxic Chemicals Safety Act of2010. 
122 


24968.101

band constituted a pyramid, with many more chemicals produced at the lower tonnage bands than 

at the highest: 

o > 1 ,000 metric tons/year: 2,700 substances, plus I, 700 transpOited intermediates with reduced 

registration requirements; 

o I 00-1,000 metric tons/year: 2,460: 

o I 0-1 00 metric tons/year: 4, 980; and 

o 1-10 metric tons/year: 17.500. 16 

• The IUR data you cite has two other major features that lead to significant underestimates of the 

actual number of chemicals in U.S. commerce. 

o There are many exemptions from IUR reporting. For example, polymers are exempt and 

not included in the counts you provide, yet 30.000 of the roughly 84,000 chemicals on the 

TSCA Inventory are polymers. 

o The IUR has required only very infrequent reporting (once every five years) of only a 

single year's manufacturing data. Both EPA's and our own analyses of data from past 

IUR reporting cycles demonstrate that. because of major year-to-year fluctuations in 

chemical production and import, such infrequent reporting has led to a highly inaccurate 

picture of what chemicals are actually in U.S. commerce and in what quantities. 

Unfortunately, while this deficiency has been addressed in the CDR, we will have to wait 

until at least late 2016 to get annual production data because implementation of that 

feature of the CDR was delayed until then. 

EPA's analysis of data from multiple cycles of reporting under the IUR prior to 

2006 -and before EPA added reporting of inorganic chemicals and raised the reporting 

threshold from I 0,000 to 25,000 pounds per year per site- found that nearly 14,000 

chemicals had been reported above 10,000 pounds per year per site in one or more 

reporting cycles between 1990 and 2002, many more than are reported in any single cycle 

because of the year-to-year fluctuations. 17 

Use reporting under the most recent (2006) cycle of the !UR was exceedingly disappointing, due to a 

variety of limitations in the program. 18 The paucity of use information EPA received from companies led 

it to propose major changes to this aspect of the !UR, some of which were incorporated into the final 

CDR rule issued last year. As your question points out, however, EPA will have to wait unti12016 to 

obtain use information on the chemicals subject to CDR reporting- again, limited only to that minority of 

chemicals in commerce produced above the 25,000 pounds per year per site reporting threshold. 

With respect to the part of your question regarding TSCA Section 8(a), EPA does have authority to issue 

mandatory reporting rules- though each rule must be limited to specified chemicals, and only requires 

one-time reporting of already available information. In addition, "small manufacturers" are exempted by 

statute from being subject to such a rule. Section 8(a) rules also generally require EPA to go through lull 

16 See European Commission, Joint Research Center, ''Assessment of additional testing needs under REACH," 

September 2003, Table I, 12, available at 

17 See "How can EPA more efficiently identifY potential risks and facilitate risk reduction decisions for non-HPV 

existing chemicals? Developed by Broader Issues Work Group (BIWG), National Pollution Prevention and Toxics 

Advisory Committee (NPPT AC), October 6, 2005, p. 4, available at 

http:/iw\Vw.cp_'!,gQY!Q_ppL!J.Pl'!ill:CJl.llhS!finaldrnl't.D.<:>D1'P-"Pape@l.Q.ClQ&lli 

"See USEPA, TSCA Inventory Update Reporting Modifications; Proposed Rule, 75 Federal Register, Friday, 

August 13, 2010, p. 49646; and Denison, R.A., et al., 2010, EDF comments on EPA's proposed rule, available at 

!illni.'hlogs.cdf.orghlanotechno]Qgy!lilesi:)_OJ 0'1 O:EIJF comments on lt:R.J'.l:D.uQ~i Rule I 0-12.pdf. 
123 


24968.102

notice-and-comment rulemaking, a process that can take years. The time and resource burden on EPA to 

develop such rules has effectively limited their use under TSCA, and they simply do not provide a viable 

means for EPA to obtain the kind of comprehensive data on all chemicals in commerce needed for 

prioritization and risk assessment. 

Finally, your question also asserts that there are ample hazard data on chemicals in commerce. If the 

numbers you cite from the OECD portal 657,802 chemicals and 560,920 endpoints- are correct, that 

means that, on average, less than one endpoint per chemical are available. Even the basic "minimum" 

hazard data set prescribed by the OECD has about two dozen endpoints regarded as necessary to conduct 

a screen-level hazard assessment of a given chemical. 

It is widely accepted that there are major gaps in the data available to assess the risks of even the most 

widely used chemicals. 19 EPA examined the extent to which basic screening-level hazard data were 

publicly available on chemicals that had recently reached the high-production-volume (HPV) level of 

production of one million pounds per year, and found the following: 20 

Of 23 5 chemicals that were manufactured at HPV levels in 1998 and 2002 (but not 1990): 

o 115 ( 49%) had no publicly available hazard data for any of the six major hazard endpoint 

groups examined. 

o Only 2% of them had publicly available screening-level hazard data for at least one 

endpoint in each of the six major hazard endpoint groups examined. 

Of 286 chemicals that were manufactured at HPV levels in 2002 but not earlier: 

o 166 (58%) had no publicly available hazard data for any of the six major hazard endpoint 

groups examined. 

These findings indicated data gaps even larger than those of EPA's I 998 data availability study21 

conducted on chemicals identified as HPV in 1990- data that led to the launch of the voluntary HPV 

Challenge program.22 For those chemicals, EPA found that: 

• 43% had no publicly available hazard data for any of the six major hazard endpoint groups 

examined. 

7% had publicly available screening-level hazard data for at least one endpoint in each of the six 

major hazard endpoint groups examined. 

19 See for example, Dix, D. eta!., The ToxCast Program for Prioritizing Toxicity Testing of Environmental 

Chemicals, Toxicological Sciences 95(1), 5-12 (2007), available at !ill~I;:Yw.rygJi.,nln!,nih_,gQ]Ij:>gbmcd l(i9Jil:?J2. 

20 58'" (2006) and 561

h (2005) Reports of the TSCA Interagency Testing Committee to the Administrator, U.S. 

Environmental Protection Agency, available at !.;i£a-hf'JiYILC~£.QID!JS.g2Qil~; and personal communication to the 

author from John D. Walker, EPA Office of Pollution Prevention and Taxies, December 2006. Note that, if 

anything, these numbers overstate the extent to which a full screening-level hazard data set is available, because the 

search method employed groups together multiple endpoints and scores the endpoint category as having data 

available if even a single study for a single endpoint was found. Hence, a chemical that has a single algae study but 

no fish or Daphnia study would still be scored as having ecotoxicity data available. 

21 See EPA's 1998 Data Availability Study, available at www.epa.gov/chcmrtk/pubsigcncralihazchcm.htm. 

22 Unfortunately, the HPV Challenge fell far short of its promise to develop and make public a basic set of hazard 

data for this earlier batch ofHPV Chemicals. See Richard A. Denison, High Hopes, Low Marks: A final report cord 

on the High Production Volume Chemical Challenge (Environmental Defense Fund 2007), at 

www.edt:orgidocuments/6653 Higi)H_opcsl.owMarks.pdf. 
124 


24968.103

4. You expressed a concern that the public, state governments and even workers who may be 

directly exposed to chemicals are denied access to the great majority of chemical information 

that companies submit to EPA because the companies have been given wide latitude to claim it as 

confidential, However, that is not accurate: under section 14(b} ofTSCA, no corifidentiality 

claims are al/owedfor health and safety studies, other than narrow categories of il?formation 

Thus, virtually all the safety data itself is made public to all. Furthermore, under OSHA 

requirements, mamifacturers must provide hazard iiJ[ormation even for chemicals whose identity 

is claimed confidential, And, CBI protections are needed to ensure that the United States can 

remain the center of research and development for new chemistries- including greener ones. So 

does a problem really exist with the protections afforded to confidential business il?formation 

today? 

RESPONSE: First, the scope of my statement was much broader than the health and safety studies 

addressed under section 14(b) to which your question refers, and includes information on use and 

exposure that is collected by EPA. I, for one, believe there are legitimate bases on which certain types of 

information should be eligible for protection as CBI under TSCA; the problem has been that far more 

information has actually been claimed as such by industry, and EPA simply lacks the resources to review 

the claims, which must be done on a case-by-case basis; without a review and challenge, the claim 

remains in place indefinitely, whether or not it is legitimate.23 

Your question states that "under section 14(b) of TSCA, no confidentiality claims are allowed for health 

and safety studies, other than narrow categories of information. Thus, virtually all the safety data itself is 

made public to all." However, for decades EPA has routinely allowed companies to claim- and maintain 

-the identity of the chemical to which a health and safety study pertains to be masked. The result is that 

the public only knows that some mystery chemical may cause a health or environmental effectinformation that is truly useless. 

Despite TSCA's explicit language making clear that data from health and safety studies are not protected 

from disclosure by CBI claims, EPA has typically accepted CBI claims without review even as to health 

and safety data, thereby preventing disclosure of health and safety information, including chemical 

identity, for example in Section 8(e) substantial risk notices. These notices describe health and safety 

studies or data that reasonably support the conclusion that certain chemical substances or mixtures present 

a substantial risk of injury to health or the environment. Though all Section 8(e) notices are posted on 

EPA's website, companies frequently assert that the names of the chemicals at issue constitute CBI, and 

EPA typically accepts these claims without question unless someone seeks the information through a 

request under the Freedom of Information Act (FOIA). Thus specific chemical names are redacted from a 

significant number of Section 8(e) notices posted on EPA's website. including a majority of the chemicals 

covered by the notices received during some months, replaced with "generic'' names that provide no 

means of identifying the chemical in question.24 EPA statistics indicate that, for fiscal years 2006 through 

23 For a more detailed analysis of the problems with CBI under TSCA, see the posts on EDF's Chemicals blog: 

"Worse than we thought: Decades of out-of-control CBI claims under TSCA," at 

http:/iblt}gs.cd[org/ nanotcchnologY20 l 0.:021 12/worsc~than~wc-thought ~dc~~Jcs-of-out -o f:-~ontrQ]:-£b i-cJillJJ1.Ji: 

under-tscal; and "How should the problem of'secret chemicals' be addressed?" at 

24 See, for example, See h.:!Jn./ www.epa.gov.:opptintr.'tsca8c'pubs 1

8emonth1yrcports 12009.18cnov2009.html. 
125 


24968.104

2009, nearly 70% of Section 8(e) notices submitted to EPA contained CBI claims, and for more than 40% 

of them the chemical identity was specifically claimed as CBI. 25 

Absent specific chemical names, the health and environmental risk information provided in Section 8(e) 

notices is of little or no public value. As a recent report by the Congressional Research Service stated, the 

value of8(e) submissions and EPA's website making the studies available to the public "is greatly 

reduced by the confidentiality claims of the submitters: in most cases, the identity of the chemical is 

concealed."26 

Critical health and safety information has been shielded from public view because of both submitters' 

assertion of excessive and often unfounded CBI claims and the failure of EPA routinely to review and 

reach determinations as to the legitimacy of those claims. Eighteen years ago, EPA identified 

"inappropriate confidentiality claims" as impairing ''the dual goals of public education about chemical 

substances and public participation" that were enshrined in TSCA.27 The EPA's Final Action Plan stated, 

"The unmistakable purpose behind the participatory opportunities provided in TSCA is to afford the 

public the chance to contribute meaningfully to the regulatory process'' and indicated that inappropriate 

CBI claims were thwarting the legislative purpose ofTSCA (see pp. 3, 5). Nonetheless, industry claims 

ofCBI protection for health and safety information and, in particular, for chemical identity, have 

continued unabated and virtually unchecked. 

A study undertaken by the U.S. Governmental Accountability Office (GAO) in 2005 acknowledged the 

problem, recognizing that under TSCA "chemical companies claim much of the data submitted as 

confidential."28 The GAO noted the relevance of information provided under TSCA to the general public: 

"Individual citizens or community groups may have a specific interest in information on the risks 

of chemicals that are produced or used in nearby facilities. For example, neighborhood 

organizations can use such information to engage in dialogues with chemical companies about 

reducing chemical risks, preventing accidents, and limiting chemical exposures.'' 

At the time of its study, the GAO reported that although "EPA has the authority to evaluate the 

appropriateness of these confidentiality claims," the agency stated that it lacked the resources to challenge 

large numbers of claims. Indeed, EPA's reluctance to review claims was related to the scale of the 

problem, noting that a 1992 EPA study "indicated that problems with inappropriate claims were 

extensive." 

EPA has recently proposed a new policy, under which it is beginning a general practice of reviewing 

confidentiality claims for chemical identities in health and safety studies and data from those studies and, 

by which it announced that it docs not expect such chemical identities to be entitled to confidential 

25 See EPA, TSCA Statistics for Congressional Briefing (Documents Receivedfrom FY 06 through FY 09) (received 

from EPA by OMB Watch pursuant to FO!A request) (undated). 

26 See Linda-Jo Schierow, Cong. Research Serv., CRS RL 34118, The Toxic Substances Control Act (TSCA): 

Implementation and New Challenges 12 (July 28. 2009). 

27 See Office of Pollution Prevention and Toxics, U.S. EPA, Final Action Plan: TSCA Confidential Business 

Information Reform 5 (1994) (Final Action Plan). 

28 See GAO, GA0-05-458, Chemical Regulation: Options Exist to Improve EPA 's Ability to Assess Health Risks 

and Manage Its Chemical Review Program, at intro (2005). 
126 


24968.105

treatment unless they explicilly contain process information or reveal portions of a mixture.29 If fully 

implemented, this new policy will begin to bring practice into line with the statute. Unfortunately, the 

chemical industry has indicated it may mount a legal challenge to EPA's new policy. This is why 

clarifying and codifying a prohibition under TSCA from making CBI claims for health and safety studies, 

including for the identity of the subject chemical, is a necessary part ofTSCA reform, as reflected in 

S.847. 

Finally, your question states: "'Furthermore, under OSHA requirements, manufacturers must provide 

hazard information even for chemicals whose identity is claimed confidential." This statement refers 

primarily to OSHA's hazard communication standard and related requirements for manufacturers to 

provide Material Safety Data Sheets (MSDSs). Unfortunately, MSDSs fall far short of providing an 

effective and comprehensive means of providing hazard information to workers or other stakeholders. 

First, only available information need be provided, and hence the major gaps in hazard information 

available for the great majority of chemicals in commerce mean that even where MSDSs incorporate the 

most current information, most of them will fail to provide even a basic hazard profile of their subject 

chemical. Second, many studies have found MSDSs to be notoriously incomplete, out of date and 

inaccurate; see, for example OSHA's own summary of studies published that examined the quality of 

MSDSs;30 and a 2008 meta-analysis of 24 published, peer-reviewed studies that have examined MSDS 

quality,31 which concluded: 

"Despite the fact that these studies varied in methodology and spanned a period of more than 15 

years, a number of common themes emerged regarding inaccuracies, incompleteness, 

incomprehensibility and overall low use of MSDSs. The results of the literature review suggest 

that there are serious problems with the use of MSDSs as hazard communication tools." 

"Sec "Notice of General Practice of Reviewing Contidentiality Claims for Chemical Identities in Health and Safety 

Studies and Data from Health and Safety Studies Submitted Under the Toxic Substances Control Act," 75 Federal 

Register 29,754 (May 27, 2010), available at http:,/rll!lfket.acccss.gpo.gov::m.tfrrul.UQIJl::.l~(,furu!f. 

30 OSHA (2004) "!Iazard Communication in the 21st Century Workplace: Appendix re: Studies/Investigations rc: 

Hazard Communication/' available at ~~~~w.oshJl:govrJsg/hazco!n/finalrn~.JsrL"J).0!1-J.HDJl:_:;~r.r_..z.llilLx. 

31 Nicoll, A.M. et al., "Accuracy, comprehensibility, and use of material safety data sheets: a review," Am J lnd 

Med. 2008 Nov;51(11):861-76, available at 

l!.lm;.!c_www.ncbiJllm. 0_ih.govipgbnlfd/1865 1 5zj'?orilinalpos= 1 &ito<;l:'.Entr~cmtcm2,!'lcntre;JJ,,Q.mcJ.Pllimled Rc 

:;~lt_<Panclj'uhmc\]_Jkfilldl1Bspot1Pan£LPuhJlJL~'dlJl· 
127 

Senator LAUTENBERG. Thanks very much, Mr. Denison. 

And I thank each one of you. 

It is interesting to hear some divergent views, not unexpected. 

This is a complicated subject, but it is I think less than help to 

solve our problems as to look at unenforceability, that kind of 

thing. I mean, I believe, and it was summarized by a couple of you, 

and that it is the number of people who have expressed concern, 

the number of conditions that violate our sense of what is right in 

terms of our responsibilities. 

There is no doubt in my mind and minds of responsible scientific 

units, scientific bodies that there are problems lurking out there. 

And in the design for us to try to deal with those, does a single 

child’s endangerment require a bill passed in here, a piece of legislation? Probably not, but when you start to see it all over the Country and the statistics tell you that there are problems with fertility 

and problems with this, and exposure, of course, Ms. Brody, to 

Vietnam, that is a classic in American history and the chemical 

business. 

But, look, my mission, and I said it earlier, and I think that Senator Inhofe and I have set the kind of a platform that says say 

what you want; say what you believe. But keep an open ear to 

what is going on. Keep you eyes open as to what is going on with 

the fright that exists over the condition of children. 

There is one statement that wasn’t really a statement. It was the 

child’s voice. We loved hearing that. I have 13 grandchildren. 

So I ask Ms. Brody, the chemical industry employs more than 

70,000 people in my State of New Jersey. I want to protect these 

employees, their jobs and their health. And you are a member of 

the United Steelworkers Union and a representative of other 

unions that work with chemicals. How many people are in the 

steelworkers union? 

Ms. BRODY. The steelworkers union has about 1 million members 

right now. 

Senator LAUTENBERG. And the total membership of your allied 

groups? 

Ms. BRODY. Between the 11 unions and four environmental organizations, 15 million people all together. 

Senator LAUTENBERG. How might reforming TSCA, as we propose, affect employment in these industries? 

Ms. BRODY. Earlier this year, Senator Lautenberg, we did a 

study of the economic benefits of a green chemical industry in the 

United States. And we commissioned the University of Massachusetts-Amherst to really tell us what was going on in the chemical 

industry and what could TSCA reform do positively or negatively 

to impact that industry. 

Because first and foremost, we need each of our members working and we need to do something about the economic crisis in the 

United States. And what we found is that unemployment in the 

chemical industry didn’t start to go down during the great recession of 2008, but actually has been dropping since 1992. So that 38 

percent of the jobs that used to be there aren’t there anymore, and 

that this happened while the chemical industry stayed profitable at 

4 percent per year during that entire time. 

128 

And that what had been going on is that the chemical industry 

had stayed profitable by cutting costs, by cutting research and development costs so that they were less than half of industry overall, and by cutting labor costs and putting people out of work. 

And the TSCA reform actually, by moving us from a time when 

the smart money in the chemical industry is on making the stuff 

you were making 40 years ago, to a new day when making safer 

chemicals lets you create more market share; could actually put 

people back to work and turn those numbers around. 

Just one point that we noticed in this, the only part of the American chemical industry that has been growing jobs and growing in 

profitability is the most regulated part, the part of pharmaceutical 

chemicals, including a lot of people working in your State who actually are employing more people every year in the one part of the 

industry where companies have to prove that their products are 

safe before they are put on the market. 

Senator LAUTENBERG. Thank you. 

Mr. Dooley, over the summer, the American Chemistry Council 

suggested alternative language for one small, but important, part 

of the Safe Chemicals Act. Providing that kind of specific proposal 

increases the odds that we can find a bipartisan middle ground. 

Now, are you willing to commit to providing specific alternatives to 

all the other sections of the Safe Chemicals Act that you strongly 

criticized? 

Mr. DOOLEY. We have been involved in constructive discussions 

through the process that was sponsored with you, as well as with 

other stakeholders. And I think that we have seen progress at a 

very high level in terms of general concepts on a host of issues. 

But unfortunately, we think that this is an issue of such complexity that it is going to take a significant period of time to really 

resolve all those very, very complex and difficult issues. And we 

have provided the example, one of the most recent examples was 

attached to our testimony, was I think the most comprehensive 

proposal for a prioritization process that we submitted to the Committee, as well as to EPA. 

We are committed to do that on a host of issues. 

Senator LAUTENBERG. Yes, but again, will you provide your specific alternatives? 

Did you hear my question? 

Mr. DOOLEY. Yes, I did. We will provide the information and our 

ideas in the appropriate fashion. 

Senator LAUTENBERG. Thank you very much. 

Senator Inhofe. 

Senator INHOFE. Thank you, Mr. Chairman. 

I have just two questions, one that I am going to ask Mr. Dooley. 

It is nice to be with you again. You have a lot of people up here 

with whom you have served in the past. 

I am concerned, and you have addressed this, but not thoroughly 

enough, about how this could adversely affect new products. That 

is what I am concerned about. I have always taken great pride that 

we try to be ahead of the rest of the world, and could you address 

that for me? 

Mr. DOOLEY. I would be delighted to. I would like to use maybe 

our greatest concern about the underlying bill, with the safety 

129 

standard which would require us to provide with a reasonable certainty and no harm a chemical from all aggregate exposures. 

Basically, what the intent of this legislation is to adopt the same 

policy and procedures that we use for pesticides, where you actually have a risk cup. I was a farmer prior to coming to Congress. 

I dealt with pesticides. And when you registered a pesticide, you 

had a limited number of applications on a limited number of crops 

for a product that was going to be biologically active and try to kill 

either a bug or a weed. You could define those pathways of exposure. 

That process does not work on industrial chemicals that have 

thousands and thousands of pathways of exposure. And I will provide this to the Committee at an appropriate time, but we have a 

chlorine tree here, which shows the hundreds and hundreds of different products that chlorine is used in. Now, if you use the proposal of the safety standard that is under this legislation, it would 

require anyone that was going to be making a new products or a 

new mixture that had chlorine in it, they would have to do an aggregate assessment of the exposures resulting from not just their 

new product, but from all uses in commerce today. 

And so if you think about it for a minute, chlorine is in this 

water. It is an integral part of trying to make sure it is pure. Chlorine is in the varnish that is on your desk. Chlorine is in the semiconductors that are in your phone. 

So does chlorine, if you had this risk cup perspective, does the 

chlorine that is in the water, does it fill it up this much? In the 

ink, does it fill it up this much? In the semiconductors, does it fill 

it up this much? Maybe in the batteries in your pacemaker, does 

it take it up to the top? 

And so you have a new innovative company out there that has 

a new application for chlorine that might be the cutting edge technology that is going to ensure that the U.S. manufacturers are 

going to be the lead in solar cell technology, yet the risk cup is full. 

And so where do they go? How do they ensure that they can get 

approval from EPA? How can even a startup company that has limited resources and capacity, how do they even have the ability to 

assess the aggregate exposure? 

This bill with this safety standard is a prescription to deny the 

U.S. manufacturers’ ability to be at the forefront of innovation and 

creating jobs. 

Senator INHOFE. Thank you, Mr. Dooley. This might be my birthday, but I don’t have a pacemaker. 

[Laughter.] 

Senator INHOFE. One last question, a little bit over our time, but 

I just want to ask Mr. Matthews, because I have heard it stated 

very times that States are ill-equipped to deal with these things. 

And the term that has been used is ‘‘a complex maze of regulations 

across the Country.’‘ 

Could you address that? 

Mr. MATTHEWS. I would be pleased to do that. I think Senator 

Gillibrand indicated numbers I hadn’t even seen before. There were 

something like 25 States that have adopted 80 different chemical 

management laws over the last 9 years. And I think we heard testimony from Mr. Sturdevant that that is a difficult issue for States 

130 

to take on because they don’t necessarily have all the tools to address the toxicity of chemicals and to understand the use and exposure information that I referred to. 

And that this would be best done at the Federal level where we 

can marshal resources one time in this Country, not duplicate that, 

and assure that at whatever the standard actually is, we have uniformity in that regard so that a company like a S.C. Johnson or 

a Procter and Gamble, which has products in all the retail shelves 

and in all of our homes, can have one 50-State strategy, instead of 

a strategy across multiple States, now 25 and growing, for formulation, for labeling and so on. 

So I think on both sides of the issue, it is both unburdening the 

States in a very difficult area. It is reducing the resources in this 

Country that are being applied to doing that from potentially 50 

down to one Federal Government role. And it is industry that will 

be able to, in our industry in particular, to market their products 

knowing that if they meet the Federal standard, they will have provided a safe product to the marketplace. 

Senator LAUTENBERG. Senator Cardin, please. 

Senator CARDIN. Well, first, Senator Lautenberg, let me thank 

you for your leadership on this issue. You have been incredible in 

pointing out the risk factors and putting a face on it as to the individuals who are impacted by what we do, by our failure to provide 

adequate protection. So I thank you very much and I thank you for 

holding this hearing. 

Mr. Dooley, it is nice to see you again. I respect very much your 

views. I was interested in your oral response, but I read your written statement also where you point out that the Toxic Substance 

Control Act needs to be changed. I looked at what happened in my 

own State of Maryland with BPA, where because of the inability 

of the national government to provide safety standards, the State 

had to act. 

It is not the ideal circumstance. The ideal circumstance is to 

have the Federal Government provide the blanket protection we 

need for the Nation, allow States to be able to push the envelope 

if they can, but to know that there is the backstop at the national 

level. We don’t have that today. 

So I very much value your judgment, and I want to followup on 

the Chairman’s point, that we need to work together. We need to 

make sure that we encourage innovation. I am all for that. But I 

was disappointed by your response to Chairman Lautenberg because you said it could take a lot of time. Too many people are affected by this. We have to get this moving. We can’t say let’s wait 

another decade for a study to come back and then determine what 

we should be doing at the national level. 

This is a safety issue. And we need your help and we don’t have 

time. And we need to do this in a bipartisan manner. I agree with 

that. But you have the expertise, but you also have the credibility 

so that we could get something done sooner rather than later that 

will help the people of this Country and help job growth in this 

Country. 

So I just encourage you to have a greater sense of urgency than 

at least I interpreted from your reply. 

131 

Mr. DOOLEY. Well, I guess, Senator, I would respond is that I 

think it is unfortunate that we are having a hearing on this legislation today; a bill that is very similar to that which was introduced 

2 years ago; a bill that we have been involved in extensive discussions with Senator Lautenberg and his staff, explaining what our 

concerns and objections were; that we have had extensive conversations with the NGO community, telling them what our concerns 

and objections were, as well as some ideas in terms of how they 

can improve it. 

And when we are faced with a situation, if we would have seen 

maybe another iteration that showed some progress, the tenor of 

our comments might be a lot different. 

Senator CARDIN. And I would point out, if we had your bill before 

us so that we could take a look at it and compare it, I think it 

would be more constructive. The Chairman challenged you to come 

forward with recommendations. It is not one-sided here. 

Mr. DOOLEY. And we have provided significant recommendations. 

I would be delighted to meet with you and your staff and explain. 

And in terms of the safety standard that you have proposed here 

that we object to, we have an alternative. 

Senator CARDIN. The question is this. Here is the point. You say 

in your statement that the current law needs to be reformed. If the 

industry truly believes that, then you need to come forward with 

what you believe is necessary, and respond point by point to what 

Senator Lautenberg has put in his bill so that we can sit down here 

and try to make some sense out of this. 

But if your objective is to defeat legislation, if that is your objective, then I understand what you are doing. But if your objective 

is to get legislation enacted, I don’t understand what you are doing. 

Mr. DOOLEY. Our objective is to see the modernization of TSCA 

in a way that provides the appropriate level of safety, ensuring the 

safety of the chemicals that are used for their intended purposes 

that are in commerce. And ensuring that we can do so in a manner 

that allows this U.S. chemical industry to continue to be at the 

forefront of innovation. 

Senator CARDIN. I accept that. 

Mr. DOOLEY. They are not mutually exclusive. 

Senator CARDIN. I accept that. Then I just urge you to be more 

forthcoming on your recommendations so that we can try to get to 

where the real problems are, and try to get the ability at the national level to provide the safety standards that allow innovation, 

which is what the industry needs and what the American public 

needs. 

That is why I just urge you to be more open so that we can get 

answers to the issues that have been raised. We don’t want to continue under the current system that puts such a burden on States 

to act because of the failure of the Federal Government to provide 

the basic protection that is needed. 

Mr. DOOLEY. The only thing I will conclude, this is my last comment. Sometimes I would say we have been providing answer. We 

have been providing solutions to what the industry likes and would 

like to see, which we think would be appropriate. 

Unfortunately, they are not the answers that some of the authors 

and some of the proponents of the legislation, supporters of the legVerDate Aug 31 2005 15:05 Nov 01, 2017 Jkt 000000 PO 00000 Frm 00135 Fmt 6633 Sfmt 6633 S:\_EPW\DOCS\24968.TXT VERN
132 

islation that we are testifying on today want to hear. And so just 

because they are not embodied in this legislation doesn’t mean that 

this industry hasn’t been offering what we think are concrete solutions and proposals. 

Senator CARDIN. I appreciate that. I will make one final observation here. It is clear in this political environment, the way we get 

legislation enacted is for both sides to come together. This Committee has a history of working together on issues. We just passed 

out a surface transportation bill by an 18 to zero vote. It contains 

some things in there I don’t like. It contains some things in there 

Senator Crapo doesn’t particularly like, but we were able to get it 

done. 

If there is a good-faith effort to get legislation enacted, then participate with us. If you objective is to make sure nothing gets 

through this Congress, then I understand what you are saying. But 

be straight with us as to what your objective is. 

Your testimony leads me to believe that you want to see reform 

passed by the U.S. Congress and signed into law. If that is the 

case, I don’t know where you are on this issue. I know Senator 

Lautenberg’s bill. I have read Senator Lautenberg’s bill. I would 

welcome specifics, rather than just saying no, this doesn’t work; 

this doesn’t work; this doesn’t work. What works? 

And I will just conclude by saying, Ms. Brody, I appreciated your 

response to say that regulation does create jobs if we do it in the 

right way. Thank you for that point. 

Senator LAUTENBERG. Thanks very much. 

Senator Crapo. 

Senator CRAPO. Thank you very much, Mr. Chairman. 

Again, I want to thank you for holding this hearing today, and 

specifically, I want to convey my thanks to you for being willing to 

work with us in a bipartisan fashion. 

Senator Cardin is right. We have an incredibly toxic political environment here in Congress right now, but this Committee is one 

of the committees where that brutal toxicity has not yet been able 

to rear its head. We have some fights and obviously we have some 

different points of view, but we have, I think, a good-faith intention 

on the parts of all of the Members on this Committee to try to find 

the common ground and build the consensus to make progress in 

the ways that will benefit our Country on all of these issues. 

And I just want to relay that message to all of the stakeholders 

on this issue. I believe that the Members of this Committee are sincere. And I will say to my colleagues on the Committee, I think 

that the stakeholders whom I have worked with are sincere and 

want to find a solution to the problems that we face. And so I will 

tell you, that is the only way that we will be able to move forward, 

particularly in this political climate. 

So I just wanted to make that comment. I wish Senator Inhofe 

was here so I, too, could wish him happy birthday, but I will do 

that privately as I get a chance to do so a little bit later. 

With regard to the questions I have, I think I will start, Mr. Matthews, with you. TSCA was designed to be a chemical management 

statute, and we are moving into a focus now on approaching it in 

the light of protecting workers and first responders and so forth, 

at least in one context of the discussion. 

133 

Could you discuss those dynamics as to how do we try to move 

forward and achieve that re-focus? 

Mr. MATTHEWS. Yes, Senator, thank you. 

Yes, I agree with the premise that TSCA is a chemical management statute. It is worth reflecting on the fact that there are other 

statutes and other agencies besides EPA who have a role in some 

of the issues which are being or would propose to be addressed 

through the Safe Chemicals Act, and that is an area of concern 

that there would be overlapping and inconsistencies. 

It is a big job to define the right standard, to run chemicals 

through the criteria that would be adopted for safety, and to define 

what a safe use of those chemicals is. 

And Senator, you may have been absent when I was talking 

about what we think is needed here is substantial additional use 

and exposure information, and to some extent that will cover some 

of the areas that you have identified of concern. 

So I don’t think there is an inconsistency in the notion that this 

law can and perhaps should provide enough data so that there is 

a fuller picture of where it is being used, how it is being used, and 

the exposures that are being created. 

But at some point, I would say, Senator, that the line has to be 

drawn where while that is true, if we start to regulate workplace 

exposures we are going to run into conflict with OSHA, and that 

is probably, I will say in my judgment, more trouble than it is 

worth. I think OSHA is a robust statute and can and is being administered appropriately. 

One other specific you mentioned I think was emergency workers. And I will say this, we have discussed that issue. It is a little 

down in the weeds, if I may say that, but it is an important issue, 

but it is below the level of trying to find common ground. That is 

not the driver. 

But it has come up, for example, in the context of confidential 

business information. And in that context, we have talked about 

there will be circumstances where speed and the disclosure of information is critical, and are there ways in which that can be accomplished while, again, still protecting proprietary considerations. 

And I think we have begun to identify some of those alternatives. 

And again, I would use the word, as other Senators have here, it 

is all about finding solutions to the problem which we mutually 

agree must be addressed through this law. 

Senator CRAPO. Well, thank you. And let me just raise another 

issue. It kind of relates to the unintended consequences issue, but 

right now we are seeing, in my opinion, in the Federal Government, at the Federal level across many different industries and 

issues, an explosion of regulatory activity. 

Now, I understand that there are different points of view about 

the impact of that activity on the economy and on safety and 

soundness and other factors. One concern that I have is that as we 

move forward in looking at what the proper statutory and then ultimately regulatory climate should be, is that we have a multiplicity of agencies with jurisdiction over same or similar activities. 

Not in this area, but we have been doing a lot of activity in the 

financial arena recently in terms of regulatory activity, and there 

are some companies who deal with as many as five or six or seven 

134 

regulators. And in some cases, they actually have different definitions of the same kinds of activities and different requirements on 

the same activities that are impossible to meet. In other words, 

they can’t meet one without failing to meet the other. And we run 

into these inconsistencies in the regulatory world. 

I don’t know the answer to this question, but do we face that 

kind of risk here in terms of the potential for not identifying accurately where the jurisdictional boundaries are between different 

agencies? 

Mr. MATTHEWS. Senator, if that question is directed to me, I 

would be pleased to say yes, we do face that. I think earlier testimony about the States stepping into the vacuum and creating 

many different rules for similar chemicals and similar products is 

one example of that. 

I think at the Federal level, as we just mentioned, the notion 

that a substance may be used in different products and suddenly 

that implicates OSHA; that implicates FDA considerations and 

other agencies. It is a reality. There is no perfect solution to that. 

But I do think that care needs to be taken in adopting a reform 

TSCA that we don’t, with respect, that Congress does not go too far 

in creating additional conflicts where, again coming back to the 

purpose and goal, this is chemical management legislation and I 

think that that needs to remain the focus. 

But I must underscore again, at the risk of repetition, that the 

information that will come to the agency will be substantial; will 

have implications elsewhere; and certainly this law as drafted, if 

I recall, permits under defined circumstances the sharing of that 

information with other agencies which have the appropriate authorities to address some of those other issues. 

So I do agree that this is a consideration and we just need to 

keep our eye on that ball as we go forward. 

Senator CRAPO. Thank you. I know some of the others may want 

to respond to this, but my time is up, so maybe in a next round 

I can get further into that. 

Senator LAUTENBERG. Thanks very much. 

Senator Udall? 

Senator UDALL. Thank you, Senator Lautenberg. And I thank 

you for holding this hearing and know that you are always looking 

out for your children and grandchildren and concerned about these 

kinds of impacts, chemicals on them; and also looking out for consumers. So I appreciate your laying a bill out there. 

I also am concerned about this matter that was brought by first 

the Chairman and then by Senator Cardin. And I think there is 

definitely an issue of urgency. Maybe I should just approach this 

a little different way because I think the thrust of the question is 

still the same, though. 

While EPA maintains a list of chemicals under TSCA, which is 

nearly 80,000 chemicals that are out there, only 200 have ever 

been examined under the Act and only five banned. Testing by the 

Centers for Disease Control and Prevention has found more than 

212 industrial chemicals in the bodies of most Americans. 

And there have been a lot of television programs. I remember 

one Bill Moyers did where he went and got his blood tested and 

he said, ‘‘I’m walking around with all these chemicals and I am a 

135 

guinea pig.’‘ And I think people have seen that and they know that 

is out there and they are concerned about that. 

And of these 212 industrial chemicals in the bodies of most 

Americans, including at least six known carcinogens and dozens 

have been linked to cancer, birth defects and other adverse health 

effects, GAO has called TSCA a :high-risk area of law ripe for reform.’‘ 

So my question is, Mr. Dooley and Mr. Matthews, are you advocating for our body burden of chemicals to go up over time? So are 

you saying 10 years from now, instead of 212, we should have 400? 

It is kind of a simple question, yes or no. 

Are you pushing for, because that is what the urgency is here is 

to try to say we are in an unacceptable situation. There is I think 

some suggestion here that we may mark up this bill. If you are 

marking up a bill, you want to see language. And I think it is very 

urgent that we see something more than just criticism of the particular language that is in the bill. 

But please, on the body burden question. That is just a yes or 

no question, Cal. 

Mr. DOOLEY. It is a no. 

Senator UDALL. So you are not advocating for it to go up? OK. 

Mr. DOOLEY. No. The issue, Senator, is that we have to have a 

system in place. 

Senator UDALL. And are you concerned about it? 

Mr. DOOLEY. We are absolutely concerned about it, and we think, 

and that is what we are advocating for the modernization of TSCA. 

There has to be a system in place that ensures that we can do an 

evaluation of the safety resulting from a combination of evaluating 

the hazard and exposure of a particular chemical; understanding in 

terms of what it the exposure resulting from use of that chemical 

for its intended purposes; understanding at what level and threshold that chemical might pose a risk to health and safety. 

And then when we make a determination through the regulatory 

process and EPA having the authority there, they determine that 

this risk of exposure is too high, well, then we have to put in place 

controls. We totally support that. And we are doing that today 

when we are engaged with EPA in submitting new chemicals for 

approval. EPA has a lot of authority to do this today. And we work 

with them, trying to ensure that we are responding appropriately. 

But it is, you know, I will be honest. I take offense when anyone 

would even insinuate that our industry is supporting an increase 

in the body burden of chemicals over a period of time. 

Senator UDALL. Well, that is where we are headed right now. 

Where do you think we are headed? Because it has been going up 

year after year. We put TSCA in place in 1976 and what has happened since then? TSCA and the regulatory agencies don’t have the 

ability. You know that. They do not have the ability to pull chemicals off. One of the most dangerous chemicals was asbestos. We 

had a failure to regulate under TSCA. It is a carcinogen, outright 

carcinogen. 

So I don’t think you can sit there at the table and say, oh, yes, 

we want to see them pulled off. They are going up and up and up. 

Mr. DOOLEY. There needs to be a process in place, which we support, where you would have a scientific evaluation of the exposures 

136 

of the chemical that we have determined that pose a safety or environmental risk. There needs to be a process in place that ensures 

that the industry can manage those exposures in a fashion that ensures that the threshold of that exposure and the amount of those, 

the body burden of those does not pose a health and safety risk. 

Senator UDALL. I am really sorry. I have run over time here. Mr. 

Chairman, I wish I could stay and hear more of the testimony and 

hear Senator Carper, who I know is a great champion for consumers on this. I am going to have to leave, but you need to pursue 

this bill. We need to mark up this bill. We need to move forward 

with this. 

Thank you. 

Senator LAUTENBERG. Thanks. And while you are still here, Senator Udall, the conclusion from our friend Mr. Dooley, I think it is 

summarized broadly that this is a prescription for failure. And 

when we give it that kind of an umbrella, the sun is not going to 

shine through there, but we will talk more. 

Please, we are anxious to hear from Senator Carper. 

Senator CARPER. Thanks, Mr. Chairman. 

I am not going to pick on former Congressman Dooley. His reputation in the House was actually somebody who was pretty good 

at working across the aisle and pretty good at coming to consensus. 

And I am going to ask you, and then I am going to ask the other 

four witnesses as well, to join in just answering a couple of questions. And one of those is what would you say is maybe the largest 

outstanding issue that the environment and public health communities and industry need to come together on in order to further 

strengthen this proposal, but to also get it passed? At the end of 

the day, we need to enact something. 

And would you just respond to that? And I will ask our other witnesses to do the same. 

Mr. DOOLEY. I would contend that really the most important 

issue that we need to come to grips on and find a consensus on is 

on the safety standard, is where we contend that the reasonable 

certainty of no harm from aggregate exposures we think will lead 

to paralysis on the regulatory agency. It is not conceivable for industry to meet, and so we need to see some modification of that for 

a workable solution. 

Senator CARPER. All right. Let me ask Mr. Sturdevant. 

Mr. STURDEVANT. I would echo that. I think getting the right 

safety standard that ensures that, A, it has to be a safety standard 

that can be met; but B, just flipping this paradigm where we put 

chemicals out there and then see what happens over the course of 

year, I think moving that up front so we know that these chemicals 

are safe before going into commerce is the right thing. 

Senator CARPER. All right. 

Ms. Brody. 

Ms. BRODY. I agree it is the safety standard. But I have been 

doing this long enough that I remember when the American Chemical Council and its previous names was opposed to TSCA reform. 

And it is only under Mr. Dooley that that position has changed. So 

I appreciate the leadership that has created that, but I have sat 

in too many rooms like this where the chemical industry said that 

137 

TSCA was working perfectly well and that all chemicals in use 

were safe. 

So I think the safety standard is a really important conversation, 

but I think we have to actually sit down and say if reasonable certainty of no harm from aggregate exposure isn’t the right standard, 

what other words give the American people what this law is supposed to do, a way of knowing that chemicals in use are safe. 

Senator CARPER. OK. Thank you for those comments. 

Mr. Matthews. 

Mr. MATTHEWS. Senator, I agree that the safety standard is at 

the heart of it all. I would just add that for this statute to work, 

it has to be, we think, a risk-based approach. And for risk-based 

determinations to be made, the system needs better use and exposure information. Our industry has said we understand that and 

we are prepared to come forward and provide that information, and 

we think that will make a substantial difference. 

Second, having said that, we are extremely concerned about the 

provisions in the proposed legislation on confidential business information. We are concerned that it will be a disincentive to innovation; that it sets artificial timelines for the expiration of proprietary information that in many cases is unrelated to a timeline. 

And so that, and that are other aspects of the CBI issue that concern us. 

And on one related point, I would like to say a word about new 

chemicals. While that is primarily an issue that ACC has championed, there is a very direct affect on the downstream community. 

And that is that if they can’t innovate, we can’t innovate. We rely 

on our suppliers to help us find the right products that our customers and consumers are interested in buying, and we don’t want 

to stay with the same products that have been on the shelves, I 

think, for the last 40 years was the reference. 

And so we echo the concern that the new chemicals program if 

it is working should not be so radically changed as to make it a 

disincentive to develop newer, greener, safer chemicals. Those are 

my thoughts. 

Senator CARPER. All right. Well said. Thanks. 

Mr. Denison. 

Mr. DENISON. Thank you, Senator. In my view, the most important issue is to ensure that a reformed TSCA uses the best available science to make decisions about chemicals. Many of the issues 

that are in contention are actually recommendations of this Nation’s highest scientific body, the National Academy of Sciences, 

that calls on EPA to assess the aggregate risks of chemicals, that 

we are constantly looking at one use of a chemical at a time and 

we are looking at an average population exposure, rather than protecting the most vulnerable populations that may be more susceptible or more highly exposed; and rather than understanding that 

people are being exposed to chemicals from multiple sources. 

I think we have to find a way to make a workable approach to 

dealing with aggregate exposure, because I would agree with Mr. 

Dooley that it is more complicated than it is in the pesticide area. 

But the notion of pretending like we can look at one use of a chemical at a time and not look across those uses and aggregate it is 

138 

simply inconsistent with the best available science today as it is 

being even practiced today by the USEPA. 

Senator CARPER. OK. Thank you all for responding. 

Mr. Chairman, my time is expired, and I don’t have time to ask 

this question or at least get answers for it. But I at just want to 

put it on the table and then will followup in writing. 

But over the last couple of years, several nations, I think among 

them Canada, Australia, maybe Korea, China, parts of Europe, and 

some other countries have undertaken reforms of their own nation’s chemical safety laws. And the question I will ask you to answer for the record is: What can we learn from them? What should 

we drill down on and take away from those experiences? 

I used to say when I was Governor that some other, whatever 

issue we are working on in Delaware, I used to say some other 

State has solved this issue. They figured it out. They solved it. 

What we have to do is find them and figure out what they did. And 

so I think that might be helpful as well. 

I have a couple of other questions. That is one of them, but thank 

you all very much for coming here. We need to address this. We 

need to find a way to come together. And my hope is that under 

the leadership of our Chairman and Senator Crapo, Senator Inhofe 

and a lot of people’s good will, we can do this. 

Senator LAUTENBERG. Yes, we will keep the record open for some 

time and would ask that anything submitted to you in writing, 

please as prompt as you can, as fully as you can. 

Now, we are pleased to have Senator Whitehouse with us. 

Senator. 

Senator WHITEHOUSE. Thank you, Chairman Lautenberg and 

Ranking Member Crapo. I am delighted to be here with you and 

I appreciate the work that you both have done to try to come together on a TSCA reform bill. 

My question is for Mr. Dooley about the American Chemistry 

Council. It is my understanding, correct me if I am wrong, that the 

American Chemistry Council has not yet come up with proposed 

statutory language that would propose the changes that you think 

are necessary; that your contribution so far has been more that of 

a critique of the existing language than a proponent of an alternative. 

My specific question is, if I am correct about that, would you provide the Committee with a detailed redline of the Safe Chemicals 

Act this year so that we can see specifically what your proposal is 

and have that to work with as we try to move forward. 

Mr. DOOLEY. We would be prepared, as we have been engaged 

in substantive conversations on how we think that we can most effectively move forward with a modernization of TSCA. And we can 

offer suggestions in terms of how we think the legislation should 

be constructed. 

Senator WHITEHOUSE. Would you put those suggestions in writing in legislative format so we can be specific about them? 

Mr. DOOLEY. In terms of serving in Congress and now serving in 

the outside world, we obviously have some concerns about what is 

the prerogative of the institution, versus an outside entity in terms 

of responsibility. My view is that it is your prerogative and the 

Committee’s and Congress’s prerogative in terms of actual drafting 

139 

of legislative language. But we are certainly committed to be a 

partner to help ensure that in your construct of that language it 

would reflect our policy priorities would be. 

Senator WHITEHOUSE. This is nobody’s first rodeo here, and we 

have all certainly been involved in legislative matters in which the 

private sector has a very specific point of view. Indeed, from time 

to time, we are presented with legislation that has actually been 

drafted by industries. 

So I think the question about the prerogative is one that really 

by the boards and it is really more a matter of willingness. And I 

would urge you to do what you can to try to put your desires and 

wishes into a redline markup format. I think that is the most effective way for you to engage. I believe you want to be constructive. 

I think if you don’t put ideas forward, but are simply sniping from 

the woods on the sides, it doesn’t create the image of somebody who 

is trying to be constructive. 

People can say no and move the ball around all day long, but it 

is a positive effort to go through the trouble, as we have all discovered when we are drafting legislation, to try to put something in 

writing. And I think it would be an important sign of good faith 

and good will and a desire to make progress on the part of the industry if you would reconsider that and put something into writing. 

I think it puts you in a much better position and a much fairer 

position, and it lets the other interests who are engaged in this discussion have a sense of where you really stand and that you are 

not just kind of in the weeds saying no to things. And I don’t think 

that is the place you want to be, but I think unless you do that, 

that is the place where you end up being. 

Mr. DOOLEY. I just think it is kind of interesting that it was over 

a year ago, I guess, that there were a lot of folks concerned that 

we would be working with some Members of Congress that we 

thought would be more aligned with our interests and having them 

introduce a bill that would reflect our interests. And I think a lot 

of folks determined that that would be counterproductive to a process going forward. 

Senator WHITEHOUSE. That is not our process. We now have a 

bill and we are simply asking for a redline proposal. 

Mr. DOOLEY. And I guess this where there is just a note of frustration. We have met with Members of this Committee staff on the 

majority side. They are pretty aware of what we think needs to be, 

and we have given them ideas and suggestions. We haven’t given 

them legislative language, but they are not reflected in the draft 

that we have today. And that is not necessarily because of a lack 

of specific suggestions that we have offered, but it is a fundamental 

disagreement on the direction to go. 

So I don’t want people to think because we haven’t necessarily 

provided specific legislative language that we haven’t engaged in 

offering some pretty specific solutions, but there could be that they 

are not reflected in the legislation because there is a fundamental 

disagreement. 

Senator WHITEHOUSE. Well, my time has expired, but I continue 

to believe that it would be both advisable and helpful to the process 

if you would take your wishes for this legislation and actually 

140 

make them public and write them down in a way that everybody 

can look at and comment on them. 

Thank you. 

Senator LAUTENBERG. Thanks very much, Senator Whitehouse. 

You weren’t here before, but we are still planting what I will say 

is old ground here. 

Mr. Dooley, you have been here. You know it isn’t, and the reason you don’t get to pick out the people that you want to do these 

things, you don’t have the votes. That is fairly simple. And you are 

a smart fellow and you know that as much of a bite of the apple 

as you would like to take, that it is never going to be a majority. 

So please do what you can to respond, and where we fail, you 

know, point that out in more specific terms, but be as I think you 

see running through here, a little more constructive instead of unenforceable and that kind of thing. Figure out ways to get it done. 

You have a powerful organization there and we are happy to see 

you here, but with your compliments about my staff and the other 

Members’ staffs here, I thought we were maybe going to clean 

house. But I have thought it through, and they are really very 

good, as you described them in the beginning. 

[Laughter.] 

Senator LAUTENBERG. So we will go on with a couple of questions 

that I have, and Senator Merkley is back, and Senator Crapo is 

still here. 

I would like to ask Mr. Denison a question. The Safe Chemicals 

Act as prescribed would require the industry to demonstrate the 

safety of new chemicals before they enter the market. And some 

have criticized that that requirement is too burdensome and have 

suggested preserving TSCA’s current approach to new chemicals. 

What is needed in terms of new chemicals to have some strength 

in this program? 

Mr. DENISON. Thank you, Senator. 

I think given the limited authority and capacity that EPA was 

given under TSCA, it has done as good a job as it can in trying 

to address new chemicals coming onto the market; 1,500 notices 

are received every year. EPA has to process those within 90 days. 

And one of the major flaws is that it has, in almost all cases, no 

data that is submitted along with those chemicals by which it can 

make a decision about whether to allow that chemical on the market or impose conditions. 

The other countries in the developed world require a minimum 

set of safety information to come in when a chemical is filed. And 

that is something that the Safe Chemicals Act would address by requiring a level of information. 

Now, the bill indicates already that the level of information 

ought to be tiered and varied based on the nature of the chemical, 

how much is produced, how it is going to be used, and what else 

is known about it. So I want to emphasize, it is not a one-size-fitsall requirement. It would set an extremely high bar for any new 

chemical to get on the market, but there needs to be sufficient information for EPA to make a reasoned decision. 

Moreover, TSCA fails to have a mechanism by which EPA can 

readily revisit a new chemical after it is on the market should its 

production or use pattern change significantly. Only if it goes 

141 

through an onerous regulatory process for each and every chemical 

can it get that kind of look-back provision, the ability to look again 

at a chemical if its use has expanded, for example, into a consumer 

product category that it wasn’t used in before. 

The bill would provide an ability for EPA to look at those chemicals, and again this is consistent with the approach taken in other 

countries. Canada, which the American Chemistry Council and 

other industry players have often pointed to as a model program, 

actually does have a process by which chemicals as they enter into 

commerce and their use expands, more data are required and the 

government is required to re-review those chemicals in a tiered 

fashion. 

We think that kind of an approach could balance the need to ensure that you are not stifling innovation and overly impeding the 

introduction of new chemicals, but at the same time ensure there 

is some significant degree of safety assured of those chemicals before they get embedded in our economy, when it is very hard to do 

anything about it. 

We need that gate to be at the beginning of the process and not 

wait until we find some problem 10, 20 years later to actually ensure the safety. 

Senator LAUTENBERG. Mr. Sturdevant, the Safe Chemicals Act 

would preserve the ability of a State to go beyond the Federal 

standard on chemical safety to protect our citizens. How would establishing the strong Federal system on chemical safety affect the 

ability to establish the State-level regulations? Where might the 

States come in there, because we are trying to preserve an option 

for the States that they see a greater need for supervision? 

Mr. STURDEVANT. I think with the changes envisioned in the bill, 

with a stronger Federal system, the need for the States to engage 

in these activities would decline I am sure. I think that there 

would still be cases where the ability to address problems that are 

occurring in particular States should be maintained. But I think 

that what we would see instead is just sort of a more normalized 

State-Federal relationship like we see with a whole bunch of other 

statutes where there is good Federal backstops and then States can 

tailor regulations accordingly in their own States. 

So I think that we would see that kind of normalized relationship 

where States address problems if and when they are needed, as opposed to trying to address the fundamental challenges that we 

have all been talking about here today that really need to be addressed at the Federal level. 

So I think that a result from me and my agency would be we 

would end up spending less time and energy on these efforts because we know that they are being addressed at the Federal level. 

Senator LAUTENBERG. Thank you. 

Senator Crapo, do you have something? 

Senator CRAPO. Yes, Mr. Chairman. 

I just wanted to make an observation, a comment, and the witnesses can comment on this if they would choose. But it seems to 

me that there is sort of a consistent message point coming from the 

Democratic side of the aisle to the Chemistry Council here that 

they have to come forward with statutory language or their response is not acceptable. 

142 

Although it is not unheard of for participants or stakeholders on 

an issue to propose statutory language, I don’t know that I recall 

very many cases in which a Committee has demanded that and 

sort of set that bar as the bar of proper participation on an issue. 

I would tell you that if the effort is to create the impression that 

failure to come forward with a proposed alternative statutory proposal is the only acceptable way to engage on that issue, I think 

that is wrong. I can say that the American Chemistry Council and 

other stakeholders have been in my office many, many times to discuss this issue. I know that they are sincere about wanting to move 

forward. 

As far as I am aware, their concerns have been very, very well 

expressed. And I believe that every Member of this Committee 

knows what the conflicts are in terms of disagreements about the 

issues with regard to the statute. 

So I just felt like I had to say that because I felt like there was 

an impression being created that there was not an engagement or 

that there was not a willingness to try to work toward finding a 

solution and that has certainly not been my experience. 

Senator LAUTENBERG. If I might, just a quick response. I think 

that if you have a chance to look through Mr. Dooley’s testimony 

and his commentary, I got the impression that it was thought by 

Mr. Dooley that we weren’t paying enough attention to what they 

were offering. So my response was to say, OK, give us some statutory language here. But that isn’t intended to be a word-for-word 

kind of thing. It is, OK, give us the challenge to what you see. 

And we invite the participation of Mr. Dooley just because we 

have some differences here. And I think that it is fair for you to 

voice your organization’s views, but on the other side, you have 

seen the run-through here, including friends on both sides of the 

aisle, as to, OK, don’t like it. 

Be more specific about what it is and maybe even do an evaluation that says, OK, we are willing to dismiss the fact that science 

says that there are some episodes of health problems as a consequence of fairly active use of some chemical here or there. 

What we are trying to do, and trying very hard to do, is begin. 

I started off in my comments this morning with we want an open 

process and you are included in that opening, obviously. But I 

think it has to be more specific as to not only what you don’t like, 

but how would you fix it. And I think that is a reasonable request. 

Senator CRAPO. My only comment was to the effect that it has 

been my impression that there has been very aggressive and extensive engagement from all sides. This is an issue on which I have 

seen a tremendous amount of activity. And I thought that there 

was an impression being created that was not accurate and I don’t 

want that impression left in this hearing, that any of the participants and stakeholders have not been very engaged in trying to 

help make their positions and their proposed approaches known to 

the Committee. 

Senator LAUTENBERG. Fair enough. 

Senator WHITEHOUSE. If I might add, I don’t doubt for a moment 

that there has been heavy engagement. I think it helps with the 

transparency of the engagement when there is actual language 

that is produced. That is my only point. 

143 

Senator LAUTENBERG. Senator Merkley. 

Senator MERKLEY. Thank you, Mr. Chair. 

I wanted to explore a little bit the interaction between American 

companies and the current chemical regulation regime in the European Union. And I was wondering, Ms. Brody and Mr. Sturdevant, 

if you could describe succinctly some of the distinctions between 

the European system and the current American system? Of course, 

recognizing that our American companies are already engaged in, 

if you will, working with or within the framework that is laid out 

in Europe. 

Ms. BRODY. Let me just start. Thank you for the question, Senator. 

Virtually all of the major players in the American chemical industry are global companies and are selling to the European Union 

and other markets. 

You would agree with me, Cal? 

And so all of them are looking at the new law in Europe, 

REACH, and figuring out how to test their chemicals and if their 

chemicals will meet the REACH safety standard. So I think it actually adds to this discussion about if the Safe Chemicals Act as written isn’t the right language for the American Chemistry Council, 

what is? Because we have this statute moving in Europe and in 

other countries that is new and provides a place to start with in 

thinking about how can American chemical law add to what is already going on in other parts of the world. 

And I think it is very appropriate to look at how much money 

the American chemical industry is already spending to test their 

chemicals for the European market and to figure out how every 

single dollar that is being spent there can add information to what 

we could do to get the kind of exposure, information and use information that we need about chemicals in the United States, and to 

do that in an important new way. 

I think it is important to add, though, that European chemicals 

law was as broken as American chemicals law still is. And the European Union and its new Parliament took strong action with the 

opposition of the American Chemistry Council hard and heavy 

against REACH being enacted. But now that it is the law of the 

European Union, there is a whole lot we can learn from that and 

build on in what we do in TSCA reform. 

Senator MERKLEY. OK, great. 

Mr. Sturdevant. 

Mr. STURDEVANT. My knowledge of REACH is quite general so 

I won’t go into specifics. But one thing that has come out of 

REACH that I think is both worth looking at very hard and has 

already been beneficial is the amount of information that is coming 

out of the reporting required there. So that has been one of the key 

challenges for us at the State level is gaining access to information. 

So REACH is actually providing us information that we haven’t 

had access to before. 

And I certainly understand the concerns expressed by Mr. Matthews about information and sharing too much information, and 

that inhibiting innovation. I think that there is a lot of room for 

improvement in the current law on confidential business informaVerDate Aug 31 2005 15:05 Nov 01, 2017 Jkt 000000 PO 00000 Frm 00147 Fmt 6633 Sfmt 6633 S:\_EPW\DOCS\24968.TXT VERN
144 

tion, how that is kept confidential. I think that there is a happy 

medium to be found here and REACH could perhaps inform that. 

Senator MERKLEY. Thank you. 

And to anyone on the panel who would like to comment on it, my 

impression is that the effort has been made to craft this bill that 

is before us in a fashion that the information prepared on chemicals for Europe would satisfy the U.S. law. Do you all share that 

view or do you have a different view? It would be helpful. 

Mr. DENISON. I think there has been a concerted effort to ensure 

that we not reinvent the wheel or create a system that requires duplicate testing, et cetera. There is absolutely information coming 

from REACH that will be directly relevant in the U.S. and we 

should make sure that our EPA has the authority to get access to 

that information and that it is used in informing and meeting the 

requirements that industry faces in providing minimum information. 

So the bill I think goes very far in describing a variety of types 

of information, including existing information being developed 

under other jurisdictions that could be used to satisfy the data requirements under this bill. So it would only be the gaps that remain after that other information is factored in that would be a 

new burden, if you will, on the American industry. 

We have an advantage in going second here because the European Union has gone first. And they are taking a lot of arrows in 

the back because of that. But that actually makes the lift for the 

U.S. under TSCA reform that much easier. 

Senator MERKLEY. Mr. Matthews and Mr. Dooley, I think both 

of your associations have members who export products to Canada, 

which has yet a different structure, and to Europe. Any insights on 

how those reporting requirements are going? And also the degree 

to which essentially as information is developed for that market, 

whether that also then largely would address the requirements 

that we are seeking here in this Act? 

Mr. DOOLEY. Just a couple of comments. One on the REACH. Obviously, all of our companies are participating, complying with that. 

There is the data that we are providing to meet those requirements. I would say that based on our analysis of the legislation, 

the 847, it is unclear whether or not that data would be similar or 

identical. And obviously, we would be interested in seeing to the 

greatest extent possible a harmonization of those data requirements. 

But I would also cite that we would look to the Canadian model 

as being the preferred model over the REACH in that it does embrace a much more of a prioritization process where you would 

focus the resources of EPA, as well as the private sector, on those 

chemicals of the greatest concern, that we think would then lead 

to greater, more positive developments ensuring safer chemicals in 

commerce. 

So we think the Canadian model is actually one which is, from 

our perspective, would work better from a regulatory context, 

achieving a similar level of safety outcomes, and would also be 

more cost-effective and efficient from the industry perspective. 

Senator MERKLEY. Thank you. 

Senator LAUTENBERG. The record will be kept open. 

145 

Before closing the hearing, I ask unanimous consent to have Senator Boxer’s statement to be put in the record. 

[The prepared statement of Senator Boxer was not received at 

time of print.] 

Senator LAUTENBERG. And the letter from the United Steelworkers, from the American Nurses Association, and a statement 

from the Procter and Gamble Company. 

[The referenced documents follow:] 

146 


24968.141

November 17, 2011 

Hon. Barbara Boxer 

Chair, U.S. Senate Committee on Environment and Commerce 

Hon. Frank Lautenberg 

Chair, Subcommittee on Superfund, Toxics and Environmental Health 

Dear Senators Boxer and Lautenberg: 

Thank you for holding today' s hearing on the Safe Chemicals Act. Of course, Charlotte 

Brody, a member of the United Steelworkers, is scheduled to testify. Our union fully supports 

her remarks. 

We also want to thank you, your staff, and your counterparts in the House who are 

working hard to reform the Toxic Substances Control Act. You have our complete support. 

Our union represents the majority of unionized chemical workers in the United States. 

We make plastics, fertilizers, pesticides, synthetic rubber, pharmaceuticals, fibers, cosmetics, 

paints, pigments, solvents, acids, bases and the thousands of organic and inorganic chemicals 

that our society depends on. We also represent hundreds of thousands of workers who use 

chemicals on the job. 

Our members have a huge stake in chemical safety. When a new chemical goes into 

production, we are the first to be exposed, and as the makers of that chemical we suffer the 

highest exposures. Our families, like all American families, are exposed to chemicals in the air 

they breathe, the water they drink, the food they eat, the products they use. TSCA reform is 

sometimes described as requiring more chemical testing. However, all chemical get tested even 

now. We test them in the bodies of our workers, our children, ourselves. All too often, the 

hazards of a chemical are uncovered through epidemiological studies- literally by counting the 

bodies- decades too late. Most of those studies are done on workers. We think chemicals ought 

to be tested in the lab, not in people. We are sick of being guinea pigs. 

Our union also has a huge stake in the economic health of the chemical industry, and all 

the industries which use chemicals to make the products and provide the services that form our 

economy. As a matter of fact, we have the greatest stake of all. When a firm crashes or a plant 

closes, top management goes elsewhere or floats gently down on their golden parachutes. 

Investors take a hit, but find other opportunities. We are the ones in the unemployment lines. 

We hear a lot today about 'Job-killing regulations." It seems that every proposed rule, 

every piece of legislation designed to protect the health, safety, or financial security of ordinary 

Americans gets attacked as "job-killing." Frankly, we just don't buy it. 

Let us consider the cost of doing nothing. A study in the May issue of the journal "Health 

Studies" estimates the medical costs of childhood environmental disease- disease caused by 

chemical pollution- at 77 billion dollars a year. And that was only for the hazards we know but 
147 


24968.142

don't yet adequately control, not for the thousands of chemicals we foist on our children, 

chemicals whose hazards we do not know. 

Another study this one a 2005 review by the National Institute for Occupational Safety 

and Health- puts the annual cost of occupational disease between 128 and 155 billion dollars a 

year. Not all of that is from chemical exposures, of course, but much of it surely is. 

Of course these are rough estimates at best. The true economic burden may be lower or it 

may be higher. We don't really know, and we can't really know until we know more about the 

hazards of the chemicals in commerce, and we will only know that through a modernized TSCA 

law. 

Let us look at the benefits ofTSCA reform. The Blue-Green Alliance is an organization 

founded by my union and the Sierra Club. It now includes more than a dozen unions and 

environmental organizations. In a recent study sponsored by the Alliance, James Heintz and 

Robert Pollen of the University of Massachusetts in Amherst, looked at production and 

employment trends in the U.S. Chemical Industry. They concluded that a shift to a safer, greener 

industry could promote innovation, ensure access to global markets, meet the growing consumer 

demand for safer products, protect shareholder value by reducing the risk of environmental 

disasters, and- most important for us create tens of thousands of new jobs in the chemical 

industry and the industries which use its products. 

The issue of competitiveness is especially important. Europe has adopted a strong new 

system known as REACH (Registration, Evaluation and Authorization of Chemicals) designed to 

assure that chemicals and products made with chemicals are safe to manufacture and use. Unless 

the United States follows suit, consumers around the world will ultimately come to trust 

European products more than they trust American products. 

In short, we reject the claim that safer chemicals and greener chemistry will kill jobs. We 

believe they will, in fact, create jobs and protect the long-term future of the chemical industry. 

We represent chemical workers. We would not support your legislation in its present form if we 

thought it would put our members out of work. 

Thousands of our members work in the chemical industry. They want to make things that 

are safe for them, safe for their kids, and safe for the planet. They know that in the long run, their 

jobs depend on that as welL 

Thank you again for holding today's hearing and for your continuing effort to protect the 

health, safety, and economic security of the American people. 

Sincerely yours, 

Leo W. Gerard 

International President 
148 


24968.143

Grocery Manufacturers Association Statement before the Senate Committee on 

Environment and Public Works and Subcommittee on Superfund, Toxics, and Health's 

Hearing on the Safe Chemicals Act 

November 17,2011 

GMA appreciates the leadership of Chairman Frank Lautcnberg (D-NJ) and Ranking Member 

James Inhofe (R-OK) in their efforts to more fully understand the broad scope of stakeholder 

perspectives on reform of the Toxic Substances Control Act (TSCA). Their constructive 

leadership has continued to increase the understanding necessary to move a difficult issue such 

as this one forward. 

While S.84 7 is unworkable in its current form- unmodified since introduction- and contains 

many serious problems that would need to be resolved, GMA believes the goal of modernizing 

TSCA is achievable and stands ready to work with policymakers to modernize the law. 

GMA supports modernizing TSCA in a manner that will promote innovation and protect 

American jobs while ensuring consumer confidence in our chemical management system. 

Specifically, among others core principles, GMA supports legislation that will: 

• Promote Innovation - TSCA reform should boost confidence in government chemical 

management and promote even greater innovation by chemical manufacturers and users. 

• Review Priority Chemicals EPA should establish a system to quickly identify and 

review "priority" chemicals based upon both hazard characteristics and exposures, 

including exposures to children. 

• Provide Adequate Use, Exposure and Toxicity Information EPA should work with 

chemical manufacturers and users to ensure that EPA has timely and adequate 

information of chemical hazards, exposures and uses, including uses in children's 

products. 

• Clarify Risk Management Tools- EPA should have clearer risk-based authorities to 

specify risk management measures that will ensure that chemicals of concern are 

reasonably expected to be safe for their intended uses. 

• Leverage and Integrate Chemical Reviews Policymakers should take steps to 

leverage the chemical management programs undertaken by other nations and to integrate 

the patchwork quilt of laws governing chemical management. 

• Use the Best Available Science Policymakers should ensure that EPA relies upon the 

best available science regardless of its source. 

GMA looks forward to continuing the dialogue with government, public health, environmental 

and industry representatives to reach a responsible policy solution on this critical issue. 
149 


24968.128

Written Statement of 

The Procter & Gamble Company 

Before 

The Committee on the Environment and Public Works 

And 

Subcommittee on Superfund, Taxies and Environmental Health 

Joint Legislative Hearing on the Safe Chemicals Act (S 847) 

United States Senate 

Washington, D.C. 

November 17, 2011 
150 


24968.129

The Procter & Gamble Company's (P&G) Purpose- to touch and improve lives, now 

and for generations to come - inspires everything that we do. P&G is committed to 

manufacturing and marketing safe, innovative and sustainable products that provide 

essential benefits to consumers, while protecting human health and the environment. 

We have over 700 scientists and regulatory compliance specialists in our 

comprehensive product safety management organization who ensure all our products 

are safe for consumers and the environment before they go to market and monitor the 

products while in the market. 

The Procter & Gamble Company is the world's leading consumer products company 

operating in more than 80 countries worldwide. Our portfolio of recognized brands 

includes numerous household and industrial products, the ingredients of which are 

directly subject to EPA regulation under the Toxic Substances Control Act (TSCA). Our 

chemicals division, P&G Chemicals, is a global leader in the manufacture and marketing 

of oleochemicals. We have a committed interest in working with Congress and all 

stakeholders to ensure that legislation to modernize TSCA results in a workable 

regulatory program that effectively protects the public and the environment while 

retaining the ability for us to innovate and introduce sustainable products to the market. 

P&G recognizes that consumers are concerned about chemicals used in everyday 

products and fully supports efforts to improve public confidence in the safety and 

management of chemicals through the modernization of TSCA. P&G takes pride in the 

work that we do to understand our consumers' needs, habits, practices, and 

suggestions that allow us to deliver product innovations that delight our consumers and 

improve their lives. Our work to understand consumers' interests in strengthening the 

US chemical management system is no different. P&G has actively engaged in 

discussions with Safer Chemicals Healthy Families (SCHF) because we know that by 

working to understand each other's interests, concerns and positions we can collectively 

develop informed solutions that will establish an effective, workable and comprehensive 

chemicals management policy. We appreciate Senator Lautenberg and Senator 

lnhofe's similar efforts in conducting a dialogue over the last 6 months with 

stakeholders. Today's legislative hearing further allows stakeholders to express the 

need for TSCA modernization, outline how such reform should occur, and work towards 

a collaborative process that will ultimately deliver a modernized TSCA built from the 

foundation of stakeholder interests. 

Because of our commitment to ongoing dialogue, P&G recently hosted at our corporate 

headquarters in Cincinnati, Ohio, members of SCHF for a two day discussion on 

chemical management in commerce and TSCA. Our objective was to demonstrate our 

chemical and product safety assessment processes, show how we've built TSCA 

compliance into the rhythm of our daily business, and share ideas on how TSCA can be 

modernized. We were able to highlight in practice several of our chemical safety 

programs which demonstrate the following principles we have embraced for TSCA 

modernization: 
151 


24968.130

• Promote human health (with particular focus on children's health) and the 

environment through a risk-based chemicals management program, 

administered by the EPA. 

• Protect and promote sustainability through innovation. 

• Establish an efficient risk-based process that uses hazard, use and 

exposure information to identify and prioritize chemical substances for 

timely assessment and (when needed) proportionate risk management 

actions. 

• Set an updated, appropriate safety standard that can easily be applied in 

chemical assessment to inform EPA decisions. The process/framework 

by which EPA determines acceptance of priority chemicals substances 

against this standard must reflect key of principles of risked-based 

decision making. 

• Encourage mutual acceptance and effective use of existing information 

provided to other governments' chemical management programs and 

promote further development, validation and acceptance of evolving 

alternative test methods and assessments to reduce reliance on 

unnecessary animal testing. 

• Provide EPA with sufficient Congressional funding, resources and 

empowerment to achieve clearly outlined policy objectives and timelines. 

• Protect legitimate confidential business information to maintain a 

competitive and innovative marketplace. 

After this visit, P&G and SCHF agreed to continue dialogue on specific aspects of S 847 

that are critically important to our business. These detailed discussions have provided 

valuable insights and revealed opportunities for common ground solutions that could 

contribute to an updated TSCA. 

P&G supports the intent of Congress to implement legislation to modernize TSCA with a 

purpose of ensuring the protection of human health and the environment and enhancing 

public confidence in the US chemical management program. TSCA modernization 

needs to preserve and protect the ability of industry to bring sustainable innovations to 

market and to maintain the competitiveness of the US economy in the global 

marketplace. We look forward to continuing engagement with Congress to ensure 

TSCA modernization achieves an effective, workable and comprehensive US chemical 

management policy. 

Julie Froelicher 

U.S. Regulatory Affairs Manager 

The Procter & Gamble Company 

Chuck O'Hara 

Senior Manager, Global Government Relations 

The Procter & Gamble Company 
152 

Senator LAUTENBERG. And with that, I thank all of you. I 

thought it was certainly an interesting meeting, but I think it is 

one that will help us move our legislation along. 

And Mr. Dooley, we wait to hear from you and any of you who 

have further comments you would like to make in writing. 

Thank you very much. 

The meeting is closed. 

[Whereupon, at 11:55 a.m., the committee was adjourned.] 

[Additional material submitted for the record follows.] 

STATEMENT OF HON. MAX BAUCUS, 

U.S. SENATOR FROM THE STATE OF MONTANA

Chairman Lautenberg, thank you for holding this important hearing today on S. 

847, the Safe Chemicals Act of 2011. 

The Toxic Substances Control Act (TSCA) needs to be reformed. There is a broad 

consensus that it is outdated. And this bill is an appropriate starting point for that 

effort. 

I have heard many times in recent years from Montanans who are passionate 

about improving chemical safety. Parents from across Montana, and mothers in particular, are worried about the products that surround their children. Montanans 

who suffer acute chemical sensitivity would lead better lives with a more transparent system. And I never forget the many Montanans touched by the nightmare 

of the asbestos contamination of the town of Libby, Montana—and the clear failure 

of TSCA to address the toxicity of asbestos. 

TSCA is not adequately protecting Americans, and it is our obligation to fix it. 

Congress should give EPA better tools to keep our families safe, including strong 

up-front requirements for obtaining data about chemicals and the ability to 

prioritize the risk of different chemicals. 

Looking forward, the more we can do to promote green chemistry innovation, the 

more new jobs we will create, technology we will export, and families we will keep 

safe. Rivertop Renewables in Missoula, Montana, is a perfect example of this kind 

of innovation. A balanced bill ought to ensure that homegrown companies like 

Rivertop can continue to lead the chemical industry. 

Thank you again for your hard work in crafting this bill and keeping the process 

inclusive. I look forward to working with you toward an agreement in this committee. 

153 


24968.106

BUSINESS ALLIANCE COMMITTED TO FINDING THE RIGHT 

APPROACH TO UPDATING TSCA 

WASHINGTON, D.C. (November 17, 2011) --The American Alliance for Innovation, an 

alliance of trade associations representing a broad spectrum of the economy, issued the 

following statement regarding today 's joint legislative hearing on the ''Safe Chemicals 

Act" bejhre the full Senate Committee on Environment and Public Works and the 

Subcommittee on Superfimd, Taxies and Environmental Health: 

"We appreciate the efforts of Chairman Lautenberg and Ranking Member Inhofe to 

tackle the numerous and complex issues involved with updating the Toxic Substances 

Control Act (TSCA) so the law ensures the safe use of chemicals, encourages innovation, 

and protects American jobs. 

"The recent discussions amongst certain stakeholders were constructive and can help 

provide a foundation to bring TSCA into the modern world of chemical management. 

While these discussions have led to a greater understanding of the differing viewpoints 

on important aspects of reforming TSCA, there are still many serious issues that need to 

be resolved and much more work to be done. 

"We think the Safe Chemicals Act, as \Witten, is not the answer. However, we are 

committed to continuing to work with all stakeholders -regulators, downstream users, 

raw material suppliers, distributors, retailers, and environmental, consumer, animal 

welfare and labor groups -to help Congress tind the right approach for updating TSCA. 

Since TSCA impacts every corner of our economy, we believe that both industry and 

consumers need to have confidence that any changes to the law lead to a more effective 

and efficient system of regulating chemicals." 

### 
154 


24968.107

The American Alliance for Innovation represents businesses both large and small in 

industries including the following sectors: aerospace, agriculture, apparel, automotive, 

building materials, chemical and raw material production, consumer and industrial 

goods, distribution, energy, equipment manufacturers, electronics, healthcare products 

and medical technology, food and grocery, information technology, and retail. 

Adhesive and Sealant Council 

Alliance of Automobile Manufacturers 

American Apparel & Footwear Association 

American Chemistry Council 

American Cleaning Institute (ACI) 

American Coatings Association 

American Coke & Coal Chemicals Institute 

American Forest & Paper Association 

American Iron and Steel Institute 

American Petroleum Institute 

Automotive Aftermarket Industry Association 

Consumer Specialty Products Association 

Corn Refiners Association 

CropLife America 

Edison Electric Institute 

Fashion Accessories Shippers Association (FASA) 

Fashion Jewelry & Accessories Trade Association 

Flexible Packaging Association 

Grocery Manufacturers Association 

Industrial Minerals Association North America (IMA-NA) 

International Diatomite Producers Association 

International Fragrance Association North America 

International Sleep Products Association 

Juvenile Products Manufacturers Association (JPMA) 

National Association of Chemical Distributors (NACD) 

National Association of Manufacturers 

National Association for Surface Finishing 

National Association of Printing Ink Manufacturers 

National Electrical Manufacturers Association (NEMA) 

Nationallndustrial Sand Association 

National Mining Association 

National Oilseed Processors Association 

National Petrochemical & Refiners Association 

National Retail Federation 

North American Metals Council 

Personal Care Products Council 

Pine Chemicals Association 
155 


24968.108

Plastic Pipe and Fittings Association 

Portland Cement Association 

Responsible Industry for Sound Environment (RISE) 

Society ofChcmical Manufacturers and Affiliates (SOCMA) 

Specialty Graphic Imaging Association 

SPI: The Plastics Industry Trade Association 

Textile Rental Services Association 

The Fertilizer Institute 

The Vinyl Institute 

Travel Goods Association (TGA) 

Treated Wood Council 

Utility Solid Waste Activities Group 
156 


24968.109

american cleaning institute"" 

fm herrer llvmg 

November 17, 2011 

Honorable Frank Lauten berg 

Chairman 

Subcommittee on Superfund, Taxies & Environmental Health 

Committee on the Environment & Public Works 

United States Senate 

Washington, DC 20510 

Honorable James Inhale 

Ranking Member 

Committee on the Environment & Public Works 

United States Senate 

Washington, DC 20510 

RE: Full and Subcommittee on Superfund, Taxies and Environmental Health Joint Hearing: 

"legislative Hearing on the Sale Chemicals Act (S. 847}" 

Dear Chairman Lautenberg and Ranking Member lnhofe: 

The American Cleaning Institute" (ACI) is the trade association representing the $30 billion U.S. cleaning 

products market. ACI members include the formulators of soaps, detergents, and general cleaning 

products used in household, commercial, industrial and institutional settings; companies that supply 

ingredients and finished packaging for these products; and oleochemical producers. ACI and its 

members are dedicated to improving health and the quality of life through sustainable cleaning products 

and practices. ACI's m1ssion is to support the sustainability of the cleaning products industry through 

research, education, outreach and science-based advocacy. 

ACI and its members support the modernization of TSCA. ACI has previously written to the Committee 

that a modernized TSCA would help improve public confidence that the chemicals used to manufacture 

consumer products and packaging are safe. ACI members believe that product safety is the foundation 

of consumer trust, and the consumer products industry devotes substantial resources toward achieving 

this goal. 

In many ways, TSCA has been at the forefront of innovative developments in the U.S. and globally. Our 

members are committed to manufacturing and marketing innovative and sustainable products that 

provide essential benefits to consumers while protecting human health and the environment. A 

modernized TSCA has the potential to promote even greater innovation in furtherance of sustainable 

cleaning products. 

Improvements in the law should recognize changes in science and technology and advance innovation. 

The U.S. Environmental Protection Agency (EPA) needs to take full advantage of information and data in 

chemical management programs undertaken by other nations. The Agency needs sufficient information 

to better inform Agency chemical management and assessment decisions. 

ACI has called for improvements in TSCA since well before the current Congressional efforts to amend 

the law. ACI commends the stakeholder meetings process undertaken by your offices over the last 

several months. ACI appreciates engaging as a direct participant with your staff on the most critical 

issues related to updating the law. ACI remains concerned, though, that the whole of S. 847 would create 

1331 l NW, Suite 650 Washington, DC 20005 202.347.2900 

voww.ci&oninginstltute~org 
157 


24968.110

high hurdles to American manufacturing, particularly when it comes to product and process innovations, 

and ACI suggests the development of new legislation. This can occur through the stakeholder process 

which has been valuable and constructive for ACI member companies, and the process should continue 

ACI remains committed to a bipartisan, bicameral dialogue to fashion a reasonable approach to updating 

TSCA in order to promote the safe use of chemicals; build public confidence in the chemical management 

system; protect American jobs, and maintain the U.S. global leadership role in chemical innovation. 

Ernest S. Rosenberg 

President & CEO 

cc; Members of the U.S. Senate Committee on Environment & Public Works 
158 


24968.111

7U1 Pr.nnsylva111aAvenuc.N.W 

101\08.555\ fax. 102.588 5786 

~ Edison Electric ......, Institute 

:-.Jovember 17, 2011 

The Honorable Barbara Boxer 

Chairman 

200Q4 1696 1'1\'IW.eei org 

Committee on Environment & Public Works 

United States Senate 

112 Senate Hart Office Building 

Washington, DC 20510-0505 

The Honorable James Inhofe 

Ranking Member 

Committee on Environment & Public \Vorks 

United States Senate 

205 Senate Russell Office Building 

Washington, DC 20510-3603 

Dear Senators Boxer and lnhofe: 

Power by Association"' 

Thomas R. Kuhn 

Pres1dent 

ln anticipation of the legislative hearing scheduled for November 17 on S. 847, the Safe 

Chemicals Act, the Edison Electric Institute (EEl) would like to alert you to a specific 

concern with the text of S. 847. As currently drafted, we believe a provision of the bill 

would inadvertently upset the federal regulatory program for PCBs that has worked well for 

the past 30 years in ensuring the safe use of PCBs in electric and natural gas pipeline 

equipment. 

Through the Utility Solid Waste Activity Group (USWAG), EEl has worked successfully 

with EPA during the Agency's implementation and administration of a robust and mature 

PCB regulatory program under TSCA § 6(e). Pursuant to TSCA § 6(e), EPA has developed 

a regulatory program requiring that the use of PCBs in electric and gas pipeline equipment 

does not pose an unreasonable risk to human health or the environment. 

This federal PCB regulatory program is working welL An August 2010 technical report, 

"Inventory and Cost Estimates for PCB-Containing Electrical Equipment Owned/Operated 

by U.S. Electric Utilities," prepared by ENVIRON International Corp., found that the 

"amount of PCB-containing electrical equipment in use by U.S. electric utilities has been 

reduced by approximately 78%" since the last equipment survey in 1981 and that the 

amount of PCB-containing equipment still in service now constitutes less than 3% of all 

electrical equipment in use throughout the country. 
159 


24968.112

November 17, 20 I I 

Page 2 

Given the success of the federal PCB program, we are concerned that, as currently drafted, 

S. 847 could throw the implementation and status of this program into chaos. This problem 

stems from the text in S. 847 that would replace the entirety of TSCA § 6(e), which is the 

statutory basis for the existing PCB regulations. The new text inS. 847 would require EPA 

to Hnd, prior to authorizing the usc of PCBs in electric equipment and natural gas pipelines, 

that such uses do not "present a substantial endangerment to human health or the 

environment." As explained above, the existing statutory text in§ 6(e) already requires that 

such uses be based on a finding that they do not pose an "unreasonable risk to health or the 

environment" 

While it is unclear precisely what the difference is between these two standards, a literal 

reading of the text in S. 847 would mean that the usc of PCBs in electric and natural gas 

pipeline equipment would be prohibited until EPA made a finding that such uses do not 

"present a substantial endangem1ent to human health or the environment." Upon enactment 

of the bill and until such a finding is made, one could read the legislation as creating an 

immediate prohibition on the continued use of certain transmission and distribution 

equipment still in service in the United States. 

Our second concern is with the text inS. 847 directing that, upon ratification by the United 

States of the Stockholm Convention and other international conventions, the text of those 

conventions shall apply to the use and disposal of chemical substances in the United States, 

"notwithstanding any other provision of law." With respect to PCBs, this would mean that 

the PCB phase-out and disposal directives in the Stockholm Convention would supersede 

the existing federal PCB regulations, which would again throw into regulatory uncertainty 

the use of certain transmission and distribution equipment still in service in the United 

States. 

Based on preliminary discussions with Committee staff, we do not believe that the draflcrs 

of S. 84 7 intended for the legislation to produce the above complications for the federal PCB 

regulatory program. As this important legislation moves forward, we look forward to 

working with you towards a resolution of our concerns. 

ec: The Honorable Senator Lauten berg 

TRK:mh 
160 


24968.113

November 17,2011 

Dear Senator Lautenberg: 

We thank all who are making protection of God's children and God's Creation a priority by 

taking action to reform our nation's broken chemical policy. As people of faith from diverse 

traditions, we affirm that reforming current chemical policies is vital to protecting people and 

life on God's Earth. 

We have worked to educate people of faith about protecting our bodies as temples of the 

Holy Spirit. Thousands of Christians have signed our Christian Principles for a Healthy Body 

and Spirit, and many more interfaith friends have signed our Interfaith Statement on 

Chemical Policy Reform. 

For years, in our work with our member communions as well as state councils of churches, 

we have emphasized the importance of better understanding and attending to the needs of 

babies and children's health. Any good chemical policy law should have mechanisms to do 

this. 

We also take very seriously the Biblical mandate to care for the "least of these" (Matthew 

25). In the case of chemical policy reform, this means communities that are historically 

disproportionately exposed in chemical hotspots are cared for. It also means having better 

protections for workers who are exposed to toxic chemicals each day. Any effective chemical 

policy must ensure communities of color and low-income communities do not bear a 

disproportionate burden and that existing harm is mitigated. It should also offer means for 

proper protection for workers. 

We urge Congress to take immediate action to update our nation's chemical policy that will 

ensure the safety of both existing and new toxic chemicals so that we can protect vulnerable 

populations such as children, women, the elderly, communities of color, low-income 

communities, and workers, as well as God's Creation, from the negative health impacts of 

toxic chemicals. 

Sincerely, 

Cassandra Carmichael 

Director, Eco-Justice Programs of the National Council of Churches 
161 


24968.114

WRITTEN ST ATI:MENT OF THE 

NATIONAL PETROCHEMICAL & REFINERS ASSOCIATION (NPRA) 

AS SUBMITTED TO THE 

FULL AND SUBCOMMITTEE ON SUPERFUND, TOXICS AND ENVIRONMENTAL 

HEALTH 

Committee 011 Enviro11me11t am! P11blie Works 

United Senate 

For a Joint Hearing entitled, 

"Legislative Hearing on the Safe Chemicals Act" 

November l7, 21111 
162 


24968.115

NPRA, 

and Environmental Health joint 

balance evident 

Lurw''"' placed the 

supply 
163 


24968.116

hand over valuable American intellectual property to other manufacturing regions that are 

targeting innovative American companies. 

NPRA recommends a more targeted legislative approach to TSCA reform rather than a 

comprehensive rewrite approach. Stakeholders have identified specific challenges that EPA is 

not meeting and those should serve as the focus for statute updates. If a comprehensive rewrite 

ofTSCA happens instead, then the chances of meaningful reform in the near future would be 

minimized. NPRA is ready and willing to find solutions to TSCA implementation challenges, 

including targeted updates to legislation. In principle, NPRA supports the following and will 

continue to work with other stakeholders to find common ground: 

1. Legislative language should require EPA to conduct a tiered and targeted 

prioritization scheme, conceptually a sieve-based approach, which considers hazard 

and exposure throughout the process. The system employed by Canada under the 

Canadian Chemical Management Plan should serve as a model because it is the only 

system that has been proven to prioritize a large number of chemicals within a welldefined time period. Legislative language should reflect what was learned from the 

experience in Canada, especially with regard to realistic time frames. 

2. A new safety standard should be appropriate for industrial chemicals and not 

attempt to mimic standards used for pesticides, food contact materials or other 

substances that have a higher potential for ingestion-based exposures. There is 

nothing more important to NPRA's members than the safety of the products they 

produce. However, industrial chemicals that are not intended for food contact or as 

pesticide active ingredients should not be regulated in a manner that reflects those 

product uses. Industrial chemicals should meet a standard that considers hazard and the 

potential for exposure, and should be based on an existing standard that has a strong legal 

precedent. 

3. A safety assessment process should be tiered and targeted, and consider hazard and 

the potential for exposure throughout. The process should also have a voluntary onramp for a chemical user who wishes to have a particular product or ingredient 

assessed and is willing to shoulder the burden for meeting the safety standard. The 

safety assessment process should follow traditional hazard, exposure and risk assessment 

approaches, which are typically tiered and targeted. The process should begin at a 

screening level, using existing information and conservative models, using hazard 

information to determine the level of detail in an exposure assessment, and using the 

potential for exposure to drive information requirements on hazards. EPA should be 

required to develop a transparent and science-based safety assessment process, with 

thorough descriptions of each tier and the expected outcomes of each step in the process. 

4. EPA should be required to develop a system by which it can employ a transparent 

and science-based process for evaluating and weighing data and scientific studies. 

Current risk assessments at EPA lack transparency and stakeholders are often left 

wondering how EPA came to its conclusions in particular assessments. EPA has never 
164 


24968.117

devised a systematic, transparent, science-based approach to weight-of-the evidence, 

which is essential for appropriate chemical regulation. 

5. TSCA modernization should ensure the protection of American intellectual 

property. It is important that detailed information about American chemical products is 

not publicly available. Otherwise, it would greatly impair American innovation by 

enabling overseas competitors to easily discover the formulations and chemical 

compounds of American products through government databases. Overseas firms would 

then be able to manufacture these products, possibly at a lower price, and export them to 

the United States, placing American companies at a competitive disadvantage. Data 

could be shared with state and international governments so long as the appropriate 

security requirements are in place. 

6. Hazard, use and exposure information available to and used by EPA should be 

enhanced and driven in a tiered, targeted and risk-based manner. EPA needs certain 

information to ensure the protection of human health and the environment. The burden 

should be on industry to provide information to the agency. The information 

requirements should be appropriate to meet EPA's needs for assuring safety, with 

requirements for hazard information being driven by the potential for exposure (i.e., 

evidence that exposure will occur) and exposure information being driven by relevant 

hazard endpoints (i.e., exposure pathways that reflect the hazard information). In 

addition, the burden of information reporting should be shared along the manufacturing 

supply chain to maintain economic efficiencies and not overburden any particular sector. 

7. EPA should be held to reasonable schedules and time lines when developing the 

processes, guidance and other items called for in the revised statutory language. 

Historically. EPA has been slow or hesitant to develop transparent regulatory processes 

subject to public comment. In the past three years the number of public meetings on 

TSCA implementation has dwindled considerably. TSCA modernization should consider 

holding the agency to well-defined time lines for the development of items required by 

the statute. 

8. TSCA modernization should include preemption provisions to avoid a patchwork of 

different state Jaws that disrupt the flow of interstate commerce. Some stakeholders 

point to a lack of confidence in the current TSCA statute and EPA's reluctance to use 

certain authorities as key drivers tor state-level regulatory activity. Appropriate TSCA 

modernization should restore confidence in the federal chemicals management system, 

require EPA to use its authorities in an appropriate manner and make the perceived need 

for state action moot. 

Chemical control laws are not like other environmental laws, where the federal 

government sets a baseline for performance. Rather, chemical control laws directly affect 

the commercial activities associated with chemicals, which directly affects the interstate 

flow of goods. There is a strong legal history protecting interstate commerce and federal 

preemption of state chemical control laws is consistent with legal precedents that pertain 
165 


24968.118

to interstate commerce. Federal preemption of state regulations is a critical part of any 

TSCA modernization package. 

9. Congress should maintain the scope ofTSCA and not attempt to create a legal 

umbrella that addresses issues outside of chemicals in commerce. The U.S. has a 

multitude of laws that address environmental and other issues associated with chemicals. 

When modernizing TSCA, Congress should not attempt to resolve issues with other 

statutes- e.g., environmental justice, right-to-know, recycling, etc. 

10. TSCA modernization should maintain the risk and use based exemptions currently 

in TSCA regulations. These include existing exemptions for non-isolated intermediates, 

impurities, byproducts, and research & development substances. These exemptions were 

developed through careful deliberations by EPA with public input, and have worked well 

over the years to achieve practical implementation of the requirements while maintaining 

protection of human health and the environment. 

NPRA reiterates its support for rational modernization ofTSCA and commends Senators 

Lautenberg and Inhofe on their efforts to create a bipartisan discussion on a path forward. The 

discussion is still in the beginning phases and should be allowed to evolve in a manner that 

maximizes the potential of reaching middle ground. Because chemical control laws can directly 

impact the entire manufacturing supply chain, NPRA believes great care and deliberation are 

necessary. 

NPRA appreciates the opportunity to submit this statement for the record and is willing to work 

with the Committee to contribute to more detailed discussions on how to find a middle ground on 

TSCA reform. 
166 


24968.119

November 16, 2011 

The Honorable Barbara Boxer 

Chainnan 

Senate Committee on Environment and Public Works 

112 Hart Senate Office Building 

\Vashington. DC 20510 

The Honorable James Inhofe 

Senate on Environment and Public Works 

205 Russell Senate Ot11ce Building 

Washington, DC 20510 

Re: Full and Subcommittee on Superfund, and Environmental Health Joint 

Legislative Hearing on the Chemicals Act 

Dear Chairman Boxer and R;mking J\1emhcr lnhofe: 

On behalf of the members of the Society of Chemical Manufacturers and AHiliates 

(SOCMA), l would like to shm·e with 

week: S. 847, the Safe Chemicals Ad 

trade association representing the batch, custom and chemical industry. 

over 200 member most of which are small to me•diutm·siz,ed businesses with less than 

$!00 million in sales. Despite their our members make $60 billion 

on the U.S. economy and of 

largest exporters. 

discussions, in we over 

legislation. Our belief is those discussions made 

those aspects ofTSC A that most warrant improvement those 

rnade to work) in their current fOrm. As those discussions 

stakeholder TSCA needs to be modernized, and 

that modernization should occur. Because 

necessarily could not benefit from those discussions. lnsteaJ, it 

to the concerns-· and misconceptions -that have been associated 
167 


24968.120

!!!IIIII I 

with TSCA. Most of chemical 
168 


24968.121

• First HPV Test Rule months t!·om proposal to final 

• Second HPV Test Rule· 30 months from proposal to tina! 

• Third HPV Test Rule· 20 months from proposal to tina! 

tara 

that there was no organized 

to issue them. 

from non-consumer users, such enhanced 

implementation of it. 

will only be as uset\11 as EPA's 

received proper 

The Committee and Subcommittee can and should revise the Safe Chemicals Act in light 

of the recent stakeholder discussions. In so, it should be guided how the costs 

and associated with increased data 

in the chemical 

concern to date. Congress will to ensure 

have heard and flat-out false, statistics 

This misinformation not be the legislative driver that has been. More reliable 

information on industrial chemicals in commerce can be found 

as. We also 

A complete 
169 


24968.122

is not, and \vould stifle the innovation 

to promote. 

Sincerely, 

Lawrence Sloan 

President and CEO, 

Green Chemistry that we 

Senate Committee on Environment and Public Works 

sure you also 
170 


24968.123

Testimony of Dr. Paul A. Locke 

Associate Professor at John Hopkins Bloomberg School of Public Health, 

Department of Environmental Health Studies, Center for Alternatives to Animal Testing 

Submitted to The Senate Committee on Environment and Public-Works, 

Subcommittee on Superfund, Toxics and Environmental Health joint hearing entitled, 

"Legislative Hearing on the Safe Chemicals Act." 

Thursday, November 17, 2011 

10:00 AM EST 

EPW Hearing Room - 406 Dirksen 

Good morning Chairwoman Boxer, Chairman Lautenberg, Ranking Member Inhofe, and 

members of the committee. I am Dr. Paul Locke and I am an environmental health scientist and 

attorney. I am an associate professor at the Johns Hopkins University Bloomberg School of 

Public Health in the Department of Environmental Health Sciences, Division of Toxicology. I 

am also a member of the faculty of the Johns Hopkins' Center for Alternatives to Animal 

Testing. 

Introduction 

Passed in 1976 to correct the indiscriminate use of chemicals in the environment, the Toxic 

Substances Control Act (TSCA) is the principal US law governing industrial chemicals. 

However, over the past 35 years, it has become clear that a considerable toxicological 

information gap exists about chemicals in commerce. The current provisions of the TSCA law 

have failed to fill and perhaps have even exacerbated that gap. 

For the past several years, bills have been introduced in Congress to reauthorize TSCA. Filling 

the toxicological information gap has been one of the driving forces for this call for substantial 

change. 

I want to commend Senator Frank Lautenberg who has been a long-time advocate for TSCA 

reform and is the primary sponsor for "The Safe Chemicals Act of2012." As a public health 

professional, I recognize the importance of strengthening TSCA and improving toxicity testing 

of chemicals. This bill is a major step in that direction. The Safe Chemicals Act of 2011 is 

ambitious, and would amend TSCA by adding or changing over 34 sections, including adding 

new findings, policies, and goals; reforming provisions on disclosure of data; requiring minimum 

data sets; and incorporating green chemistry provisions. The bill would shift the burden of 

proving the safety of existing chemicals from EPA to industry. It would also require companies 

to develop and submit minimum data sets for chemicals; require EPA to prioritize chemicals 

based on risk; expedite risk reduction for high concern chemicals; provide greater public access 

to reliable chemical information; and promote innovation and green chemistry. 
171 


24968.124

Rather than a complete analysis of this proposed legislation, my testimony here is focused on the 

provisions of the bill that most directly impact toxicity testing or seek to fill the toxics 

information gap described earlier. In particular, I want to stress that unless the Safe Chemicals 

Act incorporates a replacement-first approach for toxicity testing, it cannot meet its critical goal 

of filling the toxics information gap. A replacement-first approach to testing is one that would 

utilize testing techniques such as computational toxicology and other in vitro methods to collect 

data ahead of traditional animal-based toxicity testing. These replacement tests, which have 

been evolving rapidly, are generally faster and more efficient than animal tests. I will focus on 

four key areas where a replacement-first approach would greatly aid in carrying out the proposed 

purposes of the bill. These key areas are: 

A. Adding findings, policies and goals, and a changed definition of toxicity 

B. Minimum data set requirements, especially tiered data 

C. Prioritization and classification of chemicals 

D. Specific requirements to reduce animal-based testing 

A. Added findings, policies and goals, and a changed definition of toxicity 

The current toxicology testing scheme for chemicals in commerce in the US has left much to be 

desired. This view was substantiated by an external review of EPA toxicity testing 

commissioned by the EPA and carried out by the US National Academy of Sciences (NAS), 

National Research Council (NRC). In 2007, the NAS/NRC published a report, Toxicity Testing 

in the 21st Century: A Vision and a Strategy (NRC, 2007). This report set out a new paradigm 

for how chemicals should be tested based on advances in toxicology. Over the next two decades, 

the NAS/NRC envisions the emergence of a system of toxicity testing that will utilize high 

throughput methodologies, human cell lines, and the study of the perturbation of pathways of 

toxicity that underlie the progression toward disease endpoints. It also envisions the 

abandonment of the current animal-intensive, low throughput, patchwork system in favor of a 

program that will be more predictive, cheaper, faster, and more scientifically robust. Federal 

agencies, including EPA, have embraced the NAS/NRC vision and strategy. 

Sections 3 and 4 of the Safe Chemicals Act of2011 address many of the existing problems with 

the current TSCA law. Taken together, these new provisions show explicitly that the Safe 

Chemicals Act of2011 was meant to take on the toxic ignorance problem that has been so 

clearly documented in scientific, policy, and legal literature. Specifically, section 4 of the Safe 

Chemicals Act of 20 II would amend section 3 of TSCA, by adding several new definitions and 

changing currently existing ones. This clause is very broad, and indicates that the bill intends for 

EPA to cast a wide net in assessing the potential harm that could result from chemical exposure. 

The comprehensive list of endpoints is followed by a final clause that seems targeted at the 

pathways and perturbations approach advocated by the NAS/NRC vision and strategy. 

Specifically, adoption of the pathways and perturbations concepts from the NAS/NRC report as 

part of this definition would improve and sharpen it. 

B. Minimum data set requirements, especially tiered data 
172 


24968.125

TSCA currently does not require testing of any compound, or set out a minimum data set. The 

Safe Chemicals Act of2011 would amend section 4 ofTSCA to add a specific requirement that 

EPA establish, by regulation, a minimum data set for chemical substances for which testing is 

required. The changes in this section would require that the minimum data set provide for varied 

(or tiered) data so that a screening-level risk assessment could be carried out. This amendment to 

TSCA specifically states that EPA must "encourage and facilitate the use of alternative testing 

methods and testing strategies to generate information quickly, at low cost, and without the use 

of animal-based testing, including toxicity pathway-based risk assessment, in vitro studies, 

systems biology, computational toxicology, bioinformatics, and high-throughput screening." 

Other changes to this section discuss testing methodologies, and specifically include "in-vitro 

tests" in the list of test methods that the EPA can demand. 

If the bill, as currently written, were enacted into law, these new provisions might be helpful in 

moving chemical testing in a replacement focused direction. However, a major weakness exists 

in these provisions and in the bill generally, which should be corrected. The bill merely states 

that EPA should "encourage and facilitate" replacement alternatives. This phrasing stops short of 

what is needed. To reach the goals of this new TSCA law, EPA should be required to develop 

and use alternatives in regulatory decision making. More specifically, the bill should require 

EPA to implement the NAS/NRC vision and strategy fully. (Later in the bill, another NAS/NRC 

report is specifically referenced, so adding an additional reference to the Toxicity Testing report 

would not be new or unprecedented.) The language in the bill focusing on disease endpoints 

would benefit from redrafting so that the pathways underlying the endpoints, instead of the 

endpoints themselves, were emphasized. 

C. Prioritization 

The Safe Chemicals Act of2011 would add a provision to TSCA section 6 focusing on 

prioritization and risk management (Safe Chemicals Act of201 I, section 7, amending TSCA 

section 6). Under this new section, EPA would be required to develop and publish a list of 

compounds divided into three priority classes. Priority class I would contain chemicals that EPA 

determines require immediate risk management. Priority class 2 would consist of chemicals that 

EPA determines require a safety standard determination. The third priority class would contain 

chemicals that require no immediate action. A US interagency committee would be established 

to make recommendations to EPA regarding prioritization. 

This new prioritization requirement is central to resolving one of the key problems of the current 

TSCA program, and directly confronts the toxics information gap. Replacement alternatives are 

well suited to the prioritization decisions that will be needed if this provision were to become 

law, for the same reasons that replacement alternatives are well suited to tiering and sorting. A 

successful prioritization program will require replacement alternatives, which can be deployed 

inexpensively, quickly, and in a high throughput format to aid in decision-making. 

Replacement alternatives will also be very useful for manufacturers, who bear the burden of 

providing information to EPA to carry out safety standard determinations on those compounds 

placed in category 2. EPA will thus need to be ready to accept these alternatives in evaluating 

chemical safety. This section of the bill could benefit from a specific provision or provisions that 
173 


24968.126

acknowledge the need for replacement alternatives in assuring success in prioritization, and also 

by adding a specific requirement that the interagency committee contain at least one member 

with expertise in replacement alternatives for toxicity testing. 

D. Specific requirements to reduce animal-based testing 

Section 30 of the Safe Chemicals Act of 2011 addresses the need to minimize the use of animals 

in testing chemical substances and mixtures. Section 30 is divided into four major subsections: 

The first subsection (subsection a) requires EPA to take action to minimize the use of animals in 

testing, including: encouraging and facilitating the use of existing data; reducing or replacing 

animal testing methodologies; grouping chemicals (if scientifically appropriate) so that the 

testing of one chemical substance can serve as a surrogate for decision-making about the group; 

forming industry consortia to avoid duplicative testing; submitting parallel data from animal and 

non-animal tests; and funding replacement-first research and validation studies. 

The second subsection (subsection b) establishes an interagency science board on alternative 

testing methods. This board will be composed of members of various federal agencies. Its 

purpose is to provide independent advice and peer review to Congress and EPA on the use of 

alternatives and the implementation of this section. This group must issue a report one year after 

it is formed that lists testing methods for reducing animal use. This report must be updated and 

reissued every three years. 

The third subsection (subsection c) requires EPA to consult with the interagency board 

established in section 30(b) to develop a strategic plan to improve the development and implementation of alternatives. The report is to be focused on test methods that can be used to carry 

out safety standard determinations. Every two years. EPA must submit to Congress a report that 

describes progress and discusses studies undertaken to implement this section. 

The fourth and last subsection (subsection d) contains provisions for adapting or waiving 

required animal-based testing at the request of a chemical manufacturer. To waive animal 

testing, it must be shown that the animal test is not applicable because the chemical substance 

does not have the property for which the animal test is given, the specific endpoint is not 

technically practical, or the chemical substance cannot be tested at a concentration that does not 

cause pain, distress, severe irritation, or corrosion. 

If enacted in its current form The Safe Chemicals Act of 2011 would be the first environmental 

law provision to explicitly include a section addressing the reduction of animal-based testing. For 

US law, it represents a changed approach to testing that, for the most part, is aligned with a 

replacement-first approach. To more effectively implement a replacement-first approach, 

however, this section should be changed so that EPA is required to do more than "encourage and 

facilitate" non-animal testing. It should require the development and use of non-animal tests and 

provide funding for EPA and other federal governmental agencies to strengthen their programs 

in computational and in vitro toxicology. In other words, the bill should contain "technologyforcing" provisions to chart a clear path to the use of non-animal toxicology as soon as the 

development of science allows. Also, the criteria contained in subsection d should be expanded 
174 


24968.127

so that replacement alternatives can be substituted for animal toxicity tests based on scientific 

rationales, such as validation, or a demonstration that a replacement test, or series of tests, is as, 

or more, predictive than the animal-based test. 

Conclusion 

From the perspective of protecting public health and creating an environment in which the best 

scientific testing is utilized, a replacement-first strategy is consistent with improving toxicity 

testing and reducing the toxics information gap. It also offers the best chance to achieve those 

goals. In particular, section 30 of this bill is an important and ground-breaking provision that 

acknowledges the desirability of reducing animal testing and using the toxicological tools of the 

twenty-first century for decision making. 

Still, the bill needs to be strengthened so that the move toward a replacement-first approach is 

clear. More assertive language is necessary to both (I) implement the vision and strategy of the 

NAS/NRC toxicity testing report, and (2) incorporate the replacement-first approach that the 

vision and strategy contains. Without these changes, it is not likely that TSCA reauthorization 

efforts will be able to fulfill one of their key goals- reducing the gap in toxicity information that 

has plagued public health decision-making for more than 30 years. 
175 


24968.131

TESTIMONY OF 

PHYSICIANS COMMITTEE FOR RESPONSIBLE MEDICINE 

BEFORE THE 

SENATE COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS 

AND 

SUBCOMMITTEE ON SUPERFUND, TOXICS, AND ENVIRONMENTAL HEALTH 

ON 

THE SAFE CHEMICALS ACT, S.847 

November 17, 2011 

SUBMITTED November 22, 2011 

Nancy Beck, PhD 

Physicians Committee for Responsible Medicine 

5100 Wisconsin Ave NW, Suite 400 

Washington, DC 20016 

nancybeck226@gmail.com 

Chad Sandusky, PhD 

Physicians Committee for Responsible Medicine 

5100 Wisconsin Ave NW, Suite 400 

Washington, DC 20016 

csandusky@pcrm.org 
176 


24968.132

The Physicians Committee for Responsible Medicine is a national non-profit group of over 

125,000 doctors and laypersons advocating for preventive medicine and ethical standards in 

research and testing. We appreciate the opportunity to submit written testimony for the record. 

We have provided legislative language aimed at ensuring that the legislation moves forward on 

the basis of the best available science. The use of cell-based, tissue-based and computational 

methods for chemical testing, rather than the use of animals, is critical to the legislation's ability 

to protect public health. Non-animal methods have the potential to provide more accurate and 

human-relevant inforn1ation, much more quickly and affordably. While the extensive use of 

animals for chemical testing is a significant concern, it is one that has been largely ignored in the 

discourse on this legislation. We believe the language suggested below will help decrease 

reliance on animal usc, and in turn, increase protection of public health. 

SUGGESTIONS FOR S. 847: 

SEC. 3. FINDINGS, POLICY, AND GOAL 

CHANGE: 

(b) POLICY. It is the policy of the United States that-

(6) to reduce the reliance on animal testing in hazard assessment; 

(61) to guarantee the right of the public and workers to know about the hazards and uses 

of chemical substances that the public and workers may be exposed to by maximizing public 

access to infonnation on chemical safety and use; and 

(+lD to strengthen cooperation between and among the Federal Government and State, 

municipal, tribal, and foreign governments 

JUSTIFICATION: This is a goal of many in and outside Congress and is linked hand-in-hand 

with the ability to collect new human-relevant hazard data on thousands of substances in a time(v 

manner. 

SEC. 5. MINIMUM DATA SETS AND TESTING OF CHEMICAL SUBSTANCES 

CHANGE: 

'(d) Exemptions.-

'(2) Action by administrator. In accordance with paragraph (3) or (4), the Administrator shall 

exempt an applicant under paragraph (I), if, on receipt of the application, the Administrator 

determines that-

'(A) the chemical substance for which the application was submitted is equivalent to a 

chemical substance for which-

'(i) data has been submitted to the Administrator in accordance with a rule or order under 

subsection (a) or (b); or 
177 


24968.133

'(ii) data is being developed in accordance with the rule or order; QI 

'(iii) data is being developed in accordance with another regulatory purpose; and 

'(B) submission of data by the applicant for the substance would be duplicative of data that-

'(i) has been submitted to the Administrator in accordance with the rule or order under 

subsection (a) or (b); or 

'(ii) is being developed in accordance with the rule or order; or 

'(iii) is being developed in accordance with another regulatory purpose. 

JUSTIFICATION: All data, including that developed for other regulatory agencies, countries, or 

purposes out~ ide of this Act, should be brought to bear to prevent duplicative testing. 

SEC. 6. MANUFACTURING AND PROCESSING NOTICES. 

CHANGE: 

'(a) New Chemical Substances and New Uses of Chemical Substances.-

'(3) New uses of existing chemical substances that meet the safety standard.-

'(A) In general. For an existing chemical substance for which the Administrator has 

determined under section 6(b) that the manufacturers and processors of the chemical substance 

have established that the substance meets the applicable safety standard, no person may 

manufacture or process the chemical substance for uses, at production volumes, or in manners 

other than those the Administrator specified in the safety standard determination, unlcss-

'(i) the manufacturer or processor submits to the Administrator-

'(!) a notice of the intention of the manufacturer or processor to manufacture or process the 

substance for a new use, at a new production volume, or in such other manner as is inconsistent 

with a specified condition or term for that substance; and 

'(II) all any necessary updates to the minimum data set as determined by the Administrator 

relevimt-te-t~e, or other new manner ofmanufac~ 

processing; 

.JUSTIFICATION: This language makes it more likely that companies will enter into a 

conversation with the Agency about what new testing might be required, instead of assuming some 

tests must be done when, depending on the new use or production volume, this may not be the 

case. The goal is to avoid "one-sizejits-all" data collection. 

CHANGE: 

'(b) Submission of Data.-

'(I) In general. A person shall submit to the Administrator data in accordance with the rule or 

order at the time that notice is submitted under subsection (a), except as provided under 

subsection (b)(2), if the person is required to submit to the Administrator-

'( A) under subsection (a), a notice prior to beginning the manufacture or processing of a 

chemical substance; and 

'(B) under section 4(b ), test data for the chemical substance prior to the submission of the 
178 


24968.134

notice. 

'(2) Exceptions to minimum data set.-

'(A) A person may, upon application, request exception from specific requirements of the 

minimum data set described in section 4(a), either before or concurrent y.rjth submission of notice 

under subsection (a). 

'(B) The administrator shall determine whether such cxception(s) will be granted within 30 

days of receipt of application, and make such this determination in accordance with section 

30(b)(l) and section 3Q{U 

_'.ill Availability. Subject to section 14, the Administrator shall make any test data submitted 

under paragraph (I) available on a publicly accessible Internet site. 

JUSTIFICATION: This absolutely crucial change clarifies that Congress's intent is to avoid 

"one-size~fits-al/" testing schemes in the new substances sector, just as is providedfor in this Act 

for existing substances. It allows companies to applyfor testing exceptions if there L1· reason to 

believe certain test are unnecessary for any relevant reason, such as existing data alreac(v in the 

EPA's possession, characteristics of the new substance, or information about related substances. 

As the Act is written now, companies must submit, animal- and resource-intensive toxici(v data at 

the same time as thev notify the EPA of their intent to manufacture the substance, prompting 

companies to conduct potential!)lllllwarranted testing. This language creates an opportuni(V.for 

dialog between the company and the EPA regarding the generation of data. At the same time it 

provides quick turnaround.for both the agency and the company, and allows some .f/exibili(V to 

companies who wish to bring newer, potential!v safer, chemicals to market but are concerned 

about the upfront costs of traditional toxicity data generation. 

CHANGE: 

'(c) Content and Availability of Notice.-

'(!)Content. Notice under subsection (a)(!) shall include-

'(A) the declaration described in section 8(a)(2); 

'(B) the minimum data set described in section 4(a) and considering subsection (b)(2): and 

'(C) a statement that the chemical substance will meet the applicable safety standard. 

JUSTIFICATION: Referring to changes in 6(b}. 

CHANGE: 

'(d) Exemptions.-

'(2) Equivalent Similar chemical substances.-

'(A) In general. The Administrator shall, upon application, fully or partially exempt any 

person from the requirement to submit data under subsection (a) if, on receipt of an application, 

the Administrator determines that-

'(i) the chemical substance for which the application was submitted is eqlli-valentstructurally 

or toxicologically similar to a chemical substance for which data has been submitted to the 
179 


24968.135

Administrator as required by this Act; and 

'(ii) submission of data by the applicant on the chemical substance would be duplicative of 

data which has been submitted to the Administrator in accordance with this Act. 

JUSTIFICATION: Scientific support can be provided to show that two or more structurally or 

toxicological(v very similar, but slightly different (i.e., not equivalent) substances have very 

similar toxicological properties, making testing of such substances duplicative. 

SEC. 30. REDUCTION OF ANIMAL-BASED TESTING. 

CHANGE: 

'(a) In general. Tests on animals shall not be performed if another scientifically satisfactory 

method of obtaining the infonnation sought, not entailing the use of an animal, is reasonably and 

practicably available. Testing on animals for the purpose of this Act shall be undertaken only as 

a last resort when all other data sources have been exhausted. Where adequate animal test data 

exist for a toxicological or ecotoxicological endpoint, further animal testing for the same 

endpoint shall not be required. 

JUSTIFICATION: Such a requirement is the best incentive to develop and use non-animal 

methods, which is crucial for ethical, scientific, and practical reasons alike. This language is 

similar to that enacted in other chemicals legislation worldwide (such as REACH in the European 

Union), and will help implement the National Academies' vision for "Toxicity Testing in the 2 F' 

Century", which envisions faster, cheaper, and more human relevant tests instead of current(v 

relied-upon animal tests. More focused, strategic testing and the generation a_{ more humanrelevant data will also save EPA resources. 

CHANGE: 

'(£:b) Interagency Science Advisory Board on Alternative Testing Methods.-

'(!) Establishment. Not later than 90 days after the date of enactment of the Safe Chemicals 

Act of 20 II, the Administrator shall establish an advisory board to be known as the 'Interagency 

Science Advisory Board on Alternative Testing Methods' (referred to in this subsection and 

subsection (de) as the ' Board'). 

'(2) Composition. The Administrator shall-

'(A) appoint the members of the Board, including, at a minimum, representatives of-

'(i) the National Institute of Environmental Health Sciences; 

'(ii) the Centers for Disease Control and Prevention; 

'(iii) the National Toxicology Program; 

'(iv) the National Cancer Institute; flfld 

'(v) the National EPA-Tribal Science Council; and 

'(vi) not fewer than 3 non-agency members with expertise in alternative testing methods; and 
180 


24968.136

'(B) ensure that at least 'h of the members of the Board have specific scientific or practical 

expertise in the development or implementation of test methods that replace or reduce animalbased testing; and 

'(~B) ensure that no individual appointed to serve on the Board has a conflict of interest that is 

relevant to the functions to be performed, unless-

'(i) the individual promptly and publicly discloses the conflict; and 

'(ii) the Administrator determines that the conflict is unavoidable. 

JUSTIFICATION: The public sector contains individuals with years of e>:pertise in the 

development and use of non-animal methods and alternatives to animal tests, and it is essential 

that the EPA consult this expertise in addition to federal agency representatives 

CHANGE: 

'(5) Report. Not later than I year after the date of enactment of the Safe Chemicals Act of 

2011, and every _fJ years thereafter, the Administrator, in consultation with the Board, shall 

publish in the Federal Register a list of testing methods that reduce the use of animals in testing 

under section 4. 

JUSTIFICATION: The.fast-developing scientific fields related to the development of non-animal 

toxicity testv require updates of a list of accepted testing methods more ji·equently than every 3 

years. 

CHANGE: 

'(Qe) Implementation of Alternative Testing Methods. To promote the development and timely 

incorporation of new testing methods that are not animal-based, the Administrator shall-

'( I) in consultation with the Board, and after providing an opportunity for public comment, 

develop a strategic plan to promote the development and implementation of alternative test 

methods and testing strategies to generate information used for safety standard determinations 

under section 6(b) that do not use animals, including toxicity pathway-based risk assessment, in 

vitro studies, systems biology, computational toxicology, bioinformatics, and high-throughput 

screening; 

'(2) beginning on the date that is 2 years after the date of enactment of the Safe Chemicals Act 

of 2011 and every 2 years thereafter, submit to Congress a report that describes the progress 

made in implementing this section; l!fld 

'(3) fund and carry out research, development, performance assessment, and translational 

studies to accelerate the development of test methods and testing strategies that arc not animalbased for use in safety standard determinations under section 6(b ); and 

'(4) after an opportunity for public comment, establish policies within the administration of 

this Act that create incentives for the development of alternative test methods and the use of such 

methods, testing strategies, and other measures to reduce animal-based testing as described in 

this section. 
181 


24968.137

JUSTIFICATION: Market and other incentives to develop and use non-animal toxicity tests, and 

the increased uptake of those tests, will save company and EPA resources, protect human health 

by allowing the collection of data more quickly, and accomplish ethical societal goals. 

SEC. 32. COOPERATION WITH INTERNATIONAL EFFORTS. 

CHANGE: 

(a) 'In cooperation with the Secretary of State and the head of any other appropriate Federal 

agency (as detem1ined by the Administrator), the Administrator shall cooperate with 

international efforts as appropriate-

'( I) to develop a common protocol or electronic database relating to chemical snbstances; or 

'(2) to develop safer alternatives for chemical substances; or 

'(3) to harmonize testing methods and procedures. 

JUSTIFICATION: International cooperation to harmonize testing methods and procedures saves 

businesses and governments millions ofdollars and saves thousands of animals by preventing 

duplicative testing. Cooperating with other regulatory agencies' efforts to replace animal tests 

also saves research resources and encourages scientific progress. 
182 


24968.138

Statement for the Record 

Submitted by S. C. Johnson & Son, Inc. 

Legislative Hearing on the Safe Chemicals Act of 2011 

Senate Committee on Environment and Public Works 

November 17, 2011 

S. C. Johnson & Son, Inc. (SC Johnson) is pleased to submit these comments for the record 

following the November 17, 2011, legislative hearing on the Safe Chemicals Act of 2011 held 

jointly by the Committee on Environment and Public Works and the Subcommittee on 

Superfund, Toxics, and Environmental Health. SC Johnson appreciated the opportunity and 

invitation by Subcommittee Chairman Senator Frank Lautenberg (D-NJ) to testify before the 

Subcommittee in February of this year in support of modernizing the current Toxic Substances 

Control Act (TSCA), and respectfully submits these comments to convey our continued support 

for updating the 35-year old statute and to reiterate what we believe are the essential "building 

blocks" of effective TSCA modernization. 

SC Johnson has been a family-owned and managed business for 125 years. Fisk Johnson, the 

family's fifth generation Chairman and CEO, is dedicated to delivering innovative, high-quality 

products to consumers, excellence in the workplace, and a long-term commitment to the 

environment and the global communities in which we operate. Based in Racine, Wisconsin, 

where it was originally founded, SC Johnson is one of the world's leading manufacturers of 

household cleaning, home storage, air care, shoe care, and insect control products. We market 

well-known leading brands such as GLADE®, OFF!®, PLEDGE®, RAID®, SCRUBBING 

BUBBLES®, SHOUT®, WINDEX®, ZIPLOC®, and KIWI® in the U.S. and beyond, and among 

the brands we market outside the U.S. are AUT AN®, BAYGON®, and MR. MUSCLE®. We 

employ approximately 12,000 people globally and operate in virtually all countries around the 

world. You can learn more about SC Johnson by visiting our public website at 

www.scjohnson.com. 

SC Johnson wishes to acknowledge and thank Senator Lautenberg and his staff for their 

willingness to reach out to and engage numerous stakeholders involved in the TSCA 

modernization debate, including our company, trade associations representing the downstream 

formulator industry of which we are an active member (e.g., CSPA, ACI and GMA), and the 

leading non-governmental organizations (NGOs) that have long supported updating U.S. 

chemical management policies, most notably the Environmental Defense Fund and the Safer 

Chemicals, Healthy Families Coalition. Directly and through CSPA, SC Johnson has actively 

participated in an informative dialogue with these NGOs on specific aspects of the Safe 

Chemicals Act of 2011 -a process that not only has helped the parties to better understand 

each other's perspectives on key TSCA modernization topics, but also to identify areas of 

potential consensus that could form the basis of meaningful and successful legislation. 

We also wish to commend both Senator Lautenberg and Ranking Member Senator James 

lnhofe (R-OK) for initiating a series of substantive stakeholder meetings this past summer in 

which many of these organizations were invited to share their perspectives on key elements of 

the Safe Chemicals Act of 2011 and to discuss potential solutions. We believe this kind of 

open, honest dialogue is essential to developing sound public policy and represents a 

commitment by well-intentioned legislators to understand differing viewpoints on TSCA 

modernization and to work through the challenging issues and policy questions, so as to 

ultimately arrive at a workable and effective legislative end-product. We trust the Committee's 

leadership will seek to continue this productive dialogue as the debate further evolves. 
183 


24968.139

As we testified at the Subcommittee's February 2011 hearing, SC Johnson strongly supports 

modernization of TSCA and is committed to playing a constructive role in helping to develop 

workable changes to the current statute. As a consumer-facing company, maintaining a high 

level of consumer confidence in the safety and performance of each one of our products is a 

responsibility we take quite seriously. We believe updating TSCA for the 21'' Century will, in 

part, help improve consumers' confidence in the products they purchase for their homes and 

families. While we still consider TSCA to be primarily a chemical-based vs. a product-based 

statute, we believe TSCA can be responsibly updated to achieve three very important goals: (1) 

enhancing consumer confidence in the safety and performance of consumer products; (2) 

achieving consistent chemical management policy across the 50 states; and (3) keeping pace 

with global chemical regulatory developments. To that end, there are a few essential principles 

for TSCA modernization that we will continue to advocate, which are described in more detail in 

our February 2011 testimony: 

Balanced transparency: SC Johnson strongly supports transparency in the U.S. chemical 

management program in a way that balances our genuine desire to inform, and thus 

empower our consumers, with the need to protect legitimate CBI, which helps ensure 

continued innovation and success in the competitive marketplace. 

Informing a risk-based system: We urge EPA to work with chemical manufacturers and 

downstream product formulators to ensure that the Agency has sufficient information on 

chemical hazards, exposures, and uses, including uses in children's products. By 

committing to provide such exposure and use information, formulators like SC Johnson are 

agreeing to a new reporting obligation, but one we believe is necessary to properly inform a 

risk-based safety evaluation process. 

Promoting greener chemistries: Any TSCA modernization effort should promote the 

transition to more sustainable alternatives, and not hinder manufacturers' ability to formulate 

out of one ingredient and into another with a more beneficial environmental and human 

health profile. 

Industry needs sufficient time to respond to new regulatory requirements: It is vitally 

important for policymakers to ensure that the chemical industry throughout the "value chain" 

has sufficient time to transform itself and implement the technological and scientific tools 

needed to accomplish the mission of a modernized TSCA. 

Promoting innovation: Any changes to current TSCA should promote sustainable innovation 

by chemical manufacturers and their customers by emphasizing simplicity, flexibility, and 

protection of intellectual property. 

Further, SC Johnson believes meaningful TSCA modernization must also embrace the following 

principles: 

Establish a risk-based prioritization process: We believe an effective priority-setting process 

must be risk-based, taking into consideration a chemical's hazard characteristics and all 

relevant exposure pathways. Prioritization is essential for EPA to focus on the most critical 

chemicals first, and will in turn bolster public confidence that chemicals of highest concern 

are being addressed first. Neither our resources nor EPA's are limitless. Prioritization will 

help ensure we proceed in an economically responsible manner. 
184 

Æ 


24968.140

Update the safety standard: EPA should establish a risk-based methodology to determine 

whether a priority chemical is reasonably expected to be safe for its intended use. This will 

entail the use of exposure data in conjunction with hazard data to make risk-based 

determinations. Safety determinations should consider the likelihood and potential exposure 

to the intended population, including children and other sensitive sub-populations, as well as 

the anticipated benefits from use of a chemical and the availability of suitable alternatives. 

Leverage and integrate chemical reviews: Policymakers should leverage chemical 

management programs and reviews undertaken by other nations and integrate the 

patchwork of national laws governing chemical management, when it makes sense to do so. 

This includes accepting valid data generated to meet another country's requirements, so as 

to minimize duplication of animal-based testing. 

Use the best available science: It is essential for policymakers and regulators alike to rely on 

the best available, scientifically valid data and information, employing well-documented 

methodologies and meeting reasonable quality control standards, regardless of its source, 

and to discourage the kind of hype and misleading information that we have seen in recent 

years. 

We believe the incorporation of these principles will lead to legislation that will effectively 

modernize and strengthen current TSCA, and thereby enable consumers to use chemicallyformulated products with confidence that they are safe for the environment and their families. 

SC Johnson pledges to keep working with Chairman Lautenberg, Ranking Member lnhofe and 

other Committee members to develop a TSCA modernization proposal that reflects the abovementioned principles and results in an effective, confidence-inspiring, and workable U.S. 

chemical management system. 

SC Johnson appreciates having the opportunity to provide these comments for the hearing 

record.