ACC doubles down on its revisionist history of the Lautenberg Act’s reforms to new chemical reviews under TSCA

Richard Denison, Ph.D.is a Lead Senior Scientist.

Last August, Scott Pruitt announced that the Environmental Protection Agency (EPA) would reverse course in its conduct of risk reviews of new chemicals under the reforms made in 2016 to the Toxic Substances Control Act (TSCA) by the Lautenberg Act.  The changes will effectively return the program to its pre-Lautenberg state – under which few chemicals were subject to any conditions and even fewer to any testing requirements – or make it even weaker.

In December, despite indicating it had already made the changes Pruitt had previewed, EPA held a public meeting and accepted public comments on the changes.  EDF filed extensive written comments, as did many other stakeholders.

Undeterred by the facts, ACC persists in its wishful thinking that the law’s provisions on new chemicals are meant to maintain the status quo and that this is what stakeholders wanted.

Among them was, of course, the American Chemistry Council (ACC).  While I won’t describe those comments at any length here, ACC’s primary thesis was that the Lautenberg Act made no significant changes to the new chemicals provisions of TSCA, and that this was in keeping with the wishes of Congress and an acknowledgment that the program has always worked just fine.

If this thesis sounds familiar, it should:  ACC has basically echoed this talking point ever since the Lautenberg Act was signed into law nearly 20 months ago.  In seeking to support its case, one of the most outlandish of ACC’s arguments is this one:  ACC asserts that it was the TSCA reform bill passed by the House of Representatives in June 2015 that “led to” the final bill that became the new law, and that because the 2015 House bill made no changes at all to the new chemicals section of TSCA, that is evidence that this was what Congress intended.

In fact, at least with respect to new chemicals, it was the Senate bill – which made extensive changes to the new chemicals section of TSCA – that was reflected in the final bill that became law.  Indeed, Congress expressly rejected the House bill’s decision not to touch these provisions, by instead adopting virtually all of the changes made to these provisions by the Senate bill.

Nonetheless, undeterred by these facts, ACC persists in its wishful thinking that the law’s provisions on new chemicals are meant to maintain the status quo and that this is what stakeholders wanted.

This new round of public comments on the law’s effect on new chemical reviews under TSCA played out almost exactly a year after the first round in December 2016-January 2017.  In that earlier round, ACC also insisted that Congress intended no significant change to those reviews.  In response, EDF included in our comments 23 pages of statements from both members of Congress and stakeholders. The statements demonstrate both that the law was intended to and did make major changes to new chemical reviews under TSCA, and that many stakeholders had emphasized the need for those changes.

Given ACC’s continued state of denial and perpetuation of its revisionist history of this issue, I feel compelled to include the content of those 23 pages here.  Here you go:  

Appendix A is a sampling of excerpts from various factsheets and statements, from members of both the majority and minority, which indicate that the changes to the new chemicals provisions of TSCA were among the most significant reforms of the Lautenberg Act.

Appendix B provides witness statements from House and Senate hearings records from the 113th and 114th Congresses.  These statements, made by a wide array of stakeholders – from health organizations, labor, environmental groups, and state governments, as well as then-current senior EPA management – identified concerns with the old new chemicals program or embraced the reforms in the new law.

Notably, this includes a statement from ACC’s own CEO and President Cal Dooley lauding the Senate bill’s new chemicals provisions (which were virtually entirely adopted in the new law) as significant and necessary to restore public confidence.

Appendix A:
Quotations from Members of Congress and the President
on TSCA’s New Chemicals Provisions

  1. From the S. Senate Environment and Public Works Committee majority document: REFORMING THE TOXIC SUBSTANCES CONTROL ACT, Q&A

 "How will TSCA reform strengthen oversight of chemicals used in millions of everyday products? …

  • Ensuring EPA makes an affirmative finding of safety of new chemicals before they come to market."

http://www.epw.senate.gov/public/_cache/files/aa2ac4d1-15bb-4e71-9588-909d49bdcff2/tsca-reform-marketing-packet-5.19-final.pdf [page 4]

  1. From the website of Senator Tom Udall (D-NM) on the Frank R. Lautenberg Chemicals Safety for the 21st Century Act:

“We're exposed to hundreds of chemicals in our daily lives. Nearly 1,000 chemicals go on the market each year. But only a handful had ever been reviewed for safety — out of the more than 85,000 in commerce. As a result, we didn’t know the full impact of these chemicals on our health . . . .

The new law: …

  • Requires the EPA to review and approve the about 1,000 new chemicals that come on the market each year;”

http://www.tomudall.senate.gov/chemicalsafety/

The following are in chronological order:

  1. From a March 10, 2015 press release from Senator Shelly Moore Capito (R-WV) upon her cosponsorship of the Frank R. Lautenberg Chemical Safety for the 21st Century Act:

“The new Udall-Vitter bill builds on and strengthens the 2013 proposal by . . . mandating that new chemicals cannot be manufactured until the EPA has approved them.”

From the release that describes the legislation:

“Mandates safety reviews for new and existing chemicals . . .

  • Requires a safety finding for new chemicals before they can enter the market.”

https://www.capito.senate.gov/news/press-releases/capito-co-sponsors-frank-r-lautenberg-chemical-safety-for-the-21st-century-act

  1. From a March 10, 2015 press release from Senator Tom Udall (D-NM) upon introduction of the Frank R. Lautenberg Chemical Safety for the 21st Century Act.

“The new Udall-Vitter bill builds on and strengthens the 2013 proposal by . . . mandating that new chemicals cannot be manufactured until the EPA has approved them. . . .

Core provisions of the Frank R. Lautenberg Chemical Safety for the 21st Century Act: . . .
Mandates safety reviews for new and existing chemicals . . .

  • Requires a safety finding for new chemicals before they can enter the market.”

http://www.tomudall.senate.gov/?p=press_release&id=1880

  1. From a March 10, 2015 press release from Senator David Vitter (R-LA) upon introduction of the Frank R. Lautenberg Chemical Safety for the 21st Century Act:

“Core provisions of the Frank R. Lautenberg Chemical Safety for the 21st Century Act: . . .

Mandates safety reviews for new and existing chemicals . . .

  • Requires a safety finding for new chemicals before they can enter the market.”

https://www.vitter.senate.gov/newsroom/press/vitter-udall-introduce-landmark-legislation-to-protect-our-families-from-toxic-chemicals [Link appears to have been removed upon Sen. Vitter’s departure from the Senate]

  1. From the December 18, 2015, statement on the Senate floor by Senator Tom Udall (D-NM) upon Senate passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, CONGRESSIONAL RECORD—SENATE S8872, December 18, 2015:

“. . . In 2009 the Obama administration laid out six essential principles for TSCA reform. The bill we passed last night meets all six of those principles, and I will go through each one individually. . . .

Principle No. 2, manufacturers should provide EPA with the necessary information to conclude that new and existing chemicals are safe and do not endanger public health or the environment.

Our bill gives EPA new authorities to develop testing data and requires a finding of safety before new chemicals—as many as 1,500 a year—enter the market. The finding on safety needs to be done not like it is done today but before they enter the marketplace.”

https://www.congress.gov/congressional-record/2015/12/18/senate-section/article/s8872-2?q=%7B%22search%22%3A%5B%22Udall+Lautenberg%22%5D%7D&r=5

  1. From remarks made by Senator Tom Udall (D-NM) at a December 22, 2015, bipartisan press conference following Senate passage of the Frank R. Lautenberg Chemicals Safety for the 21st Century Act:

“As many as 1,500 new chemicals come on the market each year, but there is no cop on the beat making sure they're safe for consumers or our environment. This bill will require the EPA to test all of them, make sure they’re safe and put the focus where it ought to be — on how these chemicals affect the most vulnerable in New Mexico and across the country.”

https://www.booker.senate.gov/?p=press_release&id=350

  1. From a May 20, 2016 EPW Committee majority press release announcing a bipartisan, bicameral deal on TSCA reform with quotes from Members involved in the agreement – a quote from Senator Tom Udall (D-NM):

"The new law will protect the most vulnerable, ensure EPA is testing all new chemicals and has the authority to take action if chemicals are unsafe. . .”

http://www.epw.senate.gov/public/index.cfm/2016/5/bicameral-bipartisan-deal-reached-on-tsca-reform

  1. From a May 24, 2016 House floor statement by Representative Gene Green (D–TX 29th) upon House passage of the TSCA Modernization Act, CONGRESSIONAL RECORD—HOUSE H3028-H3029, May 24, 2016:

“This bipartisan, bicameral legislation will reform our broken chemical safety law for the first time since 1976, and directly addresses TSCA’s fundamental flaws. . . The most notable improvements in the bill are . . . requiring a safety finding before new chemicals are allowed to go to market. . .”

https://www.congress.gov/crec/2016/05/24/CREC-2016-05-24-pt1-PgH2989-2.pdf [page 40]

  1. From a May 24, 2016 House floor statement by Representative Frank Pallone (D-NJ 6th) upon House passage of the TSCA Modernization Act, CONGRESSIONAL RECORD—HOUSE H3026, May 24, 2016:

“Mr. Speaker, the bill before us today is a step forward in reaching this important goal. Let me briefly describe some of the improvements. . . It will ensure that new chemicals are reviewed and regulated, if necessary, before they go on the market . . .”

https://www.congress.gov/crec/2016/05/24/CREC-2016-05-24-pt1-PgH2989-2.pdf [page 38]

  1. From a June 7, 2016 statement on the Senate floor by Senator David Vitter (R-LA) upon passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, 2016 CONGRESSIONAL RECORD—SENATE S3513, June 7:

“Very soon, the EPA will be required to determine that all chemicals are safe before they go to the market.”

https://www.congress.gov/crec/2016/06/07/CREC-2016-06-07-pt1-PgS3511.pdf [page 3]

  1. From a June 7, 2016 statement on the Senate floor by Senator Jeff Merkley (D-OR) upon passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, 2016 CONGRESSIONAL RECORD—SENATE S3515, June 7, 2016:

“The Frank R. Lautenberg Chemical Safety for the 21st Century Act will tremendously improve how we regulate toxic chemicals in the United States — those that are already in products and should no longer be used and those new chemicals that are invented that should be thoroughly examined before they end up in products — and make sure that toxic chemicals don't find their way into our classrooms, into our bedrooms, into our homes, into our workplaces.”

https://www.congress.gov/crec/2016/06/07/CREC-2016-06-07-pt1-PgS3511.pdf [page 3]

  1. From a June 7, 2016 Senate floor statement by Senator Tom Udall (D-NM) upon final passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, CONGRESSIONAL RECORD—SENATE S3513, June 7, 2016:

“Today, the old TSCA allows new chemicals to go to market without any real review, an average of 750 a year. Very soon, the EPA will be required to determine that all chemicals are safe before they go to the market.”

https://www.congress.gov/crec/2016/06/07/CREC-2016-06-07-pt1-PgS3511.pdf [page 3]

  1. From a June 7, 2016 statement for the record by Senator Barbara Boxer (D-CA), Senator Edward J. Markey (D-MA), Senator Tom Udall (D-NM), and Senator Jeffrey A. Merkley (D-OR), CONGRESSIONAL RECORD—SENATE S3516, June 7, 2016:

“As the lead Senate Democratic negotiators on H.R. 2576, (hereinafter referred to as the Frank R. Lautenberg Chemical Safety for the 21st Century Act), we submit the following additional views that describe the intent of the negotiators on elements of the final bill text. . .

  1. New Chemicals

While existing TSCA does not preclude EPA from reviewing new chemicals and significant new uses following notification by the manufacturer or processor, it does not require EPA to do so or to reach conclusions on the potential risks of all such chemicals before they enter the marketplace. EPA has authority to issue orders blocking or limiting production or other activities if it finds that available information is inadequate and the chemical may present an unreasonable risk, but the burden is on EPA to invoke this authority; if it fails to do so within the 90-180 day review period, manufacture of the new chemical can automatically commence. This bill makes significant changes to this passive approach under current law: For the first time, EPA will be required to review all new chemicals and significant new uses and make an affirmative finding regarding the chemical's or significant new use's potential risks as a condition for commencement of manufacture for commercial purposes and, in the absence of a finding that the chemical or significant new use is not likely to present an unreasonable risk, manufacture will not be allowed to occur. If EPA finds that it lacks sufficient information to evaluate the chemical's or significant new use's risks or that the chemical or significant new use does or may present an unreasonable risk, it is obligated to issue an order or rule that precludes market entry or imposes conditions sufficient to prevent an unreasonable risk. EPA can also require additional testing. Only chemicals and significant new uses that EPA finds are not likely to present an unreasonable risk can enter production without restriction. This affirmative approach to better ensuring the safety of new chemicals entering the market is essential to restoring the public's confidence in our chemical safety system.”

https://www.congress.gov/crec/2016/06/07/CREC-2016-06-07-pt1-PgS3511.pdf [page 6]

  1. From a June 7, 2016 statement on the Senate floor by Senator Patrick Leahy (D-VT) upon passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, CONGRESSIONAL RECORD—SENATE S3535, June 7, 2016:

“. . . the Lautenberg act gives the EPA enhanced authority to require testing of both new and existing chemicals, requiring safety reviews for all chemicals in active commerce and a safety finding for new chemicals before they are allowed on the market.”

https://www.congress.gov/crec/2016/06/07/CREC-2016-06-07-pt1-PgS3534-3.pdf [page 1]

  1. From a June 8, 2016 press release from Senator Corey Booker (D-NJ) upon final passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act:

“I am proud of the long-overdue improvements I fought to include in this bill, including provisions that    . . .  give more scrutiny to new chemicals before they come on the market. . .”

https://www.booker.senate.gov/?p=press_release&id=433

  1. From a June 22, 2016 press release from Senator Sheldon Whitehouse (D-RI) upon the signing of the Frank R. Lautenberg Chemical Safety for the 21st Century Act:

“The Lautenberg Act mandates review of all chemicals currently in commerce and requires review of new chemicals before allowing them into the marketplace.  . . . ‘The bill the President signed today is an historic step forward for public health and our environment,’ said Whitehouse. ‘For the first time, Americans will know that the chemicals they encounter in everyday products are reviewed for their safety.’ ”

https://www.whitehouse.senate.gov/news/release/whitehouse-attends-signing-of-the-frank-r-lautenberg-chemical-safety-for-the-21st-century-act

  1. From a June 22, 2016 statement of President Barack Obama at the signing ceremony for the Frank R. Lautenberg Chemical Safety for the 21st Century Act:

“The Frank R. Lautenberg Chemical Safety Act for the 21st Century will make it easier for the EPA to review chemicals already on the market, as well as the new chemicals our scientists and our businesses design.”

https://www.whitehouse.gov/the-press-office/2016/06/22/remarks-president-bill-signing-frank-r-lautenberg-chemical-safety-2st

Appendix B:
EPA and Stakeholder Testimony on TSCA’s New Chemicals Provisions
at TSCA Hearings in the 113th and 114th Congresses

I. U.S. House of Representatives (in reverse chronological order)

April 29, 2014 Tuesday

CHEMICALS IN COMMERCE ACT;

COMMITTEE: HOUSE ENERGY AND COMMERCE;

SUBCOMMITTEE: ENVIRONMENT AND THE ECONOMY

Statement of James Jones Assistant Administrator Office of Chemical Safety and Pollution Prevention U.S. Environmental Protection Agency (EPA)

The new chemicals provisions in Section 5 of the current discussion draft also do not align with the principles, in that they do not require that the EPA conclude that new chemicals are safe and do not endanger public health or the environment, elements of Principle 2 and another keystone of a credible chemical safety program. In addition, the risk management authorities for new chemicals in the current discussion draft are weaker than those in TSCA.

http://docs.house.gov/meetings/IF/IF18/20140429/102160/HHRG-113-IF18-Wstate-JonesJ-20140429.pdf [page 5]

***

April 29, 2014 Tuesday

CHEMICALS IN COMMERCE ACT;

COMMITTEE: HOUSE ENERGY AND COMMERCE;

SUBCOMMITTEE: ENVIRONMENT AND THE ECONOMY

Statement of Andy Igrejas Director Safer Chemicals, Healthy Families

3) The draft continues to weaken EPA authority over new chemicals.

The chemical industry has long argued that TSCA's current new chemicals program works, while public health and environmental advocates have argued that it is inadequate. It is perplexing, therefore, that the draft continues to weaken the new chemicals program as opposed to improving it.

First, the draft eliminates current TSCA authority to require testing or impose requirements on the basis that the new chemical may be produced in substantial quantities and result in significant or substantial human exposure or environmental release.

Secondly, it eliminates the authority to impose workplace safety requirements on manufacture and processing of the new chemical, an important aspect of EPA's new chemicals program that has added to public health protection.

The new draft restores one element of the existing law that was removed in the previous draft, which is welcome, but the net effect of the discussion draft is still to undermine EPA's authority over new chemicals.

Most Americans are surprised when they learn that chemicals can enter the marketplace without having to demonstrate that they are safe. It is unthinkable that, in the name of reform, Congress would undermine the limited oversight authority that currently exists.

http://docs.house.gov/meetings/IF/IF18/20140429/102160/HHRG-113-IF18-Wstate-IgrejasA-20140429.pdf [page 5]

***

March 12, 2014 Wednesday

CHEMICALS IN COMMERCE ACT;

COMMITTEE: HOUSE ENERGY AND COMMERCE;

SUBCOMMITTEE: ENVIRONMENT AND THE ECONOMY

Statement of Anna Fendley, MPH Member United Steelworkers

  1. New Chemicals

The new chemicals program under TSCA is the part of the program that allows EPA to review information about a chemical prior to it going on the market. The CICA would weaken the existing provisions in TSCA for oversight of new chemicals. Real reform would require that companies be required to provide the data EPA needs to assess a chemical's safety and that new chemicals be shown to meet a health-only safety standard before they go on the market as a way to protect health and improve confidence in the safety of new chemicals.

Section 5 of CICA makes it nearly impossible for EPA to require companies to submit health and safety information for new chemicals before they go on the market. EPA must complete a review of the premanufacture notice and make a safety determination (using the "unreasonable risk" standard) within 90 days or the company can put the product on the market and states are preempted from acting on the chemical. Manufacturers are not required to provide safety data for the chemical, and EPA does not have the ability to compel testing before the chemical goes on the market at the end of the 90 day review period. Additionally, there are a number of problematic exemptions in Section 5(f) that manufacturers and processors can claim to avoid providing information to EPA. The exemptions would, however, allow for problematic worker exposure to potentially harmful chemicals.

http://docs.house.gov/meetings/IF/IF18/20140312/101890/HHRG-113-IF18-Wstate-FendleyMPHA-20140312.pdf [page 7]

***

March 12, 2014 Wednesday

CHEMICALS IN COMMERCE ACT;

COMMITTEE: HOUSE ENERGY AND COMMERCE;

SUBCOMMITTEE: ENVIRONMENT AND THE ECONOMY

Statement of Michael Belliveau President and Executive Director Environmental Health Strategy Center

The House Discussion Draft would roll back existing TSCA authority on new chemicals, chemicals in products, and testing of chemicals, which are among the few areas where the U.S. Environmental Protection Agency (EPA) has been able to make limited progress using outdated policy tools.

[cont.]

EPA has required testing of chemicals for only about 200 of the 62,000 chemicals 'grandfathered in' when TSCA was signed into law in 1976, and fewer than 15% of new chemicals have adequate health and safety data. The large number of poorly tested chemicals in everyday products alarms parents nearly as much as the known hazardous chemicals that are still in widespread use.

Arguably, the correct policy response would be to require chemical manufacturers to provide minimum data sets for all chemicals, sufficient at least for screening level assessments of hazard, exposure and risk. That's the policy principle embodied in the 2007 REACH legislation in Europe, which warns of "no data, no market," and is similar in principle to the data requirements now imposed by Walmart and Target, among others, who are requiring suppliers to provide information on chemicals.

[cont.]

  1. Both Bills Roll Back Current Law: Weakening the Review of New Chemicals

Under current TSCA 5(e), EPA may restrict manufacturing of new chemicals pending the development of testing information, if the new chemical may present an unreasonable risk to human health and the environment or will be produced in substantial volumes and have substantial environmental release or significant or substantial human exposure. Most new chemicals lack adequate data to make that determination, minimum data sets are not required, and EPA has only 90 days to complete its initial review b before manufacturing of the new chemical can begin. However, EPA has often mustered its limited TSCA authority to enter into negotiated consent agreements with chemical manufacturers that require additional testing, worker protections, restrictions on environmental releases and pollution control equipment for new chemicals.

The Chemicals in Commerce Act would significantly curtail EPA's authority to review and regulate new chemicals. Both the House and Senate bills raise the bar higher before action can be taken, requiring EPA to determine whether or not the chemical is likely to result in an unreasonable risk of harm to human health and the environment. 5(c)(3). Further, because of the lack of a health- based safety standard in the House bill (see #1 above), EPA must now weigh costs and benefit factors before taking action on a new chemical under the House bill.

Both bills further limit EPA's authority to require testing of new chemicals that lack sufficient data to determine whether or not they are "likely" to present an unreasonable risk. This roll back eliminates EPA's ability under TSCA 5(e) to block manufacturing of the chemical until such additional testing information is developed. Under the House bill, in evaluating a new chemical during the 90-day pre-manufacturing review period, if EPA determines that additional information is needed to make an "unreasonable risk" determination, the agency can request that the manufacturer submit such additional information. 5(c)(2)(B). EPA can extend the review period for the development of additional information but only "by agreement with the submitter." 5(c)(2)(B)(ii). If the submitter is not cooperative, it is free to submit a notice of commencement of manufacture pursuant to 5(c)(4) unless EPA determines that the chemical is "likely" to present an unreasonable risk. But if data are inadequate to support such a determination, the new chemical enters commerce with poorly understood hazards.

http://docs.house.gov/meetings/IF/IF18/20140312/101890/HHRG-113-IF18-Wstate-BelliveauM-20140312.pdf [page 2]

***

February 4, 2014 Tuesday

TOXIC SUBSTANCES CONTROL ACT;

COMMITTEE: HOUSE ENERGY AND COMMERCE;

SUBCOMMITTEE: ENVIRONMENT AND THE ECONOMY

Testimony of Jennifer Sass, Ph.D., Senior Scientist, Natural Resources Defense Council and, Professorial Lecturer, George Washington University

Generally speaking, any substance on the TSCA inventory can be manufactured or processed for any use, and in any amount, without requiring any reporting to, or registration with, EPA. This is a central reason why EPA and the public have so little idea of what chemicals are used in what amounts, for what purposes, and in what products. It is also a major reason why reporting, testing, assessment and regulation authorities need to be strengthened by Congress to inform and protect the public.

Substances on the inventory – whether grandfathered “existing chemicals” or those approved in the new chemicals program based on particular assumptions about uses and production volumes may subsequently be adopted for other uses and at much higher production levels that greatly expand the potential for environmental or human exposure. One disturbing example that illustrates this fact is the persistent, bioaccumulative and toxic flame retardant Firemaster 550, promoted by its manufacturer as a “safe substitute” for certain PBDE flame retardants that were being phased out after they had been identified in the blood and breast milk of most Americans as well as wildlife at the North Pole. Now Firemaster 550 is being ubiquitously found in house dust and wildlife. Some of the chemical components of Firemaster 550 had been on the TSCA inventory for decades before showing up in the mix of this particular flame retardant.

http://docs.house.gov/meetings/IF/IF18/20140204/101706/HHRG-113-IF18-Wstate-SassJ-20140204-U2.pdf [page 12]

***

February 4, 2014 Tuesday

TOXIC SUBSTANCES CONTROL ACT;

COMMITTEE: HOUSE ENERGY AND COMMERCE;

SUBCOMMITTEE: ENVIRONMENT AND THE ECONOMY

Statement of Jerome Paulson, MD, FAAP Chairperson, Council on Environmental Health, Department of Federal Affairs American Academy of Pediatrics

[Recommendations]

5) Companies must develop a public information document for each new chemical marketed. This document should be in lay language and approved by EPA before the chemical is marketed. A companion document should be updated with each new formulation every three years.

http://docs.house.gov/meetings/IF/IF18/20140204/101706/HHRG-113-IF18-Wstate-PaulsonJ-20140204-U1.pdf [page 6]

***

November 13, 2013

COMMITTEE: HOUSE ENERGY AND COMMERCE

SUBCOMMITTEE: ENVIRONMENT AND THE ECONOMY

Questioning of Jim Jones, EPA:

SHIMKUS: Senate Bill 1009, in your opinion, strengthen EPA's ability to prevent dangerous new chemicals or those with inadequate information from entering the market?

JONES: Yes, Congressman.

The — to clarify, the existing statute does not require EPA to make an affirmative finding of safety to — for a new chemical, as 1009 requires an affirmative finding on the part of the EPA before a new chemical can enter the market. As it relates to data generation, interestingly, my attorneys have read the bill to provide EPA with the ability to require the generation of data if necessary to make a finding.

There are other stakeholders who are not reading that provision the same way, which to me is an indication that there may be a need for clarification around that.

[cont.]

SHIMKUS: Many witnesses have testified before our committee on the strengths and successes of existing TSCA, Section 5, provisions for new chemicals, and new uses of existing chemicals. Notwithstanding Senate 1009 makes changes to Section 5, do you consider these changes appropriate?

JONES: You know, I think it is surprising to most people that we do not need to affirmatively determine safety before a chemical enters the market, so I think that that change is an important one, that the Agency affirmatively say, yes, this chemical is safe before it enters the market.

SHIMKUS: Could these changes negatively impact innovation in the United States?

JONES: So I don't — you know, when people talk about innovation, which we are very sensitive to at EPA and try to facilitate it, I don't think they think of it as innovation of unsafe things. So I don't view a requirement that the Agency affirmatively determines something meets a safety standard as impacting innovation in a negative way. I actually think it will facilitate innovation, because innovation should be around safe things.

SHIMKUS: Right. I appreciate that.

***

LATTA: One is, do you believe that the categories that this bill creates for new chemicals will or could negatively impact specialty chemical manufacturers?

JONES: The new chemical provisions, Congressman, is that what you are…

LATTA: Right.

JONES: I don't believe so. I believe that we will be able to make decisions in a timely manner under the Lautenberg-Vitter bill on new chemicals.

LATTA: And again, could you define that timely manner?

JONES: So the current requirement is that we evaluate compounds within 90 days. If we see a problem, we need to inform the submitter. Under the Lautenberg-Vitter bill, that 90 days remains.

We have the ability to extend it by one 90 day — or two periods of time, but it shouldn't exceed another 90 days. So we are still talking about very short periods of time for our review of new chemicals.

***

DEGETTE: OK. Now, S. 1009 also changes the requirements for entry into commerce of new chemicals. It is my understanding that maybe as 80 or 90 percent of new chemical applications currently contain no data on potential impacts to human health. Is that correct?

JONES: That is correct.

DEGETTE: So under current law, the EPA wouldn't be making an affirmative decision about a new chemical's safety before it enters the market, is that correct?

JONES: That is correct.

DEGETTE: Under S. 1009, the EPA must make a decision about the likely safety of a new chemical, is that right?

JONES: That is correct.

DEGETTE: But will the EPA have data about the new chemicals to accurately make the safety determination?

JONES: So we expect that there will be — for many situations, the models that we use to predict hazard will allow us to make such determinate — likely to meet the safety standard determination for many chemicals. There will be some chemicals which, when we use predictive models, they are going to raise enough concerns that we are going to want to see health and safety data generated.

DEGETTE: OK. Well, I appreciate you — I appreciate that answer, but I am a little concerned because it seems a little bit vague, and I think that's one of the areas of this bill we can really work on, is setting clearly what data the EPA needs to be given for certain classes of chemicals. So I look forward to working with you and also with the committee on those issues.  Thanks.

MCNERNEY: Waiting and listening, Mr. Chairman. Thank you.

Mr. Jones, in your testimony, I believe you stated that S. 1009 requires affirmative standards. Would you please elaborate that, especially with regarding enforcement, how those affirmative standards would be enforced in the new law?

JONES: Thank you.

So it is — that comment reflects specifically to the new chemicals provision in 1009. Under existing law, the Agency, when a new chemical is submitted, we have 90 days to evaluate it, and only if we identify a problem are we able to work with the manufacturer to prevent it from being introduced into commerce. Under S. 1009, it requires the Agency to make an affirmative finding of meeting the safety standard before the manufacturer can move that chemical into commerce.

MCNERNEY: OK. That is a good thing, I think.

JONES: I would think so, yes.

MCNERNEY: You also stated that in S. 1009, the language would make it as difficult as the unreasonable risk or least burdensome language in TSCA to enforce rules as it has been for TSCA with asbestos. Can those — can that language be modified in your opinion to remove some of those barriers, and make it reasonable to enforce?

http://docs.house.gov/meetings/IF/IF18/20131113/101468/HHRG-113-IF18-Transcript-20131113.pdf  [page 31]

***

November 13, 2013

COMMITTEE: HOUSE ENERGY AND COMMERCE

SUBCOMMITTEE: ENVIRONMENT AND THE ECONOMY

Questioning of Cal Dooley, American Chemistry Council and Ernie Rosenberg, American Cleaning Institute:

SHIMKUS: Thank you very much.

Now I'll recognize myself for five minutes for the first round of or the round of questionings. And my first question I want to direct to Mr. Dooley, Mr. Rosenberg, and I think Mr. Garfield.

And it's based upon the question — let me start this, is based upon the question that I asked Mr. Jones. And many witnesses have testified before our committee on the strengths and successes of existing TSCA Section 5 provisions for new chemicals and new uses of existing chemicals.

Are the changes to TSCA Section 5 in the Senate bill needed and why? Cal, if you would start.

DOOLEY: ACC, you know, supports the provisions of the modifications of Section 5 in CSIA. We recognize that it is important, even with the new chemicals, that you do have provisions that do allow for EPA to make an affirmative determination that the new chemical will likely meet the safety standard, and that we accept that it is an obligation upon the industry and the manufacturer to provide that information to allow them to make that determination.

SHIMKUS: Mr. Rosenberg?

ROSENBERG: Thank you.

EPA has asked hundreds of manufacturers for data in the new chemical program since its inception. Without exception, those data have either been provided or the premanufacture notice was withdrawn.

So the deficiencies, if you will, in Section 5, in my view, go to where you end up if you really want to regulate a new chemical, and you end up in Section 6. 31 Section 6 has the least burdensome alternative hurdle, which I completely agree with Jim Jones, is an unmanageable hurdle for the agency.

So the changes that are made in Section 5 in the bill do one important thing. They do what we're really looking for which is create a more credible program. And the fact that there's an affirmative determination gives at least most people a level of comfort that things haven't just gone through because the deadline expired.

http://docs.house.gov/meetings/IF/IF18/20131113/101468/HHRG-113-IF18-Transcript-20131113.pdf [page 128]

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November 13, 2013 Wednesday

CHEMICAL SAFETY IMPROVEMENT ACT;

COMMITTEE: HOUSE ENERGY AND COMMERCE;

SUBCOMMITTEE: ENVIRONMENT AND THE ECONOMY

Statement of Andy Igrejas National Campaign Director Safer Chemicals, Healthy Families

In Section 4 EPA is directed to identify chemicals as "low priority" based on a determination that they are "likely to meet the safety standard." Those chemicals are set aside for no further action or scrutiny. In Section 5 the EPA is directed to apply the same test to a new chemical before it is allowed on the market. This is one of the bill's major selling points- that it imposes a safety screen of some kind on new chemicals for the first time. However, since "unreasonable risk" has such a clear meaning in the legislative history and case law of TSCA, it would almost certainly have the same old meaning, and therefore the same old problems, in these sections.

[cont.]

One of the lessons of TSCA is that it lacked deadlines or goals for how many existing chemicals should be reviewed or how long assessments should take. The new chemicals program, on the other hand, had clear deadlines for how quickly EPA had to respond to a pre-manufacture notice. As a result, most of the activity at EPA under TSCA has been in the new chemicals program.

http://docs.house.gov/meetings/IF/IF18/20131113/101468/HHRG-113-IF18-Wstate-IgrejasA-20131113.pdf [page 3]

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November 13, 2013 Wednesday

CHEMICAL SAFETY IMPROVEMENT ACT;

COMMITTEE: HOUSE ENERGY AND COMMERCE;

SUBCOMMITTEE: ENVIRONMENT AND THE ECONOMY

Statement of Richard Denison, Ph.D., Lead Senior Scientist, Environmental Defense Fund

CSIA requires that a new chemical be found likely to meet the safety standard before market entry: Under TSCA, new chemicals undergo a cursory pre-manufacture review, and no affirmative safety decision is required before they can enter the market. And in the review, the burden is on EPA to find a concern – hard to do when safety data are not required – in order to halt, slow or limit market entry.

CSIA for the first time would require EPA to make an affirmative finding of likely safety as a condition for the manufacture of a new chemical to commence. And while EPA still could not directly require safety testing of new chemicals, it could suspend its review pending submission of needed data, or impose conditions needed to provide the requisite assurance of likely safety in the absence of such data.

[cont.]

EPA’s authority to require testing when reviewing new chemicals and prioritizing data-poor chemicals needs to be restored. As noted earlier, CSIA would reduce the procedural and evidentiary burdens on EPA to require testing. However, it would severely limit the purposes for which testing could be required: Testing could only be required to inform safety assessments and determinations for existing chemicals, and EPA is explicitly barred from requiring testing of new chemicals and to inform prioritization of existing chemicals. This is a major step backward from current TSCA. The arbitrary restriction on testing in CSIA would lead to one of two outcomes that would be good for no one: either EPA would be forced to allow chemicals for which insufficient data exist to assess their safety to enter or remain on the market; or it would have to deny market access to or waste resources assessing chemicals that more data would show pose little or no risk.

[Emphases in original]

http://docs.house.gov/meetings/IF/IF18/20131113/101468/HHRG-113-IF18-Wstate-DenisonPhDR-20131113.pdf [page 5]

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July 11, 2013 Thursday

REGULATION OF NEW CHEMICALS;

COMMITTEE: HOUSE ENERGY AND COMMERCE;

SUBCOMMITTEE: ENVIRONMENT AND THE ECONOMY

Statement of Heather White, Esq. Executive Director Environmental Working Group

TSCA's New Chemicals Framework Fails to Adequately Protect Public Health.

In the nearly 40 years since the passage of TSCA, more than 23,000 new chemicals have been approved by the U.S. Environmental Protection Agency and added to the agency's "inventory list" of chemicals allowed for use in commerce. As the growing body of evidence on the potential health impacts of toxic chemicals demonstrates, we need to strike a better balance between getting new chemicals to the market quickly and ensuring that these substances do not harm those who are disproportionately affected by exposure, including children, workers, pregnant women and fence-line communities.

There are five major flaws with the new chemical review process under current law: When a company is looking to manufacture or import a new chemical into the U.S., current law gives EPA just 90 days to review the substance before it goes on the market. The ultimate effect of this narrow window is to give profits a higher priority than public safety.

The company must submit a pre-manufacture notice to EPA with basic information on the chemical's name, anticipated uses and disposal, as well as any test data that is known or reasonably ascertainable.7 EPA cannot require companies to perform even basic health and safety testing before filing that notice, but if the company has health and safety data, it is supposed to turn it over to EPA for review. This regulatory disconnect actually discourages manufacturers from doing safety testing because doing so would likely invite additional review by the agency. As a result, approximately half of all pre-manufacture notices include no test data at all; nearly 85 percent provide no toxicity data.

EPA faces a Catch-22 when it comes to new chemicals. The agency cannot request additional data unless it has safety concerns and it cannot adequately address safety concerns without relevant testing data. With no test data to evaluate the safety of a new chemical, EPA must use computer models, chemical comparisons and other analyses to predict how it may affect human health and the environment. At best, it operates on incomplete information. Its models and estimates are based on data about previously studied chemicals, but these do not necessarily predict how a new chemical will behave.

Even if EPA receives complete information about a new chemical in a pre-manufacture submission, the agency makes its initial assessments based on the uses listed in that notice. The company, however, is not bound to follow those stated uses. A manufacturer an quickly adopt new uses when it goes to market and produce the chemical at much higher volumes than those estimated in the pre- manufacture notice, and EPA and the public receive no notice that the manufacturer is changing its plan.

EPA evaluates a new chemical against a safety standard of "unreasonable risk of injury to human health or the environment."9 The agency bears the burden of proof and must provide evidence if it wants to delay or restrict the new chemical. The paradox is that the less information there is about a new chemical's safety, the faster it can reach the market. Not surprisingly, EPA attempts to restrict less than 10 percent of new chemicals.

TSCA is so weak that it effectively presumes that new chemicals are safe without requiring pre-market testing. The law places the burden on EPA, not the chemical manufacturer, to determine whether a chemical is safe before it goes into use. Moreover, the fees companies pay to submit pre-manufacture notices cover just 10 percent of EPA's cost of reviewing these submissions. 'This framework is inadequate to protect human health and the environment.

http://docs.house.gov/meetings/IF/IF18/20130711/101103/HHRG-113-IF18-Wstate-WhiteH-20130711.pdf [page 3]

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June 13, 2013 Thursday

TOXIC SUBSTANCES CONTROL ACT OF 1976;

COMMITTEE: HOUSE ENERGY AND COMMERCE;

SUBCOMMITTEE: ENVIRONMENT AND THE ECONOMY

Statement of Jeanne Rizzo, R.N. President and CEO Breast Cancer Fund

Require data on all chemicals. The EPA should require chemical manufacturers to demonstrate via sound scientific data that their chemical is safe. The absence of data should not default to assuming the chemical is safe.

These flaws include [cont.]:

— failure to require a minimum data set sufficient for the evaluation of new chemicals;

[cont.]

New Chemicals

Although the new chemicals program has managed to function better than the program for assessing and regulating existing chemicals, it has been hindered by key constraints that have limited its ability to ensure the safety of new chemicals entering the marketplace. These include the short period allowed for EPA to review pre-manufacture notices, , EPA's lack of authority to designate a minimum data set necessary for assessing the safety of new chemicals, and its inability to require testing by order rather than rulemaking or voluntary consent. In addition, the burden is on EPA to prove that a proposed new chemical may pose an unreasonable risk to human health or the environment rather than the burden being placed on chemical manufacturers to demonstrate the safety of their products. EPA has done its best with these limitations of the law to assess the safety of new chemicals and protect the public.

In a limited number of cases EPA has imposed conditions of use on new chemicals, or raised concerns that have led to a company to withdraw its pre-manufacturing notice and forego production of the chemical. EPA has also developed methods for reviewing new chemicals for safety in the absence of easy access to the underlying data they might otherwise have. This includes comparing proposed chemicals with other known chemicals for structural similarities to help predict how they might behave in the environment and in people. While these methods can be useful for determining certain characteristics like persistence, bioaccumulation and ecotoxicity, they fall short in other areas including anticipating harmful impacts on mammals such as reproductive and developmental toxicity. Unlike under TSCA, virtually all other industrial countries require potential manufacturers of a chemical to provide a minimum set of data up front with which the reviewing government can assess the chemical.

http://docs.house.gov/meetings/IF/IF18/20130613/100980/HMTG-113-IF18-Wstate-RizzoJ-20130613.pdf [page 6]

II. U.S. Senate (in reverse chronological order)

March 18, 2015 Wednesday

FRANK R. LAUTENBERG CHEMICAL SAFETY FOR THE 21ST CENTURY ACT

U.S. SENATE COMMITTEE ON ENVIRONMENT & PUBLIC WORKS

Statement of Lynn Goldman, M.D., M.P.H., Michael and Lori Milken Dean of Public Health, Milken Institute School of Public Health, The George Washington University

Section 5 of TSCA requires that anyone who intends to manufacture or import a new chemical substance in the United States notify EPA 90 days before commencing that activity. The EPA’s new chemicals program has over the years reviewed thousands of new chemical substances. In many cases EPA has made decisions to prevent risk before a harmful substance enters commerce. The U.S.'s new chemicals program is unique in that it requires review of chemicals prior to manufacture rather than prior to marketing as in most other countries with such systems. In contrast the EU REACH system requires registration of substances manufactured or imported in EU above 1 tonne per year. Because many chemicals that initially are manufactured for research and development never come to market, the US gives the bulk of attention to new chemicals that will never appear in commerce.

The new chemicals program in the United States does not require any testing prior to submission of a “pre-manufacturing notification” (PMN) and over half of all PMNs are submitted without any test data. The Agency has developed tools to use Structure Activity Relationships (SAR) to predict and assess the fate and effects of new chemicals. SAR is limited so it is important that EPA can obtain test data on new chemicals.

When EPA determines that there is a risk associated with a PMN it has tools that can be used to manage those risks. TSCA Section 5 gives EPA the ability to require additional tests or other measures such as disposal controls and worker protection. These provisions have caused the industry to screen out “bad actors” before presenting them to the EPA in the first instance.

The Lautenberg Act is a great improvement over TSCA in requiring an affirmation of safety by the EPA rather than triggering manufacture of the chemical by default if EPA is silent during the 90-day review. It establishes a clear expectation that new chemicals will be managed to provide reasonable assurance they will meet the new public health standard. Importantly it authorizes the EPA to suspend review and/or take intermediate action in the face of inadequate information to make a final decision. Additionally I suggest that Congress consider focusing EPA’s efforts on premarket rather than premanufacture approvals so that EPA would be able to give more attention to chemicals that actually are entering commerce.

http://www.epw.senate.gov/public/_cache/files/eb27a7b5-5b24-4f72-8f9a-55eecfde7397/tscawrittentestimonygoldmanmarch2015final.pdf [page 5]

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Questioning of Lynn Goldman, Milken Institute of Public Health, The George Washington University

CARPER: Dr. Goldman, you wrote eloquently in your testimony about the cost of inaction as a consequence of a failure to have a functional Federal toxics law. It is a testament to the idea of States as laboratories of democracy that several States have forged ahead with toxics laws in absence of a Federal system. Other States like my own State, Delaware, we don’t have the capacity or the resources to run a robust State toxics program and we depend on EPA.

How will having a Federal program help to reduce the impact of toxic exposure for people like those who live in my State and some other States? What would be the cost of inaction?

GOLDMAN. I think that how people in your State would be benefitted is by raising the floor, having a stronger safety standard that would have to apply everywhere in the Country. And also that when new chemicals come on the market that EPA would have to actually affirm that those new chemicals meet that standard. Right now, if EPA doesn’t act in 90 days, automatically the chemical enters the market. This bill would tell the EPA, no, you must affirm that it needs the new standard and that it is a health-based standard. It is not a standard for cost-benefit balancing as it is today.

http://www.epw.senate.gov/public/_cache/files/6072fb1c-06a0-48b5-9dd4-2d894a81e9c0/spw031815.pdf [page 131]

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July 31, 2013 Wednesday

STRENGTHENING PUBLIC HEALTH PROTECTIONS BY ADDRESSING TOXIC CHEMICAL THREATS

COMMITTEE: SENATE ENVIRONMENT & PUBLIC WORKS

Statement of Daniel Rosenberg, Senior Attorney, Natural Resources Defense Council

Over the past generation, scientists have gained a greater understanding of the potential health and environmental threats posed by exposure to toxic chemicals. Over the almost 37 years since enactment of the Toxic Substances Control Act (TSCA), science has raised many new concerns about the potential health effects of individual chemicals, as well as classes of chemicals. While scientific understanding has been increasing rapidly, TSCA has remained virtually dormant for existing chemicals and inadequate to assure the safety of new chemicals.

Since 1976, scientists have linked exposure to toxic chemicals to a wide array of health risks. Research increasingly indicates, for example that exposure to low doses of certain chemicals, particularly in the womb or during early childhood, can result in irreversible and life-long impacts on health. It is now commonly known that some toxic chemicals persist in the environment, sometimes for decades, and build up in the food chain and in our bodies. It is now well recognized that some chemicals are able to disturb human and other hormonal, reproductive, and immune systems and that chemicals interact so that substances that individually may be considered “safe” at low levels can act in concert to harm health.

It’s no wonder, then, that so many major independent health and science organizations have expressed concern and called for steps to better characterize and address the risks from chemical exposure.

http://www.epw.senate.gov/public/_cache/files/ac9ffa00-d5fe-4a02-9035-545b047ffc0f/73113hearingwitnesstestimonyrosenberg.pdf [page 2]

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July 31, 2013 Wednesday

STRENGTHENING PUBLIC HEALTH PROTECTIONS BY ADDRESSING TOXIC CHEMICAL THREATS

COMMITTEE: SENATE ENVIRONMENT & PUBLIC WORKS

Statement of Michael Dorsey, Chief, Homeland Security and Emergency Response, West Virginia Department of Environmental Protection

While it is difficult for me to say, as someone who has spent much of his professional life in the environmental protection business, but TSCA has provided a false sense of security to untold numbers of people in this country who have bought into the proposition that it was providing a safety net–that it was testing and evaluating new chemicals before they could come on the market. We know that is not true and we know that it will be a difficult assignment if and when CSIA comes to pass. But I think that we can all agree that it needs to be done. We owe it to our constituents.

Finally, I appear before you today as a graybeard. I have been around long enough to see some state and federal laws, rules, and regulations come to life and become implemented, and others slowly die and become forgotten. I have also seen laws with good intentions fail. TSCA is one of those failed laws. It was passed for good reasons and still has an important role to play in our country. Perhaps, its role is more important today than it ever has been. Some of what it accomplished has been very good–such as the regulation of PCBs, the elimination of lead-based paint, and the regulation of asbestos; but in the area that citizens most need protection, it has failed. It has failed to adequately test and evaluate chemicals as they enter into our lives.

http://www.epw.senate.gov/public/_cache/files/bef1ecaa-23d8-4cd9-b450-1e7de0684876/73113hearingwitnesstestimonydorsey.pdf [page 3]

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July 31, 2013 Wednesday

STRENGTHENING PUBLIC HEALTH PROTECTIONS BY ADDRESSING TOXIC CHEMICAL THREATS

COMMITTEE: SENATE ENVIRONMENT & PUBLIC WORKS

Statement of Ansje Miller Eastern States Director Center For Environmental Health

Any effective reform of TSCA should: [cont.]

— Require Basic Information for All Chemicals: Manufacturers should be required to provide basic information on the health hazards associated with their chemicals, how they are used, and the ways that the public or workers could be exposed.

http://www.epw.senate.gov/public/_cache/files/42539327-def9-4958-9f3f-72387b6a78a6/073113hearingwitnesstestimonymiller.pdf [page 2]

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July 31, 2013 Wednesday

STRENGTHENING PUBLIC HEALTH PROTECTIONS BY ADDRESSING TOXIC CHEMICAL THREATS

COMMITTEE: SENATE ENVIRONMENT & PUBLIC WORKS

Statement of Nancy Buermeyer Senior Policy Strategist Breast Cancer Fund

Lack of Safety Data – To make sound decisions about the safety of a chemical, EPA needs adequate information on a range of possible health impacts. Unfortunately, TSCA makes it extremely hard for EPA to get that necessary safety data by placing the burden on the EPA to show they need the information rather than on the industry to show their chemical is safe.

[cont.]

For new chemicals, EPA has 90 days to review the chemical before it goes into production, but it cannot compel manufacturers to submit any safety data and very few companies do so voluntarily. This leaves EPA reliant on sometimes incomplete or imperfect models to predict the toxicity of a chemical based on similarities to other chemicals that have been tested for safety. And if the EPA fails to act, the chemical goes onto the market at the end of the review period.

[cont.]

Require data on all chemicals. The EPA should require chemical manufacturers to demonstrate via scientific data that their chemical is safe. The absence of data should not default to assuming the chemical is safe.

http://www.epw.senate.gov/public/_cache/files/604afbe7-7293-4a72-8af3-3dbeb101777e/73113hearingwitnesstestimonybuermeyer.pdf [page 5]

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July 31, 2013 Wednesday

STRENGTHENING PUBLIC HEALTH PROTECTIONS BY ADDRESSING TOXIC CHEMICAL THREATS

COMMITTEE: SENATE ENVIRONMENT & PUBLIC WORKS

Testimony of Kenneth A. Cook President Environmental Working Group

Chemical companies would not be compelled to prove their chemicals are safe or even to submit a minimum amount of data to the EPA so it could assess them. The burden would fall on the EPA to show that these substances were potentially hazardous. Sometimes the agency would not have enough information to make sound decisions about chemicals.

The EPA could still let new chemicals on the market before determining that they were safe. The EPA would not face hard deadlines to assess chemical safety.

http://www.epw.senate.gov/public/_cache/files/206b83be-585c-4319-9565-02b71d908d30/73113hearingwitnesstestimonycook.pdf [page 3]

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