Senators Announce Bipartisan Bill to Modernize TSCA.

The prospects for TSCA reform just improved considerably with Wednesday’s announcement of a bipartisan agreement to overhaul the chemical safety law.

Sen. Frank Lautenberg (D-NJ) and Sen. David Vitter (R-LA) led a group of 16 senators from both parties in unveiling the Chemical Safety Improvement Act of 2013 [PDF]. The compromise legislation has already been praised by industry groups, including the American Chemistry Council, as well as public health advocates like the Environmental Defense Fund.

The Act’s chief innovation is its framework for ensuring that all chemicals are screened for safety to human health and the environment. Under the new legislation, EPA would make safety determinations for chemicals based on intended conditions of use and a risk-based assessment integrating hazard, use, and exposure information.

New chemicals would have to first pass safety screening before entering the market. Chemicals already in commerce would also undergo safety evaluations, which would be prioritized based on the substance’s risk to human health and the environment, and high-priority chemicals would undergo further safety testing by EPA. In an effort to reduce duplicative testing, EPA would be authorized to rely on existing information as well as to collect safety data from chemical manufacturers. In addition, EPA would be required to evaluate risks to vulnerable populations, like children or pregnant women, in assessing the safety of each chemical.

The bill also authorizes EPA to employ a wide range of risk management measures on unsafe chemicals, from ordering additional labeling requirements to imposing an all-out ban.

As we previously reported, Sen. Lautenberg introduced a similar bill to modernize TSCA in April, but it only won support among his fellow Democrats. The new compromise bill was criticized by the Environmental Working Group as “unacceptably weak,” but its bipartisan support means it likely has a better chance at approval in the Senate.

TSCA Reform Debuts in the 113th Congress.

Last week, Sen. Frank Lautenberg (D-NJ) and Sen. Kirsten Gillibrand (D-NY) introduced the Safe Chemicals Act of 2013, which would overhaul the Toxic Substances Control Act (“TSCA”). The Safe Chemicals Act is identical to legislation approved last year by the Senate Environment and Public Works Committee.

The Safe Chemicals Act grants greater authority to the EPA to:

  • evaluate the safety of chemicals based on risk;
  • update EPA’s TSCA Inventory, first focusing review on priority chemicals;
  • order additional testing of chemicals when existing health and safety data is inadequate;
  • require regular use reporting;
  • impose a broad range of risk-management controls for chemicals that fail to meet safety standards; and
  • establish a public database of safety determinations and health and safety data.

The legislation’s focus on risk combines both hazard- and exposure-based methods of safety assessment. Under the bill’s new safety standard, EPA must determine that there is “reasonable certainty that no harm will result to human health or the environment from aggregate exposure” to evaluated chemicals. Such safety determinations must also follow recommendations on “best available science” from the National Academy of Sciences. EPA would evaluate and make safety determinations for all chemicals in the TSCA Inventory based on a priority classification scheme which uses existing data and considers the following factors: potential impacts on human health and the environment; hazard potential, including “designations of hazard characteristics by other authoritative entities”; potential for exposure; and measurements of exposure for any given pathway, if available. For chemicals that do not meet the safety standard, EPA would be able to implement controls ranging from requiring warning labels to imposing an outright manufacturing ban.

The proposed regular use reporting would apply to manufacturers and processors, and is similar to the existing Chemical Data Reporting rule. The bill also incorporates amendments made in committee to last year’s bill which aim to better protect manufacturers’ confidential business information, including specific protections applicable to certain types of information, like “[p]recise information describing the manufacture, processing, or distribution of a chemical substance or mixture” or marketing and sales data.

Lautenberg, who has announced he will retire in 2014, has introduced several TSCA reform bills during his career, and hopes to make the Safe Chemicals Act his “signature legislation for his final term in office.” Twenty-seven other members of the Senate’s Democratic caucus have joined Lautenberg and Gillibrand in sponsoring this bill. Sen. David Vitter (R-LA) has already announced his intention to introduce a competing bill for this Congress; he led Republican efforts on TSCA modernization in the 112th Congress.

The full text of the Safe Chemicals Act is available on Sen. Lautenberg’s website.

CRS Report Published on Chemical Regulation Issues for 113th Congress

TSCA Reform:

Last week, the Congressional Research Service (“CRS”) released a new report previewing chemical regulation issues for the 113th Congress. According to CRS, lawmakers are likely to prioritize legislative priorities that languished in the last Congress, like bills that would require increased public disclosure of chemicals used in hydraulic fracturing as well as a proposal to broadly reform the Toxic Substances Control Act (“TSCA”).

Legislative TSCA reform efforts are already under way; in a January 4, 2013 statement on EPA’s release of its TSCA Work Plan draft risk assessments, Sen. Frank Lautenberg emphasized the continuing need to pass TSCA reform. A long-time advocate of TSCA reform, Sen. Lautenberg promised that he would re-introduce his Safe Chemicals Act. Last summer, the Safe Chemicals Act was successfully reported out of the Senate Committee on Environment and Public Works but failed to win Republican support and never reached a floor vote. Sen. David Vitter is reportedly preparing a competing TSCA reform bill for the new Congress as well.

CRS also highlighted scientific integrity issues that have been raised in recent years, such as the compositional balance of EPA’s Scientific Advisory Board and the need for reforming the agency’s Integrated Risk Information System (“IRIS”) for conducting chemical risk assessments. Legislators may also pick up where the 112th Congress left off on exempting the regulation of certain pesticide applications under the Clean Water Act. In addition, Congress may amend existing statutes to implement three U.S.-signed treaties on the reduction of persistent organic pollutants (“POPs”). In appropriations activity, CRS reported that Congress is expected to revise parameters for grants that address lead paint hazards in older homes, a program which is generally funded at over $100 million.

CBO Estimates Senator Lautenberg's TSCA Reform Bill Would Cost $128 Million over the Next Five Years

TSCA Reform:

On Tuesday, October 2, the Congressional Budget Office published its evaluation of the costs of implementing the amended version of S.847, The Safe Chemicals Act of 2011, which is Senator Lautenberg’s latest attempt to amend the federal Toxic Substances Control Act (TSCA).  Readers will recall that the Senate Committee on Environment & Public Works passed the amended bill on July 25, sending it to the full Senate for a vote.  Our blog post on that version of the bill is available here.

The CBO press release says the following:

“S. 847 would modify the Toxic Substances Control Act (TSCA), the law that regulates the manufacture, importation, and processing of chemicals, with the aim of shifting the burden from the Environmental Protection Agency (EPA) to chemical manufacturers to prove that substances are safe before they enter the marketplace. This new responsibility for chemical manufacturers would be accomplished primarily by increasing the amount of information about chemical toxicity and usage that they would be required to submit to EPA. Enacting this legislation also would require EPA to undertake other activities that would encourage and support the development of safer alternatives to existing hazardous chemical substances.

CBO estimates that implementing this legislation would cost $128 million over the next five years, assuming appropriation of the necessary amounts, as EPA would incur additional administrative costs to meet the new requirements imposed by S. 847.

Enacting S. 847 could affect direct spending and revenues because the bill would increase some existing civil and criminal penalties for violations of TSCA, establish some new civil and criminal penalties for violations related to that act, and authorize EPA to charge fees to chemical manufacturers. Therefore, pay-as-you-go procedures apply to S. 847. CBO estimates that any changes in revenues and direct spending would not be significant.

A copy of the CBO report is available here.

TSCA Reform Bill Headed to Full Senate

TSCA Reform:

On July 25, the U.S. Senate Committee on Environment & Public Works passed a 174-page, substantially revised version of Senator Lautenberg’s 2011 Safe Chemicals Act (S.847).  The bill was approved along party lines, with all Republicans voting against it.  It will now move to the full U.S. Senate for consideration.  Since the bill moved out of committee, we are aware of no meaningful progress toward passage of the bill on the floor of the full Senate.  Moreover, it is unlikely that a companion bill will be passed in the U.S. House of Representatives prior to the November election.  Therefore, we continue to anticipate meaningful TSCA reform efforts in 2013, but not before then.  We also expect this amended bill to remain a focal point of future negotiations in both houses.

  • Summary of Proposed Changes – Although the bill would make significant revisions to the current TSCA statute, the law’s scope would remain largely unchanged in terms of persons and chemicals subject to regulation, as well as the range of risk management measures available to EPA.  Compared to the existing statute, the bill would increase the regulatory burden of “processors,” making them subject to requirements similar to those imposed on manufacturers (e.g., notifications, risk management).  Compared to the prior version of the bill, this version places greater reliance on existing information before requiring new data and information to be generated in a targeted manner as part of a tiered evaluation process.  It limits the number of substances that must undergo a full safety determination.  It also provides greater protection for confidential business information than the last version.  Below is a short summary of some of the more noteworthy changes.
    • Inventory Reset – Manufacturers and processors would submit declarations of current or potential commercial interest in “existing” chemical substances (i.e., those on the current TSCA Inventory), and EPA would use the declarations to establish an “Active” and an “Inactive” Inventory.  The Active Inventory would list substances for which EPA received declarations of current commercial interest (basically manufacturing/ processing at the time of the new law’s enactment).  The Inactive Inventory would list substances that might be used as a substitute for a substance currently manufactured or processed.  Substances would be eliminated from the Inventory if no declaration was submitted.
    • New Chemicals Notification and Categorization – Pre-manufacturing notices (PMN) would be required for substances not on either the Active or Inactive Inventory.  (Certain exemptions would be available, but it does not appear the “articles” exemption would be based on its absence in the prior version or the current amendment.  Many of the exemptions would require some form of notification to EPA.)  More substantial data and information requirements would apply than under the current statute, even though “existing information” would be used initially.  EPA would “categorize” substances and impose data generation requirements on substances in some of the categories. The five categories are listed below.
      • Substances in the “SVHC category” would be PBTs and those that are “highly hazardous.”  They could not be manufactured or processed except under very limited circumstances requiring an exemption application (e.g., critical uses).  These would not be added to the either Inventory.
      • “Substances to Undergo a Safety Determination” would be set into one of three “Priority Classes” and then undergo a risk assessment to confirm that their manufacturing, processing, use (including in articles), etc., would meet the safety standard discussed below.  Risk management measures could be imposed in order to meet the standard.  These substances would be added to the Active Inventory while awaiting assessment because it’s anticipated that they would satisfy the standard.
      • “Substances of Very Low Concern” are not subject to risk management, and would not undergo further evaluation unless new information arose indicating a change was necessary.  They would be added to the Active Inventory.  They would be considered to have “intrinsic low-hazard properties.”
      • “Substances with Insufficient Information” would need certain data submitted and could not be manufactured or processed until the EPA had re-categorized the substance into one of the other categories.
      • “Substances Unlikely to Meet the Safety Standard” could not be manufactured or processed except under very limited circumstances requiring an exemption application. These would not be added to the either Inventory.
    • Existing Chemicals Notification Requirements – Existing chemicals would be subject to certain advance notification requirements.  Again, the “articles” exemption appears unavailable.
      • Substances on the “Inactive Inventory” would require certain limited data and other information to be submitted before manufacturing or processing could occur. 
      • Substances on the “Active Inventory” that had not undergone a safety determination would require advance notification before (1) engaging in a use not ongoing at the time of the law’s enactment or (2) substantially increasing the volume of a substance.  A submission akin to the current significant new use notification (SNUN) would be required – again certain existing data, etc., would be provided to EPA beforehand. 
      • Substances on the “Active Inventory” that had undergone a safety determination would require advance notification before undertaking a use that was not included in the determination.  The applicant would have to establish with data that the use would also comply with the standard.  EPA would impose any new risk management measures that might be necessary to meet the standard.
    • Existing Chemicals Categorization – Every five years, EPA would select a “batch” of approximately 6,000 existing chemicals.  It would then place them into “categories” very similar to the ones identified above for new chemicals.  Substances identified for safety standard determinations would be placed into one of three different “priority” classes and then reviewed. EPA might require data generation to categorize or a substance or to conduct the safety standard determination.  Risk management measures could result – again, SVHCs would be subject to expedited and highly restrictive risk management, but certain limited exceptions would be available.  Other substances unable to meet the safety standard would be banned except for under limited circumstances (e.g., critical uses).
    • Safety Standard – The safety standard proposed remains very rigorous and controversial.  It’s the same standard found in the Food Quality Protection Act.  Based solely on considering human health and the environment, including vulnerable populations, EPA must determine whether “there is a reasonable certainty that no harm will result to human health or the environment from aggregate exposure to the chemical substance.”  The burden of proof rests on the company, however.  Use in “articles” must meet the standard as well.
    • Confidential Business Information – EPA would place information into one of three categories – (1) always eligible for protection, (2) never eligible, and (3) sometimes eligible.  Most eligible information would be protected for 5 years, with a possible extension for another five years.  Certain sensitive information would receive indefinite protection.  Severe penalties would be imposed for release of protected information or for claiming protections that were unwarranted.
    • Preemption of State Laws – the bill does not include a robust preemption provision. 

A copy of the amendment to the bill is available here Final-Amendment-to-S.-847[1].  The original version is available here BILLS-112s847is.  Senator Lautenberg’s summary is available here.  And a webcast of the committee hearing is available here.

Update on TSCA "Reform" – The Summer of Bipartisan Consensus?

TSCA Reform:

Whether you think the Toxic Substances Control Act (TSCA) needs to be “reformed,” “modernized,” “updated” or simply left alone, you’re probably interested in knowing where Congressional efforts to amend the statute currently stand.  Here’s a short update, which is based on our latest understanding.  If others have additional details or insights, please feel free to share them with us here at Verdant Law.

Supposedly Senator Lautenberg (D-NJ) has agreed to set aside his current version of the Safe Chemicals Act (S.847) and attempt to achieve consensus with his Republic colleagues on the Environment and Public Works (EPW) Committee.  Although Senator Lautenberg introduced S.847 in 2011 and has not introduced a similar version in 2012, the bill has remained somewhat of a centerpiece in the negotiations with other EPW Committee members. 

While Senator Lautenberg is the leading Democratic negotiator, Senator David Vitter (R-LA) is leading the Republicans’ efforts.  Senators James Inhofe (R-OK, Ranking Committee Member), Mike Crapo (R-ID, Ranking Subcommittee Member), and Lamar Alexander (R-TN) are also playing key roles. 

Negotiations are supposed to continue over the summer.  Around Labor Day, the parties will decide whether to attempt a bipartisan markup of S.847 in Senator Lautenberg’s Superfund, Toxics, and Environmental Health Subcommittee, whether a markup is premature but negotiations should continue, or whether to terminate further negotiations for the remainder of the year.  Presumably if negotiations terminate, Senator Lautenberg might reintroduce S.847 and attempt passage in the last weeks of the current congress.  Republicans would probably oppose it, but may not be in a position to introduce a viable competing bill.

We at Verdant Law think it’s highly unlikely that consensus will be achieved and a bill passed and signed into law before the November election.  However, perhaps this summer’s efforts will point the parties in a direction that eventually leads to a workable solution.  (One can dream, right?)   Stay tuned.

EPA Announces More Muscular Use of TSCA Section 6

TSCA/Section 6 restrictions:

June 7, 2012 Jim Jones, Acting Administrator, Office of Chemical Safety and Pollution Prevention, announced that EPA plans to use TSCA §6 to ban or restrict the use of chemicals that pose an unreasonable risk.  This is an extension of the Administrator’s 2009 Comprehensive Approach to Enhance the Agency’s Current Chemical’s Management Program.  At that time, the Agency announced a renewed focus on identifying chemicals of concern and initiating appropriate risk management, including regulatory action to restrict or ban chemicals.  Jones’ Office explained that the agency intends to use its existing authority to the best of its ability until Congress enacts TSCA reform.  It noted that TSCA reform is one of the Administrator’s highest priorities.

Jones statement was made at the Environmental Council of the States’ State Environmental Protection in 2012 forum.  He spoke extemporaneously.  For further information, Jones’ Office recommends reviewing the Comprehensive Approach and the Administrator’s Essential Principles for Reform of Chemicals Management Legislation.  See also the Administrator’s September 2009 remarks announcing both efforts.

EPA Budget Would Increase Spending on Chemical Assessment and Control

EPA Budget/Chemical Control

According to an EPA press release, today the Obama Administration proposed a FY 2013 budget of $8.344 billion for the agency. The budget is $105 million below the EPA’s enacted level for FY 2012, but it increases spending by $11 million, or approximately 16%, to “protect … Americans from harmful chemicals.”  This increase for chemical assessment and control signals a clear intention to promote regulatory TSCA reform and related efforts in the absence of legislative reform. 

The press release states – “EPA is proposing $68 million, an increase of $11 million from FY 2012, to reduce chemical risks, increase the pace of chemical hazard assessments, and provide the public with greater access to toxic chemical information. Funding will sustain the agency’s successes in managing the potential risks of new chemicals coming into the market and accelerating the progress to help ensure the safety of chemicals on the market that have not been tested for adverse human health and environmental impacts.”

A complete copy of the agency’s budget proposal is available here.

EPA Assistant Administrator Steve Owens Resigns

EPA Administration/Chemical Regulation:

On Tuesday, October 25, 2011, the Environmental Protection Agency (EPA) announced the resignation of Assistant Administrator Steve Owens.  Readers will recall that President Obama appointed Mr. Owens the Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP), which is the office implementing the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Pollution Prevention Act, and other federal laws concerning chemicals management.  November 30, 2011, will be Mr. Owens’ last day in office before returning home to Arizona where he previously served as the Director of the Arizona Department of Environmental Quality.  It is unclear at this time who will assume Mr. Owen’s responsibilities and what effect his departure will have on EPA’s various chemicals management initiatives.

Mr. Owens served the EPA during a two-year period in which Congress, the courts, and various stakeholders engaged in vigorous debate and litigation over the appropriate regulation of chemicals in the United States.  In a 2010 brown-bag session (available on podcast), sponsored by the American Bar Association’s Pesticides, Chemical Regulation, and Right-to-Know Committee, Mr. Owens discussed many of the initiatives the Agency was undertaking and some of the challenges it faced as it participated and attempted to shape the debate. 

In a letter to EPA staff announcing his resignation, Mr. Owens said:

“I am writing to tell you that, after more than two years of working closely with all of you to protect Americans’ health and environment, I have made the difficult decision to leave EPA. My last day in the office will be November 30, 2011.
As many of you know, my family has remained in Arizona while I have been working at EPA headquarters in Washington. Although I have been able to get home to see my family periodically, I have essentially been away from them for more than two years. After a lot of hard thinking, we have decided that it is time for me to come home. My wife needs her husband; my sons need their father; and I need them.
While I am very happy that I will be back with my family, I will miss all of you greatly. It has been a true privilege to work with so many incredibly talented and dedicated people who are doing so much to protect the health and safety of the American people and our environment.
I am extremely grateful to Lisa Jackson for her wonderful friendship and the remarkable vision and leadership she provides to this Agency. We are truly fortunate that she is EPA’s Administrator.
As I said earlier, I will continue working alongside you all through November 30. Administrator Jackson will share additional information about the transition process shortly.
In closing, let me thank you so much for the friendship and support you have given me during my time at EPA. Please know how much I appreciate you and all that you are doing for our country.”


Upcoming Event: Chemical Regulation in Canada – Lessons for U.S. Reforms


Readers attending the ABA’s meeting in Toronto in August may be interested in the following event concerning the Canadian system for regulating industrial chemicals and lessons that system may offer the United States as it debates TSCA Reform.  A short description is embedded below, and more information about the annual meeting is available here.  The list of speakers is impressive, so the event should prove worth the time investment. 

3:45 p.m. to 5:15 p.m.

Chemical Regulation in Canada—Lessons for U.S. Reforms

Room 801A, 800 Level, MTCC, South Building

Everyone agrees that chemical regulation in the US needs to be updated. Industry, NGOs and the EPA all find fault with TSCA, the 1976 law that still governs the process. The EU and Canada are both implementing new, ambitious programs that provide models and cautionary experiences for US reforms. The EU’s REACH program has been widely criticized for needless expense and complexity and for producing slow results. The Canadian Environmental Protection Act, by contrast, is frequently cited by stakeholders as a better approach. This program will focus on features of CEPA that make it apparently more efficient and productive, and explore how compatible those processes would be with US law and expectations regarding transparency, participation and due process.


James Conrad, Washington, D.C.


Joseph Castrilli, Toronto, Ontario, Canada

Mark Duvall, Washington, D.C.

Robert Fishlock, Toronto, Ontario, Canada

Karen Levins, Mississauga, Ontario, Canada

Additional Sponsor:

Section of Environment, Energy, and Resources