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.

TSCA Fines Announced

EPA issued a News Release Monday July 23 announcing fines for violations of TSCA’s recordkeeping and reporting requirements.

The announcement details the following settlements:

  • Haldor Topsoe, Inc., paid $202,779 to settle a complaint that it had violated the 2006 IUR rule for 13 chemical substances.
  • Chemtura Corporation paid $55,901 to settle a complaint that its El Dorado, Arizona facility failed to report two chemicals pursuant to the 2006 IUR rule.
  • Bethlehem Apparatus Company paid a $103,433 to settle a complaint that it had failed to comply with import certification and export notification requirements, and that if also failed to meet 2006 IUR requirements for one chemical substance.

See below for the full News Release.

WASHINGTON – The U.S. Environmental Protection Agency (EPA) has issued complaints seeking civil penalties against three companies for alleged violations of the reporting and recordkeeping requirements under the Toxic Substances Control Act (TSCA). The alleged violations involved the companies’ failure to comply with EPA’s TSCA section 8 Inventory Update Reporting (IUR) regulations, which require companies to submit accurate data about the production and use of chemical substances manufactured or imported during a calendar year. Under TSCA, penalties can be assessed up to $37,500 per day, per violation.

Formerly known as the IUR, the TSCA Chemical Data Reporting Rule requires the collection of information about existing chemicals on the market by requiring periodic reports about the production and use of chemicals to help understand the risks they may pose to human health and the environment. The data collected by EPA is the most comprehensive source of information for chemicals currently in commerce in the U.S.

The reporting deadline for the 2006 IUR rule ended in March of 2007. EPA’s enforcement efforts have led to 43 civil enforcement actions and approximately $2.3 million dollars in civil penalties against companies that failed to report required chemical data information. The reporting deadline for the 2012 submission period of the Chemical Data Reporting Rule is August 13, 2012.

The three most recent cases are against Chemtura Corporation, Bethlehem Apparatus Company, and Haldor Topsoe, Inc., and resulted in penalties totaling $362,113.

The Chemtura Corporation is headquartered in Philadelphia, Pa. and has a facility located in El Dorado, Arizona. In a May 31, 2012 complaint, EPA alleged that the facility failed to report two chemicals pursuant to the 2006 IUR rule and assessed a penalty of $55,901. The company corrected the violations, paid the penalty and a final order was issued by the Environmental Appeals Board (EAB) on June 25, 2012.

During an inspection of the Bethlehem Apparatus Company, located in Hellertown, Pa., EPA found that the facility was in violation of the 2006 IUR Rule for one chemical substance. EPA also determined during the inspection that the company had failed to comply with the export notification requirements as required under TSCA section 12(b) and the import certification requirements as required under TSCA section 13 on a number of occasions for the same chemical substance. The company corrected the violations and paid a $103,433 penalty proposed in a May 31, 2012 complaint.

Haldor Topsoe, Inc., headquartered in Houston, Texas, is subject to a TSCA complaint that was filed on June 20, 2012. The complaint alleged that that the company had violated the 2006 IUR rule for 13 chemical substances. The complaint assessed a proposed penalty of $202,779, which the company paid on July 2, 2012.

More information about the settlements and EPA’s TSCA enforcement program: http://www.epa.gov/compliance/resources/civil/tsca/tscaiur.html

More information about TSCA reporting requirements: http://www.epa.gov/iur/


Phil Moffat to Speak at ASC 2012 Fall Expo on California's Green Chemistry Initiative

Green Chemistry Regulation:

Verdant is pleased to announce that Philip Moffat will be speaking at the Adhesive and Sealant Council’s 2012 Fall Expo in Louisville, Kentucky.  Mr. Moffat will discuss California’s efforts to use regulation to drive “green” innovation in the chemicals and consumer products industries.  His presentation, “California’s Green Chemistry Initiative – A Legal Perspective,” will cover the history of the state’s vaunted initiative, the challenges of implementing it into regulation, the current status of the regulations, as well as their projected legal and other impacts to businesses in California, the United States, and abroad.  The Fall Expo will be held from October 21- 22 at the Louisville Marriott Downtown.  More information is available here.

Verdant Chosen for ABA Team Reviewing Moldova's Draft Chemicals Law


Verdant is pleased to announce that it was selected by the American Bar Association (ABA) to be part of a small team that will provide a legal review of Moldova’s draft law on chemicals, and provide guidance on drafting related legislation.

Verdant founder Philip Moffat said “We are pleased to have the opportunity to assist Moldova’s effort.  Our attorneys are experienced in working with the chemical control laws in most of the major markets around the globe, as well as many smaller ones.  Catherine Lin, who will be Verdant’s leading contributor, is a recognized expert in the field having previously served as in-house counsel at Pfizer on global chemical control and supply chain management issues.”


The growing world-wide commitment to protect human health and the environment from dangerous chemicals and wastes has been a catalyst for action in many countries and sectors. Due to the cross sectoral nature of chemicals and waste management and the interests of various government ministries and other stakeholders in this area, well-coordinated and integrated management approaches at the national level will achieve maximum impact for the limited resources available worldwide, inclusively in the Republic of Moldova. This includes much improved links to the development planning agenda of the country. The analysis of existing mechanisms for inter-ministerial coordination in the sphere of sound management of chemicals reveals a fragmentary approach to chemicals management in different economic branches, which is an issue that will be directly addressed in this project. In this context, the UNDP “Mainstreaming of Sound Management of Chemicals in National Development Planning Processes” project aims to achieve the mainstreaming SMC priorities into national developments plans in order to strengthen country’s foundational capacities for chemicals and waste management thus minimizing the significant adverse effects of these on human health and the global environment.

Aiming at building capacities for formulation and implementation of SMC policies and fostering sustainable forms of development, the project will achieve its objective through the following outputs referring at:

  • Baseline analysis and identification of sound management of chemicals and hazardous waste priorities
  • Economic valuation of selected priorities and designing policy instruments supporting the priority SMC issues
  • Identification of opportunities for integration of SMC within national plans and subsequent mainstreaming of national SMC priorities into national development programs and plans.

The project will build-upon the UNDP-UNEP Partnership Initiative methodology to Integrating sound management of chemicals into MDG-based development planning which is a comprehensive approach to mainstreaming environmental sustainability.

National priority issues in the sphere of chemicals management in the Republic of Moldova were identified and reflected in the First National Profile on Chemicals Management in the Republic of Moldova (2008). The National Program on Sound Management of Chemicals was approved and establishes the main objectives of the sound chemicals management system to 2020. The overall aim of the program lies in developing an integrated system of chemicals management being efficient from technical, economic, social and environmental points of view.

The program further envisages harmonization of national legislations with EU legislations and sets up the necessary legal and institutional framework for establishment of Chemicals Agency in the Republic of Moldova (hereinafter referred to as the Agency). The draft Law on Chemicals will develop an integrated approach for chemicals management including import, production, processing, storage, transport, use, disposal/treatment and recycling and will be in line with the relevant international treaties. In this context, UNDP Moldova seeks to hire an international consultant (hereinafter referred to as the “consultant”) to provide legal support for revision of the draft Law on Chemicals and recommendations on relevant secondary legislation in line with EU Directives in the respective area.