The U.S. Environmental Protection Agency (EPA) released on January 4, 2013, the first draft risk assessments developed under the Toxic Substances Control Act (TSCA) Work Plan. This article explains why these assessments are important.

Barack Obama won a decisive victory in the presidential election on 6 November and the forecast for the next four years is clearer now than it was pre-election. This article offers some preliminary observations on what lies ahead regarding domestic chemical management issues at the legislative and regulatory levels.

On August 15, 2012, EPA issued proposed amendments to the significant new use rule (SNUR) for perfluoroalkyl sulfonate (PFAS) chemical substances to add seven PFAS chemical substances that have completed the new chemical review process under the Toxic Substances Control Act (TSCA). EPA has not yet commenced production or import, and to designate (for all listed PFAS chemical substances) “processing” as a significant new use. The agency is also proposing a SNUR for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances with lengths equal to or greater than seven carbons that would designate manufacturing, importing, or processing for use as part of carpets or for treating carpets.

The United States Environmental Protection Agency (US EPA) has taken some bold steps recently to strengthen its authority over existing chemicals -- using its expansive, but much maligned, authority under the Toxic Substances Control Act (TSCA). TSCA is an old statute, and believed by many to be out of date. But in “repurposing” its interpretation of its TSCA authority, US EPA has confirmed that the statute is more than a paper tiger

EPA's recent proposals to apply its Significant New Use Rules (SNUR) authority under the Toxic Substances Control Act (TSCA) to “articles” raises legal and policy issues, and presents challenges to EPA and industry. Here is why.

Enforcement actions under the Toxic Substances Control Act (TSCA) are not all that frequent. When they do occur, however, they tend to be memorable. The most recent example involves an action brought by the United States Environmental Protection Agency (US EPA) against Dover Chemical Corporation. On February 7, 2012, the Agency announced that Dover Chemical had agreed to pay a $1.4 million civil penalty for alleged violations of TSCA premanufacture notice (PMN) obligations.

Much may be headed our way this year from the Hill in connection with reform of the Toxic Substance Control Act (TSCA) and chemical initiatives advanced by the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP). The 2012 presidential election cycle is likely to influence any activity by either party or the administration over the next year.

Based on written communications from the EPA’s Office of Pollution Prevention and Toxics, questions have been raised as to the agency’s interpretation of the six chemical categories created under the Toxic Substances Control Act’s Section 8(b)(2) authority. Given the statements from EPA over the past several years and recognizing that reporting under the TSCA Chemical Data Reporting rule commenced Feb. 1 (and runs through June 30, 2012), a critically important question is whether chemical substances that would otherwise fit within the Section 8(b)(2) categories are chemical substances subject to reporting as the category under the CDR.

The United States Environmental Protection Agency (EPA) has announced significant new use rules (SNURs) for 17 chemical substances, including 'infused carbon nanostructures (generic)', that had been the subjects of pre-manufacture notices (PMNs). Now enshrined as part of the Toxic Substances Control Act (TSCA),'this action requires persons who intend to manufacture, import, or process any of these 17 chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.

The U.S. Environmental Protection Agency (EPA) released on March 20, 2012, proposed significant new use rules (SNUR) that would require companies to report all new uses of five groups of chemicals, including domestic and imported products and articles. This would give EPA the opportunity, if warranted, to prohibit or limit the activity. The chemicals, which were part of the EPA's Chemical Action Plans from 2009 through 2011, are polybrominated diphenylethers (PBDE), hexabromocyclododecane (HBCD), benzidine dyes, short-chain chlorinated paraffins (SCCP), and di-n-pentyl phthalate (DnPP). This column summarizes key points in the proposals.

If anyone is thinking big penalties under the Toxic Substances Control Act (TSCA) are a thing of the past, think again. On Feb. 7, 2012, EPA announced that the Dover Chemical Corp. has agreed to pay a $1.4 million civil penalty for the unauthorized manufacture of chemical substances at facilities in Dover, Ohio, and Hammond, Ind. The settlement resolves alleged violations of TSCA premanufacture notice (PMN) obligations for the production of various chlorinated paraffins. According to EPA, the company produces the “vast majority” of chlorinated products sold in the United States. As part of the settlement, the company has ceased manufacturing short-chain chlorinated paraffins (SCCP), which have persistent, bioaccumulative and toxic (PBT) characteristics.

The U.S. Environmental Protection Agency (EPA) recently announced that Dover Chemical Corporation has agreed to pay a $1.4-million civil penalty for alleged violations of Toxic Substances Control Act (TSCA) premanufacture notice (PMN) obligations for the production of various short-chain chlorinated paraffins (SCCP). This column explains why this enforcement action is noteworthy.

Most would agree that legislative reform of the U.S. Toxic Substances Control Act (TSCA) is long overdue. Few agree on what to change and how best to proceed. If you throw in the 2012 presidential election, you have gridlock. Commerce marches on, however, and with the Environmental Protection Agency reinventing TSCA implementation in innovative and effective ways, Reach setting the new global tone, and California creating a new template for sustainable consumer products, TSCA reform is at risk of becoming a distracting afterthought. Stakeholders must develop new strategies to survive and flourish in these fast-changing times.

Based on written communications from the Environmental Protection Agency’s Office of Pollution Prevention and Toxics, questions have been raised as to the agency’s interpretation of the six chemical categories created under Toxic Substances Control Act Section 8(b)(2) authority. Chemicals long considered part of these well-established categories identified decades ago are complex reaction products that fall under the TSCA Section 8(b)(2) category listing. Given the statements from EPA over the past several years and recognizing that reporting under the TSCA Chemical Data Reporting (CDR) rule is just around the corner, a critically important question is whether chemicals that would otherwise fit within the Section 8(b)(2) categories are subject to reporting under the CDR. This article examines this question by considering the regulatory history and guidance, prior reporting that has occurred, and business issues associated with the question.

We offer our thoughts on what may be headed our way in 2012 with regard to reform of the Toxic Substances Control Act (TSCA) and chemical management initiatives from the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP).

The US Environmental Protection Agency (EPA) proposed on December 28, 2011, significant new use rules (SNURs) for 17 chemical substances that were the subject of premanufacture notices (PMN), including seven substances with the term carbon nanotube (CNT) and seven substances with the term fullerene in their respective names. These 14 substances are subject to consent orders under Section 5(e) of the Toxic Substances Control Act (TSCA). This column provides background on, and the implications of, these proposed SNURs.

Chemical data reporting under the Toxic Substances Control Act (TSCA) just got a lot harder. That’s because on August 16, 2011, the United States Environmental Protection Agency (US EPA) issued its final Chemical Data Reporting (CDR) Rule, previously referred to as the Inventory Update Reporting (IUR) Rule.

On Aug. 18, 2011, EPA rolled out its new approach for identifying priority chemicals for review and assessment under the Toxic Substances Control Act (TSCA). EPA invited public input on its Discussion Guide: Background and Discussion Questions for Identifying Priority Chemicals for Review and Assessment (Discussion Guide), which is available at www.epa.gov/opptintr/existingchemicals/pubs/chempridiscguide.html, and convened a webinar on Sept. 7, 2011 to review the document.

Several key issues have emerged as pivotal in ongoing efforts to reform TSCA. Progress on these complex issues is central to the success of TSCA reform. On July 21, 2011, ELI convened a panel of experts to examine the central issue of whether and what standard of safety should replace TSCA’s current “unreasonable risk” standard for regulating chemicals. Topics addressed included: hazard/exposure/risk criteria; burden of proof; judicial review of Agency decisions; sensitive populations; cost-benefit analysis; and application of the safety standard to new materials/technologies.

On August 16, 2011, the U.S. Environmental Protection Agency (EPA) issued the final Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) Rule, previously referred to as the Inventory Update Reporting (IUR) Modifications Rule. The CDR Rule expands the IUR to enable EPA to collect information on the manufacturing (including importing), processing, and use of commercial chemical sub­ stances and mixtures on the TSCA Chemical Substance Inventory (Inventory). This article provides highlights of the final rule.

The U.S. Environmental Protection Agency’s use of its authority under the Toxic Substances Control Act is expanding. Its use of TSCA Section 5 ‘‘significant new use rule’’ (SNUR) authority is clearly on the increase, as most recently demonstrated by the important role that significant new use rules have in Chemical Action Plans. This article describes SNURs, their issuance and legal background, and a few key issues of which regulated entities need to be aware in responding to a proposed or promulgated SNUR.
 

Embracing new social media tools, the U.S. Environmental Protection Agency on Aug. 18, 2011, invited stakeholders to provide feedback on its new approach for identifying priority chemicals for review and assessment under the Toxic Substances Control Act (TSCA). Noting that the EPA’s online discussion forum will remain open until Sept. 14, 2011, the EPA invited public input on its “Discussion Guide: Background and Discussion Questions for Identifying Priority Chemicals for Review and Assessment” (available at http://www.epa.gov/opptintr/existingchemicals/pubs/chempridiscguide.html). The EPA has also scheduled a webinar on Sept. 7, 2011, to review and consider the Discussion Guide.

The U.S. Environmental Protection Agency (EPA) issued on August 16, 2011, the final Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) Rule, previously referred to as the Inventory Update Reporting (IUR) Modifications Rule. More information is available at http://www.epa.gov/cdr/. Set forth below are key components of the CDR Rule, how reporting will change from prior IUR reporting, and potential issues.

The U.S. Environmental Protection Agency announced on Aug. 2, 2011, the final Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) Rule, previously referred to as the Inventory Update Reporting (IUR) Modifications Rule. Proposed revisions to the rule were the subject of considerable debate, which helps explain the rule’s long (nearly a year and a half) gestation period and extensive review by the Office of Management and Budget. The rule was published on Aug. 16 in the Federal Register (76 Fed. Reg. 50816) and becomes effective on Sept. 15, 2011.

The U.S. Environmental Protection Agency (EPA) issued on July 26, 2011, an advance notice of proposed rulemaking (ANPR) concerning testing of bisphenol A (BPA). The notice applies to EPA’s chemical action plan issued under the Toxic Substances Control Act (TSCA) on BPA in March 2010. The ANPR shows the EPA is moving forward, sending a strong message that the agency isn't backing off plans to regulate BPA under TSCA, or any other chemical action plans.

The federal Toxic Substances Control Act (TSCA) has remained largely unchanged since its adoption in 1976, some 35 years ago. Congressional inaction has not gone unnoticed by state governments, which are increasingly dismayed by their federal counterpart’s seeming indifference to the public’s demand for stricter chemical controls and its growing distrust of federal chemical-control measures. As a result, states are taking matters into their own hands by adopting laws, resolutions, and related chemical-control measures.

On April 14, 2011, Senator Lautenberg (D-NJ) introduced the Safe Chemicals Act of 2011 (S. 847) to modernize the Toxic Substances Control Act (TSCA). Lautenberg initiated similar legislation, S. 3209, in the 111th Congress. Below is a summary of key differences between Lautenberg's S. 847 and S. 3209.

On April 14, Sen. Frank R. Lautenberg, D-N.J., introduced the Safe Chemicals Act of 2011, which is intended to modernize the Toxic Substances Control Act to require chemical companies to demonstrate the safety of industrial chemicals and the U.S. Environmental Protection Agency to evaluate safety based on the best available science.

On April 14, 2011, Senator Frank R. Lautenberg (D-NJ) introduced the Safe Chemicals Act of 2011. The bill is intended to amend and modernize the Toxic Substances Control Act (TSCA) to require chemical companies to demonstrate the safety of industrial chemicals and the U.S. Environmental Protection Agency (EPA) to evaluate safety based on the best available science. The bill is co-sponsored by Senators Amy Klobuchar (D-MN), Charles Schumer (D-NY), and Barbara Boxer (D-CA).

While debate continues to swirl around whether, and to what extent, the Toxic Substances Control Act (TSCA) needs retooling, just about everyone agrees that the U.S. Environmental Protection Agency (US EPA) needs more information on chemical production, use, and exposure in order to make informed decisions about chemical risk management. Most also agree that TSCA could be put to greater use for these purposes.

The U.S. Environmental Protection Agency (EPA) proposed important revisions to the Toxic Substances Control Act (TSCA) Inventory Update Rule (IUR). This column explains why chemical manufacturers and other stakeholders must be aware of the proposal and prepare now for its implications.

On April 15, 2010, Senator Frank R. Lautenberg (D-NJ) released the text of the Safe Chemicals Act of 2010, S. 3209 (SCA),1 which is intended to address the “core failings” of the Toxic Substances Control Act (TSCA).

The Toxic Substances Control Act (TSCA) allows the U.S. Environmental Protection Agency (EPA) to keep a list of chemicals that present or may present ‘‘an unreasonable risk of injury to health or the environment.’’ This authority has not been used since TSCA was enacted in 1976. In April, EPA said it intends to propose a rule to add a category of eight phthalates, a category of polybrominated diphenyl ethers, and bisphenol A to such a list. In this article, the authors explore EPA’s authority under Section 5(b)(4) of the TSCA to create a ‘‘chemicals of concern’’ list and discuss legal and policy issues that may arise.

James V. Aidala began working with the Environmental Protection Agency (EPA) as a college intern in the Office of Pesticide Programs; he returned as a policy analyst in the new Office of Pesticides and Toxic Substances (OPTS) after graduate school. From Aidala’s perspective, there was much uncertainty in the early years of Toxic Substances Control Act (TSCA), in part due to challenges with the law’s specificity regarding polychlorinated biphenyls and, later, asbestos and lead, and in part due to logistical, organizational, and legal difficulties in the early years of TSCA. He also felt that the Reagan Administration was fatal to a cohesive toxics program.

A Recent co-authored paper discussed a number of fundamental changes in U.S. regulation of commercial chemicals that should be considered in revising the Toxic Substances Control Act. As discussed in that paper, while the Environmental Protection Agency under TSCA has broad authority to require testing and reporting of hazard and exposure information on existing chemicals via rulemaking, deploying these authorities have proven cumbersome and inadequate for dealing effectively with the thousands of chemicals in commerce.

Late last December, U.S. Environmental Protection Agency (EPA) Administrator Lisa P. Jackson announced action plans on phthalates, long-chain chlorinated paraffins (LCCPs), and short-chain chlorinated paraffins (SCCPs). The four action plans are the first of many, as EPA intends to issue eight more or so in 2010. This EPA initiative announces actions that are almost breathtaking in scope, and its development and implementation of the action plan items will set a number of new precedents -- and possibly shape future legislative proposals -- that industry will need to participate in and monitor closely.

As you may know, twice each year the U.S. Environmental Protection Agency (EPA) publishes a detailed listing of all matters on which it is working. The document is referred to as the Semiannual Regulatory Agenda, and is published each spring and fall. The most recent spring issue was published on May 11, 2009.

The EPA's recently released paper, TSCA Inventory Status of Nanoscale Substances -- General Approach, is important for developers of nanotechnologies. Nanomaterials that meet the Toxic Substances Control Act (TSCA) definition of "chemical substance" are subject to TSCA reporting requirements because they may exhibit properties different from the same substances in the bulk scale. A chemical substance means, in relevant part, "any organic or inorganic substance of a particular molecular identity." 

The EPA's recently released paper, TSCA Inventory Status of Nanoscale Substances -- General Approach, is important for developers of nanotechnologies. Nanomaterials that meet the Toxic Substances Control Act (TSCA) definition of "chemical substance" are subject to TSCA reporting requirements because they may exhibit properties different from the same substances in the bulk scale. A chemical substance means, in relevant part, "any organic or inorganic substance of a particular molecular identity." 

On July 12, 2007, the U.S. Environmental Protection Agency (EPA) published in the Federal Register three separate notices related to the long-awaited Nanoscale Materials Stewardship Program (NMSP) under the Toxic Substances Control Act (TSCA). All of the notices and accompanying documents are available online.

The federal law that regulates new and existing chemical substances, including engineered nanoscale chemical substances, is the Toxic Substances Control Act (TSCA). While there is much debate over how the U.S. Environmental Protection Agency (EPA) should deploy its significant TSCA authority to address potential risks to human health and the environment posed by engineered nanoscale materials, there is no doubt that EPA is already doing so. This article provides a general overview of TSCA as it relates to new and existing chemical substances, and discusses how EPA may go about discharging its significant TSCA authority with respect to engineered nanoscale substances. 

The U.S. Environmental Protection Agency (EPA) National Pollution Prevention and Toxics Advisory Committee (NPPTAC) forwarded to EPA Administrator Stephen L. Johnson on November 22, 2005, its document entitled Overview of Issues for Consideration by NPPTAC. The Overview of Issues document sets forth NPPTAC’s “analysis and views” on a framework for a voluntary program on existing engineered nanoscale materials. The framework is intended to complement the new nanoscale chemicals requirements promulgated under the Toxic Substances Control Act (TSCA).

In a May 10, 2005, Federal Register notice, EPA announced, in an understated way, its decision to convene a public meeting on 'nanoscale materials.' The meeting notice represents the Agency's first public foray into harnessing some of nanotechnology’s promise within a regulatory framework created almost three decades ago with the enactment of the Toxic Substances Control Act (TSCA).