Articles

On September 28, 2011, the U.S. Environmental Protection Agency (EPA) published its final guidance on the weight-of-evidence (WoE) analysis it will use to evaluate the results of data submitted in response to test orders issued for Tier 1 screening under the Endocrine Disruptor Screening Program (EDSP). What follows is a brief overview of the Final WoE Guidance, which is available at http://www.regulations.gov....

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...

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...

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...

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....

On 14th July 2011, the Senate Committee on Commerce, Science, and Transportation’s Science and Space Subcommittee held a hearing on national nanotechnology investment. The hearing was held to examine the potential of nanotechnology, federal initiatives to coordinate research investments, barriers to commercialization, possible environmental and health risks, and steps Congress can take to improve the return on federal nanotechnology investments as the Committee works on drafting a...

On June 9, 2011, the Office of Science and Technology Policy (OSTP) released principles specific to the regulation and oversight of nanotechnology applications. The principles are intended to guide the development and implementation of policies, as described in “U.S. Decision-Making Concerning Regulation and Oversight of Application of Nanotechnology and Nanomaterials.” This column discusses the principles and outlines their role in the governance of nanotechnology in the United States....

For the manufacturing work force, selecting and requiring the use of personal protective equipment (PPE) is one of the most important elements of assuring a safe and healthful work environment. What PPE to wear, who pays for it and how to determine which is the right PPE to protect against a known hazard in the workplace are all critically important issues, both from the perspective of an employee’s personal safety and an employer’s freedom from...

On June 17, 2011, the U.S. Environmental Protection Agency released a much-anticipated notice describing possible approaches for obtaining information on the potential presence of nanoscale materials in registered pesticide products....

For the manufacturing work force, selecting and requiring the use of personal protective equipment (PPE) is one of the most important elements of assuring a safe and healthful work environment. What PPE to wear, who pays for it and how to determine which is the right PPE to protect against a known hazard in the workplace are all critically important issues, both from the perspective of an employee’s personal safety and an employer’s freedom from...

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...

On June 9, 2011, the Office of Science and Technology Policy (OSTP) announced that the White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) has developed a set of principles specific to the regulation and oversight of applications of nanotechnology. The principles are intended to guide the development and implementation of policies, as described in the title “U.S. decision-making concerning regulation and oversight of nanotechnology and nanomaterials”...

The European Union’s REACH regulation is a complex chemical management regulation intended to replace approximately 40 previously existing legal instruments with a single EU regulatory scheme for all chemical substances (both new and existing substances). It also creates a data compensation scheme for entities that must rely upon studies another entity generated to complete their registration for a particular chemical substance. This article provides background on REACH registration, data...

On May 19, 2011, the Office of the U.S. Trade Representative (USTR) and the Office of Information and Regulatory Affairs (OIRA) jointly issued a memorandum to U.S. departments and agencies highlighting the importance of regulatory transparency and openness to promoting international trade. The memorandum telegraphs the Administration’s renewed emphasis on the significant role international collaboration has in domestic policy development....

As nano aficionados know, last October the Australian Chemical Gazette included a notice that the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) announced that it was introducing new administrative processes for the notification and assessment of industrial nanomaterials that are considered to be “new” chemicals. The new administrative provisions were effective on January 1, 2011, and apply to any new chemical that falls under the working definition of...

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, 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)....

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, the House Science, Space, and Technology Subcommittee on Research and Science Education held a hearing entitled ‘Nanotechnology: Oversight of the National Nanotechnology Initiative and Priorities for the Future.’ According to the hearing charter, the purpose of the hearing was to examine the National Nanotechnology Initiative (NNI) and address the Nation’s research and development priorities for the future....

On the 7th March 2011, the US National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention announced that it sought comments and information on the types of hazard identification and risk management research that it should consider in updating the NIOSH 2009 nanotechnology strategic plan. What follows is an explanation of why NIOSH’s continuing research is essential, and why stakeholders are urged to help shape the content and...

At the April 7-8, 2011, CropLife America and RISE (Responsible Industry for a Sound Environment) Spring Conference in Washington, D.C., the future of nanotechnology and its applications in the agricultural sector was the subject of a panel discussion....

On May 19, 2011, the American Bar Association (ABA) Section of Environment, Energy, and Resources Committee on Pesticides, Chemical Regulation and Right-to-Know will convene a webinar on global nanotechnology governance initiatives. The program will explore the new and creative applications of existing regulatory tools and governance approaches to address the potential risks of nanotechnologies, implement new risk assessment approaches to evolving technologies, and maximize the potential...

On March 29, the U.S. Senate Committee on Environment and Public Works held a hearing entitled “Oversight Hearing on Disease Clusters and Environmental Health.” Committee Chairwoman Barbara Boxer, D-Calif., and Senator Mike Crapo, R-Idaho, ranking member of the Superfund, Toxics and Environmental Health Subcommittee, introduced the Strengthening Protections for Children and Communities from Disease Clusters Act (S. 76), also known as Trevor’s Law, on Jan. 25, 2011....

Several types of nanoscale materials recently dodged a bullet as the European Parliament declined to ban nanosilver and long multi-walled carbon nanotubes in the European Union’s Directive on the Restriction and Use of Certain Hazardous Substances in Electrical and Electronic Equipment, (more commonly known as “RoHS”). For reasons not entirely clear, detractors of these nanoscale materials tried, and failed, to ban them outright in the RoHS Recast initiative. For nano stakeholders, while...

A March 11, 2011, memorandum from the White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) sets forth the Obama Administration’s principles for regulation and oversight of emerging technologies, including nanotechnology. One might wonder why a memorandum was thought necessary, and indeed, according to some U.S. trade press reports, the memorandum reportedly was not especially welcome news in some NGO camps. According to these reports, the memorandum reflects...

The U.S. Environmental Protection Agency (EPA) reports that more than 200,000 boilers, process heaters and incinerators will be impacted by a set of Clean Air Act regulations issued on February 21, 2011. Since EPA first proposed the Maximum Achievable Control Technology (MACT) rules in April 2010, several industry sectors have argued the costs of implementing the rules would pose an unreasonable burden on businesses. In response to this criticism, EPA revised the rules in a...

...

On the 10th March 2011, the Project on Emerging Nanotechnologies (PEN) announced that it had updated its nanotech consumer products inventory, and that it continues to grow to include over 1,300 manufacturer-identified, nanotechnology-enabled products that have entered the commercial marketplace around the world. The most recent update to the group’s five-year-old inventory reflects the continuing use of the nanoscale materials in everything from conventional products like sports equipment...

The National Nanotechnology Initiative (NNI) held a joint workshop in Washington, D.C., entitled ‘US-EU Bridging Nano EHS Research Efforts’ (10th – 11th March 2011). The workshop was intended to continue the robust dialogue between the United States (US) and European Union (EU) on issues of shared concern pertinent to nanotechnology research initiatives....

On December 17, 2010, the US National Organic Program (NOP) voted to accept the recommendation of the US National Organic Standards Board (NOSB) to prohibit engineered nanomaterials from the production, processing, and packaging of certified organic products. The decision was made with little fanfare, but has big implications. ...

On May 19, 2011, the American Bar Association (ABA) Section of Environment, Energy, and Resources (SEER) Pesticides, Chemical Regulation, and Right-to-Know Committee will present a half-day webinar program on nano governance. Nanotechnology Industries Association’s intrepid leader, Dr. Steffi Friedrichs, is scheduled to present at this important program....

After more than three years of discussion, research, review, and debate, the United States Federal Trade Commission (US FTC) released proposed revisions to its Guides for the Use of Environmental Marketing Claims (the “Green Guides”) in late 2010. The Green Guides provide FTC “guidance” on what is and is not appropriate in the ever-fluid area of environmental marketing. They are designed to help product marketers avoid making false and misleading environmental claims that might violate...

On February 15, 2011, the Occupational Safety and Health Administration (OSHA) issued a revised directive that provides enforcement guidance on determining whether employers have complied with OSHA’s personal protective equipment (PPE) standards. The Enforcement Guidance for Personal Protective Equipment in General Industry, CPL 02-01-050, is the latest word from OSHA on PPE, and an important document for employers and employees alike....

The 2010 Congressional elections will likely significantly impact policy and legislative developments in the U.S. Environmental Protection Agency’s (EPA) regulation of chemicals and pesticides. The decline in the number of elected House Democratic members will make for some significant differences in EPA’s budget, legislative proposals and general operations. Meanwhile, some newly elected senators stridently oppose government expansion and want to rein in federal deficit spending,...

The U.S. Occupational Safety and Health Administration (OSHA) is tackling a major source of industrial injuries — slips, trips and falls on workplace surfaces. On May 24, OSHA proposed significant revisions to Subparts D and I of the general industry standards dealing with walking-working surfaces and personal protective equipment (PPE), respectively. This column outlines the reasons why OSHA believes changes are needed to protect workers, and key revisions to these standards....

The new Republication-led House of Representatives has expressed its concerns with what it refers to as the adverse impact of regulations on jobs and the economy....

The United Nations’ Strategic Approach to International Chemicals Management (SAICM) urges each nation to make efforts to reduce hazards associated with the use of chemicals. In response to this request, South Korea recently has taken steps to implement a process for the management of chemicals with the objective of minimizing the harmful effects that substances have on human health and the environment....

Reckitt Benckiser is a manufacturer of a variety of household cleaning and pesticide products, including rodenticides, sold widely under the D-Con brand. In recent years Reckitt Benckiser has formulated rodenticide products using what is known as a “second-generation” anti-coagulant, brodifacoum. The term second-generation refers to the lack of resistance in rodents, which has developed in some cases to earlier, “first-generation” anti-coagulant products, such as warfarin....

The trends established by the Obama Administration will continue despite the Congressional mid-term elections in November....

Domestic laws, their implementing regulations and policies, and government and private-party governance programs are now being carefully reviewed and revised to enhance their utility to manage the potential risks posed by nanoscale materials. Whether existing laws and their implementing programs are adequate to address such risks will continue to inspire debate and legislative and regulatory initiatives for years to come. This article reviews existing legal and governance oversight systems and...

There is an exciting and promising project underway that is being coordinated by the Research Foundation of the International Life Science Institute (ILSI-RF) called the NanoRelease Project....

The U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxic Substances (OPPT) and Office of Pesticide Programs (OPP) were both active with regard to nanoscale materials regulation and policy in 2010. The new year is expected to see comparable activity....

In response to concerns expressed by diverse stakeholders over the final draft of its Safer Consumer Product Alternatives (SCPA) regulations, the California Environmental Protection Agency (CalEPA) has delayed implementation of the regulations, which focus on chemicals and chemical ingredients in consumer products. The net effect of this recent development on the regulation of chemical substances in consumer products in California is uncertain. This column discusses the recent change in plans...

Determining whether the presence of nanoscale materials in chemical substances, mixtures, and articles triggers a disclosure obligation is complicated. The decision turns on a calculus that includes what law applies, what is known about the presence of nanoscale components, what knowledge standard applies, whether and how a nanoscale material is defined, and an entity’s interpretation of disclosure obligations. This article outlines the state of domestic environmental and securities law and...

On December 21, 2010, the California Department of Toxic Substances Control (DTSC) issued a much anticipated data call-in (DCI) for information regarding analytical test methods, and other relevant information, from manufacturers of nano silver, nano zero valent iron, nano titanium dioxide, nano zinc oxide, nano cerium oxide, and quantum dots....

In response to concerns vigorously expressed by diverse stakeholders over the final draft of the Safer Consumer Product Alternatives (SCPA) Regulations, the California Environmental Protection Agency (CalEPA) has effectively delayed implementation of the much-anticipated regulations....

Early in October, the Federal Trade Commission (FTC) released important revisions to its Guides for the Use of Environmental Marketing Claims (Green Guides) to make them easier for companies to use and understand....

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....

New proposed shipping rules that harmonize with international standards will require some study....