Articles

The U.S. Food and Drug Administration’s (FDA) approach to nanotechnology is the subject of intense interest for at least three reasons. First, many promising and visible applications of nano-technology include cosmetics, sunscreens, pharmaceuticals, dietary supplements, and medical devices. These products are subject to FDA jurisdiction under the Federal Food, Drug, and Cosmetic Act (FFDCA). Second, FDA faces unique challenges in regulating products of nanotechnology be-cause of the...

On the 21st of December 2011, a U.S. coalition of nonprofit consumer safety and environmental groups filed a lawsuit against the U.S. Food and Drug Administration (FDA) for alleged failure to regulate what the coalition deems health and environmental risks stemming from nanotechnology-enabled products put on the market. The coalition was led by the International Center for Technology Assessment (ICTA) and represents the following plaintiffs: Friends of the Earth, Food and Water Watch, the Center...

On the 21st of December 2011, a U.S. coalition of nonprofit consumer safety and environmental groups filed a lawsuit against the U.S. Food and Drug Administration (FDA) for alleged failure to regulate what the coalition deems health and environmental risks stemming from nanotechnology-enabled products put on the market. The coalition was led by the International Center for Technology Assessment (ICTA) and represents the following plaintiffs: Friends of the Earth, Food and Water Watch, the Center...

Consumer product manufacturers are challenged today as never before. Materials selection for consumer products invites a dizzying range of considerations: Are the chemicals hormone disruptors, carcinogens, or persistent, bioaccumulative, or toxic? What toxicogenomic biomarkers might make the product the next celebrity tort case? What labeling requirements apply? What are the implications of genetic variations among the demographic to which the product is to be marketed? These considerations, in...

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,...

On October 31, 2011, the California Department of Toxic Substances Control (DTSC) released an informal draft of their Safer Consumer Products Regulations (SCPR). The proposal came after the California Secretary for Environmental Protection instructed DTSC to stop issuing proposed regulations and to instead “take additional time to be responsive to the concerns raised and revisit the proposed regulations.”...

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The U.S. Environmental Protection Agency (EPA) proposed on December 28, 2011, Significant New Use Rules (SNURs) (i.e. 76 Fed. Reg. 81447) for 17 chemical substances that were the subject of Premanufacture Notices (PMNs), including seven substances with the term carbon nanotube (CNT) and seven substances with the term fullerene in their respective names....

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....

The U.S. Environmental Protection Agency (EPA) published 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. 76 Fed. Reg. 50816. The rule authorizes EPA to collect and disclose information on the manufacturing, processing, and use of commercial chemical substances and mixtures listed on the TSCA Inventory. The CDR Rule also sets the upcoming submission period from...

According to the press release “EPA Announces Conditional Registration of Nanosilver Pesticide Product” published by the US Environmental Protection Agency (EPA) on the 1st of December 2011, the EPA granted a four-year conditional approval for a pesticide containing a nanomaterial. The pesticide contains the active ingredient nanosilver, known to have antimicrobial properties....

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....

The U.S. Environmental Protection Agency (EPA) announced on December 1, 2011, that it granted a conditional registration for a pesticide product containing nanosilver as a new active ingredient. This is a momentous regulatory decision and very good news for supporters of nanopesticides....

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;...

In addition to the definition of nanomaterials, at the REACH Conference on the 23rd September 2011 held in Brussels, the participants discussed the implications of REACH as concerns nanomaterials....

On October 31, 2011, the National Toxicology Program (NTP) published a notice inviting comments on its proposed Report on Carcinogens (RoC) review process and announcing a public listening session to receive oral comments. This is good news, as I’ll explain....

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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...

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...

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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....