Articles

Since the discovery of fullerenes in 1985, the scientific and business communities have been exploring possible commercial applications for these intriguing materials. This article will explore one such application, the use of fullerenes in skin creams. We will discuss the perceived advantages of such use, the concerns expressed regarding risks to health and the environment from fullerenes in skin cream, and the research reported to date on cosmetic usage. The article will conclude with a...

On April 26, 2012, the Obama Administration released its National Bioeconomy Blueprint, which is intended to provide a comprehensive approach to harnessing innovations in biological research to address national challenges in health, food, energy and the environment. In a related development, the U.S. Department of Agriculture (USDA) proposed on May 1, 2012, amendments to 7 C.F.R. Part 3201, Guidelines for Designating Biobased Products for Federal Procurement.

The BioPreferred Program was established by the Farm Security and Rural Investment Act of 2002, as amended by the Food, Conservation and Energy Act of 2008. It is intended to increase federal procurement of biobased products, promote rural economic development, create new jobs, and provide new markets for farm commodities. The USDA manages the program.

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...

On October 31, 2011, the California Department of Toxic Substances Control (CDTSC) released an “informal draft” of its Safer Consumer Products Regulations. The draft does a good job of outlining how CDTSC intends to implement key mandates contained in the state’s Green Chemistry Initiative, which directs regulators to evaluate safer alternatives to chemicals that are believed to be toxic. This “Washington Watch” column summarizes key provisions of this precedent-setting, game-changing...

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...

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...

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...

On Oct.17, 2.011, the U.S. Environmental Protection Agency (EPA) announced its decision to lift the administrative stay of the Emergency Planning and Community Right-to-Know Act (EPCRA) Section 313 toxic chemical release reporting requirements for hydrogen sulfide (H2S) (CAS No.7783 6-4). The decision, which is not without controversy, has important implications for any industry sector that emits H2S.

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...

On December 19, 2011, the European Chemicals Agency (ECHA) announced that it added 20 substances of very high concern (SVHC) to the Candidate List, which now includes 73 substances.

On January 26, 2012, the Natural Resources Defense Council (NRDC) sued the U.S. Environmental Protection Agency (EPA) for approving a pesticide product containing nanosilver under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This article summarizes the lawsuit, explains what’s at stake, and discusses the lawsuit’s implications.

In August 2010, EPA announced that it was considering allowing the Swiss company HeiQ Materials Ag to enter the U.S. market with a new nanosilver pesticide and textile preservative, HeiQ AGS-20. On Dec. 1, 2011, the EPA issued a conditional registration for a pesticide product.

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...

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 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.”

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.

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 responding to a...

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 in the Federal...

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 allegations of non-compliance. Eliminating the...

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 allegations of non-compliance. Eliminating the...

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" that occur at...

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.