Articles

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.