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Tag Archives: EPA

The EPA Inspector General’s Report

The task of the Inspectors General of Federal agencies is to examine "all actions of a government agency or military organization. Conducting audits and investigations, either independently or in response to reports of wrongdoing, the OIG ensures that the agency’s operations are in compliance with the law and general established policies of the government. Audits conducted by the OIG are intended to ensure the effectiveness of security procedures, or to discover the possibility of misconduct, waste, fraud, theft, or certain types of criminal activity by individuals or groups related to the agency’s operation."

At the end of 2011, the Office of the Inspector General (OIG) of the Environmental Protection Agency (EPA) posted Report No. 12-P-0162,"EPA Needs to Manage Nanomaterial Risks More Effectively" to the reports section of its website.

The OIG, in the Introduction to the report, states that the

. . .  purpose of this review was to determine how effectively the U.S. Environmental Protection Agency (EPA) is managing the human health and environmental risks of nanomaterials.

The report notes that

EPA has the statutory authority to regulate nanomaterials. . . . EPA can regulate nanomaterials during their manufacture, formulation, distribution in commerce, use, and/or disposal through the Toxic Substances Control Act (TSCA) . . . nanomaterials in pesticides through the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) . . . . EPA can regulate nanomaterials released into the environment using the Clean Air Act; the Clean Water Act; the Comprehensive Environmental Response, Compensation and Liability Act; or the Resource Conservation …

EPA Extends comment period

Wednesday’s Federal Register carried a notice from the Environmental Protection Agency (EPA) extending the comment period for proposed methods of collecting information regarding the use of nanoscale materials in pesticides published in the Federal Register of June 17, 2011. The original deadline for submitting comments was July 18, 2011. The deadline for submission has been extended to august 17, 2011.

The 30 day extension was requested by four commenters – Croplife America, a trade group repsenting " the developers, manufacturers, formulators and distributors of plant science solutions for agriculture and pest management in the United States", the American Chemical Council, the Chemical Producers and Distributors Association, a trade group "representing the interests of generic pesticide registrants, with a membership that includes manufacturers, formulators, and distributors of pesticide products", and theInternational Center for Technology Assessment, "a non-profit, bi-partisan organization committed to providing the public with full assessments and analyses of technological impacts on society". The comments may beviewed on Regulations.gov.

Information on submitting comments is available from either the original notice or the notice published on Wednesday.…

EPA Requests Public Comment on Obtaining Information Regarding Nanomaterials in Pesticides

On June 17, 2011, the Environmental Protection Agency (EPA) published a notice in the Federal Register announcing that it was seeking "comment on several possible appraoches for obtaining information about what nanoscale materials are present in registered pesticide products. . .  . and its potential effects on humans or the environment. . . ."

Under one approach to collecting this information, EPA would use the authority granted to it by the Federal Insecticide, Fungicide,and Rodenticide Act  (FIFRA) to require applicants to "provide any factual information of which [the applicant] is aware regarding unreasonable adverse effects of the pesticide on man and the environment". If EPA adopts this approach, it would require the inclusion of "such information with applications for registrations of pesticides or pesiticide products containing ‘nanoscale materials’".

Under a different section of FIFRA, EPA would gather information using Data Call-In notices.

EPA is required to collect information regarding pesticides under section 3(a) of FIFRA. Using the information collected, EPA can then determine

1) the validity of the products claims

2) that labelling complies with FIFRA requirements

3) that the pesticide or pesticide product will not cause unreasonably adverse harm to humans or the environment.

EPA "believes that certain information concerning pesticide ingredients" – in this case, nanoscale materials, defined by EPA as (1) between 1 and 100 nanometers, (2) " exhibit unique and novel properties compared to larger particlesof the same material" and (3) has been manufactured or engineered at the nanoscale level to take advantage of those unique or novel properties …

EPA to Issue New Carbon Nanotube Significant New Use Rule

Here is an advance copy of a new multi-walled carbon nanotube significant new use rule being published tomorrow in the federal register.  It applies only to the specific carbon nanotubes that were the subject of PMN P-08-199, and binds anyone who intends to manufacture, import, or process the specific chemical substance.  It is largely consistent with past SNURs and Consent Orders for other CNTs.  For those wondering, "processors" and "processing" is broadly defined under TSCA.  It has been used in the past to include repackaging for commercial purposes, using the material in the manufacturing of new mixtures, and/or the production of articles using the substance.…

Nanoscale Carbon Toxicity Testing Proposal Submitted to EPA

 

 

The NanoSafety Consortium for Carbon just submitted a proposed toxicity testing agreement to EPA under Section 4 of the Toxic Substances Control Act covering a range of nanoscale materials including multi-walled carbon nanotubes, double-walled carbon nanotubes, single-walled carbon nanotubes, and graphene. 

 

Key elements for the curious:

  • The chemical substances to be tested may include representative (i) purified multi-walled carbon nanotubes ranging from 4 to 600 nanometers in diameter and less than 30 micrometers in length; (ii) purified double-walled carbon nanotubes ranging from 1.5 to 4 nanometers in diameter and less than 5 micrometers in length; (iii) purified single-walled carbon nanotubes ranging from .7 to 2 nanometers in diameter and less than 30 micrometers in length; and (iv) purified graphene nanoplatelets in flake/sheet form ranging from .5 nanometers to 100 nanometers thick. All test materials will be purified by the National Institute of Standards and Technology to be at least 99 percent pure. Final test materials will be approved by the EPA and will be selected to adequately represent the constituency of the final signatories to the testing agreement.

 

  • The characteristic for which testing will be conducted is subchronic inhalation toxicity in rodents, or such other toxicity testing as may be approved by EPA to achieve the intent and purpose of the testing agreement. As appropriate, consideration will be given to using in vivo instillation rather than inhalation test methods. Test data will be developed under standards based on TSCA test guidelines in 40 CFR parts 796,

Three US-UK Consortia Receive EPA Grants for Nanotech Research

On February 17 2011, the EPA, in conjunction with the Consumer Product Safety Commission (CPSC) and the UK’s Natural Environmental Research Council (NERC), announced the awarding of $12 million ($5.5 million from the EPA, $500,000 from CPSC, and $6 million from NERC) to three consortia to fund research aimed at providing a greater understanding of potential risks to human health and the environment posed by engineered nanomaterials and their increasing use in a wider variety of products.

The three consortia, the "Consortium for Manufactured Nanomaterial Bioavailability and Environmental Exposure", "Risk Assessment for Manufctured Nanoparticles Used in Consumer Products (RAMNUC)", and "The Transatlantic Initiative for Technology and the Environment", are composed of leading US and UK Universities and research centers, such as Duke University, Carnegie-Mellon University, and Lancaster University. NERC’s $6 million is limited to participating universities and research centers in the UK.  The table below provides more information.

#   

Identifier

Abstract

Principal Investigator

Institution

Grant Representative

Grant Amount

Project Period

RFA

1

R834575 Grant

Consortium for Manufactured Nanomaterial Bioavailability & Environmental Exposure

Colvin, Vicki L. Chipman, Kevin Fernandes, Teresa Klaine, Stephen J. Lead, Jamie Luoma, Sam Stone, Vicki Tyler, Charles Valsami-Jones, Eva Viant, Mark  

Rice University,Clemson University,Edinburgh Napier University,Natural History Museum (London),University of Birmingham,University of California – Davis,University of Exeter

Lasat, Mitch  

$2,000,000  

August 2010 – August 2013  

Environmental Behavior, Bioavailability and Effects of Manufactured Nanomaterials – Joint US – UK Research Program (2009)  

2

R834693 Grant

Risk Assessment for Manufactured Nanoparticles Used

New Nano-specific Regulations Forthcoming from U.S. EPA

This article originally appeared on the National Nanomanufacturing Network’s InterNano website. It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

In its ongoing efforts to guard against potential unintended environmental, health, or safety injuries related to possible exposure to certain nanoscale materials, the US Environmental Protection Agency (EPA) plans to issue three new proposed nano-specific regulations in January 2011. While EPA is already actively regulating certain nanoscale materials which it considers new chemical substances (e.g./ carbon nanotubes, fullerenes, etc.), the new proposed rules will provide EPA with greater latitude in regulating both new and existing nanoscale materials. Manufacturers working with nanoscale materials should keep a very close eye on these new proposed regulations to determine whether they will be required to comply with any of EPA’s final rulings. Additionally, there will be opportunities for public comment and input.

Significant New Use Rule

Advocacy groups have been asking EPA for years to treat nanoscale versions of existing chemical substances as significant new uses of those substances under the Toxic Substances Control Act (TSCA). These types of substances include nanoscale silver, nanoscale TiO2, and nanoscale zinc oxide. Among other things, treating these materials as significant new uses of existing chemical substances would allow EPA to limit their production, require the use of workplace safety measures, require companies to conduct toxicity testing, and require companies to prevent intentional/purposeful releases of the materials to water.

Although its exact parameters have not been released, it appears that EPA intends to issue a proposed significant new …

EPA Releases SNURS Affecting Multi-Walled and Single-Walled Carbon Nanotubes

In the Federal Register for Friday 09/17/2010, the Environmental Protection Agency (EPA), acting under the authority granted to it under section 5(a)(2) of the TSCA, issued as a final rule Significant New Use Rules (SNURS) affecting two chemical substances identified as generic multi-walled and single-walled carbon nanotubes (MWCNTs and SWCNTs respectively). These SNURs are applicable to manufacturers, importers, and processors, who will be required to notify EPA at least 90 days in advance if they intend to use these substances "for a use that is designated as a significant new use by this final rule. . . . EPA believes that this action is necessary because these chemical substances may be hazardous to human health and the environment".

This final rule is the culmination of a process that has taken over a year. EPA had issued a direct final rule in the Federal Register issue of 06/24/2009. This direct final rule affected several chemical substances, including the MWCNTs and the SWCNTs, that had been the subject of various consent decrees issued by EPA. The language of the final rule affecting the MWCNTs read as follows:

Sec.  721.10155  Multi-walled carbon nanotubes (generic).

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as multi- walled carbon nanotubes (PMN P-08-177) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.     (2) The significant new uses are:     (i) Protection in the workplace. Requirements as specified in Sec.  …

EPA Proposes TSCA Inventory Reporting Modifications

In the Federal Register issue of 08/13/2010, the Environmental Protection Agency (EPA) released for public comment a proposed rule that would, if adopted, significantly change the TSCA Inventory Update Reporting (IUR).

The first part of the notice, "Supplementary Information", explains the proposed changes to 40 CFR Parts 704, 710, and 711. The text of the proposed rule follows the Supplementary Information.

In the Supplementary Information, EPA states that it is proposing modifications to the IUR

 to meet four primary goals:     1. To tailor the information collected to better meet the Agency’s overall information needs.     2. To increase its ability to effectively provide public access to the information.     3. To obtain new and updated information relating to potential exposures to a subset of chemical substances listed on the TSCA Inventory.     4. To improve the usefulness of the information reported. EPA believes that expanding the range of chemical substances for which comprehensive information is to be reported and adjusting the specific reported information, the method and

[[Page 49659]]

frequency of collecting the information, and CBI requirements will accomplish these goals.

Reading the Supplemental Information reveals a fifth, unstated goal – the creation of uniform reporting standards that will provide EPA with the information it needs to "identify and take follow-up action on chemical substances that may pose potential risks to human health or the environment" in a more efficent and timely manner, cutting the amount of time EPA staff will need to spend reviewing submitted information, determining if EPA action is required …

EPA Releases Draft Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray

The EPA recently released a draft of its "Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray" which you can download here.  The document is 323 pages long and has 6 chapters: (i) Introduction; (ii) Introduction to Silver and Nanoscale Silver; (iii) Life-Cycle Stages; (iv) Fate and Transport in Environmental Media; (v) Exposure, Uptake, and Dose; and (vi) Characterization of Effects.

In two chapters most pertinent to our readers, the document discusses the possible EHS ramifications of the manufacturing and use of nanoscale silver disinfectants over a wide-range of issues.  Regarding Life-Cycle Stages, the document covers five primary product stages: feedstocks; manufacturing; distribution and storage; use; and disposal.  Similarly, regarding fate and transport in the environment, the document discusses air, terrestrial, and aquatic systems and factors that effect transport and fate in each media.

Overall , the document appears to mirror the approach used in EPA’s prior draft case study on nanoscale titanium dioxide used in drinking water systems and in sunscreens which was published in 2009. 

Written comments on the draft are due to EPA by September 27, 2010.

 …

EPA nanomaterial disclosure policy submitted to OMB for review

Inside Washington’s Inside the EPA newsletter carries an article regarding the EPA’s Office of Chemical Safety and Pollution Prevention submitting for review a notice outlining EPA’s intention to use its existing regulatory authority under the Federal Insecticide, Fungicide & Rodenticide Act (FIFRA) to require that manufacturers of pesticides provide more information to EPA about their use of nanoscale materials in their products.

This proposed notice was discussed at a presentation by William Jordan of EPA’s Office of Pesticide Programs (OPP) to the Pesticide Programs Dialogue Committee and also in a recent GAO report . The notice will also include OPP’s definition of nanomaterials as ingredients containing particles between 1 and 100 nanometers in size.

During his presentation, Mr. Jordan noted that this new policy resulted from concerns expressed by the public about the potential toxic effects of nanoscale materials on the environment and humans. Industry groups and pesticide manufacturers also expressed their concern that the proposed rule could taint all nanomaterials as "adverse" and affect potential future sales of pesticides that include nanomaterials.

The text of the notice is not available from OMB’s Reginfo.gov site. When it does appear in the Federal Register following OMB’s review, it will be discussed and reviewed here.…

EPA Reopens Comment Period for Proposed SNUR for MWCNT

In a notice published in the Federal register on July 28, 2010, the Environmental Protection Agency (EPA) announced that it was adding new information to its public docket EPA-HQ-OPPT-2009-0686 and was reopening the comment period for  a proposed Significant New Use Rule (SNUR) for multiwalled carbon nanotubes (MWCNTS) first published in the Federal Register on February 3, 2010.

The proposed rule requires "persons who intend to manufacture, import, or process the substance" – described elsewhere in the notice as "multi-walled carbon nanotubes(generic)" to "be used as an additive/filler for polymer composites and support media for industrial catalysts" – "for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity". This would give EPA time to assess "risks that may be presented by the intended uses and, if appropriate, to regulate the proposed use before it occurs."

Information regarding submission of comments will be found in the original notice of February 3, 2010.

The "Significant New Use" for the MWCNTS (generic) are described in the Feb. 3, 2010 notice as

certain changes from the use scenario described in the PMN could result in increased exposures, thereby constituting a “significant new use.” EPA has determined that activities proposed as a “significant new use” satisfy the two requirements stipulated in Sec.  721.170(c)(2), i.e., these significant new use activities, “(i) are different from those described in the premanufacture notice for the substance, including any amendments, deletions, and additions of activities …

GAO Provides Recommendations Regarding EPA’s Effort to Regulate Nanomaterials

On Friday, the United States Government Accountability Office issued its Report to the Chairman (Barbara Boxer) of the Committee on Environment and Public Works, US Senate, GAO-10-549:

Nanotechnology: Nanomaterials Are Widely used in Commerce, but EPA Faces Challenges in Regulating Risk.

Highlights from the report follow.  The report confirms speculation that EPA intends to issue certain new rules pertaining to select nanomaterials by the end of 2010.

Background

"EPA has taken a mulitpronged approach to understanding and regulating the risks of nanomaterials, including conducting further research and implementing a voluntary data collection program. Furthermore, under its existing statutory framework, EPA has regulated some nanomaterials but not others. Although the EPA is planning to issue additional regulations later this year, these changes have not yet gone into effect and products may be entering into the market without EPA review of all available information on their potential risk. Moreover, EPA faces challenges in effectively regulating nanomaterials that may be released in air, water, and waste because it lacks the technology to monitor and characterize these materials or the statutes include volume based regulatory thresholds that may be too high for effectively regulating the production and disposal of nanomaterials."

TSCA

"In the fall of 2009, EPA announced it would reconsider the policy described in its January 2008 document, TSCA Inventory Status of Nanoscale Substances — General Approach, and subsequently announced it planned to develop a SNUR to regulate nanoscale versions of conventional scaled chemicals that are already on the TSCA inventory as a significant new …

Nanoscale Carbon: In Vivo Tox Bibliography

The NanoSafety Consortium for Carbon has recently posted a bibliography of in vivo tox studies on its website.  The bibliography is (obviously) a work in progress.  We would greatly appreciate it if our readers would bring to our attention any pertinent articles that are not already on the bibliography.  The articles will be used to inform and guide our attempt in crafting a representative toxicity testing regime with US EPA.  Many thanks in advance for your input.…

EPA Set to Rule on FIFRA Nanosilver Petition in June

Inside EPA reports today that a "senior policy adviser for EPA’s Office of Pesticide Programs, said EPA would issue in June a long-awaited response to a 2008 activist petition asking the agency to regulate nanoscale silver under FIFRA."  The article also mentions that EPA intends to define nanoscale ingredients for FIFRA purposes as "an ingredient that contains particles that have been intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers."…

EPA to Reverse Position on ‘Existing’ Nanomaterials

Last September we predicted that sometime in 2010 EPA would reverse its "distinct molecular identity" approach to determining when and whether nanoscale materials are considered New Chemical Substances requiring premanufacturing notice and approval under the Toxic Substances Control Act (TSCA).   We have been advising clients accordingly. 

Inside EPA is now reporting that "EPA toxics chief Steve Owens" . . . "is expected to announce the shift Feb. 5."

Thus, tomorrow should be an interesting day in nano-regulatory-land.  We will provide our readers with a detailed analysis should EPA in fact reverse itself on this important issue.  Stay tuned . . .…

Australia Considers Proposal for Nano-Regulatory Reform

This article was written by John C. Monica, Jr. and Dr. Diana Bowman and originally appeared on the National Nanomanufacturing Network’s InterNano website earlier today.  It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

Dr. Bowman is a Senior Research Fellow in the School for Population Health at the University of Melbourne and a Visiting Research Fellow in the Department of International and European Law, KU Leuven. Dr. Bowman is also a co-editor, along with Matthew Hull, of the book “Nanotechnology Environmental Health and Safety: Risks, Regulation and Management,” (Elsevier, 2010).

In November 2009, the Australian Government’s Department of Health and Aging (DHA) published a public discussion paper —“Proposal for Regulatory Reform of Industrial Nanomaterials”—in relation to the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), which provides a national system of notification and assessment of industrial chemicals. For the purpose of the scheme, “industrial chemicals” include chemical entities found in, for example, many plastics and paints. And, unlike many jurisdictions, those chemicals found in cosmetic products. The paper provides concrete recommendations for the regulation of both “new” nanoscale chemical substances and “existing” chemical substances in nanoscale formulations, while thoughtfully considering legitimate business needs.

Regarding “new” nanoscale chemical substances, the paper notes that—by legal definition—these substances are those which are not already listed on the Australian Inventory of Chemical Substances and as such are subject to existing regulatory requirements. The paper also notes that several permitting exemptions currently exist for certain uses of chemicals already on the Inventory. As an …

Working Group Makes Important Contribution to EPA’s Scientific Advisory Panel on Nanosilver

This article was contributed by Dr. Rosalinda Volpe, Executive Director, Silver Nanotechnology Working Group (SNWG) and originally appeared on the National Nanomanufacturing Network’s InterNano website earlier today.  It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

On November 3 – 6, 2009 the US Environmental Protection Agency (EPA) held a Scientific Advisory Panel (SAP) meeting in Arlington, Virginia to discuss the “Evaluation of Hazard and Exposure Associated with Nanosilver and Other Nanometal Oxide Pesticide Products.”[1] The meeting was well attended. Over seventy-five people from industry, regulatory, public interest, and academic sectors attended the meeting over three days. EPA received presentations and comments from the SAP panel members during the course of the meeting, as well as six presentations during the Public Comment period, and also received over 560 written comments which can be found on EPA’s website.

One group—The Silver Nanotechnology Working Group (SNWG)[2] —made a detailed presentation[3] to EPA supporting a fundamental regulatory consideration previously overlooked by many in attendance: nanosilver has been rationally manufactured, regulated, and used commercially for over a century with no significant adverse environmental, health, and safety effects. SNWG explained that nanosilver—often called by other names such as "colloidal silver" or "millimicron silver"—has been used in a wide range of consumer applications such as swimming pool treatments and drinking water filters with an established record under FIFRA of regulated and safe use dating as far back as the 1950’s. Thus, SNWG believes that nanosilver is not a “new” material requiring some type of special regulation …

New Edition of Nanotechnology Law Report

New Edition of Nanotechnology Law Report

Inside you will find:

  • EPA Considering New Approach to Nanoscale Materials Under TSCA
  • EPA May Issue Mandatory Data Collection Rule for Nanoscale Materials Under TSCA
  • EPA Takes Aim at Antimicrobial Products Under FIFRA
  • EPA Unveils New Principles for Chemical Management Reform
  • EPA Report on the Use of Nanoscale TiO2 in Water and Sunscreens
  • EPA Withdraws Carbon Nanotube SNURs
  • Press Release: New Contributing Editor for InterNano
  • Virginia CLE presentation: “Insurance, Nanotechnology, and Risk”
  • Nanoparticles and Deaths in the People’s Republic
  • Sweating the Small Stuff
  • Soil Association Cites China Deaths in Renewed Call for Moratorium on Nanotechnology Commercialization
  • Nanotechnology Legislation in the 111th Congress
  • Mapping Nano
  • Flight of the Nanobees

 …

New Article: Examples of Recent EPA Regulation of Nanoscale Materials Under the Toxic Substances Control Act

Nanotechnology Law & Business just published our new article on the EPA’s recent treatment of nanoscale materials under the Toxic Substances Control Act.  An abstract for the article is below and you can find a copy of the article itself here.

Abstract: This article provides a summary of recent (2008-2009) regulatory efforts by the U.S. Environmental Protection Agency under the Toxic Substances Control Act concerning nanoscale materials. These efforts include entering into two consent orders with a manufacturer of carbon nanotubes; issuing four significant new use rules for two siloxane-based nanoparticles and two carbon nanotubes (and then withdrawing the latter two); intimating that new testing and data collection rules will be implemented for certain nanoscale materials; and proposing and/or requiring acute toxicity rat inhalation testing regimes in certain instances. The authors explain these developments in detail and then provide some initial strategic and legal considerations for businesses attempting to navigate this emerging regulatory thicket.

EPA Takes Aim at Anitmicrobial Products Under FIFRA

In this article, we note a couple of recent EPA enforcement actions against manufacturers allegedly making unsubstantiated antimicrobial claims for their products – much like occurred in the IOGEAR computer keyboard/mice episode in 2008.  Although these products do not purport to use nanoscale materials, the alleged claims for these products are similar to those made by manufacturers for certain nano-based antimicrobial products. Thus, our readers may be interested in EPA’s actions.

The EPA issued a press release today stating that the parent company of North Face camping and outdoor gear faces up to $1,000,000 in fines for allegedly making unsubstantiated health-related claims for almost 70 of its shoe products using Agion silver ion technology. The EPA press release states:

“At issue were more than 70 styles of footwear that incorporated an AgION silver treated footbed. The company sold the products making unsubstantiated claims that the footwear would prevent disease-causing bacteria. Specifically, The North Face made the following public health claims about the footwear on-line and on product packaging:  • ‘AgION antimicrobial silver agent inhibits the growth of disease-causing bacteria’ • ‘Prevents bacterial and fungal growth’ • Continuous release of antimicrobial agents”

The fines are being sought by EPA under the Federal Insecticide Fungicide and Rodenticide Act which prohibits unsubstantiated public health claims regarding unregistered products.

From Agion’s website: “Agion technology operates at the surface of a product through the controlled release of silver ions which attack microbes and inhibit their growth in three different ways. We offer a variety of …

EPA Scientific Advisory Panel to Discuss Nanoscale Silver at Public Meeting

A much valued contributor from CyberRegs provided us with the following information from the Federal Register that may be of interest to readers:

There will be a 4-day consultation meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review a set of scientific issues related to the assessment of hazard and exposure associated with nanosilver and other nanometal pesticide products.

DATES: The consultation meeting will be held on November 3 – 6, 2009, from approximately 8:30 a.m. to 5:00 p.m. The consultation meeting will be held at the Environmental Protection Agency, Conference Center, Lobby Level, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA 22202.

Comments. The Agency encourages that written comments be submitted by October 20, 2009 and requests for oral comments be submitted by October 27, 2009. Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

FOR FURTHER INFORMATION CONTACT: Joseph E. Bailey, DFO, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-2045; fax number: (202) 564-8382; e-mail address: bailey.joseph@epa.gov.

 

 …

EPA to Issue Mandatory Data Collection Rule for Nanoscale Materials Under TSCA

Eight months after EPA’s interim report on industry participation (or lack thereof) in its Nanoscale Materials Stewardship Program, EPA’s Toxic Substances Control Act’s ("TSCA") Interagency Testing Committee ("ITC") published a report in today’s Federal Register mentioning that EPA intends to issue a new mandatory data collection rule for nanoscale materials under TSCA Section 8(a):

"EPA intends to develop a proposed TSCA section 8(a) rule to obtain information on the production, uses, and exposures of existing nanoscale materials.  EPA has indicated that it will ensure that the chemicals where there is ITC interest as described in this unit are either included in that action or are otherwise new chemical substances subject to premanufacture notifications (PMN) reporting under TSCA.  EPA also intends to develop a proposed TSCA section 4 rule to develop needed environmental, health, and safety data."

Among other things, TSCA section 8(a) allows EPA to issue a rule requiring the mandatory submission of data regarding:

(A) The common or trade name, the chemical identity, and the molecular structure of each chemical substance or mixture for which such a report is required.

(B) The categories or proposed categories of use of each such substance or mixture.

(C) The total amount of each such substance and mixture manufactured or processed, reasonable estimates of the total amount to be manufactured or processed, the amount manufactured or processed for each of its categories of use, and reasonable estimates of the amount to be manufactured or processed for each of its categories of use or …

EPA Report on the Use of Nanoscale TiO2 in Water and Sunscreens

Last Friday, EPA’s Office of Research and Development announced in the Federal Register a 45 day comment period for its new draft case study on the use of nanoscale TiO2 in water and sunscreens:

"Nanomaterial Case Studies: Nanoscale Titanium Dioxide in Water Treatment and in Topical Sunscreen"

FR 74,146 at 38188 (July 31, 2009).  The report focuses on two specific applications of nanoscale titanium dioxide (nano-TiO2): (i) as an agent for removing arsenic from drinking water, and (ii) as an active ingredient in topical sunscreen. The draft report is divided into five chapters:

  1. Introduction
  2. Life Cycle Stages
  3. Fate and Transport
  4. Exposure – Dose Characterization
  5. Characterization of Effects

The report is formidable in length, scope, and detail.  For those looking for some quick highlights, the report provides a great series of summaries of the existing TiO2 environmental, health, and safety literature.  For example:

  • Table 4-4 presents an overview of approximately 25 existing TiO2 skin absorption/penetration studies dating back to 1997;
  • Table 5-3 provides a summary of nano-TiO2 ecological effects; and
  • Tables 5-4 through 5-6 provide a summary of health effects of nano-TiO2 particles in mammalian animal models via dermal, oral, and respiratory exposure routes.

EPA notes that the "document is not intended to serve as a basis for risk management decision in the near term on these specific uses of nano-TiO2."  Rather, its focus is on developing necessary data for "future assessment efforts." Specifically, the "document is a starting point to determine what is known and what needs to be known about selected …

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