Nanotechnology Lawyer & Attorney : Porter Wright Morris & Arthur : Nanotechnology Law Report - Germanium nanobead image provided by UT-Battelle, which manages Oak Ridge National Laboratory for the Department of Energy

This article, which appeared in the Nov. 17, 2008 issue of Pesticide & Toxic Chemical News, Volume 37, No. 3, was reproduced with permission from Agra Informa. Further use of this article is prohibited without the express written permission of the publisher. For more information about Pesticide & Toxic Chemical News, Food Chemical News or other Agra Informa publications, go to: www.foodregulation.com .

EPA earlier this month announced it is promulgating significant new use rules (SNURs) under TSCA for two nanomaterials — siloxane modified silica nanoparticles and siloxane modified alumina nanoparticles — that were subject to premanufacture notices (PMNs). Some stakeholders view the move as a further sign that EPA is willing to use its authority to regulate nanomaterials, although to what extent remains uncertain.

The rules take effect on Jan. 5, 2009 unless the agency receives critical comments before Dec. 5.
The SNURs are the latest action from EPA on the nanotechnology front. The agency recently issued a consent order for carbon nanotubes (see PTCN, Oct. 20, Page 1). In addition, EPA provided clarification of TSCA requirements for carbon nanotubes last month (see PTCN, Nov. 3, Page 23).

Fewer than 10 SNURs for nanomaterials have been promulgated, according to EPA spokesperson Enesta Jones, but she could not name the materials or when the SNURs had been promulgated because of confidential business information protections.

With the most recent SNURs, anyone who intends to manufacture, import or process either siloxane modified silica nanoparticles or siloxane modified alumina nanoparticles for a significant new use, which includes using either substance without gloves or a respirator and using either substance as a powder, is required to notify EPA at least 90 days before beginning to do so. "The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs," the agency said in a Nov. 5 Federal Register notice.

According to their PMNs, siloxane modified silica nanoparticles and siloxane modified alumina nanoparticles will be used as additives. Based on data from tests of unidentified analogous material and the substances' physical properties, EPA has determined that there are concerns for lung effects from inhalation and systemic effects from dermal exposure. However, the PMNs indicate worker inhalation exposure to the alumina nanoparticles is expected to be minimal, inhalation exposure to the silica nanoparticles is not expected, and dermal exposure to both materials is also not expected.

"Therefore, EPA has not determined that the proposed manufacture, processing, or use of the substance[s] may present an unreasonable risk," the agency said in the FR notice. "EPA has determined, however, that use without impervious gloves or a NIOSH-approved respirator with an [Assigned Protection Factor] of at least 10; the manufacture, process, or use of the substance[s] as a powder; or uses of the substance[s] other than as described in the PMN[s] may cause serious health effects."

EPA would have to be notified at least 90 days before anyone began to manufacture, process or use the nanomaterials in such ways.

The agency has also determined that the results of a 90-day inhalation toxicity test would help characterize the human health effects of the two nanomaterials, although the test isn't required.
"Manufacture can occur as long as the manufacturer does not engage in the significant new uses," Jones told Pesticide & Toxic Chemical News via e-mail.

"[The 90-day inhalation toxicity test] is the test EPA recommends to be conducted to address health concerns cited in the SNUR. In other words, if a manufacturer wants to engage in the new uses or have EPA modify or revoke the SNUR, then conducting these tests could help EPA change its original findings."

The 90-day inhalation study is the same study that is required under the recently issued carbon nanotube consent order. But the study is not designed for determining chronic effects or for nanomaterials, according to John Monica, head of the nanotechnology practice group at the law firm of Porter Wright Morris & Arthur.

Monica told PTCN that EPA can recommend alterations to a study to make it more relevant for a specific material, and in fact did so for the inhalation studies requested in some of the other non-nanomaterial SNURs also announced in the Nov. 5 FR notice.

The SNURs and consent order are a "great opportunity" to get testing done on nanomaterials, but EPA needs to sit a group of experts down to determine how chemical test guidelines need to be modified for nanomaterials, Monica said. "During the request for comments [on the SNURs], someone will raise or should raise the issue."

Monica added he would expect someone to ask EPA to identify the analagous materials and test data it used to determine there are concerns for certain effects.

The SNURs, consent order, and carbon nanotube notice indicate what EPA has maintained all along — that EPA has the authority to regulate nanomaterials under TSCA and is willing to use it, Monica said.

Betsy Mason, an associate in the law firm Goodwin Procter's Environmental and Energy Practices, echoed Monica, telling PTCN that EPA's recent actions show "the agency is willing — perhaps more now than previously — to use the different legal tools available to it under TSCA Section 5 to regulate nanomaterials."

But Mason also noted that it isn't yet clear whether the agency is shifting away from relying on voluntary industry efforts like the Nanoscale Materials Stewardship Program to "bona fide regulation and enforcement" or if it's using the SNURs and consent order as a supplement to encourage more volunteers to participate in such initiatives.

"In either case, I think it's reasonable to expect that EPA will issue more nano-related consent orders and more nano-related SNURs in the future," she said.

U.K. commission urges testing

While EPA is starting to use some of its regulatory powers to address the potential risks of nanomaterials, the United Kingdom's Royal Commission on Environmental Pollution is urging quick action on testing and regulating nanomaterials in a report published Nov. 12.

The commission, which is appointed by the Queen and funded by the government, publishes in-depth reports on critical environmental issues. In its current report, "Novel Materials in the Environment: The Case of Nanotechnology," the commission finds no evidence of harm to human health or the environment from nanomaterials.

"However, it is very early in the development of this technology, and the amount of testing has been relatively limited," the commission said in a statement. "We are aware that laboratory tests on some nanomaterials suggest that they have properties which could cause concern. This strengthens our case for an increase in the amount and type of testing to assess whether these theoretical risks are real, and to monitor their behavior in the environment."

Furthermore, this research has to be done "on a more systematic and strategic" basis, which includes evaluating methods for predicting the fate and effects of nanomaterials, better understanding of the principles that determine nanomaterial toxicity, and enhancing nanomaterial monitoring and surveillance methods, the commission says in its report.

As for the U.K. government, the commission recommends that any revisions to existing regulations should be focused on the properties of nanomaterials, not their size. "Since these properties and functionalities will often differ substantially from those of the bulk material, strict chemical equivalence does not preclude the need for a separate risk assessment," the report says. Furthermore, the government should prioritize testing, starting with those materials with properties suggesting they pose a risk to human health or the environment. The government should also require companies to report any "reasonable suspicion" that a nanomaterial poses a risk "at the earliest opportunity."

The commission's report is available at www.rcep.org.uk/novelmaterials.htm.

— Liz Buckley elizabeth.buckley@informa.com
 

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Today, US EPA issued a Federal Register notice stating the Toxic Substances Control Act (TSCA) registration requirements are "potentially applicable to carbon nanotubes."  EPA confirmed its position the CNTs are "chemical substances distinct from graphite or other allotropes of carbon listed on the TSCA inventory."  The bottom line is stated succinctly by EPA: "Many CNTs may therefore be new chemicals under TSCA Section 5."

Consequently, those companies that use or import CNTs will have to ensure such materials are registered on the TSCA inventory before manufacturing commences or importation occurs.  To determine if a particular type of CNT is already on the Inventory, manufacturers and importers can submit a bona fide intent to manufacture or import letter to EPA under 40 CFR 720.25, and EPA will respond as to the particular listing.  Further, "sometime after March 1, 2009, EPA anticipates focusing its compliance monitoring efforts to determine if companies are complying with TSCA section 5 requirements for carbon nanotubes."

The message here couldn't be more clear: if you are manufacturing or using CNTs, you must comply with TSCA.  EPA admits that some of the confusion over listing/not listing may be due to prior communications, but this notice removes all confusion.  EPA indicates that it is reviewing "several" premanufacture notices for carbon nanotubes, so it is likely many of the "common" CNTs will be registered soon.  In the meantime, expect CNTs to be treated as "new" chemicals under TSCA.

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The EC's 2006 Registration, Evaluation, Authorisation and Registration of Chemicals ("REACH") regulations place "the responsibility for the management of the risks of [chemical] substances with. . .[the companies that] manufacture, import, place on the market or use [the] substances in the context of their professional activities."  Guidance on Registration, Guidance for the Implementation of REACH, European Chemicals Agency, Version 1.3, May 2008, at p. 12.  

To this end, REACH requires companies manufacturing or importing chemical substances in quantities greater than one ton per year to register those substances before they "can be manufactured, imported or placed on the market."  As part of these requirements, "manufacturers and importers need to collect or generate data on the substances and assess how risks to human health and environment can be controlled by applying suitable risk management measures."  This can often be an expensive and time consuming process.

Providing some relief in certain circumstances, Article 2(7)(a) of Regulation (EC) No 1907/2006 provides that certain substances are exempt from registration under REACH because "sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties." These substances are listed in REACH Annex IV.

On October 8, 2008, the EC removed carbon and graphite from Annex IV "due to the fact that the concerned Einecs and/or CAS numbers are used to identify forms of carbon or graphite at the nano-scale, which do not meet the criteria for inclusion in" Annex IV.   We first posted on this possibility last June.

Commission Regulation (EC) NO 987/2008 of 8 October 2008 Amending Regulation (EC) No 1907/2006 of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes IV and V.

This decision is consistent with the U.S. Environmental Protection Agency's reasoning that nanoscale substances with new molecular identities -- such as fullerenes and carbon nanotubes -- are considered new chemical substances for purposes of premanufacturing notice submissions under the Toxic Substances Control Act.
 

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Last month we reported on a press release by Thomas Swan & Co. Ltd. of the United Kingdom indicating the company had recently entered into a PMN consent order with the EPA under the Toxic Substances Control Act (“TSCA”) concerning one of its multi-walled carbon nanotube (MWCNT) products. Barring an unusual coincidence, it appears that EPA has recently published a redacted version of the Swan Consent order here.

The order makes it clear that the PMN was submitted pursuant to § 5(a)(1) of TSCA, and that it covers a MWCNT product. Additionally, the consent order places several requirements on the manufacturer. Specifically, the manufacturer is required to:

1. Deliver 1 gram of the MWCNTs to EPA with a copy of MSDS for the product;
2. Conduct “90 day inhalation toxicity study in rats with a post exposure; observation period of up to 3 months, including bronchoalveolar lavage fluid (“BALF”) analysis (OPPTS 870.3465 or OECD 413);
3. Submit material characterization data within six months (see below);
4. Ensure employees “use gloves impervious to nanoscale particles and chemical protective clothing;” and
5. Ensure employees “use a NIOSH-approved full-face respirator with an N-100 cartridge while exposed by inhalation in the work area.”

Regarding the second requirement, the consent order also provides the manufacturer with an opportunity to submit toxicity testing data under the Agency’s new Nanoscale Material Stewardship Program as an alternative to the 90 day mouse inhalation test: “If, for example, a consortium of companies commit to testing a representative set of MWCNT for subchronic mammalian toxicity, EPA may consider waiving the triggered testing requirement. EPA would be willing to facilitate the process in coordination with other ongoing health effects testing for MWCNT nationally and internationally. EPA would consider accepting the results of such testing in lieu of triggered testing in this order.”
 

Regarding material characterization information, EPA is requiring the manufacturer to submit the following within six months:

• Type of multi-walled carbon nanotube (concentric cylinders or scrolled tubes; number of walls/tubes);
• Configuration of nanotube ends (e.g., open, capped);
• Description of any branching;
• Width/diameter of inner most wall/tube (average and range);
• Carbon unit cell ring size and connectivity;
• Alignment of nanotube along long axis (straight, bent, buckled);
• Hexagonal array orientation used in the manufacture of the nanotube;
• Particle size of catalyst used in the manufacture of the nanotube;
• Molecular weight (average and range); and
• Particle properties: shape, size (average and distribution), weight (average and distribution), count, surface area (average and distribution), surface to volume ratio, aggregation/agglomeration.

Finally, manufacturers of MWCNTs (other than Thomas Swan) will be interested in two of EPA’s general legal conclusions expressed in the consent order:

“EPA is unable to determine the potential for human health effects from exposure to the PMN substance. EPA therefore concludes, pursuant to § 5(e)(1)(A)(i) of TSCA, that the information available to the Agency is insufficient to permit a reasoned evaluation of the human health effects of the PMN substance.”

“In light of the potential risk to human health posed by the uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance, EPA has concluded, pursuant to § 5(e)(1)(A)(ii)(I) of TSCA, that uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance may present an unreasonable risk of injury to human health.”

No doubt other MWCNT manufacturers will feel the need to file PMN’s for their products similar to Thomas Swan given the language of the consent order.

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The U.S. Environmental Protection Agency's Office of Inspector General (OIG) "helps the Agency protect the environment in a more efficient and cost effective manner.  [It] consist[s] of auditors, program analysts, investigators, and others with extensive expertise" who are tasked with evaluating EPA's ability to deliver on key Agency policies.  Risk Policy Report ran an article yesterday (October 14, 2008) indicating that EPA's OIG intended to assess EPA's nanotechnology efforts in FY 2009.  We tracked down the underlying document which is attached here.  Specifically, EPA OIG intends to conduct an "[a]ssessment of EPA's Efforts to Monitor, Evaluate, and Act on Threats from the Production, Use and Disposal of Nanotechnology Products/Nanomaterials."
 

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Last week, EPA and Thomas Swan & Co. Ltd. released the agency's first manufacturing consent order with regards to nanotubes.  The consent order was entered into between the two parties through the pre-manufacture notice (PMN) portion of the Toxic Substances Control Act (TSCA).

The consent order addresses the manufacture of a multi-walled nanotube product at the Swan Chemical, Inc. plant in New Jersey.  Additionally, the consent order is the result of several months of collaboration between the company and the agency.  The consent order addresses the Elicarb (r) MW product.

The Order itself has not been released to the Federal Register, or another source, for first hand review.  While it is being touted by Thomas Swan & Co. as setting "the standard for future control of" nanotube products, I am unable to determine the extent of the agreement.  Once the Order is released for public consumption, there will be a follow-up post relating our thoughts on the contents.

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The advocacy group Environmental Defense Fund recently issued a press release declaring that all the data submitted to the EPA under the voluntary Nanoscale Materials Stewardship Program is entering a "black hole."  However, this conclusion is premature at best, and sector damaging at worst.

In its press release, Environmental Defense Fund cites to limited participation and the fact that after six months of existence, "EPA has made virtually no information public about the limited number of submissions it has received. As a result, the public can have little confidence that the program is providing the information the Agency will need to protect citizens, consumers, workers and the environment from the potential risks of nanotechnology, according to Environmental Defense Fund (EDF)."  In addition, EDF is comparing the participation in the NMSP to the weak response received by the United Kingdom's DEFRA on its voluntary program.  We've posted on the DEFRA program before.  EDF also points to EPA's original prediction of 240 submissions from 150 companies for the basic program and 15 participants in the in-depth program.  While these numbers may not have been fully realized, let's look closely at the facts now that the basic program submission deadline has passed.

First, while the NMSP has been running for six months, the entirety of that time was spent on collection submissions from voluntary participants.  There was no indication from EPA that they would release information collected on a rolling basis or somehow provide their evaluation as submissions were received.  EPA has stated that it will take time to evaluate all of the submissions and release its thoughts after a period of review.  In fact, EPA stated on its NMSP website: "EPA will publish an interim report on the program in approximately a year from its launching on January 28, 2008. A more detailed report and program evaluation will be published after approximately two years. At the time of the two-year report, EPA intends to determine the future direction of both the basic reporting and in-depth data development phases, although adjustments or decisions on future steps may be made at an earlier point if sufficient experience is gained. This would also include consideration of use of regulatory authorities under TSCA." (emphasis added).  Consequently, EPA is taking time to consider all of the information and publish two overall reports, including an interim evaluation.

Second, let's look at the numbers.  EPA received submissions from 20 organizations (including some household names) covering approximately 90 nanoscale materials.  Further, another 10 organizations committed to the basic program, but have not yet submitted.  Beyond the fact that this is potentially a significant amount of technical data to sift through, this is not analogous to DEFRA's program where, to date, eleven submission (including two in the last quarter, the report for which was just released) have been received since September 2006.  Comparing EPA's response to DEFRA's is simply unfair.  Additionally, three companies have committed to the in-depth program and more can still be added.  While its clear EPA did not receive the level of participation it hoped for, there potentially (depending on what was submitted) very significant information in the hands of EPA, and that should not be discounted.

Declaring failure minutes after the deadline for submission passes is irresponsible and does nothing more than contribute to rumor and hearsay.  EPA received a significant response from the nanotechnology sector and it will take time for the agency to fully understand the information it now possesses.  With perhaps over 100 materials to evaluate, EPA's response cannot be instantaneous, and for it to do so would conflict with its reasoned position of wanting to understand the questions surrounding nanomaterials before making statements.  Good regulation does not come from snap judgments and unconsidered public statements.  EDF should give the agency time to understand what it has.  EDF has two choices, wait for the release of the report, or file a public records request for all of the publicly available information that was submitted.  But declaring failure through a press release does not help the agency or sector get closer to the answers being sought.  Oh, and if EDF submits the records request to EPA and received copies of the submission, I wonder if a black hole will appear at EDF if it doesn't like the answers.

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Nanotechnology Law Report -- July 2008

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Cambridge, Massachusetts Nanotechnology Advisory Committee
Recommends Registration of Engineered Nanoscale Materials

Deadline for Similar Voluntary Registration Program by U.S. EPA Closes  

Washington, D.C. – July 28, 2008 – Porter Wright attorney John C. Monica, Jr., served as part of the Nanotechnology Advisory Committee of Cambridge, Massachusetts (NAC), which, after a year of deliberation and information gathering, recommended that the City require the registration of engineered nanoscale materials within city limits. The Cambridge City Counsel is set to adopt those recommendations at a meeting scheduled for tomorrow. Cambridge – host to approximately one dozen nanotechnology-related businesses – is just the second U.S. city (behind Berkeley, California) to require registration of nanomaterials.

“Interest in regulating nanotechnology has increased in recent years due to the recognition that certain materials may take on new and unexpected properties when they are engineered at the nanoscale,” said Monica, a partner in the Washington, D.C. office of Porter Wright Morris & Arthur, LLP and a recognized national authority on nanotechnology product liability and environmental health and safety issues. “The City of Cambridge has approached nanotechnology in a very deliberate, considered manner and appears poised to take steps that promote public safety without stifling nanoscale innovation,” he continued.

The NAC – comprised of citizens, scientists, industrial hygienists, university faculty, nano-businesses, and private environmental consulting firms – also recommended that Cambridge’s City Counsel act to assist businesses with updates to health and safety plans for workers; educate the public; track health and safety developments; and monitor regulatory initiatives in other jurisdictions.

The City’s steps follow closely on the heels of the July 28, 2008 deadline for the first phase of the United States Environmental Protection Agency’s (EPA’s) voluntary registration program – the Nanoscale Materials Stewardship Program (NMSP). NMSP asked companies to report voluntarily to EPA existing data concerning nanoscale materials’ uses, hazards, exposure levels, and risk-management practices. To date, about 20 companies have provided or promised to provide information.

For more information regarding nanotechnology-related legal issues, visit www.nanolawreport.com.

Porter Wright Morris & Arthur LLP is a nationally recognized law firm with more than 250 lawyers in its offices in Washington, D.C.; Cincinnati, Cleveland, Columbus, and Dayton, Ohio; and Naples, Florida. Porter Wright provides counsel to a worldwide base of clients.

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The first phase of EPA's voluntary Nanoscale Materials Stewardship Program (NMSP) closes on Monday.  For those keeping track, the most up-to-date NMSP participation statistics as of July 24, 2008 follow.  It is shaping up to be a very respectable list of participants.

Submissions Under Basic Program: (9 submissions - covering 68 nanoscale materials) DuPont; Nanophase Technologies Corporation; Nantero; Office ZPI; Quantum Sphere; Strem Chemicals; Swan Chemicals Inc.; Unidym; and one Confidential Business Information Submission.

Commitments to Submit Information Under Basic Program: (11) Arkema; BASF Corporation; Bayer Material Science; Dow Chemical; Evonik/Degussa; General Electric; International Carbon Black Association; Nanocyl North America; PPG Industries; Sasol North America; and Synthetic Amorphous Silica and Silicate Industry Association.

Commitments to Participate in the In-Depth Program: (2) Swan Chemicals Inc.; and Unidym.

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As Mike Heintz reported earlier today, the Woodrow Wilson International Center for Scholars' Project on Emerging Nanotechnologies issued a report yesterday providing some guidance regarding where it believes the next administration should start with the issue of nanotechnology regulation next January.

J. Clarence Davies, "Nanotechnology Oversight: An Agenda for the New Administration," Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, PEN 13, July 2008.

Among other suggestions, Mr. Davies advocates enacting new nano-specific legislation in the following areas.

TSCA: Mr. Davies offers specific legislative language for amending TSCA "to make clear that nanomaterials are covered as new substances." Other changes he suggests: "remove the catch-22 that requires EPA to show that a new chemical poses a risk before the agency can obtain enough information to determine whether it actually poses a risk;" "remove the conditions and requirements that guarantee that EPA can never regulate an existing substance;" and narrow TSCA’s confidential business information and data sharing provisions.

FFDCA: Mr. Davies argues the FFDCA should be amended to require submission and review by FDA of cosmetic active ingredient registration information.  He further maintains that "FDA should also be authorized to forbid marketing of any cosmetic containing an ingredient that is not safe or for which adequate test data are not available," and that applicable FDA laws should be altered "to make clear where and how to draw the line between a drug and a cosmetic."  Mr. Davies additionally recommends requiring premarket safety testing on food and cosmetic ingredients incorporating nanoscale materials, and increased post-marketing surveillance and reporting.

DSHEA: Mr. Davies calls for amending DSHEA so that it does not prohibit "FDA from imposing testing or approval on dietary supplements (vitamins, herbs, etc.) and placing the burden of proof on FDA to provide that a supplement is safe."

Other recommendations by Mr. Davies beyond long-term regulatory action are:

Research: dramatically increase federal nano-related EHS research funding (FY 2009 - $100 million; FY 2010 - $150 million), require a federal peer-reviewed EHS research plan; strengthen NNI; encourage separation of NNI promotional and oversight functions; and establish a Nanotechnology Effects Institute.

Regulatory Coordination: establish an interagency group devoted solely to nanotechnology regulation; develop a nanotechnology plan within each agency; and improve intergovernmental coordination.

Resource Requirements: increase regulatory agency budgets and staffing.

EPA: define nanomaterials as "new" chemical substances and/or "significant new uses" of existing chemical substances under TSCA; promulgate a new compulsory information collection rule under TSCA Section 8; expand regulation of anti-microbials under federal pesticide law; promote "green" technology; and evaluate the application of other EPA statutes to nanotechnology.

FDA: establish criteria for determining which nanomaterials are "new" for regulatory purposes; collect information on safety testing, forthcoming products and adverse effects; regulate cosmetics and dietary supplements.

OSHA: communicate to workers and firms about nanotechnology; use existing OSHA regulations to deal with nanoparticles; issue OSHA standards for nanomaterials.

CPSC: hire new staff to study nanotechnology exposure; create a chronic hazard advisory panel for nanotechnology products posing significant exposure risks.

Voluntary Efforts: use the DuPont-Environmental Defense framework as a basis for analyzing nanotechnology risks; issue a nanotechnology handbook for small businesses.

Public Involvement: give the public more information about nanotechnology; obtain the public's views about nanotechnology; convene a stakeholder dialogue.

Mr. Davies concludes his article with an interesting analogy: "[N]anotechnology comes in a treasure chest of riches and a Pandora's box of evils. The challenge of the new century and to the new administration is to use the treasure while keeping shut the lid on the Pandora's box."

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With all of the interest in nanosilver generated by the recent EPA petition filed by the International Center for Technology Assessment, I thought I would post some background material on EHS issues surrounding silver.  A couple of disclaimers: the material is not comprehensive, and you might see parts of it again in "Nanotechnology Law and Policy" which should be published by Thomson-West legal publishers sometime in 2009 (if I can keep pace with the production schedule).

 

Silver (CASRN 7440-22-4) is a naturally occurring metal. It is usually found in extremely low concentrations in natural waters. “Humans are exposed to small amounts of silver from dietary sources.” “Silver levels of less than 0.000001 mg silver per cubic meter of air (mg/m³), 0.2-2.0 parts silver per billion parts water (ppb) in surface waters, such as lakes and rivers, and 0.20-0.30 parts silver per million (ppm) in soils are found from naturally occurring sources.” A 50 year old person has “an average retention of 0.23-0.48 g silver.”

Silver production in 1999 was estimated at 15.5 million kilograms world-wide, with Mexico and the US leading the list of producers. It is estimated that approximately 2.5 million kgs of silver in various forms is lost to the environment in the US every year, and that 29% of that amount is released to water and 68% to land. The most prevalent release routes are purportedly from smelting operations, photographic processing supplies, manufacturing of electrical components and wires, coal combustion, electroplating operations, and cloud seeding. NIOSH estimates that 70,000 people are exposed to silver in the workplace each year and inhalation is the most important route of exposure.

People and Animals. Silver has exhibited no known toxic effects to humans. According to the EPA, human health effects from breathing, eating, and/or drinking silver are "unknown." However, if you eat, drink, or breathe enough of it, your skin may turn a blue-gray color. This permanent cosmetic condition called “argyria” is not harmful to health. It results from silver depositing in the dermis layer of skin.   Breathing high levels of silver dust may cause breathing and respiratory problems, throat irritation, or stomach pain – as with other types of particulate matter.  Silver is not a known human carcinogen, but has been shown to cause cancer when inserted in lab animals under certain conditions. There are few, if any, toxicity animal studies based on oral or respiratory silver intake. “Tests in animals show that silver compounds are likely to be life-threatening for humans only when large amounts (that is, grams) are swallowed and that skin contact with silver compounds is very unlikely to be lifethreatening.”  Some occupational studies intimate that exposure to silver may cause kidney problems, although more research is needed on this issue. 

Silver Ions.  Monovalent silver ions are very rare in the natural environment. “The acute toxicity of silver to aquatic species varies drastically by the chemical form and correlates with the availability of free ionic silver.” “For freshwater fish, the acute toxicity of silver is caused solely by silver ion interacting with the gills . . .” “On the basis of available toxicity test results, it is unlikely that bioavailable free silver ions would ever be at sufficiently high concentrations to cause toxicity in marine environments.” “About 95% of the total silver [lost to water in the environment] is removed in publicly owned treatment works from inputs containing municipal sewage and commercial photprocessing effluents, and effluents contain less than 0.07 ug ionic silver/litre.”

Drinking Water. The federal government has issued guidelines concerning the maximum level of silver allowed in drinking water (Maximum Contaminant Level – MCL): long term exposure is limited to 0.1 mg/L (previously 0.05mg/L), and short term exposure (1-10 days) is limited to 1.142 mg/L. The silver MCL was first promulgated by the United States Public Health Service in 1962 before the Environmental Protection Agency was ever formed. Silver was included on the original list on the basis of epidemiological data and the fact that it was used as an antimicrobial. The epidemiological data was based on exposures to medicinal silver and exposures through mining and metalworking. In 1989 EPA proposed changing the MCL for silver from 0.05 mg/L to 0.09 mg/L because the only potential human health concern was from argyria. “The proposal was finalized, using an CML of 0.1 mg/L, on January 30, 1991.”

Surface Water.  Silver in surface water tends to settle down into the sediment. “Silver can remain attached to oceanic sediments for about 100 years under conditions of high pH, high salinity, and high sediment concentrations of iron, manganese oxide, and organics.” Silver levels in pristine surface water in unpolluted areas are approximately 0.01 μg /L and approximately 0.01 - 0.1 μg/L in urban and industrialized areas. The federal government regulates silver in surface water through the Federal Water Pollution Control Act (aka/ Clean Water Act) -- 33 U.S.C. § 1251. “The silver criteria contains values to protect human health from ingestion of contaminated aquatic organisms and maximum acceptable concentrations to protect organisms that live in freshwater and salt water from toxic effects. The human health part of the silver criteria was drawn directly from the drinking water MCL. Criteria for the protection of aquatic life, on the other hand, were derived using a newly developed set of guidelines that called for extensive laboratory test data. The values are given as total recoverable silver.”  The freshwater criteria maximum concentration (CMC) for silver is (3.2) 100mg/L, and the saltwater CMC is (1.9).

Air. Silver is not considered an air pollutant harmful to public health or environment under the National Ambient Air Quality Standards mandated by the Clean Air Act. Purportedly “[t]reatment of air emissions containing silver is not a concern as atmospheric emissions rarely approach the federal threshold limit value for occupational exposure of 0.01 mg/m³.”

Workplace. Workplace exposures to silver present unknown/unquantified health risks to humans. Most occupational exposures to silver are purportedly through photographic processing chemicals (dermal) or inhalation of silver dust particles from the ambient air. OSHA has set the maximum air quality standard for silver at 0.01 mg/m3 based on an 8 hour workday and 40 hour workweek.

Regulation of silver hazardous waste. Resource Conservation and Recovery Act (RCRA) is designed to (in part) prevent leaching of hazardous concentrations of particular toxic constituents into groundwater, and looks back to Primary Drinking Water Standards. Any waste that contains 100 times the amount of the relevant constituent is considered a hazardous waste. The “100 times” level was designed to compensate for the dilution of materials as they pass through soil when headed for ground water. Note, howeverm that the ACRA standard does not track the 1997 amendment to the drinking water standard. Since the original drinking water standard for silver was is 0.05mg/L, the maximum allowable limit is 5.0 mg/L for RCRA purposes. Wastes containing silver at this level or above are labeled as “hazardous wastes” under RCRA and are subject to further regulation under that Act. “Under CERCLA, silver-bearing hazardous wastes are designated as hazardous substances with a reportable quantity (RQ) equal to 1 pound (.454 kg).” Any release that exceeds the RQ in a 24-hour period must be reported to the National Response Center.

Select Bibliography:

“Toxicological Profile for Silver,” Agency for Toxic Substances and Disease Registry, U.S. Public Health Service (December 1990).

P.D. Howe, et al., “Concise International Chemical Assessment Document 44: Silver and Silver Compounds: Environmental Aspects,” World Health Organization (2002).

US EPA Integrated Risk Management System (IRIS), Silver (CASRN 7440-22-4), http://www.epa.gov?IRIS/subst/0099.htm.

 “25 Years of the Safe Drinking Water Act: History and Trends.”

Many states also regulate silver. Some state standards are more restrictive than EPA standards. See, e.g., “The Regulation of Silver in Photographic Processing Facilities,” Kodak Environmental Services, J-124 (1996).

T. Purcell, et al., “Historical Impacts of Environmental Regulation of Silver,” Environmental Toxicology and Chemistry, Vol. 18, No.1, pp. 3-8, 1999.

Aquatic life testing guidelines can be found at Fed. Reg. 45:79341 – U.S. EPA. 1980. “Guidelines for determination of ambient water quality for the protection of aquatic organisms and their uses.”

65 C.F.R. 31682

“The Regulation of Silver in Photographic Processing Facilities,” Kodak Environmental Services, J-124 (1996).

US EPA, Solid Waste and Emergency Response (5305W), RCRA Photo Processing, EPA530-K-99-002, January 1999.

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By now you've heard about US EPA's voluntary nanomaterials reporting program, the Nanoscale Materials Stewardship Program.  Circle July 28, 2008 on your calendar, as that's when the window for voluntary reporting under the Basic Program closes.

While the full NMSP is slated to run for 2 full years, data submissions under the Basic Program are to be in by July 28.  This poses as bit of a problem in that the number of submissions and commitments remain low. Yes, a few months ago I said to give the program time, and I still believe that. However, with one time frame coming to an end, I'm becoming concerned at the lack of responses.

As of this posting, three companies have submitted Basic Program materials: DuPont, Office ZPI, and one confidential submission.  In addition 10 more commitments for submission under the program have been received: BASF Corporation, Bayer Material Science, Dow Chemical, Evonik/Degussa, General Electric, Nanocyl North America, Nanophase Technologies Corporation, PPG Industries, Sasol North America, and Strem Chemicals.

The concern, of course, if that if EPA does not receive enough voluntary information for it to use in educating itself on the risks posed by nanomaterials, it will make such submissions mandatory.  For my money, that's what is likely to happen.  There is still time to submit voluntary information, and still opportunities to do so confidentially.  The In-depth program will continue to run, but that portion seems to have been largely ignored.  Keep and eye on July 28--it'll come faster than you think.

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On March 5, 2008, the US EPA announced that it had fined the company IOGEAR for "for selling unregistered pesticides and making unproven claims about their effectiveness."  The fine, reached via settlement, was for $208,000, and IOGEAR has since removed its pesticide claims from the offending products.

IOGEAR was selling two wireless mouses (mice?) and a wireless mouse/keyboard combination claiming that the nano-coatings killed germs and pathogens.  While the nano-coating remains unspecified (although the quote below indicates its nanosilver), the violation was pursuant to the Federal, Insecticide, Fungicide, and Rodenticide Act (FIFRA).  EPA's representative, Katherine Taylor, associate director of the Communities and Ecosystems Division at EPA’s Region 9 was quoted a saying, “We’re seeing far too many unregistered products that assert unsubstantiated antimicrobial properties...Whether the claim involves use of an existing material such as silver, or new nano technology, the EPA takes these unverified public health claims very seriously. Consumers should always follow common-sense hygiene practices, like washing hands frequently and thoroughly.”

It was really only a matter of time until the fines began.  We've seen many examples, check out yesterday's post for the easy links, of products claiming antibacterial and microbial claims go unregistered, and it appears that it finally wore down EPA's patience.  FIFRA is pretty clear that in order to make "pest killing" claims, the product must be registered so that EPA may be satisfied that the product does not pose an unreasonable risk to consumers.  Now that nanotechnology is getting more of the spotlight, I suspect we'll begin to see more enforcement actions like this to ensure consumer products are complying with applicable legal requirements.

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The 2009 budgets for the US Environmental Protection Agency and National Nanotechnology Initiative have been released, and the numbers are interesting.  Both agencies have funds available for nano research, however note that NNI's numbers are to help that office coordinate efforts among 26 federal agencies while EPA's portion is only a small piece of the full pie. 

Key points from the $1.5 billion NNI budget include:

• increased support for research on fundamental nanoscale phenomena and processes, from $481 million in 2007 to $551 million in 2009.
• substantial ongoing growth in funding for instrumentation research, metrology and standards (from $53 million in 2007 to $82 million in 2009) and in nanomanufacturing research (from $48 million in 2007 to $62 million in 2009).
• Environmental, Health, and Safety (EHS) R&D funding in 2009 ($76 million) is more than double the level of actual funding in 2005 ($35 million) - the first year this data was collected.
• The steady growth in EHS R&D spending follows the NNI strategy of expanding the capacity to do high-quality research in this field.

Similarly, EPA's budget also provides funding for nano research and development, and in fact addresses nano in the context of the Resource Conservation Recovery Act (RCRA): "the primary objective is to determine the physicochemical properties controlling the movement of nanomaterials through soil and aquatic ecosystems. Research questions include the identification of system parameters that alter the surface characteristics of nanomaterials through aggregation (e.g. pH effects), complexation (e.g., surface complexation by dissolved organic carbon) or changes in oxidation state (e.g., chemical- or biological-mediated electron transfer)." 

EPA's total budget is $7.1 billion for fiscal year 2009, and nano-specific funding comes in at $14.9 million (or 0.21% of the total budget).  The funding is part of EPA Goal 4 of 5, "Communities and Ecosystems."

The fact that nanotechnology research funding is increasing is an encouraging sign, however, I'm concerned at the length of time it will take to complete the learning curve given the proportionally small amounts of federal investment into this increasingly important area.

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The ink isn't dry yet, and we haven't had a chance to go through it in detail, but be aware that US EPA has officially released its Nanoscale Materials Stewardship Program.  Details on the program can be found here, and prior discussion can be found here. 

The Federal Register notice on the program's release is here (73 FR 4861), and addresses the comments submitted by interested parties during the draft phase.

More information will come as we have a chance to parse the material.

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In a strange twist of bureaucratic overkill, Congress directed EPA to contract with the National Academy of Sciences (NAS) to develop a federal strategy for researching the environmental, health, and safety risks of nanotechnology.  Did you get that?  Congress is telling EPA to tell NAS to develop the research strategy.

What makes this direction curious, included in the 2008 omnibus appropriations bill signed into law in late December, is that is appears on its face to repeat work being conducted by both EPA and the National Nanotechnology Initiative (NNI).  Congress appropriated EPA $1.9 million to contract with NAS to "develop and monitor implementation of a comprehensive, prioritized research roadmap for all federal agencies on environmental, health, and safety issues for nanotechnology."  Congress would like the contract in place by the end of March.

However, the NNI released its general strategic plan on December 31, in which it provides the broad goals and priorities of the multi-agency conglomerate.  Additionally, a second strategic plan is expected from NNI by the end of January that focuses on specifically on health and safety research.  Then, sometime in March, EPA is expected to release its nanotechnology priorities as they relate to health and environmental issues.

Finally, the NAS study was called for by a coalition of industry, trade groups, and nonprofit organizations, including the American Chemistry Council, DuPont, Environmental Defense, Dow, and the Natural Resources Defense Council.  While successfully lobbying Congress for EPA's marching orders, one unnamed coalition member defended the call for NAS involvement by saying that the NNI's work is not as "robust as what we would expect from NAS." 

This last statement may be the most telling--its not exactly a ringing endorsement of NNI's work or efforts.  Clearly the various stakeholders are unhappy with the efforts and answers being provided by NNI and EPA, or they would not have gone directly to Congress for what will be the fourth study released on strategic research priorities since December 31, 2007.  My read is that the stakeholders are getting anxious for direction from federal regulators as the continuing development of nanotechnology in the absence of information is becoming unnerving to them.  And rightfully so.  I'm concerned, however, that NNI was pushed closer to the brink of irrelevance because of the vote of no confidence from the coalition.  Between that, and the duplicative work seemingly being undertaken by no less than three organizations, I'm curious to see where we'll be when the dust all settles.  I hope the four reports do not conflict with each other, thereby adding fuel to the uncertainty fire.

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The National Science Foundation has announced it call for proposals for creating the new Center for Environmental Implications of Nanotechnology.  The proposal is for grant money to help create a "national Center to conduct fundamental research and education on the implications of nanotechnology for the environment and living systems at all scales."

The Center is to focus on:

• interactions of nanomaterials with organisms, cellular constituents, metabolic networks, and living tissues;
• environmental exposure and bioaccumulation and the effects on living organisms;
• biological impacts of nanomaterials dispersed in the environment.

The solicitation is restricted to the study of nanomaterials, as defined by having one dimension between 1 and 100 nanometers, but includes the study of natural, incidental, and engineered nanoparticles.  The award is expected to be for $5,000,000 per year for five years, with one possible five-year renewal.  $4,000,000 will come from NSF funding, while the remaining $1,000,000 is expected to come from the US EPA.  The Center is expected to address a multi-disciplinary approach to studying biological interaction with nanomaterials, including the standard sciences as well as social and behavioral sciences.

Those eligible include US academic and research institutions and non-profit non-academic institutions such as museums and research labs.  Proposals are due by March 17, 2008.  More information on the solicitation can be found here.

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Environmental Science & Technology recently released an editorial discussing nanotechnology safety issues and, more importantly, the recent debate over whether EPA should regulate nanoscale materials as new chemicals under TSCA.  The editorial succinctly sets forth EPA's position, as expressed by Jim Willis, EPA's Chemical Control Division Director, on the TSCA issue this way: 

In an EPA document, TSCA Inventory Status of Nanoscale Substances—General Approach, released on July 12, the agency explained why it could not group all nanomaterials as new substances solely on the basis of size. This is because the definition of a new chemical under TSCA is based on only molecular structure or identity. If a nanomaterial contains the same molecules as a chemical already in the TSCA inventory, it is an existing chemical, says Willis. And almost all nanomaterials being researched and manufactured today are chemically identical to existing chemicals in the TSCA inventory. Thus, EPA has no authority to regulate them. Carbon nanotubes and fullerenes, for example, are made of carbon, an existing chemical in the inventory.

h/t to TGDaily.com.

 

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SmallTimes's September/October print edition just recently hit newsstands.   Featured in that magazine is our own John Monica's article entitled  "Ramping up the EPA's Nanoscale Material Stewardship Program."  (Co-blogger Michael Heintz has previously blogged about this program here and here.) 

The issue also contains a great article by Lynn Bergeson -- "The EPA's Toxic Substances Control Act: What you must know," and another by Barbara Goode -- "Framing the DuPont/ED Nano Risk Framework."

 

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In response to the Samsung Washing Machine "nanosilver" controversy last year, EPA indicated it would issue a federal notice concerning how it intends to treat silver ion generators under FIFRA. Many urged EPA to use this opportunity to issue a broad proclamation that all products containing nanoscale silver would be required to be registered as pesticides under FIFRA. NanoLawReport believed EPA would issue a significantly narrower ruling.

On Monday, EPA finally published its promised federal notice requiring products that emit silver ions or other antimicrobial substances to be registered as pesticides under FIFRA. EPA was clear that the notice is not intended to regulate nanotechnology as a whole, nor has the Agency even received information suggesting that the Samsung washing machine in question uses nanotechnology. Whether EPA will require other products containing nanosilver to be registered under FIFRA is likely to be decided on a case-by-case basis.

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Just a reminder to those interested in commenting on US EPA's draft documents concerning the Nanoscale Materials Stewardship Program (NMSP): comments are due to the Agency on or before September 10, 2007. 

US EPA is seeking comments on three draft publications: the "Concept Paper for the Nanoscale Materials Stewardship Program under TSCA, " the "TSCA Inventory Status of Nanoscale Substances - General Approach," and the Information Collection Request (ICR) in Support of EPA’s Stewardship Program for Nanoscale Materials.

The full text of all three can be found here.

Specifically, EPA is seeking comments on the following:

1. Whether the data elements that have been identified in the NMSP are appropriate for nanoscale materials;
2. Timing and phasing of submissions under the NMSP basic and in-depth programs and whether approaches for tiering data submissions are appropriate;
3. Who would participate in the NMSP and how to encourage participation, especially from small and medium sized enterprises;
4. What criteria to use for NMSP program evaluation and views on the timing and nature of any reports the Agency may issue; 
5. How to engage industry and other stakeholders in the NMSP in-depth program and approaches for generating test data;
6. The processes and roles for EPA, participants, and other stakeholders during development and evaluation of data for the in-depth program;
7. Possible approaches for identification and use of alternative sources of data, in order to minimize the burden of information collection associated with the NMSP;
8. Uses for the data submitted to EPA under the NMSP program; 
9. Issues relevant to scope, definitions and descriptions;
10. The suitability of the approach for determining the TSCA Inventory status of nanoscale materials discussed in the Inventory paper; and,
11. Whether, in combination, the TSCA Inventory paper and the NMSP concept paper are sufficiently clear in how EPA plans at this time to address nanoscale materials that are new or existing chemicals under TSCA and the NMSP.

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It has been a little over a year since the American Bar Association published its "Innovative Regulatory Approaches” to Nanotechnology discussion paper in June 2006.  During the intervening  period, EPA published its White Paper and its TSCA voluntary framework.  Both provide some general idea of where EPA is heading with environmental regulation, and in this context it is useful to take a glimpse back at the ABA paper.

 

The authors explained that the history of environmental regulation in the US has produced a regulatory system focused on controlling workplace exposures and end-of-pipe/fence line emissions, enacting management standards for hazardous wastes, and requiring increased information disclosure and risk assessment for new chemicals and pesticides. The authors also provided some insight into why they believe nanotechnology may require a different approach: the speed at which it is developing; competitive pressures; limited resources available to government regulators; difficulty in enacting new federal environmental legislation; level of scientific uncertainty and the complex risks involved in nanotechnology; difficulty in monitoring nanoscale releases; and the importance to the industry in maintaining public confidence.

The authors propose a new integrated approach to nanotechnology regulation to address these issues . Under this multifaceted approach, “[t]he goal would be to avoid the rote application of existing regulatory approaches to these 21st century technologies if a better way exists.”

In order to accomplish this goal, the ABA authors suggest several environmental accountability, mechanisms: traditional regulation and enforcement; new approaches to regulations including flexible standards; enhanced monitoring and public reporting; well-defined liability standards, voluntary industry programs, improved public education, corporate social responsibility programs, and relevant stakeholders dialogues.

Looking back, with EPA's recent White Paper and TSCA voluntary stewardship papers published within the past 6 months, the latter mechanisms suggested by the ABA authors will undoubtedly take on renewed importance and deserve further development.

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US EPA's long-awaited Nanoscale Materials Stewardship Program has finally been released for public comment and stakeholder involvement.  In fact, two Federal Register notices were issued today.  First, the notice on the Stewardship Program was issued.  Second, EPA issued a notice on the Information Collection Activities in Support of EPA's Stewardship Program for Nanoscale Materials.  Both notices and accompanying documents are available at EPA's website.

EPA will conduct a public meeting to discuss comments on this voluntary program on August 2, 2007 in Arlington, Virginia, and the comment period will run for 60 days from the date of the Federal Register notices, July 12, 2007.

Check back for more details as we review these materials.

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The Woodrow Wilson Center released a study entitled "EPA and Nanotechnology:  Oversight for the 21st Century," authored by a former high-level EPA administrator, J. Clarence Davies.  Mr. Davies argues that EPA oversight and regulation of nanotechnology is "urgently" needed.  The Wilson Center has the full text of the report available here.

The report is summarized in this Science Daily article.  The article notes the reaction from the Wilson Center's Project on Emerging Nanotechnologies:

"This new report seeks to encourage EPA, Congress, and others to create an intelligent oversight approach that empowers EPA and promotes investment and innovation in new nanotechnology products and processes," said David Rejeski, director of the Project on Emerging Nanotechnologies at the Wilson Center (PEN). "As both the chair and ranking minority member of the U.S. House of Representatives Committee on Science and Technology stated last year, 'Nanotechnology is an area of research that could add billions of dollars to the U.S. economy, but that won't happen if it is shrouded in uncertainty about its [environmental, health and safety] consequences.' "

The Science Daily article also summarizes the approach Davies recommends.  Specifically, it appears that Davies is focusing on creating an industry-EPA partnership to study the toxicity of nanotechnologies and creating an inter-agency coordinating group (possibly involving FDA and OSHA) to oversee nanotechnology regulation.   The eventual goal, it seems, is to amend the Toxic Substances Control Act (TSCA) to expand EPA's power to regulate the area.  It is promising that Davies' proposal involves significant industry cooperation in the development of any standards.  One must hope that any actual regulations or amendments to the TSCA that come from this type of approach are properly balanced to encourage innovation and America's entrepreneurial spirit while significantly mitigating any significant risk of harm from the use of nanomaterials.

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As originally reported here, EPA recently released its White Paper on nanotechnology and related issues.  After reading through the White Paper, there are several interesting points that EPA makes.

The White Paper, as expected, lays out the Agency's thoughts and ideas concerning nanotechnology and how EPA will treat it.  While the Paper begins with the Agency's role in the larger government plan concerning nanotechnology, it provides many EPA-specific items as they relate to research and regulation.

The Paper begins with EPA explaining EPA's role with regards to nanotechnology, as well as why nanotechnology is important to the Agency.  It then addresses issues such as risk assessment and development of nanotechnology from EPA's perspective.  Not surprisingly, EPA identifies several areas in which clear data gaps exist and must be filled in order to progress with nanotechnology.  However, of particular interest to those in the regulated community, the Paper provides some of EPA's thoughts on both potential regulation of nanotechnology, as well as its possible environmental benefits.

First, with regards to possible regulation by EPA, the Paper explains that the Agency maintains the position that current environmental statutes provide it with the authority to regulate nanomaterials.  This statement alone is not surprising as it is a generally accepted thought.  However, the Paper fails to discuss how some of these statutes contain trigger levels that may be inappropriate measures of nanomaterials.  For example, statutes such as the Clean Air Act and Resource Conservation Recovery Act contain measurable levels at which regulation begins, such a specific concentration or weight emitted or discharged.  Because nanomaterials may be a concern at vastly smaller measurements