A report entitled ‘Nanomaterials in the Environment: Current State of Knowledge and Regulations on Chemical Safety’ was published by the German Environmental Agency last month.Read More
The National Nanotechnology Initiative (NNI) has launched a new Nanotechnology Signature Initiative entitled Water Sustainability through Nanotechnology: Nanoscale Solutions for a Global Scale Challenge. The goal of this initiative is to take advantage of engineered nanomaterials and their unique properties to spur innovation and develop solutions that address water quality, water supply and water management issues.Read More
The latest regulation applies EU-wide, and introduces a revised definition for nanomaterials
On November 16th, 2015, the Council of the European Union adopted the new ‘novel food’ regulation, as was approved by the European Parliament on October 28th, 2015. This newly approved European Union ‘novel food’ proposal updates a 20 year-old regulation, and clarifies the categories of foods that constitute novel foods, including specific reference to nanomaterials. Novel foods are those that were not consumed by humans in significant amounts within the EU prior to 15 May 1997. The new regulations stipulate that all engineered nanomaterials will require a novel food authorization at the EU level before being used in foodstuffs.
A new definition for engineered nanomaterials has been established that will apply to all areas of E.U. food law, replacing the former definition in EC regulation 1169/2011 (food labelling). The new definition reads:
“Engineered nanomaterial means any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale. Properties that are characteristic of the nanoscale include: (i) those related to the large specific surface area of the materials considered; and/or (ii) specific physico-chemical properties that are different from those of the non-nanoform of the same material.”
This definition replaces the former definition, which stated: “engineered nanomaterial” means any intentionally manufactured material, containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm to 100 nm’ (EC regulation 1169/2011)
The revised definition may be updated and adjusted to keep up with technical and scientific progress via a delegated act. There is concern surrounding the new definition, especially regarding the unclear term “discrete functional parts”.
To ensure harmonization, the European Food Safety Authority (EFSA) will perform all assessments. EFSA found that existing information on nanotoxicokinetics and toxicology is limited and that modifications on existing methods may be necessary. Therefore, applicants will be required to submit scientific assessments and details on test method adaptations used specifically for nanomaterials. The regulation also states that EFSA will verify that the “most up-to-date methods” are used to assess the safety of nanomaterials. demand may cause uncertainty and further burden, as there are few explicit guidelines regarding the “most up-to-date” methods.
EFSA will still consider whether the novel food poses a safety risk, and whether it is as safe as a food in a comparable food category already in the market. In accordance with Directive 2010/63/EU, animal testing should be replaced, reduced, or refined where possible. Once a novel food is authorized, it can be sold in any EU member state, and will be placed on a list of novel foods that are transparent and easily accessible.
The regulation is intended to speed up authorization; the current length is approximately 3.5 years. Newly developed scientific evidence and proprietary data will not be able to be used for the benefit of another application for 5 years after novel food authorized without the agreement of the initial applicant.
The regulation must still be formally published in the EU’s Official Journal and will then enter into force 20 days later.
The new regulation:
The US EPA is transitioning to new electronic reporting formats and these changes take place starting in January 2016.
Under these new electronic reporting regulations, users are required to use the Central Data Exchange (CDX) for electronic submission of Premanufacture Notices (PMNs), TSCA section 5 Notices and Supporting Documents to the Agency. These changes were communicated in a direct final rule issued on July 20th, 2015 and take effect starting January 19th, 2016.
Changes include “new methods for accessing the e-PMN software, new procedures for completing the electronic-PMN (e-PMN) form, changes to the CDX registration process, adds the requirement to submit “bona fide intents to manufacture” electronically, and changes to the procedure for notifying EPA of any new manufacturing site of a chemical substance for which an exemption was granted by EPA.
This action is intended to further streamline and reduce the administrative costs and burdens of TSCA section 5 notifications for both industry and EPA.”
In anticipation of these new electronic reporting requirements, the EPA hosted a series of webinars in August and September to familiarize users with the new software and requirements. To review these courses, see the US EPA webinar reviews here.
As these new requirements take effect January 19th, 2016 the EPA is strongly encouraging submitters to register as soon as possible for CDX and the updated e-PMN software (thin client) to avoid any delays in submissions.
For further information on these changes, including if this action applies to you, see here.
he EPA closed its public comment period on August 5th, 2015 for its initial proposal to require one-time reporting and recordkeeping information from manufacturers of nanoscale materials including: specific chemical identity, production volume, manufacturing and processing methods, exposure and release information, and existing data on environmental and health effects.
Sixty nine comments were received from industry, private individuals, business associations, academia, NGOs, and other organizations, including Vireo Advisors. More than forty of the 69 comments on EPA’s proposed TSCA Reporting and Recordkeeping Requirements rule for nanoscale materials were from industry, associations and industrial partners. Nine not-for-profit (NFP) organizations submitted comments on TSCA’s proposed rule, including six non-governmental organizations (NGOs) and two state government agenciesunanimously supporting reporting and recordkeeping requirements by the EPA for nanoscale materials.
Many commenters expressed concerns about the vague definition a ‘reportable chemical substance’ including definition of ‘unique and novel’ characteristics. EPA proposes defining a reportable chemical substance as ‘a chemical substance that is solid at 25 °C and atmospheric pressure that is manufactured or processed in a form where the primary particles, aggregates, or agglomerates are in the size range of 1–100 nm and exhibit unique and novel characteristics or properties because of their size.’ Some NGOs noted the possibility of manufacturers and processors taking advantage of the ambiguous definition to avoid reporting, and prefer the definition be based solely on size. More than half of industry comments addressed the definition of ‘reportable chemical substances’, and highlighted issues with the terms “unique and novel”, “particle”, “enhanced properties”, “trace amounts”, “film”, “coating”, and “aggregates and agglomerates”. NGOs would also like clarity or changes regarding the definition of ‘reportable substance’ – for example, explanation of the phrase ‘trace amounts’ and ‘release information’.
Industrial commenters sought EPA’s rationale for choosing ‘seven times the standard deviation of the mean’ approach of distinguishing discrete forms and further commented that no available methods are available to consistently and reliably measure the suggested properties. There were numerous calls for better and more specific guidance on the issue. Most NGOs would like to see the inclusion of a wider range of discrete forms and materials. Two NGOs suggested using a 10% change would be more sensitive than the proposed ‘seven times the standard deviation of the mean’ approach of distinguishing discrete forms. Several also suggested that a change in any of the 3 factors should trigger separate reporting.
One area of dissent between NFPs and industry was EPA’s proposal to exempt nanoclays, nanofilms, and nano ZnO. Whereas most NGOs did not support the exemptions, twenty-six industry/association comments supported exemptions for zinc oxides, nanoclays and films, and/or requested exemptions for other materials, including: color pigments, articles, naturally occurring materials, polymer substances, nanoscale substances incorporated into a polymer matrix, all biological materials, TiO2, and carbon black, among others.
Similarly, while several NGOs specifically support the 135 day review period, many industrial commenters opposed it over concerns about competitive disadvantages, negative signals to the public and the marketplace that nanoscale materials pose more risk, and concerns raised about exceeding the EPA’s statutory authority.
Finally, industry expressed concerns about the burden of collecting and reporting, and requested EPA revisit the exemption threshold, not include period reporting, and harmonize data collection with recent Canadian reporting rules (hyperlink here) as well as ensure no overlap between other required reporting, and narrowing the required reported information. EPA responses are not anticipated before calendar year 2016.
The US Environmental Protection Agency (EPA) is proposing reporting and recordkeeping requirements for nanoscale chemical substances in the marketplace under the Toxic Substances Control Act (TSCA). This initial proposal would require one-time reporting and recordkeeping information from manufacturers of nanoscale materials including specific chemical identity, production volume, manufacturing and processing methods, exposure and release information, and existing data on environmental and health effects. The EPA has extended the public comment period for 30 days until August 5th, 2015.
Shatkin co-authored an article about the Proposed Reporting Rule for Nanoscale Materials that was picked up by the National Law Review. EPA held a public meeting on the rule in June 2015. Shatkin’s co-authored summary of the meeting is here. The proposed rule and instructions for submitting comments are in the docket folder.
During a Panelist Discussion in the Symposium on Sustainability and Commercialization at TechConnect/Nanotech15, it was suggested that EPA may not finalize the rule until after the 2016 elections, with reporting required at least 6 months later, in 2017. The proposed rule and instructions for submitting comments are in the docket folder.
KEY COMMENTS on the rule by Shatkin/Vireo:
1. Definitions: the definition of a Reportable chemical substance
1. “.. manufactured or processed in a form where the primary particles, aggregates, or agglomerates are in the size range of 1-100 nm and…” “…exhibit unique and novel characteristics or properties because of their size” and “…does not include substances with “trace amounts” of nanoscale particles”
2. These definitions do not allow potential submitters to determine whether they have a reportable chemical substance. EPA needs to provide definitions of these terms that relate to measureable properties.
2. Further, the definition of a “Discrete form of a reportable chemical substance” is problematic because some properties are more accurately measured than others, which means there may be greater or lesser ability to discern materials for certain types of substances, including polydisperse mixtures, and high aspect ratio substances. The ability to accurately measure size versus say, surface reactivity, is not uniform and the selection of model assumptions affects the resultant measurements, including the ability to discern seven times the standard deviation of the mean. I recommended EPA provide guidance on measurement methods, and consider whether to uniformly apply the 7X standard deviation to all properties.
3. Third, EPA included a section in the Proposed Reporting Form on the product Life-cycle. I raised the issue of the lack of understanding of this issue among many industry professionals, and suggested EPA provide guidance on the topic.
Other key industry comments:
- The 135 day review period was noted as raising concern about economic impacts, in that it exceeds the standard 90 day review period for new substances.
- Potential burden on industry, especially smaller companies without internal resources to prepare the required information.
- The minimum size criteria for reporting. At $4 million, some expressed concern that even non-profitable companies will have to report.
July Industry Webinar Summary and Q&A with US EPA Staff
On July 29th a webinar featuring Jim Alwood of US EPA was hosted by SEMI, the Nano Business Commercialization Association, the Semiconductor Industry Association (SIA) and SESHA, aiming to clarify TSCA Section 8(a) proposed rule for chemical substances manufactured or processed as nanoscale materials, and answer pertinent questions from various industry stakeholders.
In the Q&A, questions sought clarification and guidance on the definition of a reportable chemical substance. Vague terminology such as “unique”, “novel” and “trace” used by the EPA in its proposed ruling was highlighted as needing clarification. Additional questions focused on how industry should identify nanoscale materials, including recommendations for tests for non-uniform materials, EPA didn’t offer much guidance beyond what is set forth in the proposed rule and called on industry to comment for clarification.
Other industry questions centered around whether specific forms of nanostructures would be included under the new ruling such as bound versus unbound nanoscale materials, nano-structured integrated circuits, or nanoscale materials incorporated into articles. Of note, the EPA suggested that generally, film, nano-structured integrated circuits, and nanoscale materials incorporated into articles are likely not chemical substances that would be reportable under the new rule; however, companies should seek clarification by commenting on the proposed ruling.
Clarification was also sought from the EPA on distinguishing between processor activities and user activities of nanostructures and if any guidance will be provided. Broadly, the EPA stated that processors change materials formulations, either chemical or form; if there is no change in the starting material formulation, a company may be considered a user and exempt from reporting under TSCA Section 8(a).
Jim Alwood reiterated that now is the chance for stakeholders to have the EPA address and clarify issues by commenting on the proposed ruling. The proposed rule and instructions for submitting comments are in the docket folder with a deadline set of August 5th, 2015.