The Center for Food Safety (CFS) filed suit on December 16, 2014, in the U.S. District Court for the District of Columbia against the U.S. Environmental Protection Agency (EPA) over its failure to regulate novel nanomaterial pesticides. CFS states in its press release that in 2008, it filed a legal petition requesting that EPA regulate nanosilver products as pesticides. EPA opened a public comment period on November 19, 2008, in response to the petition, but according to CFS, “nearly six years later the agency has still failed to respond to Plaintiffs’ 2008 Petition, a failure that violates the mandates of the Administrative Procedure Act (APA).” The petition states that since the 2008 petition was filed, “hundreds of new pesticidal nano-silver products have reached the market without any pesticide oversight from EPA.” CFS asks the court to order EPA to respond to its petition “without further unlawful delay.” The plaintiffs represented by CFS legal counsel in the lawsuit are CFS, its sister non-profit, the International Center for Technology Assessment, as well as Beyond Pesticides, the Center for Environmental Health, Clean Production Action, and the Institute for Agriculture and Trade Policy.
The European Commission (EC) issued a December 11, 2014, press release concerning European Union (EU) food labeling requirements that will take effect December 13, 2014. The European Parliament and the Council adopted the requirements in 2011. The requirements are intended to ensure that consumers receive clearer, more comprehensive, and accurate information on food content, and help them make informed choices about what they eat. Under the requirements, all ingredients present in the form of engineered nanomaterials must be clearly indicated in the list of ingredients. The names of such ingredients must be followed by the word “nano” in brackets. According to the EC, food business operators have had three years “to ensure a smooth transition towards the new labelling regime for prepacked and non-prepacked foods.” In addition, the regulation “provides for exhaustion of stocks for foods placed on the market or labelled before 13 December 2014.” The EC states that work is underway to develop an EU database to facilitate the identification of all EU and national mandatory labeling rules in a simple way. The work for the creation of the database should be carried out during 2015.
The National Nanotechnology Coordination Office (NNCO) announced on December 5, 2014, that, in collaboration with the European Commission (EC), it will hold the 2015 “EU-U.S.: Bridging NanoEHS Research Efforts” joint workshop on March 12-13, 2015, in Venice, Italy. According to NNCO, the workshop will bring together the U.S.-European Union (EU) Communities of Research (COR), which serve as a platform for U.S. and EU scientists to share information on nano environmental health and safety (EHS) research. NNCO states that this workshop, the fourth since 2011, is intended to develop further and support the CORs’ activities. The six CORs are:
Exposure through the Life Cycle, with Material Characterization;
Ecotoxicity Testing and Predictive Models, with Material Characterization;
Predictive Modeling for Human Health, with Material Characterization;
Databases and Ontologies;
Risk Assessment; and
Risk Management and Control.
Due to space limitations, pre-registration for the workshop is required. Registration is on a first-come, first-served basis and will be capped at approximately 100 participants. Registration is now open.
EPA Fall 2014 Regulatory Agenda Includes Item Concerning TSCA Section 8(a) Rule for Nanoscale Materials
The U.S. Environmental Protection Agency’s (EPA) Fall 2014 Regulatory Agenda, which was posted on the Office of Management and Budget’s (OMB) website on November 21, 2014, includes an item concerning Section 8(a) Toxic Substances Control Act (TSCA) reporting and recordkeeping requirements for chemical substances when manufactured or processed as nanoscale materials. According to the item, the proposed rule would require that persons who manufacture these nanoscale materials notify EPA of certain information, including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. EPA states that the proposed reporting of these activities will provide it “with an opportunity to evaluate the information and consider appropriate action under TSCA to reduce any risk to human health or the environment.” The item states that EPA intends to publish a notice of proposed rulemaking in January 2015. As reported previously, on October 6, 2014, EPA submitted a proposed rule to OMB, where it currently remains under review.
On November 24, 2014, the European Parliament (EP) Committee on Environment, Public Health and Food Safety (ENVI) considered draft legislation concerning novel foods. The Committee amended the draft legislation, proposing a moratorium on the use of nanomaterials in food based on the precautionary principle. The Committee approved the amended draft legislation by a vote of 57-4, with two abstentions. EP Member James Nicholson (ECR, UK), who is steering the legislation through the EP, stated that he was not completely satisfied with the vote. According to Nicholson, it is “essential that cloning and nanomaterials be dealt with separately.” The Committee’s press release states that foods for which production processes require risk assessments, including nanomaterials, should not be authorized until they are approved by the European Food Safety Authority (EFSA). The press release notes that “[s]pecial attention should also be paid to food packaging containing nanomaterials, to prevent them migrating into food.” In addition, in line with the precautionary principle, all novel food should also be subject to post-market monitoring. The Committee amended the existing definition of nanomaterials to bring it in line with EFSA recommendations, and dropped the threshold for a food ingredient to qualify as “nano” from the European Commission’s proposed 50 percent to ten percent. The Committee unanimously approved a mandate for Nicholson to begin negotiations with the Council of Ministers, with one abstention. The Council has yet to adopt its negotiating position.
On November 24, 2014, the U.S. Department of Agriculture (USDA) announced that the U.S. Forest Service (USFS) has released a report that details the pathway to commercializing affordable, renewable, and biodegradable cellulose nanomaterials from trees. The report, entitled Cellulose Nanomaterials -- A Path Towards Commercialization, is the result of a May 2014 workshop that brought together a wide range of experts from industry, academia, and government to ensure that commercialization efforts are driven by market and user materials needs. The USFS, in collaboration with the National Nanotechnology Initiative, organized the workshop. Participants included over 130 stakeholders from large volume industrial users, specialty users, federal government agencies, academia, non-government organizations, cellulose nanomaterials manufacturers, and industry consultants. According to USDA, the workshop generated market-driven input in three areas: opportunities for commercialization; barriers to commercialization; and research and development roles and priorities. Issues identified by participants included the need for more data on materials’ properties, performance, and environmental, health, and safety implications, and the need for a more aggressive U.S. response to opportunities for advancing and developing cellulose nanomaterial.
The European Chemicals Agency (ECHA) published on November 3, 2014, an announcement of appeal of a June 17, 2014, contested decision following a compliance check of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration submitted by Tioxide Europe Limited for titanium dioxide. In the contested decision, ECHA requested Tioxide Europe Limited submit the following information: name or other identifier of the substance; composition of the substance; and description of the analytical methods used. The appellants request that the Board of Appeal annul the contested decision in so far as it requests the submission of information related to phases, nanoforms, and surface treated nanoforms as described in the contested decision. According to the appellants, the information related to the identification of titanium dioxide currently included in the registration dossier complies fully with the REACH requirements, taking into account the available guidance documents, and in particular the ECHA guidance for identification and naming of substances under REACH and the regulation on classification, labeling, and packaging of substances and mixtures.
The Ministry of Ecology, Sustainable Development, and Energy published a report, available only in French, concerning the second round of mandatory reporting of nanomaterials. Under Decree No. 2012-232, companies that manufacture, import, and/or distribute a “substance with nanoparticle status” in an amount of at least 100 grams per year must submit an annual report with substance identity, quantity, and use information. According to the report, 10,417 declarations were submitted by June 1, 2014, compared to 3,409 declarations submitted as of July 1, 2013.
The European Parliament (EP) Committee on Environment, Public Health, and Food Safety (ENVI) has posted a study entitled ENVI Relevant Legislative Areas of the EU-US Trade and Investment Partnership Negotiations (TTIP). The study analyzes the main differences between European Union (EU) and U.S. legislation in eight areas: human medicines and medical devices; cosmetics; food and nutrition; sanitary and phyto-sanitary; nanomaterials; cloning; raw materials and energy; and motor vehicles. According to the study, while nanomaterials are regulated under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation in the EU and the Toxic Substances Control Act (TSCA) in the U.S., “REACH is much more stringent than TSCA.” Under REACH, all chemicals on the EU market must be registered, which includes the submission of safety data. Under TSCA, the submission of safety data is required only in particular cases, and chemicals on the market before 1976 can remain on the market without any testing or registration requirements. In addition, the study states, fewer restrictions on chemicals are imposed in the U.S., “where a large amount of information on chemicals may be kept confidential.” While there are currently no nanomaterial labeling policies in the U.S., several EU regulations require the labeling of nanomaterials contained in specific products, in particular cosmetics and food. According to the study, specific legislation dedicated to nanomaterials is still under development in the EU and U.S. The study states that, in addition to explicit rules for nanomaterials, “a definition of [nanomaterials] should be agreed at international level to enhance the dialogue between stakeholders from different countries or sectors and thus the harmonisation of legislation related to [nanomaterials].”
Australian Pesticides and Veterinary Medicines Authority Hosts Symposium on Nanotechnology Regulation
On October 28, 2014, the Australian Pesticides and Veterinary Medicines Authority (APVMA) held a nanotechnology regulation symposium on developing a regulatory framework for nanotechnologies in Australian agriculture and animal husbandry. The program was based on a draft report entitled Regulatory Considerations for Nanopesticides and Veterinary Nanomedicines. The report addresses relevant aspects of nanotechnology, including definitions, metrology, physicochemical properties, manufacture, and the potential impacts on human health and the environment. The draft report suggests that “a pragmatic approach, based on the durability of formulated product, may be the way forward.” According to the draft report, nanoparticles require a very different approach for fate and effect assessment to that for conventional agricultural and veterinary (AgVet) chemicals. The report recommends a minimum set of characterization criteria for nano-AgVet chemicals. APVMA intends to release a final document by the end of January 2015.