Volume 11, No. 2 • Summer 2016 Environmental Protection Agency (US EPA) and the Food and In This Issue Drug Administration (FDA) to require companies to submit data on worker exposures to nanosilver before products con- • Recent Government Briefs taining nanosilver are allowed into the marketplace. These • Reports, Reviews, White Papers, and Books groups also supported implementing controls to mitigate ex- • Hot-off-the-Presses: Peer-reviewed Research posures (e.g., eliminating exposure to nanosilver or using less- Articles of Note hazardous substances) and recommended that companies be • Upcoming Meetings and Conferences required to submit safety data on potential risks to workers • New Product Review (e.g., liver and lung effects). Specifically, these groups noted the need to address women's exposures to nanosilver (e.g., for reproductive endpoints), because most occupational studies Recent Government Briefs of this substance have focused on men. Link to the Risk Policy Report, by Reynolds: http://insideepa.com/risk-policy-report/niosh-for- goes-novel-limit-nanosilver-citing-insufficient-risk-da- NIOSH Not Issuing New Recommended ta Exposure Limit for Nanosilver The docket, including comments and supporting documenta- tion, can be accessed here: Based on the comments it received on the draft document https://www.regulations.gov/#!docketDetail;D=C "Health Effects of Occupational Exposure to Silver Nanomate- DC-2016-0001 rials," the National Institute for Occupational Safety and Health (NIOSH) has decided it will not issue a specific recommended NIOSH Releases Guide to Protect exposure limit (REL) for occupational exposures to nanosilver, due to insufficient data. According to the January 21, 2016, Nanotechnology Workforce Federal Register notice, this document "contains a review and assessment of the currently available scientific literature on In March 2016, NIOSH released a document titled "Building a the toxicological effects of exposure to silver nanoparticles in Safety Program to Protect the Nanotechnology Workforce: A experimental animal and cellular systems, and on the occupa- Guide for Small to Medium-Sized Enterprises." The purpose of tional exposures to silver dust and fume and the associated this guide is to provide business owners "with the tools nec- health effects." The comment period for the document ended essary to develop and implement a written health and safety on April 22, 2016. program to protect" their employees. The guide focuses on "considering and managing the potential, unintended conse- Industry groups generally supported NIOSH's decision to not quences to human health and the environment that might ac- set a separate REL for nanosilver, because, according to the Sil- company development and use of the technology." It outlines ver Nanotechnology Working Group (SNWG), "nanoscale silver issues and strategies related to risk minimization, risk manage- is not significantly different from conventional silver, and… ment, occupational hazards and controls, and federal and in- nanosilver has a long record of safe use and regulatory over- ternational regulations and compliance, among others. sight" (Reynolds, 2016). Industry groups also reiterated their support for using risk management practices to ensure that The guide can be accessed here: worker exposures do not exceed the current REL for all forms http://www.cdc.gov/niosh/docs/2016-102/pdfs/2016- of silver. 102.pdf Public health groups emphasized the need to strengthen the document's language. They also wanted the United States 1 GRADIENT gradientcorp.com EH&S Nano News Center for Food Safety, and the International Center for Tech- Industry Calls for a Narrowed TSCA nology Assessment. The groups' suit, on which we reported in our spring issue, objects to US EPA's approval of a conditional Reporting Rule registration for NSPW-L30SS (formerly Nanosilva), a nanosilver antimicrobial/pesticide product. In its Answering Brief, US EPA Industry representatives have repeated their call for US EPA to argued that "it properly determined that Nanosilva had insuf- clarify and narrow the scope of its proposed Toxic Substances ficient time to generate data," because the agency "imposed Control Act (TSCA) Section 8(a) reporting rule for nanoscale new data requirements on Nanosilva simultaneously with its materials, which was published in the Federal Register on grant of NSPW-L30SS's registration." US EPA further argued April 6, 2015. The Rule would require a one-time submission that the use of NSPW-L30SS nanosilver would reduce the of data on a chemical's properties, as well as "require that environmental silver load, because the product is applied at companies that intend to manufacture reportable substances much lower rates than conventional silver (also used in antimi- after the rule takes effect report to the agency at least 135 crobial/pesticidal applications), has low mobility once applied, days before commencing manufacturing." Industry officials and leaches silver from the treated material "into the environ- are urging US EPA to drop the future reporting requirement, ment at levels below what measuring instruments can detect." "arguing the agency is exceeding its TSCA authority and US EPA also noted that the petitioners are not challenging has failed to justify certain provisions" (Reynolds, 2016). In US EPA's finding that the use of NSPW-L30SS "will not cause a March 16, 2016, letter to US EPA, the NanoManufactur- unreasonable adverse effects." US EPA has asked the court to ing Association contended that the current Proposed Rule deny the environmental groups' petitions. would lead to "duplicative reporting" on existing products and delays in the commercialization of new products. US EPA Read more at: intends to issue the final rule by October 2016. http://nanotech.lawbc.com/2016/03/epa-defends- conditional-nanosilver-registration Link to the Risk Policy Report, by Reynolds: http://insideepa.com/daily-news/industry-reiterates- US EPA's Answering Brief can be accessed here: call-narrow-nano-rule-epa-seeks-further-clarity http://nanotech.lawbc.com/wp-content/uploads/ sites/539/2016/03/00178682.pdf US EPA's Proposed Rule can be accessed here: https://www.regulations.gov/#!docketDetail;D=EPA- HQ-OPPT-2010-0572 Reports, Reviews, White Papers, The April 6, 2015 Federal Register notice can be accessed here: and Books https://www.gpo.gov/fdsys/pkg/FR-2015-04-06/ pdf/2015-07497.pdf The letter from the NanoManufacturing Association can be ac- Harmonization of Environmental Safety cessed here: http://insideepa.com/sites/insideepa.com/files/docu- and Health Terminology ments/mar2016/epa2016_0657a.pdf Different stakeholders, such as the scientific community, in- US EPA's Spring 2016 Regulatory Agenda item can be viewed ternational bodies and government agencies, and industry here: groups, use different nano-related environmental health and http://www.reginfo.gov/public/do/ safety terms. Because of this, NANoREG, a project under the eAgendaViewRule?pubId=201604&RIN=2070-AJ54 European Union's 7th Framework Programme, decided to harmonize these terms. The Joint Research Centre (JRC), the European Commission's science and knowledge service, pub- US EPA Files Answering Brief in lished "NANoREG Harmonised Terminology for Environmen- tal Health and Safety Assessment of Nanomaterials" on April Response to Environmental Group 12, 2016. This report is the result of the project's "attempt at bringing common understanding and consistency in the use Petitions of key terms in the environmental health and safety (EHS) as- sessment of nanomaterials." Specifically, all project partners On March 8, 2016, US EPA filed an Answering Brief in response have agreed upon the terminology they will use in their activi- to petitions filed by the Natural Resources Defense Council, the 2 GRADIENT gradientcorp.com EH&S Nano News ties and documents. The report describes the methodology In late 2015 and early 2016, the Organisation for Economic used to select the 43 key terms and their supporting defini- Co-operation and Development (OECD) released six addition- tions, as well as the information sources used. al papers (Nos. 62 through 67) in its Safety of Manufactured Nanomaterials series. The NANoREG report can be accessed here: http://publications.jrc.ec.europa.eu/repository/ Considerations for Using Dissolution as a Function of Sur- bitstream/JRC100906/jrc%20technical%20report- face Chemistry to Evaluate Environmental Behaviour of nanoreg%20terminology%20ehs%20assesse- Nanomaterials in Risk Assessment (No. 62). Because there ment%20nms.pdf are no standardized test methods for evaluating the dissolu- tion of nanomaterials in various environmental and biological media, this project's purpose was to "identify an approach to Nanoparticles Found in Baby Formula help guide current regulatory environmental risk assessments when evaluating dissolution information using the current In May 2016, the Friends of the Earth (FOE), an environmental state-of-the-science; and extend, as far as possible using our non-profit group, released a document titled "Nanoparticles in Baby Formula: Tiny New Ingredients Are a Big Concern" that current understanding from silver nanoparticles (the case- reports on detections of hydroxyapatite nanoparticles (nano- study) to other metal-based nanoparticles." The approach HA) in samples of popular brands of baby formula. Arizona described in the report classifies dissolution values as high, State University, which FOE commissioned to analyze the for- moderate, low, or negligible,