Monthly Update for September 2016
EPA Extends Comment Period On PIPs: On August 17, 2016, the U.S. Environmental Protection Agency (EPA) extended the comment period on its White Paper describing how EPA intends to modify its current approach to plant-incorporated protectants (PIP) in breeding line intermediates. 81 Fed. Reg. 54803. Comments are now due on September 29, 2016.
EPA Seeks Comment On Draft Integrated Risk Information System (IRIS) Assessment For Ethyl Tertiary Butyl Ether: On September 1, 2016, EPA announced a 60-day comment period for the draft IRIS Toxicological Review of Ethyl Tertiary Butyl Ether (ETBE). 81. Fed. Reg. 60351. The draft document was prepared by the National Center for Environmental Assessment (NCEA). EPA released the draft IRIS assessment for public comment and discussion at the forthcoming October 26, 2016, IRIS Public Science Meeting. Comments are due by October 31, 2016.
EPA To Host Symposium On PIPs: On August 24, 2016, EPA’s Biopesticides and Pollution Prevention Division announced that it will hold a public symposium on September 29, 2016, on the types of data that support the registration of PIPs. 81 Fed. Reg. 57902. The symposium will be held in the EPA Office of Pesticide Programs’ first floor conference center at One Potomac Yard South in Arlington, Virginia, and can be attended in person or through a live webcast. The symposium is intended to provide a forum for PIP developers, the agricultural sector, and the public to receive information on the scope of the scientific review process that determines the safety of PIPs and on the pesticide registration process as a whole. The majority of PIPs registered in the past 20-plus years use insecticidal traits of bacterial proteins to enhance the plant’s resistance to insect herbivores. EPA, U.S. Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA) representatives will give an overview of the regulatory system that applies to biotechnology in the United States in the context of the Coordinated Framework for Regulation of Biotechnology. Participants will have multiple opportunities to interact directly with the regulators and ask questions. Presentation materials will be available following the meeting. The event is open to the public, but registration is required to participate in either person or electronically. EPA encourages registration on or before September 26, 2016, if you wish to participate in person.
NTP Seeks Information On Antimony Trioxide: On September 9, 2016, the National Toxicology Program (NTP) requested information on antimony trioxide toxicity, exposure, and use to help NTP prepare to evaluate antimony trioxide’s carcinogenicity. 81 Fed. Reg. 62513. NTP will review the chemical for possible inclusion in the Report on Carcinogens (RoC). The RoC lists chemicals that are known or reasonably anticipated to cause cancer in people. Antimony trioxide’s primary use is in flame retardants used in textiles and plastics. The deadline for receipt of information is October 11, 2016.
Ninth Circuit Denies EPA’s Request For Six-Month Extension On Chlorpyrifos Decision; Grants Three-Month Extension: On August 12, 2016, a three-judge panel of the Ninth Circuit Court of Appeals issued an order denying EPA’s request for an additional six months to decide whether to ban agricultural uses of chlorpyrifos. The court granted EPA a three-month extension, stating that “this is the final extension, and the court will not grant any further extensions.” EPA sought the six-month extension to allow time for it to complete two scientific analyses that may bear on EPA’s conclusions in the final rule, and to request further public comment before taking final action on a prior proposal to revoke all chlorpyrifos tolerances. The court concluded that EPA’s request for a six-month extension “is not justified in light of EPA’s history in this matter as well as the court’s previous extensions.” The court stated that EPA’s request was “another variation on a theme ‘of partial reports, missed deadlines, and vague promises of future action’ that has been repeated for the past nine years,” and that “nothing has changed that would justify EPA’s continued failure to respond to the pressing health concerns presented by chlorpyrifos.” For additional information, see our blog.
EPA Issues Notice Establishing SACC: On August 26, 2016, EPA issued a notice that it has created under Section 9(a) of the Federal Advisory Committee Act (FACA) and pursuant to Section 26(o) of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the Science Advisory Committee on Chemicals (SACC). 81 Fed. Reg. 58925. The notice solicits comments and requests nominations for new members of the SACC. The SACC expects to meet in person or by electronic means (e.g., via webinar) approximately three to four times a year, or as needed and approved by the Designated Federal Officer (DFO) and its meetings will be held in the Washington, D.C. metropolitan area. EPA’s notice states that the purpose of the SACC is to “provide independent advice and expert consultation, at the request of the EPA Administrator, with respect to the scientific and technical aspects of risk assessments, methodologies, and pollution prevention measures or approaches supporting implementation of [amended TSCA].” The SACC will be composed of approximately 14 members who will serve as Special Government Employees or Regular Government Employees (RGE). Nine of the 14 members of the SACC will most likely be selected from existing EPA Chemical Safety Advisory Committee (CSAC) members, and EPA will select five new members from among the candidates nominated via this notice and other sources. CSAC members who are interested and available for the SACC include:
- Holly Davies, Ph.D., Senior Toxicologist, Department of Ecology, State of Washington, Olympia, WA;
- William Doucette, Ph.D., Professor, Department of Civil and Environmental Engineering, Utah State University, Logan, UT;
- Panos G. Georgopoulos, Ph.D., Professor of Environmental and Occupational Health, Rutgers Biomedical and Health Sciences — School of Public Health, Rutgers, The State University of New Jersey, Piscataway, NJ;
- Kathleen Gilbert, Ph.D., Professor, Department of Microbiology and Immunology, University of Arkansas for Medical Sciences, Little Rock, AR;
- John Kissel, Ph.D., Professor of Environmental and Occupational Health Sciences, University of Washington, Seattle, WA;
- Jaymie Meliker, Ph.D., Associate Professor, Program in Public Health, Department of Family, Population, & Preventive Medicine, Stony Brook University, Stony Brook, NY;
- Kenneth Portier, Ph.D., Vice President, Statistics and Evaluation Center, American Cancer Society, Atlanta, GA;
- Daniel Schlenk, Ph.D., Professor of Aquatic Ecotoxicology and Environmental Toxicology, University of California, Riverside, Riverside, CA; and
- Kristina Thayer, Ph.D., Deputy Division Director of Analysis and Director, Office of Health Assessment and Translation, National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC.
EPA will publish the names, affiliations, and brief biographical sketches of the interested and available nominees in the Federal Register for a 30-day public comment period. Comments and nominations are due by October 11, 2016. Updates concerning the SACC will be available on EPA’s CSAC website. More information is available in our blog.
The SACC needs to be populated with a diversity of skill sets and individuals who know how TSCA operates in real time. Qualified industry representatives with solid TSCA credentials are urged to consider becoming a nominee to ensure the SACC represents the full spectrum of interests it was intended to reflect.
EPA Identifies Mercury Compounds Prohibited From Export: On August 26, 2016, EPA identified mercury compounds prohibited from export as of January 1, 2020. 81 Fed. Reg. 58926. Under new TSCA Section 12(c)(7)(B), EPA was required to publish a list of mercury compounds prohibited from export within 90 days of June 22, 2016. The notice fulfills EPA’s obligations. The five mercury compounds that cannot be exported as of January 1, 2020, are: mercury(I) chloride or calomel; mercury (II) oxide; mercury (II) sulfate; mercury (II) nitrate; and cinnabar or mercury sulphide. These compounds are generally manufactured or imported in small quantities, used in laboratory chemistry and electrochemistry, or occur in industrial waste or byproducts. For additional information, please visit online.
EPA Issues Guidance Relating To Pathogenic Claims: On September 2, 2016, EPA issued guidance to registrants on the process for making claims against emerging viral pathogens not on EPA-registered disinfectant labels (Guidance). A draft of this Guidance was issued in April 2016 and comments were sought at that time. More information concerning the draft Guidance is available in our blog item EPA Combats Emerging Pathogens Through Updating Guidance for Antimicrobial Pesticide Products. The current Guidance document, which EPA states “provides general guidance to registrants that can be used to identify effective disinfectant products for use against emerging viral pathogens and to permit registrants to make limited claims of their product’s efficacy against such pathogens,” includes changes incorporated following EPA’s review of the three public comments received in response to that draft. The Guidance retains the voluntary two-stage process, but amends the first stage as indicated:
In the first stage, which may be performed prior to any outbreak, registrants with an eligible disinfectant product may submit a request, via label amendment or during the registration of a new product, to control a specific emerging viral pathogen to add a designated statement . . . to the master label and additional terms to the product registration. If the product meets the eligibility criteria suggested in this Guidance, [EPA] generally will approve the amendment. Approval of the amendment would include additional terms and conditions of registration regarding how the designated statement may be published and communicated.
In its response to comments document, EPA responded to several comments, including:
- Changes were made to EPA’s mandated non-label statements to remove certain language that could be considered redundant.
- EPA is developing a coordinated process with the Centers for Disease Control and Prevention (CDC) for the purpose of providing a more standardized and consistent approach to emerging viral pathogen outbreaks. Once this process is established, EPA expects to consult with USDA to develop a similar approach.
- The Guidance document allows for the addition of emerging pathogen claim language to the master label during the new product registration process if the product is eligible. Additional language has been added to multiple locations in the Guidance document to clarify that the process is appropriate for new product registrations.
- EPA “may consider allowing use of additional modes of claim communication under future versions of this Guidance document, however, hangtags and other promotional materials are not authorized at this time. Because the statements authorized under this Guidance are pesticidal claims that do not meet the [Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)] registration criteria, it is essential that these off-label claims are not made outside of an emerging pathogen outbreak as described in the Guidance. Accordingly, the Guidance limits these off-label claims primarily to communications outlets that are wholly within the registrant’s control (800 numbers, social media and websites) from which the off-label claims can be immediately removed. Hangtags and other promotional materials directed towards general consumers are largely out of the registrant’s control once the products enter the chain of commerce, and may persist long after the period during which the off-label claims are authorized.”
EPA also notes that this Guidance document “provides general guidance to EPA, pesticide registrants, applicants for pesticide registrations, and the public. This Guidance is not binding on EPA or any outside parties, and EPA may depart from the guidance where circumstances warrant and without prior notice.”
EPA Convenes Second Industry Stakeholder Meeting On Development Of Fees Rule: On September 13, 2016, EPA convened its second industry stakeholder meeting to discuss the development of a fees rule under the Frank R. Lautenberg Chemical Safety for the 21st Century Act; a copy of the presentation is available here. Under new TSCA Section 26(b)(4)(E), EPA is required to solicit input in support of fees rulemaking. EPA convened its first stakeholder meeting on August 11, 2016. Comments submitted by the August 24, 2016, deadline are available in the docket. During its second meeting, EPA stated it would continue to consider input received by Friday, September 23, 2016; any additional comments should be sent to firstname.lastname@example.org. EPA states it intends to send its proposal to the Office of Management and Budget (OMB) by mid-October 2016, and expects a proposed rule will be published by the second half of December 2016. For additional information, see our blog.
EPA Settlement Telegraphs Changes To General Permit Coverage For Facilities With Coal-Tar Sealed Pavement: On August 16, 2016, EPA reached a settlement in Clean Water Act (CWA) lawsuits filed over its 2015 Multi-Sector General Permit (MSGP) for Stormwater Discharges from Industrial Activities. 80 Fed. Reg. 34403 (June 16, 2015). The MSGP is the collective term for the CWA National Pollutant Discharge Elimination System (NPDES) program’s general permits for stormwater discharges from industrial facilities spanning 29 sectors, including, but not limited to, chemical manufacturing, textile mills, and timber products. EPA reissues the MSGP every five years. Under the terms of the recent settlement agreement in Waterkeeper Alliance v. EPA (2d Cir. 15-02091), EPA agreed to take certain steps in its proposal for the 2020 MSGP reissuance, and also will propose specific permit changes and provisions not included in the current MSGP. The agreed upon actions and proposed permit changes include the following:
- EPA will sponsor and fund a National Research Council (NRC) study that will evaluate and provide recommendations on: (1) potential changes to current benchmark monitoring requirements used to evaluate the performance of stormwater control measures; (2) the feasibility of numeric retention standards (e.g., volumetric control standards for a percent storm size or based on percentage of imperviousness); and (3) the industrial sectors that EPA should prioritize for its consideration of increased monitoring requirements in the next permit cycle.
- EPA will propose that industrial facilities using coal tar sealant “to initially seal or to re-seal pavement and thereby discharge polycyclic aromatic hydrocarbons (‘PAHs’) in stormwater are not eligible for coverage under the MSGP and must either eliminate such discharges or apply for an individual permit.”
- EPA will propose an escalating series of additional actions permittees must take when stormwater discharges exceed benchmark monitoring targets.
- EPA will propose measures aimed at preventing stormwater discharges that could result in recontamination of Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) sites.
The MSGP applies to industrial facilities in Massachusetts, New Hampshire, New Mexico, Idaho, the District of Columbia, most tribal lands, and U.S. territories where EPA serves as the NPDES permitting authority. Facilities located in the other 46 states are subject to state-issued stormwater discharge permits. The EPA MSGP serves as a model for many state permits, and revisions to the EPA permit will typically drive future changes to states’ permits when the permits are due for renewal. As part of the settlement, EPA agreed to propose the 2020 MSGP by September 1, 2019, or nine months after the NRC issues its final report, but no later than September 1, 2020. The EPA proposal will likely open a 60-day comment period. The settlement agreement does not, however, specifically address the timeframe for comment.
FDA Proposes Amendment Of GLP For Non-Clinical Laboratory Studies: On August 24, 2016, a proposal by FDA to amend the Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies (21 C.F.R. Part 58) was published in the Federal Register to “require the use of a complete quality system approach (proposed GLP Quality System) when a nonclinical laboratory study supports or is intended to support an application or submission to FDA.” 81 Fed. Reg. 58342. The objectives of the proposed amendments are to build quality systems into the planning, conduct, and reporting of nonclinical laboratory studies and ensure data quality and integrity, while allowing industry flexibility to meet the proposed requirements.
Many requirements in 21 C.F.R. Part 58 are considered outdated and/or are not commensurate with use of current technology in nonclinical laboratory studies. This proposal is primarily intended to update the regulations to reflect today’s practices in study conduct and, in particular, the conduct of multi-site studies. Included among the many significant changes proposed by FDA are:
- Additional standard operating procedures (SOP) to ensure conformity with the proposed requirement for a GLP Quality System;
- Revised definitions of “testing facility” and “test site” to address the functions and requirements unique to multi-site studies; and
- Updated responsibilities assigned to key roles in a GLP study, including but not limited to the Sponsor, Management, Study Director, Quality Assurance Unit, Principal Investigators, and contributing scientists.
The U.S. is a signatory to the Organization for Economic Cooperation and Development’s (OECD) GLP Mutual Acceptance of Data (1981, revised 1997) and, as an OECD member country, FDA participated in the development of the OECD Principles of GLP (ENV/MC/CHEM(98)17) and related guidance documents. Several of the proposed changes to 21 C.F.R. Part 58 were therefore based on or are intended to be consistent with OECD Principles of GLP.
In totality, the proposed amendments improve the utility of 21 C.F.R. Part 58 in the context of today’s testing paradigms and regulatory landscapes. Many have been quick to note that several requirements set forth in the proposed amendments are impractical and contradict the flexibility these amendments purportedly will impart. The overall costs of the proposed amendments are estimated to average $51.9 million (annualized over a ten-year period assuming a 7 percent discount rate), although FDA emphasizes that a value cannot be placed on the anticipated benefits of the proposed rule, i.e., improved data quality and reliability.
The full details of these proposed FDA GLP amendments and instructions for submitting comments during the 90-day public comment period can be found online. Comments must be submitted by November 22, 2016.
FDA Bans Certain Consumer Antiseptic Products: On September 6, 2016, FDA issued a final rule establishing that certain active ingredients used in over-the-counter (OTC) consumer antiseptic products intended for use with water (referred to as consumer antiseptic washes) are not generally recognized as safe and effective (GRAS/GRAE) and are misbranded. 81 Fed. Reg. 61106. FDA issued the final rule after considering the recommendations of the Nonprescription Drugs Advisory Committee (NDAC), public comments on FDA’s notices of proposed rulemaking, and all data and information on OTC consumer antiseptic wash products that have come to FDA’s attention. The 19 affected active ingredients are:
- Iodophors (Iodine-containing ingredients)
- Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
- Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
- Nonylphenoxypoly (ethyleneoxy) ethanoliodine
- Poloxamer — iodine complex
- Povidone-iodine 5 to 10 percent
- Undecoylium chloride iodine complex
- Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
- Methylbenzethonium chloride
- Phenol (greater than 1.5 percent)
- Phenol (less than 1.5 percent)
- Secondary amyltricresols
- Sodium oxychlorosene
- Triple dye
This final rule amends the 1994 tentative final monograph for OTC antiseptic drug products published on June 17, 1994. The final rule is part of the ongoing review of OTC drug products conducted by FDA. The rule is effective September 6, 2017.
FDA Provides $21.8 Million For FSMA Produce Safety Rule Implementation: On September 9, 2016, FDA announced that it would be awarding $21.8 million to support 42 states to help implement the FDA’s Food Safety Modernization Act (FSMA) produce safety rule. The rule, which was made final in November 2015, establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. States and territories were classified into five tiers of funding eligibility based on the estimated number of farms growing covered produce within their jurisdictions. The funding opportunity is for five years, subject to the availability of funding from Congress. Larger farms will need to comply with certain aspects of the produce safety rule requirements beginning in January 2018, with smaller produce operations having additional time to comply.
FDA Issues Final Rule Regarding GRAS Substances: On August 17, 2016, FDA issued a final rule that amends and clarifies the criteria in its regulations for when the use of a substance in food for humans or animals is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA) because the substance is GRAS under the conditions of its intended use. 81 Fed. Reg. 54960. FDA is also amending its regulations to replace the voluntary GRAS affirmation petition process with a voluntary notification procedure under which any person may notify FDA of a conclusion that a substance is GRAS under the conditions of its intended use. FDA states that the clarified criteria for GRAS status is intended to “help stakeholders draw more informed conclusions about whether the intended conditions of use of a substance in food for humans or animals complies with the FD&C Act, and the notification procedure will enable stakeholders to be aware of whether [FDA has] questioned the basis of a conclusion of GRAS status.” This rule will become effective on October 17, 2016.
FDA Issues Draft Guidances Under The FSMA For Animal Foods And The Classification Of Activities For Farms And Facilities: On August 25, 2016, FDA issued three notices for three draft guidances that are now available for comment: “Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities,” 81 Fed. Reg. 58421; “Human Food By-Products For Use As Animal Food,” 81 Fed. Reg. 58521; and “Current Good Manufacturing Practice Requirements for Food for Animals,” 81 Fed. Reg. 58519.
FDA intends for the first draft guidance concerning classification to assist businesses in determining whether the activities they perform are within the “farm” definition, and states that it is “aimed at helping food businesses determine which of the Food Safety Modernization Act (FSMA) rules apply to their operations.” This draft guidance provides hypothetical examples of operations that may be subject to the FSMA Produce Safety rule or to the FSMA Preventive Controls for Human Food or Animal Food rule. Per FDA’s regulations, a “farm” is a:
[F]acility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. Washing, trimming of outer leaves of, and cooling produce are considered part of harvesting. The term “farm” includes:
- Facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership; and
- Facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.
Comments on this guidance are due by February 21, 2017, to ensure they are considered before FDA begins work on the final version of the guidance.
The other two draft guidances are intended to assist “industry with the implementation of the Preventive Controls for Animal Food rule.” The Current Good Manufacturing Practice (CGMP) guidance is intended to help domestic and foreign facilities that manufacture, process, pack, or hold animal food for consumption in the United States, and that are required to register as food facilities under FFDCA determine whether and how they need to comply with the CGMP requirements of the CGMP, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals final rule, in areas such as personnel, plant and grounds, sanitation, water supply and plumbing, equipment and utensils, plant operations, and holding and distribution. Comments on this guidance are due by November 23, 2016, to ensure they are considered before FDA begins work on the final version of the guidance.
The Human Food By-Products guidance will assist facilities that manufacture, process, pack, or hold human food such as wheat middlings, grain products from grain milling, and vegetable pulp, and then subsequently provide the human food by-products for use as animal food, in determining what requirements in the Preventive Controls for Animal Food rule apply to their human food by-product.
Comments on this guidance are due by November 23, 2016, to ensure they are considered before FDA begins work on the final version of the guidance.
Review Published Of Nanomaterials For Products And Application In Agriculture, Feed, And Food In The European Union (EU): The European Food Safety Authority (EFSA) requested a review of the already marketed and in-development applications of nanomaterials in the agri/feed/food sectors. The results of the review are published in the August 2016 issue of Trends in Food Science & Technology in an article entitled “Nanomaterials for products and application in agriculture, feed and food.” The article highlights include:
- Nanotechnology is applied in agricultural production, animal feed, food processing, additives, and food contact materials;
- Nano-encapsulates, silver, titanium dioxide, and silica are the most often mentioned nanomaterials in the literature;
- A comparison between marketed and in-development applications indicates a trend moving from inorganic to organic nanomaterials; and
- Nanotechnology is an enabling technology, therefore product description should contain the function of a nanomaterial in the product.
U.S. Army ERDC Survey Will Inform Risk Management Tool For Developing Nano-Enabled Products And Nanomaterials: The U.S. Army Engineer Research and Development Center (ERDC) is developing a web-enabled information and screening tool intended to help small businesses integrating or developing nanoscale materials address uncertainty related to regulatory compliance and environment, health, and occupational safety (EHOS) risks. To that end, ERDC conducted a brief survey to identify resources, regulations, and risks that are most important to companies and other organizations involved in product and material development. According to ERDC, the insights provided through the survey will help develop user requirements for a tool that can address future EHOS and regulatory needs in nanotech development. ERDC is a member agency of the National Nanotechnology Initiative through its affiliation with the Department of Defense, and it has produced many tools and publications in this research area. ERDC is partnering with the Jordan Valley Innovation Center at Missouri State University on this effort to augment EHOS expertise with its knowledge of emerging trends in the nanomaterial space. All responses will be held in confidence by researchers at the ERDC, and will be used primarily for the purpose of developing a tool to help businesses that use or are considering use of nanoscale materials account for relevant risks and regulations. Responses were due August 31, 2016.
EC Requests Scientific Opinion On Colloidal Silver (Nano): The European Commission (EC) has requested a scientific opinion from the Scientific Committee on Consumer Safety (SCCS) on colloidal silver (nano). Under the Cosmetics Regulation, any cosmetic product containing a nanomaterial must be notified to the EC six months prior to being placed on the market. If the EC has concerns about the safety of the nanomaterial, it will refer it to the SCCS for a full risk assessment. According to the EC, it has received 63 notifications of cosmetic products containing colloidal silver in nano form. The EC states that, according to the applicants, colloidal silver is used in nano uncoated form both in leave-on and rinse-off oral cosmetics products, including toothpastes and skin care products with a maximum reported concentration limit of one percent and specifications as reported in the EC’s request. The EC states that it has concerns on the use of colloidal silver in nano form because of the potential for nanoparticles to be absorbed and enter into the cells. The EC requests the SCCS conduct a safety assessment of the nano form of colloidal silver covered in the notifications listed in the annex to its request, in the above-mentioned categories of products, taking into account the reasonably foreseeable exposure conditions.
- In view of the above, and taking into account the scientific data provided, the SCCS is requested to give its opinion on the safety of the nanomaterial colloidal silver when used in cosmetics, including toothpastes and skin care products with a maximum concentration limit of one percent, taking into account the reasonably foreseeable exposure conditions; and
- The SCCS is requested to address any further scientific concerns with regard to the use of colloidal silver in nano form in cosmetic products.
The SCCS’s scientific opinion is due six months from receipt of the EC’s request.
EC Requests Scientific Opinion On Styrene/Acrylates Copolymer (Nano) And Sodium Styrene/Acrylates Copolymer (Nano): The EC requested a scientific opinion from the SCCS on styrene/acrylates copolymer and sodium styrene/acrylates copolymer in nano forms. Under the Cosmetics Regulation, any cosmetic product containing a nanomaterial must be notified to the EC six months prior to being placed on the market. If the EC has concerns about the safety of the nanomaterial, it will refer it to the SCCS for a full risk assessment. According to the EC, it has received eight notifications of cosmetic products containing styrene/acrylates copolymer and sodium styrene/acrylates copolymer in nano forms. The EC states that, according to the applicants, the ingredients are used in nano coated form in leave-on cosmetic products with a maximum reported concentration limit of 0.06 percent and specifications as reported in the list appended to the EC’s request. The EC states that it has concerns on the use of sodium styrene/acrylates copolymer (nano) and styrene/acrylates copolymer (nano) because of the potential for nanoparticles to be absorbed and enter into the cells. The EC’s request to the SCCS lists the following questions:
- In view of the above, and taking into account the scientific data provided, the SCCS is requested to give its opinion on the safety of the nanomaterial styrene/acrylates copolymer and sodium styrene/acrylates copolymer when used in leave-on cosmetics products with a maximum concentration limit of 0.06 percent, taking into account the reasonably foreseeable exposure conditions; and
- The SCCS is requested to address any further scientific concerns with regard to the use of styrene/acrylates copolymer and sodium styrene/acrylates copolymer in nano form in cosmetic products.
The SCCS’s scientific opinion is due six months from receipt of the EC’s request.
National Academies Publishes Prepublication Version Of Triennial Review Of The NNI: In early September 2016, the National Academies published a prepublication version of the Triennial Review of the National Nanotechnology Initiative. The National Nanotechnology Coordination Office (NNCO) asked the National Research Council (NRC) to conduct a triennial review of the National Nanotechnology Initiative (NNI). In particular, the NRC was asked to assess: (1) mechanisms to advance focused areas of nanotechnology toward advanced development and commercialization; and (2) the physical and human infrastructure needs for successful realization in the U.S. of the benefits of nanotechnology development. According to the report, the NNI “not only needs to invest in research and discovery, it needs to focus on translating research results into commercial products.” The report assesses NNI mechanisms to advance focused areas of nanotechnology towards advanced development and commercialization, with particular attention to advancing nanomanufacturing (Chapters 2 and 3) and the adequacy of the physical and human infrastructure (Chapters 4 and 5) to support research as well as private sector innovation. The report concludes that the NNI, including the interagency bodies and the NNCO, “continues to add value to the portfolio of activities across participating agencies.” Looking ahead, the report recommends that the NNI can significantly increase that value by focusing on research that will enable progress and success in other advanced technology areas of priority, especially advanced manufacturing. At the same time, the report states, the NNI agencies “are called on to sustain investment in and facilitate access to physical infrastructure and to take steps to realize the full value of educational materials and programs.” In the course of identifying targeted areas in which to focus, NNI agencies have the opportunity to consider the NNI’s goals and the criteria for continuing to invest resources in its coordination and management.
Global Summit On Regulatory Science Focused On Nanotechnology Standards And Applications: The 2016 Global Summit on Regulatory Science (GSRS) was held September 7-9, 2016, in Bethesda, Maryland. Each GSRS meeting focuses on an area of regulatory science that would benefit from discussions aimed at identifying future research directions, and this GSRS meeting focused on nanotechnology standards and applications, building on an October 11, 2015, GSRS workshop. The 2015 workshop focused on physico-chemical measurements and standards relevant to nanomaterials in the “pristine state” and in complex matrices. This meeting expanded on that focus to include both physico-chemical and biological measurements and standards for specific applications, namely nanomaterial-containing drugs, medical devices, food and food contact materials, and personal care products. The goals of the meeting were to:
- Educate a broad group of stakeholders on the state of the art in nanotechnology science, measurement methods, and standards for regulatory applications;
- Identify the most immediate needs in nanotechnology science, measurement methods, and standards relevant to regulatory applications; and
- Facilitate greater coordination between stakeholders in the development of standards.
The desired outcomes of the meeting include:
- Publication of a meeting report: Information generated by the brainstorming panel sessions will be summarized to capture and prioritize needs for new consensus-based documentary standards, guidance documents, and reference materials specifically targeted for regulatory applications of nanotechnology products. Similarly, state-of-the-art and existing gaps in nanotechnology regulatory science will be addressed across a broad spectrum of applications. This information will be incorporated in a publicly available report; and
- Global consensus for a centralized website: There are a number of websites that contain information on standards, for example, the Nanotechnology Standards Database hosted by the American National Standards Institute. A new, centralized website containing links to existing lists of international standards is needed to consolidate the information in a single location. It could be examined whether this website can be part of the EU’s Nanomaterials Observatory to be established and hosted by the European Chemicals Agency (ECHA).
The read-ahead material is a 26-page document listing U.S. and international regulatory agency guidance documents, documents from other organizations, documentary standards, publicly available protocols, and nanoscale reference materials.
Synopsis Available For 2016 U.S.-EU: Bridging NanoEHS Research Efforts Joint Workshop: The synopsis is available for the June 6-7, 2016, U.S.-EU Nano Environmental and Health Safety (NanoEHS) Research Efforts joint workshop. According to the synopsis, the first day of the workshop was devoted to an interactive nanoEHS scrimmage in which the groups collectively responded to a spill of a hypothetical nanotechnology-enabled product. U.S.-EU Communities of Research (COR) representatives planned the scrimmage, and the highlights and findings from the scrimmage are expected to be reported in the scientific literature. The synopsis states that the rest of the workshop included plenary presentations and discussions, as well as breakout sessions in which each of the seven CORs met to discuss accomplishments and set priorities and plans for the coming year. The final plenary session was an open discussion where the need to assess the current state of nanoEHS knowledge emerged as a significant priority for the entire community. According to the synopsis, several participants noted that “this is a substantial and complex task to undertake, but that the CORs are uniquely positioned to contribute to such an activity.” The synopsis includes summaries of the COR breakout sessions:
- Characterization COR: Discussions during the Characterization COR breakout session highlighted how issues of poor data quality and reproducibility can negatively impact research and translation in areas as diverse as nanoEHS and biomedicine.
- Databases and Computational Modeling for NanoEHS COR: The conversations in the Databases and Computational Modeling for NanoEHS COR breakout session touched on key findings from the nanoEHS scrimmage, including the utility of the mock safety data sheets (SDS). According to the synopsis, the SDSs were generally regarded as helpful, but “[n]otably, the scrimmage participants assumed that the SDSs were valid, and the data supporting the SDS were not examined.”
- Human Toxicity COR: The following improvements for future scrimmages were suggested: documenting the wide range of opinions in response to the scrimmage scenario; giving each COR different starting information; and focusing more on the nanotechnology-specific aspects of the materials. As an idea for the next scrimmage, participants suggested looking at common consumer products (e.g., sunscreen, antimicrobial textiles, carbon nanotubes in electronics) to determine if there is agreement among the CORs on exposure implications, as well as on potential impacts on human health or the environment.
- Ecotoxicity COR: The two main topics discussed during the Ecotoxicity COR breakout session were quantification of nanomaterials in organism tissues after ecotoxicology testing and more environmentally relevant ecotoxicity testing.
- Exposure through Product Life COR: Breakout session attendees brainstormed possible focus areas for the COR to address, with the following high-level needs emerging: (1) data on chronic exposures to engineered nanomaterials; (2) information on scenarios in which engineered nanomaterials may be released from consumer products; and (3) methods to detect and quantify rapidly engineered nanomaterials in products at levels of potential exposure concern.
- Risk Assessment COR: Participants discussed the lessons learned from the nanoEHS scrimmage, with the primary conclusions that: (1) differences exist between risk assessment reference documents, governance, and communication across the U.S. and Europe; and (2) differences exist between the scientific assessment of risk carried out within this research community and the short-term evaluation and management processes required for successful management and communication of emergency situations.
- Risk Management and Control COR: Dr. Ulla Vogel, EU Co-Chair, described the potential routes of worker exposure as inhalation, ingestion, and dermal and noted that inhalation is considered the major route of occupational concern for nanomaterials. U.S. Co-Chair Dr. Vince Castranova gave a presentation on “Proposed Amendments to OECD Subacute and Subchronic Inhalation Test Guidelines.” According to Castranova, two changes appear likely: (1) the current limit for mass median aerodynamic diameter (MMAD) may change from the current 1-4 micrometers (μm) limit to less than 2 μm; and (2) the current biological analysis of pulmonary response may change from histopathology alone to histopathology plus analysis of damage and inflammatory markers in bronchoalveolar lavage samples. Further, it appears that measurement of lung burden and clearance of pulmonary nanoparticles will be recommended as optional.
Draft 2016 NNI Strategic Plan Available For Public Comment: On September 13, 2016, NNI announced in the Federal Register the availability of the draft 2016 NNI Strategic Plan for public comment. 81 Fed. Reg. 62937. The NNI Strategic Plan represents a consensus among NNI agencies on the high-level goals and priorities of the NNI, and on specific objectives to be pursued over at least the next three years. The NNI Strategic Plan provides the framework under which individual NNI agencies conduct their own nanotechnology programs, coordinate activities with those of other NNI agencies, and collaborate. The draft 2016 NNI Strategic Plan states that over the life of the NNI, its focus has broadened from investments in foundational research in nanomaterials and nanotechnology-enabled devices to include activities concerning how these nanomaterials and devices can be incorporated into nanotechnology-enabled systems. This update of the Strategic Plan “reflects that evolution and addresses how the NNI agencies will collaborate with each other and the broader nanotechnology community to expand the ecosystem that supports fundamental discovery, fosters innovation, and promotes the transfer of nanotechnology discoveries from lab to market.” It includes the following goals:
- Advance a world-class nanotechnology research and development program;
- Foster the transfer of new technologies into products for commercial and public benefit;
- Develop and sustain educational resources, a skilled workforce, and a dynamic infrastructure and toolset to advance nanotechnology; and
- Support responsible development of nanotechnology.
Comments are due September 23, 2016.
BRAG Biobased Products News And Policy Report: Bergeson & Campbell, P.C.’s (B&C®) consulting affiliate, B&C® Consortia Management, L.L.C. (BCCM), manages the Biobased and Renewable Products Advocacy Group (BRAG®). For access to a weekly summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to www.braginfo.org.
Because Congress just returned from its August recess, we do not have anything to report. We will resume the Legislative Developments in the October update.
CPSC Proposes Diminished Testing For Certain Phthalates: On August 17, 2016, the Consumer Product Safety Commission (CPSC) responded to requests from toy manufacturers and others and proposed a rule to determine that certain plastics with specified additives would not contain the specified phthalates prohibited in children’s toys and child care articles. 81 Fed. Reg. 54754. Under the proposal, based on these determinations, the specified plastics, which include polypropylene, polyethylene, high-impact polystyrene, and acrylonitrile butadiene styrene, with specified additives would not require third-party testing for compliance with the mandatory phthalates prohibitions on children’s toys and child care articles. Comments are due by October 31, 2016.
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