March 18, 2019

March 18, 2019

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March 15, 2019

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Human Carcinogens, Antimicrobial Pesticides, Cross-State Air Pollution: Federal Law Updates for Chemical Law and Science

FEDERAL ISSUES 

TSCA/FIFRA/IRIS/NTP/TRI

EPA Extends Comment Period On Proposed SNUR: On October 21, 2016, the U.S. Environmental Protection Agency (EPA) announced that it has reopened the comment period on a proposed Significant New Use Rule (SNUR) under the Toxic Substances Control Act (TSCA) as requested by a commenter. 81 Fed. Reg. 72759. The proposed rule would amend the TSCA significant new use regulations to align them with revisions to the Occupational Safety and Health Administration’s (OSHA) Hazard Communications Standard (HCS), as occasioned by OSHA’s March 2012 final rule modifying the HCS to conform to the United Nations’ (UN) Globally Harmonized System of Classification and Labelling of Chemicals (GHS), changes to OSHA’s Respiratory Protection Standard, and the National Institute for Occupational Safety and Health (NIOSH) respirator certification requirements pertaining to respiratory protection of workers from exposure to chemicals. The proposed rule would also amend regulations for SNURs previously proposed and issued and make a “minor” change to reporting requirements for premanufacture notices (PMN) and other TSCA Section 5 notices. 

Our memorandum “TSCA Reform: Proposed Changes to SNUR Procedures Would, Perhaps Inadvertently, Result in Disclosure of CBI to Third Parties/Possible Competitors” also brings to light another important legal issue, concerning interesting anomalies that appear in the proposal’s discussion of bona fide requests and the disclosure of information potentially considered confidential. EPA proposes to modify the procedures for determining if a specific substance or chemical use is subject to a SNUR when the substance, production volume, or use is claimed as confidential business information (CBI). The source of EPA’s authority to disclose CBI in the ways described in the proposed rule is unclear, as neither old nor new TSCA specifies them, such as the statutory basis and rationale for informing a bona fide intent notice (BFN) submitter of confidential use or production volume conditions. Also, EPA does not justify why disclosure to the BFN submitter is necessary. The current proposed SNUR provides for neither equal disclosure nor equal confidentiality as a result of a BFN submission. Comments are due November 21, 2016

 DHHS Issues 14th Report on Carcinogens: On November 3, 2016, the U.S. Department of Health and Human Services (DHHS) released the 14th Report on Carcinogens (RoC). 81 Fed. Reg. 76621. New listings included in the 14th RoC include six new listings and one revised listing in this edition. The revised listing is for trichloroethylene, which was previously listed as reasonably anticipated to be a human carcinogen and is now listed as known to be a human carcinogen. Five of the new listings are in the category of known to be a human carcinogen: Epstein Bar virus, Kaposi sarcoma-associated herpesvirus, human T-cell lymphotropic virus type 1, human immunodeficiency virus-type 1, and Merkel cell polyomavirus. The new listing in the category of reasonably anticipated to be a human carcinogen is for cobalt and cobalt compounds that release cobalt ions in vivo

EPA Proposes Two Test Methods And Guidance For Evaluating Antimicrobial Pesticides: EPA recently announced for comments the availability of two proposed test methods and associated testing guidance for evaluating antimicrobial pesticides against two biofilm bacteria, Pseudomonas aeruginosa and Staphylococcus aureus. EPA states that registrants of antimicrobial products with public health claims are “required to submit efficacy data to EPA in support of the product’s registration” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA is soliciting comments on the clarity of the standard operating procedures and the regulatory guidance. The two test methods are: "Single Tube Method with Splashguard for Evaluating Disinfectant Activity against Pseudomonas Biofilm -- 2015 Method Performance Study"; and "Proposed Procedure: EPA MLB SOP MB-20: Single Tube Method for Determining the Efficacy of Disinfectants against Bacterial Biofilm." The Draft Guidance to Assess the Efficacy of Antimicrobial Pesticide Products Intended to Control Public Health Biofilms on Hard, Non-Porous Surfaces describes biofilms and their public health significance; the two test procedures for developing efficacy data supporting biofilm claims; products that may be eligible for biofilm claims; test criteria; data submission procedures for efficacy data; and labeling guidance. The draft guidance states that the term biofilm “is reserved for claims against biofilm that contain specific bacteria that are directly or indirectly infectious or pathogenic to humans,” and “biofilm claims are considered to be public health claims for which the agency must review and approve appropriate efficacy data.” EPA states: “Examples of use sites that may be supported by the biofilm test methodologies herein, and found acceptable, include restrooms, shower stalls, sink basins or drains (excluding the drain pipe) and nearby hard, non-porous surfaces of walls, countertops, and instrument trays in patient care areas of hospitals. In contrast, claims against non-public health slimicides must also be supported by appropriate efficacy data, however, submission of the data is only required when requested by the EPA.” Comments will be accepted until January 21, 2017

EPA Issues Final 2016 NPDES Pesticide General Permit: On November 1, 2016, EPA published its Final National Pollutant Discharge Elimination System (NPDES) Pesticide General Permit for Point Source Discharges from the Application of Pesticides in the Federal Register, which regulates discharges to waters of the United States from the application of biological pesticides and chemical pesticides that leave a residue. 81 Fed. Reg. 75816. The 2016 NPDES Pesticide General Permit (PGP) replaces the 2011 PGP, which expired on October 31, 2016. The PGP applies to the following geographic areas where EPA serves as the NPDES permitting authority: the States of: Massachusetts, New Hampshire, New Mexico, and Idaho; District of Columbia; all U.S. territories except the U.S. Virgin Islands; federal facilities in Delaware, Vermont, Colorado, and Washington; discharges in Texas that are not under the authority of the Texas Commission on Environmental Quality, including activities associated with oil and gas exploration (see Appendix A of the Final 2016 PGP for further description); and all areas of Indian Country that are not covered by an EPA-approved permitting program (see Appendix A for Indian Country covered within each EPA Region). Similar to the 2011 PGP, the 2016 PGP contains additional permit conditions and modifications that some states and tribes added through the Clean Water Act (CWA) Section 401 certification process and/or the Coastal Zone Management Act process. Part 9 of the 2016 PGP provides a detailed breakdown of any additional requirements. Forty-six states have delegated authority to administer state versions of the PGP. The majority of states recently revised and reissued their respective state PGPs for another five-year permit cycle. The 2016 PGP requirements are nearly identical to those in the 2011 PGP, with the exception of the following two updates included in the 2016 PGP:

Electronic reporting (Part 7.8) -- All reporting under the 2016 PGP (i.e., Notice of Intent (NOI), Annual Report, and Notice of Termination (NOT) submissions) must be submitted via EPA’s eNOI system to be consistent with EPA’s Electronic Reporting Rule.  EPA will make these reports publicly available through a searchable index tool -- eNOI search.  More information on electronic reporting, and access to the Central Data Exchange for NOI, Annual Report, and NOT submissions is available here.

Updated definition of the National Marine Fisheries Service (NMFS) Listed Resources of Concern -- Following consultation between EPA and NMFS, as required under Section 7 of the Endangered Species Act (ESA), EPA expanded the Listed Resources of Concern to include additional species not included in the 2011 PGP definition. Under Part 1.1.2.4, pesticide discharges that overlap with NMFS Listed Resources of Concern trigger additional NOI requirements to certify that the discharges and discharge-related activities are not likely to affect adversely federally listed “endangered” or “threatened” species, or federally-designated “critical habitat.” Permittees may consult EPA’s PGP NMFS Listed Resources of Concern -- Interactive Mapping Tool to determine whether a discharge activity will overlap with these Resources of Concern. Appendix I provides endangered species instructions for affected permittees. EPA states in the corresponding Fact Sheet for the 2016 PGP that it continues to estimate that less than two percent of the total number of Operators in the PGP coverage areas will need to meet additional permit requirements to meet ESA-related provisions.

The 2016 PGP permit conditions went into effect on October 31, 2016, and the PGP will expire in five years on October 31, 2021. 2016 PGP coverage is automatic through January 12, 2017, without the submission of an NOI, but pesticide Operators (i.e., pesticide applicators) must comply with all 2016 PGP conditions as of October 31, 2016. For any discharges commencing on or before January 12, 2017, that will continue after this date, a decision-maker must submit an NOI no later than January 2, 2017, to ensure PGP coverage, and for any discharges subsequent to January 12, 2017, an NOI submission is required no later than ten days before the first discharge. Table 1-1 at Part 1.2.3 outlines which decision-makers must submit NOIs based on the particular pesticide use pattern, location (i.e., if discharging to a designated Outstanding National Resource Water), and acreage thresholds. Table 1-2 at Part 1.2.3 provides applicable NOI submission deadlines, including grace periods for NOI filing for discharges in response to a Declared Pest Emergency. EPA’s webpage for pesticide NPDES permitting includes links to the final 2016 PGP, a related fact sheet, the permitting decision tool, and information on eNOI and ESA procedures. Although the 2016 PGP largely mirrors the 2011 version of the permit, it will be important for decision-makers to familiarize themselves with the new electronic reporting requirements (Part 7.8). EPA’s eNOI system is publicly searchable and could subject PGP permit holders to additional scrutiny by citizens and advocacy groups concerned about potential environmental and public health implications of pesticide applications in their areas. Decision-makers should consult EPA’s “PGP NMFS Listed Resources of Concern -- Interactive Mapping Tool and the Alternative PGP Sources of Information for NMFS Listed Resources of Concern” to determine where discharges may overlap with these areas and trigger additional permit conditions.

RCRA/CERCLA/CWA/CAA

Final Rule Amends Cross-State Air Pollution Rule: EPA on October 26, 2016, issued a final rule amending its Cross-State Air Pollution Rule (CSAPR) under the Clean Air Act (CAA). 81 Fed. Reg. 74504. The rule amends regulations under 40 C.F.R. Parts 52, 78, and 97 to update the CSAPR to address interstate transportation of ozone with respect to the 2008 National Ambient Air Quality Standard (NAAQS) for ozone. EPA promulgated the original CSAPR on August 8, 2011, to address interstate transport of ozone pollution under the 1997 ozone NAAQS and interstate transport of fine particulate matter (PM2.5) pollution under the 1997 and 2006 PM2.5 NAAQS. EPA believes the October 26, 2106, final rule will reduce ozone season emissions of oxides of nitrogen (NOX) in 22 eastern states that can be transported downwind as NOX or, after transformation in the atmosphere, as ozone, and can negatively affect air quality and public health in downwind areas. For these 22 eastern states, EPA is issuing Federal Implementation Plans (FIP) that generally provide updated CSAPR NOX ozone season emission budgets for the electric generating units (EGU) within these states, and that implement these budgets via modifications to the CSAPR NOX ozone season allowance trading program that was established under the original CSAPR. EPA is issuing these new or revised FIP requirements only for certain states that have failed to submit an approvable State Implementation Plan (SIP) addressing interstate emission transport for the 2008 ozone NAAQS. The FIPs require affected EGUs in each covered state to reduce emissions to comply with program requirements beginning with the 2017 ozone season (May 1 through September 30). EPA also intends that these CSAPR revisions address the July 28, 2015, remand by the United States Court of Appeals for the District of Columbia Circuit of certain states’ original CSAPR phase 2 ozone season NOx emission budgets. The final rule is effective on December 27, 2016

EPA To Retain Current Lead NAAQS: In a decision published on October 18, 2016, EPA has decided to retain the current NAAQS for lead. 81 Fed. Reg. 71906. The primary and secondary lead standards of 0.15 micrograms per cubic meter lead in total suspended particles as a three-month average thus will remain in place. EPA did note, however, the “attendant . . . increasing uncertainty of risk estimates for lower air Pb concentrations,” thus possibly setting the stage for a lowering of the NAAQS when EPA revisits the issue in five years, as required under the CAA. The final rule is effective November 17, 2016

EPA Releases Three Guidance Documents On Data Use For CERCLA/RCRA Lead Assessments: EPA has quietly released three documents providing guidance on how and whether lead risk assessments under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund) should include short-term exposure scenarios, updated variables on blood lead data, and other information and data. The three guidance documents (all dated August 2, 2016) are: “Recommendations for Using Blood Lead Data at Superfund and RCRA Corrective Action Sites (OLEM Directive 9285.6-52)”; “Recommendations for Assessing Short-Term Exposure Scenarios Involving Lead at Superfund Sites (OLEM Directive 9295.6-54)”; and “Transmittal of Update to the Adult Lead Methodology’s Default Baseline Blood Lead Concentration and Geometric Standard Deviation Parameters (OLEM Directive 9285.6-55).” 

The first document transmits recommendations from the Technical Review Workgroup for Metals and Asbestos (TRW) on how or whether to use blood lead data in Superfund lead risk assessments.  The second directive transmits the TRW technical document entitled “Recommendations for Assessing Short-Term Exposure Scenarios Involving Lead at Superfund Sites.” It notes that short-term exposures to lead have typically not been considered in assessments involving lead and provides guidance on how to do so. This document cautions that short-term exposure to lead “may pose risk of neurocognitive effects to children.” The guidance also states that EPA is developing an “All-Ages Lead Model” that will allow site assessors to implement one of two alternative models of lead pharmacokinetics to “explore short-term exposure scenarios.” The third directive adjusts EPA’s default parameters that alter a preliminary remediation goal (PRG) for lead. EPA is specifically recommending an increase in the PRG for soil lead concentrations from 2,240 parts per million (ppm) to 2,737 ppm. Taken collectively, this trio of documents represents a significant shift in how EPA assesses risk of lead contamination at CERCLA and Resource Conservation and Recovery Act (RCRA) sites.  The documents are available online. 

EPA Issues Final Rule Revising RCRA Hazardous Waste Import/Export Requirements: On October 28, 2016, EPA issued a pre-publication of a final rule significantly amending the hazardous waste import and export requirements under RCRA.   EPA states that the rule amends existing regulations to make them more consistent with the current import-export requirements for shipments between members of the Organization for Economic Cooperation and Development (OECD); enable electronic submittal to EPA of all export and import-related documents (e.g., export notices, export annual reports); and enable electronic validation of consent in the Automated Export System (AES) for export shipments subject to RCRA export consent requirements prior to exit. (The AES resides in the U.S. Customs and Border Protection’s Automated Commercial Environment (ACE)). The rule removes and reserves 40 C.F.R. Part 262 Subparts E and F, and expands the applicability of a reorganized and clarified 40 C.F.R. Part 262 Subpart H to all hazardous waste transboundary shipments, including those import and export shipments of universal waste managed under 40 C.F.R. Part 273 and specific hazardous wastes (such as spent lead-acid batteries) managed under 40 C.F.R. Part 266. Exporters of hazardous waste shipments, and the transporters carrying such shipments, to Canada, Chile, Mexico, and any non-OECD country will be required to comply with OECD procedures under new or renewed consents issued after the effective date of this action. Importers and receiving facilities of hazardous waste shipments, and the transporters carrying such shipments, from Canada, Chile, Mexico, and any non-OECD country similarly will be required to comply with OECD procedures under new or renewed consents issued to either the foreign exporter or the U.S. importer after the effective date of this action. This final rule is effective on December 31, 2016

EPA Proposes Rule On Internet Posting Of And Confidentiality Determinations For Hazardous Waste Export And Import Documents:   On October 28, 2016, EPA issued a pre-publication of a proposed rule that would amend the hazardous waste RCRA international shipment requirements. The proposed revisions would require exporters of hazardous waste and facilities that receive hazardous wastes from foreign sources to maintain a single, publicly-accessible website to which documents can be posted regarding the confirmation of receipt and confirmation of completed recovery or disposal of hazardous waste import and export shipments. EPA is concurrently proposing confidentiality determinations with respect to CBI claims for the individual documents and compiled data for certain types of documents. EPA believes these changes will improve information on the movement and disposition of hazardous wastes. EPA further believes it will enable interested stakeholders to benefit from the provision of publicly-accessible data to monitor proper compliance with the RCRA regulations and help ensure that hazardous waste import and export shipments are properly received and managed. Comments on this proposal will be accepted for 60 days following publication of this rule in the Federal Register

FDA

FDA Issues Proposed Rule On Uses of Ozone-Depleting Substances: On October 26, 2016, the U.S. Food and Drug Administration (FDA) issued a proposed rule to amend its regulation on uses of ozone-depleting substances (ODS), including chlorofluorocarbons (CFC), to remove the designation of certain products as “essential uses” under the CAA. 81 Fed. Reg. 74364. Essential-use products are exempt from the ban by FDA on the use of CFCs and other ODS propellants in FDA-regulated products. FDA states it is proposing this action because alternative products that do not use ODSs are now available and because these products are no longer being marketed in versions that contain ODSs. This action, if finalized, will remove the essential-use exemptions for sterile aerosol talc administered intrapleurally by thoracoscopy for human use and for metered-dose atropine sulfate aerosol human drugs administered by oral inhalation. This rule is not expected to be controversial as the alternatives have been in place for the impacted devices for some time. Comments are due December 27, 2016. 

FDA Provides Industry Clarifications On Disclosure Statements In Draft Guidance On Four Rules Implementing FSMA : On October 31, 2016, FDA issued a notification of the availability of “Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA Food Safety Modernization Act: Guidance for Industry.” 81 Fed. Reg. 75349. The draft guidance is intended to provide industry clarification on the disclosure statements made by suppliers and manufacturers describing certain hazards that have not been controlled by them, as required by certain provisions in FDA’s four final rules implementing the Food Safety Modernization Act (FSMA). The notice lists these rules in Table 1. FDA covers how to detail hazards under the four rules and offers examples on what documents it considers as “documents of the trade.” Comments on the draft guidance are due May 1, 2017

FDA Provides Questions And Answers Regarding Food Facility Registration Under FSMA In Draft Guidance: On November 8, 2016, FDA issued a notification of availability of “Questions and Answers Regarding Food Facility Registration (Seventh Edition): Draft Guidance for Industry.” 81 Fed. Reg. 78526. This draft guidance contains 15 sections of a multisection guidance intended to provide updated information relating to the food facility registration requirements in the Federal Food, Drug, and Cosmetic Act (FFDCA). The seventh edition is intended to address questions and provide additional information on the Amendments to Registration of Food Facilities final rule from July 2016. Comments are due on February 6, 2017.  

NANOTECHNOLOGY

NIOSH Presentation On Engineering Controls For Nanotechnology Now Available: On September 27, 2016, the NIOSH Board of Scientific Counselors (BSC) met, and its discussion included engineering controls and nanomaterials. Kevin H. Dunn, Sc.D., CIH, a NIOSH Division of Applied Research and Technology (DART) mechanical engineer and member of NIOSH’s Nanotechnology Research Center, provided an update to the BSC on NIOSH’s evaluations, findings, recommendations, and guidance for reducing occupational exposures to nanomaterials through engineering controls. NIOSH recently posted Dunn’s presentation online. According to the presentation, NIOSH has a good understanding of how exposures occur and how to control them. NIOSH needs to continue to conduct field studies to identify new processes and materials, however. The question of whether NIOSH should be doing any laboratory work on quantifying control effectiveness was raised. In addition, NIOSH needs to have a better understanding of how to communicate with its target audience. Future plans include developing three additional Workplace Design Solutions on common nanotech tasks/processes, including reactor operations (harvesting and cleaning); powder collection/dumping (large bag dumping and powder packing); and large scale material handling. 

ECHA Board Of Appeal Annuls Four Decisions Requesting Substance Identity Information On A Nano Structured Substance: In cases A-008-2015, A-009-2015, A-010-2015, and A-011-2015, the European Chemicals Agency (ECHA) Board of Appeal examined appeals against compliance check decisions made by ECHA requesting further substance identity information from four registrants of a “nano structured” substance. As reported in our July 29, 2015, blog item, ECHA adopted the contested decisions on December 17, 2014, following a compliance check under the dossier evaluation procedure of the submitted registration. In each contested decision, ECHA found that the registration did not comply with the requirements of Article 10(a)(ii), as well as Annex VI, Section 2 of the Registration, Evaluation, Authorization and Restriction of Chemicals Regulation (REACH). ECHA requested that each appellant submit the following information: name, molecular, and structural formula, or other identifier of the substance (Annex VI, 2.1 and 2.2); composition of the substance (Annex VI, 2.3); and description of the analytical methods used (Annex VI, 2.3.7). 

ECHA announced in its October 12, 2016, ECHA Weekly that the Board of Appeal found that the contested decisions “breached the principle of legal certainty as some of the terms used, specifically ‘grades’, ‘forms’ and ‘nanoforms’, were not clearly defined and did not allow the Appellants to clearly ascertain what information they were required to provide in order to comply with the Agency decisions.” The Board of Appeal annulled the contested decisions. The appellants raised other pleas (e.g., whether ECHA could legally require them to submit further information to allow for a more detailed identification of the nanoforms of the registered substance). The Board of Appeal concluded that since it is not clear from the contested decisions what information the appellants are required to provide, it was not possible to decide on the legality of those requests. 

ECHA Committee Adopts First Opinion Approving Nano Biocide: On October 13, 2016, ECHA announced that the Biocidal Products Committee adopted three opinions supporting the approval of active substances for use in biocidal products, including its first opinion on a nanomaterial. The Committee supports the use of pyrogenic, synthetic amorphous silicon dioxide, nano, surface treated for insecticides, acaricides, and products to control other arthropods (product-type 18). ECHA’s October 13, 2016, annex to a news alert states that pyrogenic, synthetic amorphous silicon dioxide, nano, surface treated, is an existing active substance. The intended use is in insecticide products used indoors by professional operators by spraying for the control of poultry red mite (Dermanyssus gallinae) to protect domestic animals (fowl) in places such as chicken-breeding farms or egg-producing farms. France is the evaluating competent authority of the active substance application. The adopted opinions will serve as a basis for final decision making by the European Commission and the European Union Member States. The approval of an active substance is granted for a defined number of years, not exceeding ten years. ECHA states that the opinions will be available on its website “in the near future.” 

EPA Proposes SNUR For Functionalized Carbon Nanotubes (Generic): On October 27, 2016, EPA proposed SNURs for three chemical substances that were the subject of PMNs, including functionalized carbon nanotubes (generic). 81 Fed. Reg. 74755. According to the notice, the PMN states that the substance will be used as a thin film for electronic device applications. Based on structure-activity relationship analysis of test data on analogous carbon nanotubes and other respirable poorly soluble particulates, EPA identified potential lung effects and skin penetration and toxicity induction from inhalation and dermal exposure to the PMN substance. Further, EPA predicts toxicity to aquatic organisms via releases of the PMN substance to surface water. EPA states that it does not expect significant occupational exposures due to the use of impervious gloves, and because the PMN is used in a liquid and is not spray applied except in a closed system. EPA does not expect environmental releases during the use identified in the PMN. Therefore, EPA has not determined that the proposed manufacturing, processing, and/or use of the substance may present an unreasonable risk to human health or the environment. EPA states that it has determined, however, that any use of the substance without the use of impervious gloves, where there is potential for dermal exposure; manufacturing the PMN substance for use other than as a thin film for electronic device applications; manufacturing, processing, or using the PMN substance in a form other than a liquid; use of the PMN substance involving an application method that generates a mist, vapor, or aerosol except in a closed system; or any release of the PMN substance into surface waters or disposal other than by landfill or incineration may cause serious health effects or significant adverse environmental effects. Based on this information, according to EPA, the PMN substance meets the concern criteria at 40 C.F.R. Section 721.170(b)(3)(ii) and (b)(4)(ii). EPA promulgated final SNURs on May 16, 2016, for these three chemical substances. EPA received notices of intent to submit adverse comments, however, and withdrew the direct final SNURs on July 14, 2016. EPA notes that the applicable review periods for the PMNs submitted for the three chemical substances all ended prior to June 22, 2016, the date on which President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which amends TSCA. Comments on the proposed PMNs are due November 28, 2016

NIOSH Announces Sampling Strategy To Help Identify Potential Nanomaterial Exposure In An Occupational Setting: On November 1, 2016, NIOSH published a blog item entitled “Never fear! NEAT 2.0 is here! -- How to perform nanomaterial exposure assessment in the workplace.” NIOSH notes that in 2009, it developed and was the first to recommend using the nanoparticle emission assessment technique (NEAT). According to NIOSH, NEAT made use of a condensation particle counter to identify tasks that result or can result in the emission of nanoparticles into the surrounding air. Task-based filter samples were then used to confirm the presence of nanoparticles, using both laboratory elemental analysis and electron microscopy. NIOSH states that this initial approach did not effectively address the potential for background contamination from incidental nano-sized particles or exposure over a full workday. It was also heavily dependent on the use of direct reading instruments (DRI), which are nonspecific aerosol monitors and subject to interferences such as background incidental particles. Based on the need to surmount these limitations, and a desire to learn more about potential occupational exposures, NIOSH updated NEAT. The September 2016 issue of the Journal of Occupational and Environmental Hygiene includes an article on the update, “Refinement of the Nanoparticle Emission Assessment Technique into the Nanomaterial Exposure Assessment Technique (NEAT 2.0).” NIOSH states that NEAT 2.0 “is a more robust sampling strategy that places a stronger emphasis on full workday exposures, incorporates background monitoring, and emphasizes the importance of integrated filter sampling in the worker’s breathing zone over the use of DRIs.” 

According to NIOSH, in performing the above steps, a comprehensive exposure assessment can be performed and assist with the identification of potential nanomaterial exposure in an occupational setting. NIOSH states that NEAT 2.0 “will guide facilities in determining exposure potential for workers who are handling or using engineered nanomaterials. By determining exposure potential, the facility can then work to control exposure making use of mitigation strategies and the hierarchy of controls.” 

NNCO Announces 2016 NNI Strategic Plan: On November 1, 2016, the National Nanotechnology Coordination Office (NNCO) announced the release of the 2016 National Nanotechnology Initiative Strategic Plan. The 21st Century Nanotechnology Research and Development Act of 2003 requires National Nanotechnology Initiative (NNI) agencies to develop an updated Strategic Plan every three years. The 2016 Strategic Plan represents a consensus among the 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 Strategic Plan provides the framework under which individual agencies conduct their own mission-specific nanotechnology programs, coordinate these activities with those of other NNI agencies, and collaborate. The Strategic Plan states that the focus of the NNI has broadened from investments in foundational research in nanomaterials and nanotechnology-enabled devices to include activities directed at how they can be incorporated into nanotechnology-enabled systems. The 2016 Strategic Plan reflects this change 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.” For more information on the Plan, see our blog item, "NNCO Announces 2016 NNI Strategic Plan."

OECD Publishes A Number Of New Reports In Series On The Safety Of Manufactured Nanomaterials, Including Nanosilver Case Study And Gold Nanoparticle Occupational Exposure Assessment In Pilot Scale Facility: In November 2016, OECD published the following new reports in its Series on the Safety of Manufactured Nanomaterials:

Toxicokinetics of Manufactured Nanomaterials: Report from the OECD Expert Meeting

Although the OECD website lists an additional report, Titanium Dioxide: Summary of the Dossier, its link does not work. 

Germany Publishes Action Plan Nanotechnology 2020: The Federal Ministry of Education and Research (BMBF) recently published an English version of its Action Plan Nanotechnology 2020. Based on the success of the Action Plan Nanotechnology over the previous ten years, the federal government will continue the Action Plan Nanotechnology for the next five years. Action Plan Nanotechnology 2020 is geared towards the priorities of the federal government’s new “High-Tech Strategy” (HTS), which has as its objective the solution of societal challenges by promoting research. According to Action Plan Nanotechnology 2020, the results of a number of research projects “have shown that nanomaterials are not per se linked with a risk for people and the environment due to their nanoscale properties.” Instead, this is influenced more by structure, chemical composition, and other factors, and is thus dependent on the respective material and its application. Action Plan Nanotechnology 2020 states that the results from risk research “will be introduced into regulations in all relevant areas, such as occupational, consumer and environmental law.” Germany will continue the work already begun on analytical verifiability of existing legal regulations concerning nanomaterials since standardized instrumental and analytical methods for exposure assessment and routine control are still largely lacking. According to Action Plan Nanotechnology 2020, Germany is committed to continuing with the development and adaptation of OECD test guidelines to create the prerequisite for comparability of international research results. 

ISO Publishes Measurement Technique Matrix For Characterization Of Nano-Objects: The International Organization for Standardization (ISO) recently published ISO/TR 18196:2016, “Nanotechnologies -- Measurement technique matrix for the characterization of nano-objects.” The document provides a matrix intended to guide users to commercially available techniques relevant to the measurements of common physiochemical parameters for nano-objects. Some techniques are also applicable to nanostructured materials. As scientific advances are made and additional commercial measurement techniques become available, ISO will periodically review and update the document to maintain its relevance. ISO notes that many of the listed techniques have not been validated through round-robin testing or any other means for the measurement of nano-objects. ISO states that the document “is intended as a starting point and resource to help identify potentially useful and relevant techniques; it is not an exhaustive or primary source.” ISO recommends that once a technique has been identified, the reader refer to relevant international standards and conduct a literature search for similar or comparable applications. Other sources of information include instrument manufacturer’s applications notes and technical literature. 

BIOBASED/RENEWABLE PRODUCTS

MISCELLANEOUS

EPA Releases Environmental Justice Strategic Plan For 2016-2020: On October 27, 2016, EPA published the “EJ 2020 Action Agenda: The U.S. EPA’s Environmental Justice Strategic Plan for 2016-2020.” The EJ 2020 Action Agenda is EPA’s strategic plan for advancing environmental justice for the years 2016-2020, and it will build on the foundation established by EPA’s previous plan, Plan EJ 2014, as well as decades of environmental justice practice by EPA, communities, and EPA’s partners. EJ 2020 has three overarching goals:

  1. To deepen environmental justice practice in EPA’s programs that improve the health and environment of overburdened communities;

  2. To work with federal, state, tribal, community, and industry partners to expand EPA’s impact across the country; and

  3. To measure the progress EPA is making on its most significant environmental justice challenges.

The EJ 2020 Action Agenda consists of eight priority areas and four significant national environmental justice challenges, and EPA lays out its objectives, the plan for achieving them, and how it will measure success. The priority areas are rulemaking; permitting; compliance and enforcement; science; states and local governments; federal agencies; community-based work; and tribes and indigenous peoples. The national environmental justice challenges are lead disparities; drinking water; air quality; and hazardous waste sites. EPA states that it expects to review and, as appropriate revise, the actions it undertakes to meet its goals. The EJ 2020 Action Agenda notes that every national program and region has assumed the responsibility of co-leading at least one of the plan’s priority areas. 

California DPR Proposes New Regulation Giving Further Protections To Children From Pesticide Exposure: The California Department of Pesticide Regulation (DPR) recently proposed a regulation that it states is intended to “(1) provide minimum statewide standards for all agricultural pesticide applications near public K-12 schools and child day care facilities; (2) provide an extra margin of safety in case of unintended drift or when other problems with applications occur (e.g., equipment failure causes an unintended release of pesticide, or an abrupt change in weather conditions); (3) increase communication between growers and schools/child day care facilities; and (4) provide information to assist schools and child day care facilities in preparing for and responding to pesticide emergencies.” 

Specifically, the regulation is proposed to prohibit many pesticide applications for the production of an “agricultural commodity” within a quarter mile of schoolsites from Monday through Friday between 6:00 a.m. and 6:00 p.m. “Schoolsites” are defined by Education Code Section 17609(f) as “any facility used as a child day care facility, as defined in Section 1596.750 of the Health and Safety Code, or for kindergarten, elementary, or secondary school purposes.” The regulation requires California growers and pest control contractors to notify public K-12 schools and child day-care facilities and county agricultural commissioners (CAC) when certain pesticide applications are made within a quarter mile of these schools and facilities.

Comments on the proposed regulation are due by November 17, 2016. DPR states that a final regulation is expected to become effective in September 2017. Many have concerns with the proposed regulation, which DPR has been discussing publicly for some time. These concerns include what many believe are significant economic impacts to growers and others that they believe may not have been adequately considered and are not necessary for appropriate use of registered pesticides. Registrants and others should review the proposal carefully.

©2019 Bergeson & Campbell, P.C.

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