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September 1, 2017

Monthly Update for September 2017

Bergeson & Campbell, P.C.


EPA Adopts 2017 NAICS Codes For TRI: On August 16, 2017, the U.S. Environmental Protection Agency (EPA) announced that it is updating the list of North American Industry Classification System (NAICS) codes subject to reporting under the Toxics Release Inventory (TRI) to reflect the Office of Management and Budget’s (OMB) 2017 NAICS code revision. 82 Fed. Reg. 39038. As a result, facilities would be required to use 2017 NAICS codes when reporting to TRI beginning with TRI reporting forms that are due on July 1, 2018, covering releases and other waste management quantities for the 2017 calendar year. EPA is also modifying the list of exceptions and limitations associated with NAICS codes in the Code of Federal Regulations (C.F.R.) for TRI reporting purposes by deleting the descriptive text. EPA believes that these amendments are non-controversial and does not expect to receive any adverse comments. In addition to the direct final rule, EPA also proposed on August 16, 2017, the same amendment. 82 Fed. Reg. 39101. In the event that adverse comment is received on the direct final rule, the proposal will be considered. If no adverse comment is received, no further action will be taken and the direct final rule will become effective on November 15, 2017. Adverse comment on the direct final rule must be received by September 18, 2017. If EPA receives adverse comment, EPA will withdraw the direct final rule and it will not take effect. Comments on the proposed rule are due by September 18, 2017.

EPA Announces Additional Negotiated Rulemaking Committee Meeting Dates: On August 18, 2017, EPA announced the scheduling of two additional meetings of the Negotiated Rulemaking Committee on June 5, 2017. 82 Fed. Reg. 39402. The purpose of the Committee is to negotiate a proposed rule that would limit chemical data reporting requirements under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, for manufacturers of any inorganic byproduct chemical substances when such byproduct chemical substances are subsequently recycled, reused, or reprocessed. The purpose of the Committee is to conduct discussions in a good faith attempt to reach consensus on proposed regulatory language. This negotiation process is required by TSCA Section 8(a)(6). The notice announces the details of two upcoming meetings of the Committee, which are both open to the public, and that serve as the third and fourth meetings of the Committee. The third Committee meeting was held on September 13-14, 2017. The fourth Committee meeting will be held on October 25, 2017, from 9:00 a.m. to 5:00 p.m. and on October 26, 2017, from 9:00 3:00 p.m.

EPA Announces Scheduling Of SAP Meeting: On August 3, 2017, EPA announced the scheduling of revised comment period dates for the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) meeting regarding the “Continuing Development of Alternative High-Throughput Screens to Determine Endocrine Disruption, Focusing on Androgen Receptor, Steroidogenesis, and Thyroid Pathways.” 82 Fed. Reg. 36137. This SAP meeting will now be held on November 28-30, 2017. Requests to make oral comments at the meeting should be submitted on or before November 7, 2017. Please consult the Federal Register for details.

On September 13, 2017, EPA issued three supporting documents for the November 28-30, 2017, FIFRA SAP meeting regarding the “Continuing Development of Alternative High-Throughput Screens to Determine Endocrine Disruption, Focusing on Androgen Receptor, Steroidogenesis, and Thyroid Pathways.” The supporting documents include: Transmission of Steroidogenesis Background MaterialsTransmission of Androgen Receptor Background Materials; and Transmission of Primary Materials (Whitepaper & Charge Questions). More information is available in our blog item. Written comments will be accepted on or before October 16, 2017. Comments may be submitted online via Docket ID EPA-HQ-OPP-2017-0214-0001, mail, or hand delivery.

EPA Announces Update To The Pesticide Electronic Application Submission Portal: On August 28, 2017, EPA announced the first of three feature and functionality updates to the Pesticide Submission Portal (PSP) expected this year. The portal is a web-based application allowing registrants to submit pesticide application packages to EPA electronically. The PSP application is accessed through EPA’s Central Data Exchange (CDX) Network, which requires user registration. This new PSP, version 1.4, release expands the feature to allow users to submit voluntary data related to specific registration review cases. Users can submit study citations, data matrices (Form 8570-35), cover letters, and studies (protocols, study profiles, supplemental study data) using the new “Voluntary Submission” link on the PSP home page. This new release also allows users to resubmit previously submitted 90-day responses. Once a 90-day response or data submission has been successfully transmitted to the Office of Pesticide Programs (OPP), users may now modify responses to data requirements, cite additional studies, upload additional documents, and change how the product registration is supported. In addition to these changes, the update introduces enhancements and bug fixes. EPA also released the OPP Pesticide Submission Portal (PSP) User Guide Version 1.4, which provides detailed instructions on how to use the PSP application and guidance on how to prepare a package for electronic submission. Applicants using PSP need not submit multiple electronic copies of any pieces of their applications; EPA states that the requirement to submit multiple copies of data in Pesticide Registration (PR) Notice 2011-3 is applicable only to paper submissions. Pesticide registrants who previously submitted information via paper, CD, or DVD may instead use the portal and forego the courier costs of sending to EPA. More information about the Electronic Submissions of Pesticide Applications is available on EPA’s website.

EPA Releases Draft Guidance For Pesticide Registrants On Notifications, Non-notifications, And Minor Formulation Amendments: On September 6, 2017, EPA announced the availability of and requested public comment on draft guidance, PR Notice 2017-XX: Notifications, Non-notifications and Minor Formulation Amendments. 82 Fed. Reg. 42094. EPA states it is issuing this notice to “align the notification program with the requirements of the Food Quality Protection Act (FQPA) and [the Pesticide Registration Improvement Act (PRIA)] and to clarify the processes for accepting minor, low risk registration amendments to be accomplished through notification, non-notification or as accelerated amendments.” EPA is requesting comments, and specifically information on projected cost implications of this draft updated guidance. PR Notices are issued by OPP. EPA states that PR Notice 2017-XX will update and clarify “the scope of changes accepted by notification, non-notification and minor formulation amendments for all pesticide products, and supersedes both PR Notices 95-2 and 98-10 in their entirety.” The PR Notice lists the changes from PR Notice 98-10 in a table. More information is available in our blog. Comments on this PR Notice are due October 6, 2017, and can be submitted online under Docket ID EPA-HQ-OPP-2016-0671.

EPA Issues Proposed Correction To Antimicrobial Pesticides Data Requirements Regulation: On August 18, 2017, EPA issued a Federal Register notice stating it is proposing a correction pertaining to the “200 ppb (parts per billion) level” described in the antimicrobial pesticides data requirements regulation codified at 40 C.F.R. Part 158, subpart W “to clarify that the 200 ppb level is based on total estimated daily dietary intake for an individual and not on the amount of residue present on a single food, as is incorrectly implied by the current regulatory text.” 82 Fed. Reg. 39399. Per the conditions of a settlement agreement with the American Chemistry Council that became effective on March 2, 2015, EPA was directed to issue this proposed correction to make the language consistent with the U.S. Food and Drug Administration’s (FDA) policy set forth in its Guidance for Industry, Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations (April 2002). EPA states that this proposed correction will “reduc[e] uncertainty and will result in a decrease in the number of inquiries registrants may make to EPA seeking clarification on this particular point.” Comments are due by October 17, 2017.

EPA Extends Period For Comments On SACC Candidates: On September 6, 2017, EPA published a notice in the Federal Register extending the period for public comments on the candidates for consideration for the Science Advisory Committee on Chemicals from September 5, 2017, to September 17, 2017. Comments can be submitted online in Docket Identification Number EPA-HQ-OPPT-2016-0713. EPA is considering candidates for SACC membership listed in the August 26, 2016, Federal Register notice pool of requested nominees; the 29 candidates for membership identified in the December 9, 2016, Federal Register notice; and the additional candidates provided in the August 3, 2017, Federal Register notice. More information on the background, qualification of members, and the process of obtaining nominees is available in our memorandum “EPA Seeks Comment on Nominations to “Augmented” Science Advisory Committee on Chemicals.”

EDF Petitions Review Of Third TSCA Framework Rule: On September 1, 2017, the Environmental Defense Fund (EDF) filed a petition for review in the U.S Court of Appeals for the D.C. Circuit (No. 17-1201) of the EPA’s final TSCA framework rule TSCA Inventory Notification (Active-Inactive) Requirements, published on August 11, 2017 (82 Fed. Reg. 37520). This is the third and final challenge by EDF to the framework rules implementing amended TSCA (there are only three framework rules), but the seventh total challenge, as other parties have also petitioned for review. On August 11, 2017, EDF petitioned for review of the TSCA framework rules Procedures for Chemical Risk Evaluation under TSCA and the final rule Procedures for Prioritization of Chemicals for Risk Evaluation, filed on August 11 (Second Cir. Case Nos. 17-2464 and 17-2403, respectively). Per the Consolidation Orders of the United States Judicial Panel on Multidistrict Litigation, both of EDF’s August 11 petitions have now been consolidated with other petitions for review of the same orders. Case No. 17-2464 was moved to the Fourth Circuit, and Case No. 2403 was moved to the Ninth Circuit. In the Fourth Circuit, the opening brief, record from agency, and the appendix are due September 20, 2017, and the response brief is due October 20, 2017. In the Ninth Circuit, the Petitioners’ briefs are due October 30, 2017, and Respondent EPA’s briefs are due November 28, 2017.

EPA Extends Compliance Date For Substantiation Of Confidential Information: On September 15, 2017, EPA announced that due to recent severe weather events, EPA is extending the compliance date for submitters who claimed information as confidential between June 22, 2016, and March 20, 2017, to provide substantiation for those claims. Specifically, EPA is now giving submitters until October 19, 2017, to submit the substantiations required by TSCA Section 14(c)(3). EPA is providing this additional flexibility in response to concerns raised by industry stakeholders regarding the ability to meet the previous September 19, 2017, deadline and because of the impacts of Hurricanes Harvey and Irma. A pre-publication of the Federal Register notice is available online.


EPA Proposes Revisions To Amino And Phenolic Resins MACT: On August 24, 2017, EPA proposed revisions to the Maximum Achievable Control Technology (MACT) standards under the Clean Air Act (CAA) for the manufacture of amino and phenolic resins. 82 Fed. Reg. 40103. EPA is proposing revisions to the standards for continuous process vents (CPV), which are currently codified at 40 C.F.R. Section 63.1405. EPA is proposing to revise the standards for back-end CPVs at existing sources based on hazardous air pollutant (HAP) emissions test data it has received from petitioners seeking revisions to the standard. EPA is also considering revising the standard for front-end CPVs at existing sources, and to extend the compliance date for the proposed revised emission limit for back-end CPVs at existing sources. Additionally, EPA is proposing requirements for storage vessels at new and existing sources during periods when an emission control system used to control vents on fixed roof tanks is undergoing planned routine maintenance. EPA estimates this proposal, if promulgated in final, would reduce compliance costs to this industry by $2.1 million per year. Comments are due by October 23, 2017.

EPA Sets Deadline For Mandatory Use Of Automated Export System For Hazardous Waste Exports: On August 29, 2017, EPA announced that the Automated Export System (AES) filing compliance date for export shipments of hazardous waste and certain other materials is December 31, 2017. 82 Fed. Reg. 41015. After this date, all exporters of manifested hazardous waste, universal waste, and spent lead-acid batteries for recycling or disposal, and all exporters of cathode ray tubes for recycling will be required to file EPA information in the AES or AESDirect for each export shipment. Paper notifications of intent to export and other export-related documentation will no longer be allowed after the compliance date.

EPA Postpones Steam Electric Power Plant Effluent Guidelines Rule For Two Years: On September 13, 2017, EPA announced that it will soon issue a final rule delaying by two years certain compliance deadlines for the effluent limitations guidelines and standards for steam electric power plants (ELG Rule) that EPA issued in November 2015. The final rule postpones the compliance dates for the best available technology economically achievable (BAT) effluent limitations and pretreatment standards (PSES) for two wastestreams at existing sources, bottom ash transport water and flue gas desulfurization (FGD) wastewater, for a period of two years. Last month, EPA announced that it would reconsider BAT effluent limitations and PSES in the 2015 rule that apply to bottom ash transport water and FGD wastewater. As part of this upcoming rulemaking, EPA will provide an opportunity for public comment on any proposed revisions to the 2015 rule. At this time, EPA stated that it does not intend to conduct a rulemaking that would potentially revise BAT effluent limitations and PSES in the 2015 rule for fly ash transport water, flue gas mercury control wastewater, and gasification wastewater, or any of the other requirements in the 2015 rule. A pre-publication copy of the final rule is available online.

EPA To Reconsider Certain Coal Ash Rule Provisions: EPA on September 14, 2017, granted two petitions to reconsider substantive provisions of the final rule regulating coal combustion residuals (CCR) as nonhazardous waste under Subtitle D of the Resource Conservation and Recovery Act (RCRA). EPA promulgated the CCR rule on April 17, 2015. 80 Fed. Reg. 21301. On May 12, 2017, the Utility Solid Waste Activities Group (USWAG) filed a petition seeking reconsideration of 11 specific provisions of the final CCR rule, including provisions prohibiting the use of alternative points of compliance for ground water contamination, regulating inactive surface impoundments, and defining what activities constitute beneficial use of CCR. AES Puerto Rico LLP submitted a petition on May 31, 2017, seeking reconsideration of certain on-site storage practices. In reviewing the petitions, EPA determined that it was appropriate, and in the public’s interest, to reconsider specific provisions of the final CCR rule based in part on the authority provided through the Water Infrastructure for Improvements to the Nation (WIIN) Act. EPA stated that it is not committing to changing any part of the rule, or agreeing with the merits of the petition. The current rule went into effect on October 19, 2015, and regulates how CCR generated from electric utilities and independent power producers is managed and disposed of in surface impoundments and landfills. The rule also defines what constitutes beneficial use of CCR, and, therefore, is excluded from the rule’s requirements. In December 2016, the WIIN Act was enacted into law. Section 2301 of the WIIN Act provides authority for states to operate permit programs under Subtitle D of RCRA, as long as EPA determines that the state’s requirements are as protective as the standards in the 2015 final rule or successor regulations. Should EPA decide to revise specific provisions of the final CCR rule, it will go through a notice and comment process.


FDA Announces Availability Of A SECG On Mitigation Strategies To Protect Food Against Intentional Adulteration: On August 25, 2017, FDA issued a notice announcing the availability of a small entity compliance guide (SECG) for industry entitled Mitigation Strategies to Protect Food Against Intentional Adulteration: What You Need to Know About the FDA Regulation. 82 Fed. Reg. 40484. FDA states this SECG is being released with the intention to help small entities comply with the final rule Mitigation Strategies to Protect Food Against Intentional Adulteration issued May 27, 2017 (81 Fed. Reg. 34166), and to “reduce the burden of determining how to comply by further explaining and clarifying the actions that a small entity must take to comply with the rule.” FDA’s examination of the economic implications of the final rule determined that it will have a significant economic impact on a substantial number of small entities. FDA is accepting comments on the guidance and there is no set deadline.

FDA Releases FSMA Third-Party Certification Program User Fee Rates For FY 2018: On August 29, 2017, FDA issued a notice in the Federal Register announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2018, which apply from October 1, 2017, through September 30, 2018. 82 Fed. Reg. 41029. The standard fee (adjusted base amount) for a premarket application, including a biologics license application (BLA), and for a premarket report and a BLA efficacy supplement, is $310,764 for FY 2018. For all submissions other than a 30-day notice and a 513(g) request for classification information, the small business fee is 25 percent of the standard (full) fee for the submission — $77,691. For a 30-day notice, and a 513(g) request for classification information, the small business fee is 50 percent of the standard (full) fee for the submission — $155,382. The annual fee for establishment registration, after adjustment, is set at $4,624 for FY 2018There is no small business rate for the annual establishment registration fee; all establishments pay the same fee. The remainder of the FY 2018 rates for all medical device fees are listed in Table 5 of the notice.

On August 29, 2017, FDA issued a notice in the Federal Register announcing the FY 2018 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the fee rate for accreditation bodies applying to be recognized in the third-party certification program that is authorized by the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Safety Modernization Act (FSMA), which apply from October 1, 2017, through September 30, 2018. 82 Fed. Reg. 41035. The FSMA Third-Party Certification Program User Fee Schedule for FY 2018 is as follows:

  • Initial Application Fee for Accreditation Body Seeking Recognition: $37,935;
  • Annual Fee for Recognized Accreditation Body: $1,752; and
  • Annual Fee for Accredited Certification Body: $2,190.

The estimated fee rates for other fee categories under the FSMA Third-Party Certification Program are as follows:

  • Renewal application fee for recognized accreditation body: $21,049;
  • Initial application fee for certification body seeking direct-accreditation from FDA: $37,935;
  • Renewal application fee for directly-accredited certification body: $28,755; and
  • Annual fee for certification body directly-accredited by FDA: $21,072.

FDA Announces Availability Of Draft Chapter Of Multichapter Guidance For Industry On Hazard Analysis And Risk-Based Preventive Controls For Human Food: On August 31, 2017, FDA announced the availability of another draft chapter of a multichapter guidance for industry entitled Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry: Chapter Six — Use of Heat Treatments as a Process Control. 82 Fed. Reg. 41364. FDA states that this multichapter draft guidance “is intended to explain [its] current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under [its] rule entitled ‘Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food,’” which was issued on September 17, 2015 (80 Fed. Reg. 55908). FDA states comments should be submitted by February 27, 2018, for those who wish their comments to be considered prior to the guidance being issued in final. Two FSMA compliance deadlines are coming up on September 18, 2017: larger animal food facilities must comply with preventive controls requirements mandated by the FSMA; and small animal food facilities — those with fewer than 500 full-time equivalent employees — will be required to meet the Current Good Manufacturing Practice (CGMP) requirements.

FDA To Host Public Meeting On Development Of Pre-DSHEA List: On September 6, 2017, FDA issued a notice in the Federal Register that it would be hosting a public meeting on the development of a list of pre-Dietary Supplement Health and Education Act dietary ingredients (DSHEA) and requesting comments on FDA’s future development of such a list. 82 Fed. Reg. 42098. FDA states that the public meeting will have two separate panels:

  1. The first panel will discuss what standard of evidence is necessary to determine that an ingredient was marketed before October 15, 1994; under DSHEA, dietary ingredients marketed in the U.S. before October 15, 1994, are not considered new dietary ingredients (NDI) and therefore are not subject to FDA’s premarket notification requirements.
  2. The second panel will discuss issues related to the process that should be used to develop the list, including: the processes for nominating and reviewing ingredients; whether an outside panel should be convened and, if so, the composition and role of that panel; how information that is claimed to be confidential should be treated; and what the ultimate list should look like.

The meeting is scheduled for October 3, 2017, from 8:00 a.m. to 5:00 p.m. (EDT). Participants can attend in-person or via webcast. Registration is available online; the deadline to register is September 25, 2017. Comments are due by December 4, 2017.

FDA Announces Availability Of A SECG On FDA Standards For The Growing, Harvesting, Packing, And Holding Of Produce For Human Consumption: On September 6, 2017, FDA issued a notice in the Federal Register of the availability of a SECG guidance for industry entitled Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the FDA Regulation. 82 Fed. Reg. 42031. FDA states this SECG is being released with the intention to help small entities comply with the final rule Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption issued November 27, 2015 (80 Fed. Reg. 74353), and to “reduce the burden of determining how to comply by further explaining and clarifying the actions that a small entity must take to comply with the rule.” FDA’s examination of the economic implications of the final rule determined that it will have a significant economic impact on a substantial number of small entities. FDA is accepting comments on the guidance and there is no set deadline.

SOT/FDA To Host 13th Colloquium On Emerging Toxicological Science: Challenges In Food And Ingredient Safety: On September 7, 2017, the Society of Toxicology (SOT) announced that in conjunction with FDA’s Center for Food Safety and Applied Nutrition (CFSAN), it would be hosting a free workshop, the thirteenth colloquium of its series on Emerging Toxicological Science: Challenges in Food and Ingredient Safety entitled In Vitro to In Vivo Concordance for Toxicity Prediction and Use in Safety Assessments. This workshop “presents scientific information that is high-quality, cutting-edge, future-oriented toxicological science” and the invited speakers will “review the state-of-the-art in using in vitro technologies for safety assessment and how they are being utilized.” The workshop is open to the public to attend in person or via webcast; registration is available online.

FDA Commissioner Addresses State Agriculture Commissioners At NASDA Annual Conference: On September 12, 2017, FDA released a Constituent Update in which FDA gave details on the FDA Commissioner Scott Gottlieb, M.D.’s address to State Agriculture Commissioners at the annual conference of the National Association of State Departments of Agriculture (NASDA). At the meeting, Gottlieb announced new steps to enhance collaboration with states, and ensure farmers are prepared for FSMA, including:

More information is available on FDA’s website.


NGOs Call For France To Require Labeling And Restriction Of Consumer Products: According to a July 12, 2017, press release, a coalition of non-governmental organizations (NGO) wrote to the French Prime Minister and several ministers to call for labeling and restriction of nanomaterials in consumer products. The NGOs request that three measures be taken “as a matter of urgency”: (1) temporarily ban titanium dioxide particles present in E171 dye until the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) working group on nano and food publishes its results; (2) better inform consumers through mandatory labeling of consumer products; and (3) ensure traceability of nanomaterials and products containing them by improving the functionality and accessibility of the French register of nanomaterials. The NGOs state that the establishment of a national strategy on nanomaterials is essential.

NIOSH Report Highlighting Second Decade Of Research Agenda Includes Nano Developments: On August 10, 2017, the National Institute for Occupational Safety and Health (NIOSH) published a report entitled National Occupational Research Agenda: Second Decade in Review | 2006-2016. The report outlines the progress and impact made in addressing occupational safety and health research needs over the second decade of the National Occupational Research Agenda (NORA). The 21 cross-sector programs included in the report include the Nanotechnology Program, which “conducts research and promotes adoption of approaches to reduce adverse effects of exposures to materials containing structures with a length scale below 100 nanometers.” In addition to the main report, NIOSH published the Sector and Cross Sector Program Supplement, which provides program-specific results on the work of each of the ten NORA sectors and 24 cross-sector programs developed by NIOSH to support the NORA sector program goals and objectives. More information regarding the reports is available in our August 17, 2017, blog item.

TURI Publishes Nanomaterials Fact Sheet: In August 2017, the Toxics Use Reduction Institute (TURI), a research, education, and policy center established by the Massachusetts Toxics Use Reduction Act of 1989, published a nanomaterials fact sheet. The fact sheet is part of a series of chemical and material fact sheets developed by TURI that are intended to help Massachusetts companies, community organizations, and residents understand the use of hazardous substances and their effects on human health and the environment. The fact sheet also includes information on safer alternatives and safer use options. According to the fact sheet, TURI researchers have started a blueprint for design rules for safer nanotechnology. The principles focus on aspects such as modifying physical-chemical characteristics of the material to diminish the hazard, considering alternative materials, and enclosing the material within another, less hazardous, material. The fact sheet provides a summary of regulations concerning nanomaterials. Massachusetts currently has no regulations specifically governing the use or release of nanomaterials. At the federal level, EPA primarily regulates nanomaterials under TSCA. The fact sheet notes that as of 2017, companies using or manufacturing nanomaterials that have not been subject to premanufacture notices or significant new use rules will be subject to a one-time reporting and recordkeeping rule. More information regarding the rule and its final guidance is available in our August 14, 2017, blog item.

NIOSH Draft Research Agenda For Manufacturing Addresses Nanomaterials: On August 23, 2017, NIOSH published a Federal Register notice requesting comment on its draft NORA for Manufacturing for public comment. The NORA Manufacturing Sector Council wrote the Agenda, which “identifies the most important occupational safety and health research needs for the next decade, 2016-2026.” According to NIOSH, the Agenda provides a vehicle for industry stakeholders to describe the most relevant issues, gaps, and safety and health needs for the sector. Objective 3 is to examine emerging risks from new technologies and explore ways in which new technologies can advance occupational safety and health in manufacturing. According to the draft Agenda, new technologies that are reshaping the manufacturing industry include nanotechnologies. Comments are due October 23, 2017.

ISO Publishes Standard Terms And Definitions For Cellulose Nanomaterial: The International Organization for Standardization (ISO) has published standard ISO/TS 20477:2017, “Nanotechnologies — Standard terms and their definition for cellulose nanomaterial.” According to ISO, in the current stage of development, several terms to describe cellulose nanomaterials coexist and have created confusion among users. ISO anticipates that as the market for cellulose nanomaterials matures, so will the standard vocabulary. Beginning to define a standard vocabulary now will facilitate future communication, eliminate confusion, remove trade barriers, and provide policy makers and regulators with a set of consensus-based terms. The standard defines terms and definitions for different types of cellulose nanomaterials, including secondary components found in cellulose nanomaterials due to their manufacturing processes. Terms are applicable to all types of cellulose nanomaterials regardless of production methods and their origin (plants, animals, algae, or bacteria).

EC Environment DG Publishes Report On Assessing The Environmental Safety Of Manufactured Nanomaterials: The European Commission (EC) Environment Directorate General (DG) published an August 2017 report entitled Assessing the environmental safety of manufactured nanomaterials. The report’s aim is “to present the most promising strategies and most significant challenges of nanomaterial characterisation, exposure, fate and behaviour, ecotoxicological hazard and risk assessment.” The report states that there is growing interest in a safe-by-design approach, which would represent a further shift towards the burden of proof approach under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. Safe-by-design would require increased cooperation between researchers, designers, developers, distributers, potential end-users, and regulators. The report suggests more incentives need to exist to publish and publicize negative results and that there is a need for platforms and networks, such as the European Observatory for Nanomaterials, “that will enable unprecedentedly accessible data and collaboration between businesses, researchers, decisionmakers and assessment experts.”

Study Examines How To Reduce Nanoparticle Emissions During 3D Printing: On August 30, 2017, Environmental Science & Technology, an American Chemical Society (ACS) publication, published a study entitled “Characterization and Control of Nanoparticle Emission during 3D Printing.” According to the abstract, the study aimed to evaluate particle emission characteristics and to evaluate several control methods used to reduce particle emissions during three-dimensional (3D) printing. The abstract states that among the eight control methods tested, the enclosure with a high-efficiency particulate air (HEPA) filter had the highest removal effectiveness (99.95 percent) of nanoparticles. The authors’ recommendations for reducing particle emissions include applying a low temperature, using low-emitting materials, and instituting control measures like using an enclosure around the printer in conjunction with an appropriate filter (e.g., HEPA filter) during 3D printing.

NIOSH Engineering Controls Program Protects Workers From Emerging Hazards: On September 6, 2017, NIOSH published a Program Performance One-Pager entitled NIOSH Engineering Controls Program. The Program’s activities include providing engineering control recommendations to protect workers from emerging hazards in nanotechnology and advanced materials used in additive manufacturing/3D printing. The Program is currently working to:

  • Complete laboratory evaluations of ultrafine particle emissions and engineering controls for 3D printing of materials that include carbon nanotubes and graphene in filaments;
  • Complete evaluations at advanced manufacturing workplaces and publish engineering control recommendations to reduce worker exposure to ultrafine particles; and
  • Publish three NIOSH engineering control workplace design solution documents to highlight effective engineering control approaches for the most common nano-manufacturing workplaces.

RIVM Announces Model To Calculate Concentrations Of Nanoparticles In The Environment: The Netherlands National Institute for Public Health and the Environment (RIVM) announced on September 6, 2017, that an RIVM researcher, Joris Meesters, modified SimpleBox, a distribution model for chemicals, to create SimpleBox4nano, a model to calculate concentrations of nanoparticles in water, soil, and air. SimpleBox4nano includes new processes that specifically apply to nanoparticles, such as the clustering of particles. Meesters tested the model using three metal oxide nanoparticles: titanium dioxide, zinc oxide, and cerium dioxide. According to RIVM, the SimpleBox model results confirm the clumping of nanoparticles with the many natural particles in the environment (clay, sediment, organic matter). The research shows that SimpleBox4nano can be used to estimate the distribution of nanoparticles in the environment. RIVM describes SimpleBox4nano as a “major step forward in the environmental risk assessment of nanoparticles.”

ISO Publishes Vocabulary Standard For Graphene And Related 2D Materials: ISO has published standard ISO/TS 80004-13:2017, “Nanotechnologies — Vocabulary — Part 13: Graphene and related two-dimensional (2D) materials.” ISO states that two-dimensional (2D) materials are a significant subset of nanomaterials, and it is important to standardize the terminology for graphene, graphene-derived, and related 2D materials at the international level, as the number of publications, patents, and organizations rapidly increases. According to ISO, these materials need an associated vocabulary as they become commercialized and sold throughout the world. The standard lists terms and definitions for graphene and related 2D materials, and includes related terms naming production methods, properties, and their characterization. ISO intends the standard to facilitate communication between organizations and individuals in research and industry, other interested parties, and those who interact with them.

2017 EU-U.S. Workshop Held September 7-8, 2017: The 2017 European Union (EU)-U.S. “Bridging NanoEHS Research Efforts Joint Workshop” was held September 7-8, 2017, at the University of Birmingham. The workshop considered current (and future) approaches to nano environmental and health safety (nanoEHS) research to close the gap between research and regulation. The Communities of Research (COR) meeting provided updates from the seven running CORs and undertake some initial scoping work for possible new COR activities (e.g., nanomedicine, nanofabrication/nanomanufacturing). The EU-U.S. workshop followed the 12th International Conference on the Environmental Effects of Nanoparticles and Nanomaterials (ICEENN 2017), which was held September 3-6, 2017. ICEENN 2017 brought together researchers, regulators, and industry to discuss recent advances in the understanding of both the fate and behavior of nanomaterials and their applications in the environmental and the key issues relating to maintaining the economic and social benefits of nanotechnology.

EC4SafeNano Survey On Demand And Supply Of Services In Nanosafety Ends September 15: Responses to the European Center for Risk Management and Safe Innovation in Nanomaterials and Nanotechnologies (EC4SafeNano) survey on demand and supply of services in nanosafety are due September 15, 2017. EC4SafeNano notes that multiple responses from different departments and groups within a single organization are possible. As reported in our April 24, 2017, blog item, EC4SafeNano wishes to develop a catalog of services matching the anticipated needs and service requirements to the supply of services from different organizations. Responses will influence the design of EC4SafeNano and ensure that issues important to stakeholders will be addressed; the catalog of services will be relevant; and services can be provided through EC4SafeNano. EC4SafeNano will anonymize and summarize the survey responses in a report that will be made available to all respondents.

Technology Development Pathways Workshop Will Highlight NNI Case Studies: The “Technology Development Pathways: Case Studies from the [National Nanotechnology Initiative (NNI)]” workshop will be held November 1, 2017. According to NNI, the workshop will showcase application areas where nanotechnology has had commercial impact. Keynote presentations will highlight the pathways companies have taken to get from research to commercialization. Panel discussions will focus on specific steps of the development pathway, such as scale up and quality control/measurement systems. Building on these successes, NNI states that conversations at the workshop will explore remaining technical challenges or innovations needed to exploit fully the commercial potential of nanotechnology over the coming decades. While the primary focus will be to share best practices from the private sector, NNI notes that federal government representatives will also participate, enabling attendees to learn of ongoing research, agency needs, and funding opportunities. The workshop is free and open to the public on a first-come, first-served basis. NNI expects registration to open on September 18, 2017.


BRAG Biobased Products News And Policy Report: Bergeson & Campbell, P.C. (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


President Trump Submits Nominations For Two EPA Assistant Administrators And PHMSA Administrator; Announces Intent To Nominate Third: President Trump on September 5, 2017, submitted to the Senate nominations for two EPA Assistant Administrator (AA) slots. Matthew Z. Leopold of Florida was nominated to serve as EPA’s General Counsel. Leopold represented Florida in the long-running Everglades case, and worked with policy makers to help move comprehensive restoration forward. Leopold previously served as an environmental policy advisor in the Washington, D.C. office of Governor Jeb Bush. The President also nominated David Ross to serve as EPA’s AA for the Office of Water. Ross currently serves as the Director of the Environmental Protection Unit for the Wisconsin Department of Justice, and previously served as a senior assistant attorney general in the Wyoming Attorney General’s Office, where he represented the Wyoming Department of Environmental Quality on water quality matters. Prior to entering public service, Mr. Ross practiced environmental law in Washington, D.C. and worked as an environmental consultant in California. President Trump announced his intention to nominate Bill Wehrum to serve as EPA AA for the Office of Air and Radiation (OAR). Wehrum previously served as EPA’s acting AA for OAR from 2005 to 2007 and as EPA’s principal deputy AA and counsel to the AA for OAR. Wehrum is currently in private law practice. On September 8, 2017, the President announced his intent to nominate Howard “Skip” Elliott to be Administrator of the Department of Transportation’s Pipeline and Hazardous Materials Safety Administration (PHMSA). Elliott is a 40-year veteran of the U.S. freight rail industry, serving over the last decade as group Vice President of Public Safety, Health, Environment and Security for CSX Transportation. His portfolio of responsibility includes hazardous materials transportation safety, homeland security, railroad policing, crisis management, environmental compliance and operations, occupational health management, and continuity of business operations.

House Passes FY 18 EPA Funding Bill: The House of Representatives on September 14, 2017, passedthe Fiscal 2018 Interior Department, Environment, and Related Appropriations bill (H.R. 3354). Lawmakers approved the bill by a 211-198 vote, heavily along party lines. The bill slashes EPA’s budget, but the cuts are far less than those proposed by the Trump Administration. The legislation also blocks implementation of several key rules, including the Waters of the United States Rule and methane standards for oil and gas operations. The bill’s fate is uncertain, as the Senate is more likely to take up its own version of an EPA funding bill.


EPA Issues Spring 2017 Regulatory Agenda: On August 24, 2017, EPA issued its semiannual regulatory agenda. 82 Fed. Reg. 40348. The notices list several TSCA actions, including the proposed N-Methylpyrrolidone and methylene chloride proposed rulemaking, and the final formaldehyde emission standards for composite wood products rule issued last December.

NAS Publishes Interim Report On Synthetic Biology: On August 21, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) released its interim report titled A Proposed Framework for Identifying Potential Biodefense Vulnerabilities Posed by Synthetic Biology. The U.S. Department of Defense (DOD) asked NAS to develop the framework to: guide an assessment of the security concerns related to advances in synthetic biology; assess the level of concern warranted for various advances and identify areas of vulnerability; and prioritize options to address these vulnerabilities.

The report provides an overview of the categories of synthetic biology and a set of initial questions aimed at guiding the assessment of concern related to the technologies and applications of the field. The framework outlines factors for assessing the levels of concern that each technology and application presents in terms of malicious use, as well as factors for assessing the capability for mitigation. The final report will use the framework to provide DOD with an assessment of concerns and mitigation options by developing informed answers to the questions posed in the interim report.

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