Monthly Update for November 2015


Bergeson & Campbell, P.C. extends its best wishes to our clients and many friends and we wish you and your family a happy Thanksgiving Day and a delightful holiday season.

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REGISTER TO ATTEND THE "TSCA REFORM PANEL SUMMIT," OR TO VIEW THE LIVE WEBCAST, AT THE ELI WEBSITE.

George Washington University (GWU) Milken Institute School of Public Health, GWU Law School, Environmental Law Institute, Arnold & Porter LLP, and Bergeson & Campbell, P.C. Present: TSCA Reform Panel Summit: What's Happening Now, and What's Next?

Thursday, November 19, 2015, 12:00 – 1:30 p.m. (EST)
George Washington University Milken Institute School of Public Health Main Auditorium, 950 New Hampshire Avenue, N.W. Washington, D.C. 20052. A light lunch will be served, beginning at 11:30 a.m.

With prospects for the Senate and House versions of TSCA reform legislation the subject of considerable speculation and conjecture, join us this Thursday, November 19, 2015, for a wide-ranging panel discussion titled "TSCA Reform: What's Happening Now, and What's Next" featuring the inside view from two former EPA Assistant Administrators, George Washington University Milken Institute School of Public Health Dean Lynn R. Goldman, M.D., M.S., M.P.H. and Bergeson & Campbell, P.C. Senior Government Affairs Consultant James V. Aidala; and Arnold & Porter LLP partner Lawrence E. Culleen, whose former EPA roles include Chief of the New Chemicals Branch, managing the premanufacture notice program under TSCA. No subject will be off-limits as these EPA alumni discuss the legislative prospects of the competing bills, the process and administrative issues that will face EPA the day after a revised law is passed, and the equally interesting prospect of what the industrial chemical community will face if this once-in-a-generation chance at TSCA reform is lost. The 75-minute panel discussion will be moderated by Lynn L. Bergeson, with a 15-minute question and answer period for audience members in the room and viewing the webcast at the conclusion. Register to attend the "TSCA Reform Panel Summit," or to view the LIVE Webcast, at the ELI website. ELI membership is not required.

TSCA/FIFRA/IRIS/NTP/TRI

EPA Extends Public Comment Period On Three Flame Retardant Clusters: On August 13, 2015, the U.S. Environmental Protection Agency (EPA) released for public comment three Toxic Substances Control Act (TSCA) Work Plan Chemical problem formulation and initial assessment documents for the following flame retardant clusters: Brominated Bisphenol A (TBBPA), Chlorinated Phosphate Esters (CPE), and Cyclic Aliphatic Bromides (HBCD). The initial public comment period was scheduled to close on October 19, 2015. Each flame retardant cluster has a separate docket assignment: Chlorinated Phosphate Esters Cluster - EPA-HQ-OPPT-2015-0068; Cyclic Aliphatic Bromides Cluster - EPA-HQ-OPPT-2015-0081; and Tetrabromobisphenol A and Related Chemicals Cluster - EPA-HQ-OPPT-2014-0730. Due to requests from various stakeholder groups, the public comment period for the three problem formulation and initial assessment documents has been extended to November 18, 2015. For additional information, please follow this link.

EPA Publishes Final Agricultural Worker Protection Standard Revisions: On November 2, 2015, EPA issued final revisions to the agricultural Worker Protection Standard (WPS) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 80 Fed. Reg. 67496. The revisions are intended to reduce occupational pesticide exposure and incidents of related illness among agricultural workers and pesticide handlers, and to protect bystanders and others from exposure to agricultural pesticide use. Highlights include:

  • January 4, 2018 (Or 180 Days After An EPA Announcement That Training Materials Are Available, Whichever Is Later): The date by which agricultural employers and handler employers will be required to comply with certain new requirements for the content of pesticide safety training for workers and handlers and pesticide safety information display (to be codified at 40 C.F.R. § 170.311(a)(3), 40 C.F.R. § 170.401(c)(3), and 40 C.F.R. § 170.501(c)(3)). EPA states it delayed implementation of the final rule regarding certain training and display materials to provide agricultural employers and handler employers time for such materials to be updated, printed, and distributed as well as to allow time for existing trainers to familiarize themselves with those new materials.
     
  • January 4, 2018: The date by which agricultural employers and handler employers will be required to comply with the requirement that the handler performing an application must immediately suspend a pesticide application if any worker or other person, other than an appropriately trained and equipped handler involved in the application, is in the application exclusion zone described in § 170.405(a)(1) or the area specified in column B of the Table in § 170.405(b)(4) (to be codified at 40 C.F.R. § 170.505(b)).

EPA also states that it is "committed to a robust outreach, communications and training effort to communicate the new rule requirements to affected WPS stakeholders." EPA has stated its intent to do the following to facilitate implementation:

  • Issue plain language "how to comply" fact sheets and guidance materials.
     
  • Develop compliance assistance materials that are targeted to specific agricultural sectors and rule requirements, such as respirator requirements or the WPS exemptions and exceptions.
     
  • Develop and disseminate new worker and handler training materials, conduct outreach to potentially affected parties, and provide assistance and resources to States and Tribes for WPS implementation.
     
  • Hold Pesticide Regulatory Education Program courses for State and Tribal pesticide program staff that will focus on WPS implementation, and Pesticide Inspector Residential Training courses for State and Tribal pesticide inspectors that will focus on WPS inspection requirements.

A more detailed analysis of the WPS final rule is available in Bergeson & Campbell, P.C.'s (B&C®) blog entry EPA Announces Revisions to Its Worker Protection Standard. More information is also available on EPA's Worker Protection Standard webpage. The rule is effective January 1, 2016.

WHO Announces Review Of Ten Chemicals: The World Health Organization's (WHO) International Agency for Research on Cancer (IARC) recently announced it will review ten chemical substances in 2016. IARC posted on its website the chemical identities, data-submission deadlines, and other information regarding three meetings it will hold in 2016. The ten chemicals are: hydrazine (Chemical Abstracts Service No. 302-01-2); 2-mercaptobenzothiazole (CAS No. 149-30-4), dimethylformamide (CAS No. 68-12-2); 3-chloro-2-methylpropene (CAS 563-47-3); 1-bromopropane (CAS No. 106-94-5); dimethyl-p-toluidine (CAS No. 99-97-8); tetrabromobisphenol A (CAS No. 79-94-7); pentachlorophenol (CAS No. 87-86-5); 2,4,6-trichlorophenol (CAS No. 88-06-2); and 3,3',4,4'-tetrachlorobenzene (CAS No. 14047-09-7). IARC's list of meetings scheduled for 2016 and data-submission and other deadlines is available online.

EPA's OCSPP Agrees To More Communication, Transparency, And Efficiency When Processing Pesticide Petitions: On October 27, 2015, EPA's Office of Inspector General (OIG) issued a report on an evaluation conducted by OIG entitled "EPA Needs Policies and Procedures to Manage Public Pesticide Petitions in a Transparent and Efficient Manner" (OIG Report). OIG evaluated how EPA's Office of Chemical Safety and Pollution Prevention (OCSPP) tracks the receipt, disposition, and resolution of public petitions, focusing on OCSPP's Office of Pesticide Programs (OPP) and its policies and procedures used to ensure consistency and transparency when responding to pesticide-related public petitions. Although pesticide petitions can be submitted to EPA under FIFRA, the Federal Food, Drug, and Cosmetic Act (FFDCA), the Administrative Procedure Act (APA), or any combination of these authorities, OIG's "At a Glance," a document summarizing the OIG Report, states that OPP "does not have policies or procedures to ensure transparency when managing public pesticide petitions." OIG's Report outlines three main areas for improvement in communication, stating that OPP has not effectively communicated with petitioners in the following manner: (1) acknowledging petition receipt; (2) providing updates about the Agency's work to resolve petitions; and (3) providing petition decisions. In addition, OIG states that OPP lacks policies and procedures to manage petitions in a generally efficient or effective manner, specifically noting petition documentation is not readily accessible, which was inconsistent with each of the EPA's Records Management Policies in place during the timeframe of OIG's review; some petition data are inaccurate, which results in the duplication of work to confirm data; according to OPP, petitions may take weeks to arrive at the correct office for action, because there is no guidance on how to submit petitions directly to OPP; and OPP does not provide guidance to the public on how to submit complete petitions, which results in some petitioners providing supplemental information, therefore increasing the time and resources to reach petition decisions. A more detailed analysis of the OIG Report is available online.

EPA Requests Comments On Revocation Of Chlorpyrifos Tolerances: On November 6, 2015, EPA announced that it is requesting comment on a proposal to revoke all tolerances for the insecticide chlorpyrifos. 80 Fed. Reg. 69079. EPA's proposal responds to an August 10, 2015, writ of mandamus by the U.S. Court of Appeals for the Ninth Circuit. The court granted this unusual relief in response to a 2007 administrative petition to cancel chlorpyrifos registrations or to revoke chlorpyrifos tolerances by the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) (Petitioners). The court's August 10, 2015, order required that EPA do one of the following by October 31, 2015: cancel the registrations of all pesticides containing chlorpyrifos; issue a proposed or final rule to revoke chlorpyrifos tolerances; or issue a full and final response to the administrative petition to cancel chlorpyrifos. In its announcement, EPA states that it "is not denying the petition because we are unable to make a safety finding based on the science as it stands currently. EPA is not issuing a final revocation rule because we have not proposed it and have not completed our refined drinking water assessment, leaving certain science issues unresolved." The court also required EPA to provide the timeline for a final rule should EPA issue a proposed revocation by October 31, and EPA notified the court of an anticipated date for a final rule of December 2016. EPA will release a completed hazard assessment and a completed drinking water analysis for comment prior to issuance of any final rule. Because EPA has not completed its hazard assessment and drinking water analysis, this means that EPA may resolve the "science issues" without the need for tolerance revocations. The proposal is based not on the risk posed by chlorpyrifos residues in food, but on the incremental risk posed by chlorpyrifos in drinking water in very specific and limited watersheds where chlorpyrifos is heavily used. EPA is required to consider such exposures in evaluating the safety of chlorpyrifos residues in food under FFDCA, as amended by the Food Quality Protection Act (FQPA). If the tolerances are revoked, this will result in cancellation of the associated food uses of chlorpyrifos. The chlorpyrifos registrant Dow AgroSciences and other pesticide industry representatives do not agree with the EPA analysis or the proposal to revoke the tolerances. In particular, questions have been raised about EPA's decision to retain the use of a 10X FQPA safety factor for infants and children based on certain epidemiology studies. EPA has acknowledged that these studies have significant limitations and that they cannot identify a specific level of concern for quantitative risk assessment. EPA has previously reduced the FQPA safety factor for chlorpyrifos to one based on the completeness of the toxicological database. If the 10X FQPA safety factor were reduced to one or even to three, the results of the current risk assessment would be very different. Comments are due by January 5, 2016. Additional information is available here.

EPA New Web Page On Secondary And Service Containers For Pesticides: On November 6, 2015, EPA announced a new web page that compiles information about secondary containers and service containers and addresses frequently asked questions. Secondary and service containers are used by the pesticide industry as part of the process of applying pesticides. The secondary container might be used to hold the diluted pesticide. In other cases, an applicator may want a smaller service container (to be filled from the large container) for ease of use. Neither type of container may be used for distribution or sale. While containers used in this way are not required to be labeled, EPA's recommendations for labeling are intended to help ensure the safe use of pesticides. The webpage combines and replaces information previously found on the Labeling Questions and Answers page and in the Label Review Manual. This is not new guidance, but EPA hopes this new resource will make information on secondary and service containers easier to find and will lead to improved handling of these containers. This new web page can be found at www2.epa.gov/pesticide-labels/secondary-containers-and-service-containers-pesticides.

EPA Issues Final SNURs For Five Chemical Substances: On November 13, 2015, EPA issued significant new use rules (SNUR) for five chemical substances that were the subject of premanufacture notices (PMN). 80 Fed. Reg. 70171. The SNURs apply to Oxirane, 2,2'-(1,6-hexanediylbis(oxymethylene)) bis-, CAS No. 16096-31-4; titante [Ti 6 O 13 (2-)], dipotassium, CAS No. 12056-51-8; and partially fluorinated alcohol substituted glycols (generic). The rule is effective January 12, 2016.

New Requirements For Submitting TSCA Section 5 Notices Take Effect In January 2016: EPA recently reminded stakeholders that new requirements for submitting TSCA Section 5 notices and support documents will take effect on January 19, 2016. EPA issued a direct final rule on July 20, 2015, amending the TSCA Section 5 electronic reporting regulations. Submitters will be required to use the new Chemical Safety and Pesticide Programs (CSPP) data flow, referred to as the new version of the electronic premanufacture notice (e-PMN) software or the "Thin Client" in EPA's Central Data Exchange (CDX) to submit TSCA Section 5 notices and supporting documents electronically. The CSPP data flow replaces the eTSCA software that submitters would download and use to prepare and submit PMNs. In addition, for the first time, submitters will also be required to use EPA's e-PMN software and CDX to submit "bona fide intents to manufacture" electronically. EPA encourages submitters who are not already registered for CDX to register for CDX and for the updated e-PMN data flow "as soon as possible." EPA will transition completely to the Thin Client software on January 19, 2016. Until then, submitters may use either the new version of the e-PMN software (Thin Client), or the previous version of the e-PMN software (Thick Client). A more detailed memorandum is available online.

EPA Extends Comment Deadline On Proposed Changes To The Certification Rule: EPA is extending the public comment period on the proposed changes to the certification rule. EPA is proposing stronger standards for pesticide applicators who are certified to apply the riskiest pesticides, known as restricted use pesticides (RUP). The goal is to reduce the likelihood of harm from the misapplication of RUPs and ensure a consistent level of protection among states. More information about this rule is available online. A more detailed analysis of the rule is in B&C's blog item entitled "EPA Proposes Stronger Standards for Certified Applicators."

A formal announcement of the 30-day extension to the comment period will be published in the Federal Register shortly. The closing date for comments is now December 23, 2015.

FDA

FDA Issues Draft Guidance For Industry: On October 14, 2015, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) issued draft guidance to industry entitled "General Considerations for Animal Studies for Medical Devices; Draft Guidance for Industry and FDA Staff." 80 Fed. Reg. 61820. The draft guidance is intended to provide industry assistance in "designing evaluation strategies for, and reporting the results of, animal studies for medical devices." The guidance is provided as a reference for "best practices for the approach to, and conduct of, animal studies, and the presentation of animal study data intended to demonstrate that the device under study is sufficiently safe" in support of the device application process. The comment period is open until January 12, 2016.

FDA Issues Draft Guidance: On October 21, 2015, the FDA CDRH issued a draft guidance entitled "Manufacturing Site Change Supplements: Content and Submission." 80 Fed. Reg. 63802. The guidance provides the "decision-making steps that FDA recommends to determine whether a premarket approval application (PMA) supplement should be submitted when a manufacturer intends to change the manufacturing site (including a change to the processing, packaging, or sterilization site) of its legally marketed PMA-approved device." Comments are due by January 19, 2016.

FDA Stays Certain Portions Of Guidance: On October 30, 2015, FDA's Center for Food Safety and Applied Nutrition (CFSAN) in response to stakeholder comments announced its decision to stay certain select parts of a final guidance entitled "Guidance for Clinical Investigators, Sponsors, and IRBs: Investigational New Drug Applications (INDs) -- Determining Whether Human Research Studies Can Be Conducted Without an IND" issued in September of 2013. 80 Fed. Reg. 66907. The partial stay is intended to "encourage scientific research into the relationship between diet and health while FDA considers comments received in response to the final guidance." FDA has republished the guidance to include the stayed parts to prevent confusion. The stay was effective immediately.

FDA Seeks Comments On The Meaning Of "Natural": On November 12, 2015, FDA requested comment on the use of the term "natural" in the labeling of human food products. 80 Fed. Reg. 69905. The notice states that FDA is establishing "a docket to receive information and comments on the use of the term 'natural' in the labeling of human food products, including foods that are genetically engineered or contain ingredients produced through the use of genetic engineering." FDA states that this action is a result of three petitions asking for "natural" to be defined in terms of its use in food labeling, and one petition asking for the term ''natural'' to be prohibited on food labels, as well as requests for administrative determinations from FDA regarding whether food products containing ingredients produced using genetic engineering or foods containing high fructose corn syrup may be labeled as "natural." Besides inviting comments on the term "natural" in the context of food labeling, FDA is also inviting comments on many very specific questions contained in the notice. The comment period is open until February 10, 2016.

RCRA/CERCLA

EPA Publishes Proposed Rule Amending Hazardous Waste Import-Export Rules: On October 19, 2015, EPA proposed revisions to its hazardous waste import and export rules. 80 Fed. Reg. 63284. Prompted by a 2013 Commission for Environmental Cooperation (CEC) report on hazardous waste exports from the U.S. and changes to the 2001 Organization for Economic Cooperation and Development's (OECD) Council Decision for waste exports and imports, on September 24, 2015, EPA announced proposed changes to 40 C.F.R. Parts 260-267, 271, and 273 regarding the export and import of hazardous wastes from and into the United States. EPA also issued the changes to address and respond to several of the concerns outlined in the EPA OIG's July 6, 2015, report entitled "EPA Does Not Effectively Control or Monitor Imports of Hazardous Waste." One of the more significant changes EPA proposes is to require shipments of spent lead-acid batteries (SLAB) exported for reclamation be accompanied by international shipping documents, akin to hazardous wastes manifests. Currently there is no requirement that SLAB exports be covered by such documents. EPA's determination that some revisions to the SLAB import/export regulations are needed is bolstered by the 2013 CEC report and its recommendations. The CEC report found that U.S. net exports of SLABs to Mexico for recycling had increased by an estimated 449-525 percent, and that there were significant discrepancies between summary data on export shipments reported to EPA annually and individual export shipment data collected under U.S. Census Bureau (Census) authority. Based on its findings, the CEC report recommended that the U.S. require the use of manifests for each international shipment of SLABs, require exporters to obtain a certificate of recovery from foreign recycling facilities, explore establishing an electronic export annual report, and better share import and export data between environmental and border agencies. EPA proposes to incorporate most of these recommendations into the revised regulations. The rule would also consolidate the hazardous waste import and export standards into one set of requirements: 40 C.F.R. Part 262 Subpart H. The rule also proposes mandatory electronic reporting to EPA. The rule also would link the consent to export with the exporter declaration submitted to U.S. Customs and Border Protection (CBP), which should provide for more efficient compliance monitoring. In addition, EPA seeks to ensure clearer matching of waste stream level consent numbers with waste streams listed on Resource Conservation and Recovery Act (RCRA) hazardous waste manifests for import and export shipments. EPA is also proposing to require the filing of export consent information as part of the exporter's electronic declaration to CBP. Comments are due by December 18, 2015.

NANOTECHNOLOGY

NanoValid Publishes "Nano To Go!": In September 2015, "Nano to go!" was published. "Nano to go!" is "a practically oriented guidance on safe handling of nanomaterials and other innovative materials at the workplace." The German Federal Institute for Occupational Health (BAuA) developed it within the NanoValid project. "Nano to go!" includes the following materials:

  • A brochure, Safe handling of nanomaterials and other advanced materials at workplaces, that supports risk assessment and risk management when working with nanomaterials. It provides safety strategies and protection measures for handling nanomaterials, as well as recommendations for storage and disposal of nanomaterials, protection from fire and explosion, training and instruction courses, and occupational health;
     
  • Field studies comprising practical examples of expert assessment of safety and health at different workplaces. They contain detailed descriptions of several exposure measurements at pilot plants and laboratories. The reports describe methods, sampling strategies and devices, summarize and discuss results, and combine measurements and non-measurement methods;
     
  • Ready-to-use presentations for university lecturers, supervisors and instruction courses; and
     
  • General documents, including useful information, templates, and examples, including operating instructions, sampling protocol, dialogue guide, and short introduction to safety management and nanomaterials.

OECD Publishes 2013 Developments On The Safety Of Manufactured Nanomaterials: OECD recently posted a new document in its Series on the Safety of Manufactured Nanomaterials, Developments on the Safety of Manufactured Nanomaterials: 2013. The document compiles information provided by delegations, together with non-member economies, on current developments on the safety of manufactured nanomaterials. According to the OECD, the document is intended to provide delegations with background information on activities related to manufactured nanomaterials, as well as other activities on nanotechnologies at the international level. The information provided in the document captures activities that occurred in OECD delegations between February and December 2013.

JRC Publishes Part Three Of Its Review Of EC's Recommendation For A Definition Of The Term Nanomaterial: The Joint Research Center (JRC) published on October 19, 2015, a report entitled Towards a review of the EC Recommendation for a definition of the term "nanomaterial": Part 3: Scientific-technical evaluation of options to clarify the definition and to facilitate its implementation. The report provides JRC's scientific-technical evaluation of options to clarify the European Commission's (EC) 2011 Recommendation on a definition of nanomaterial. In 2013, JRC started to develop a series of three scientific-technical reports based on a list of tasks addressing specific points of the EC's Recommendation. In this third report, JRC describes scientific and technical options intended to clarify the wording and facilitate the implementation of the definition. JRC states that the scope of the definition regarding the origin of nanomaterials should remain unchanged, addressing natural, incidental, and manufactured nanomaterials. According to JRC, because of the regulatory purpose of the definition, there is little evidence to support deviating from size as the sole defining property of a nanoparticle or from the range of 1 nanometer (nm) to 100 nm as the definition of the nanoscale. JRC notes that clarification of some terms used in the definition and additional implementation guidance would be useful. JRC cautions, however, that relying only on guidance documents for essential parts of the definition could lead to unintended differences in the implementation and decision making.

White House Announces Nanotechnology-Inspired Grand Challenge For Future Computing: On October 20, 2015, the White House announced a grand challenge to develop transformational computing capabilities by combining innovations in multiple scientific disciplines. The Office of Science and Technology Policy (OSTP) states that, after considering over 100 responses to its June 17, 2015, request for information, it "is excited to announce the following grand challenge that addresses three Administration priorities -- the National Nanotechnology Initiative, the National Strategic Computing Initiative (NSCI), and the BRAIN initiative." The grand challenge is to "[c]reate a new type of computer that can proactively interpret and learn from data, solve unfamiliar problems using what it has learned, and operate with the energy efficiency of the human brain." According to OSTP, the new computing capabilities envisioned in this challenge might address issues such as delivering individualized treatments for disease, allowing advanced robots to work safely alongside people, and proactively identifying and blocking cyber intrusions. To meet this challenge, OSTP states that major breakthroughs are needed in the basic devices that store and process information and the amount of energy they require, as well as in the way a computer analyzes images, sounds, and patterns; interprets and learns from data; and identifies and solves problems. Many of these breakthroughs, according to OSTP, will require new kinds of nanoscale devices and materials integrated into three-dimensional systems and could take a decade or more to achieve. OSTP "look[s] forward to working with colleagues from across the nanotechnology, computer science, and neuroscience communities to transform future computing." Stakeholders interested in helping to organize or participate in a planning activity should contact NNIChallenges@nnco.nano.gov.

European Parliament Approves Novel Foods Proposal: On October 28, 2015, the European Parliament (EP) approved proposed rules that would subject novel foods to a safety evaluation and authorization at the European Union (EU) level. According to the EP's October 28, 2015, press release, novel foods include food consisting of "engineered nanomaterials," and would be defined as "any intentionally produced material that has one or more dimensions of the order of 100 nm or less." If there is a possibility a new food could affect people's health, then the European Food Safety Authority (EFSA) would have to carry out an assessment. The proposed rules must still be approved by the Council of Ministers.

Nanotechnology Startup Challenge For Cancer Will Bring Nanotechnology Inventions To Market: On October 29, 2015, the White House OSTP published a blog item concerning the Nanotechnology Startup Challenge for Cancer (NSC2), "an open-innovation competition designed by the National Cancer Institute (NCI) and the non-profit Center for Advancing Innovation (CAI) to bring promising cancer nanotechnology inventions to market." According to OSTP, the competition "creatively combines some of the most powerful tools in the innovation toolbox to bring teams together and launch them on a path to success, while integrating multiple scientific and economic priorities of the Administration":

  • Through the National Nanotechnology Initiative, the federal government has invested over $22 billion over the past 15 years in research and development to understand and control matter at the nanoscale and develop applications that benefit society;
     
  • The Precision Medicine Initiative is developing innovative approaches to disease prevention and treatment that take into account individual differences in people's genes, environments, and lifestyles to predict better which treatments will be most effective;
     
  • The Administration is committed to accelerating the transfer of federally funded research from the laboratory to the commercial marketplace as an important contributor to economic growth. According to OSTP, the NSC2 challenge "helps to overcome two critical Lab-to-Market barriers: matching entrepreneurs to inventions, and making sure the entrepreneurs have the skills and resources to succeed";
     
  • The NSC2 Challenge includes incentive prizes intended to reach beyond the "usual suspects" to increase the number of citizen solvers and entrepreneurs tackling a problem. The Challenge will offer each winning start-up team a license to one of NCI's nanotechnology inventions, as well as support and training to help winning teams raise seed funding. Recognizing that creating a successful start-up requires individuals with a range of knowledge and talent and that the proper combination of skills may not reside within a single network of colleagues or collaborators, the NSC2 Challenge provides a tool that aspiring contestants can use to identify additional team members or find an established team to join;
     
  • To maintain America's lead as the "best place in the world to start and scale a great enterprise," the Administration is working to ensure that all Americans have a "fair shot" at entrepreneurial success. The NSC2 Challenge encourages entrepreneurship through a start-up challenge, while acknowledging that budding entrepreneurs may not yet have the skills needed to launch a successful business. The Challenge therefore offers each team accelerator training similar to the training provided through the Federal I-Corps Program, covering topics ranging from business-plan development to finding investors; and
     
  • Collaborative approaches between government and nonprofit organizations, businesses, and individuals in the private sector are an essential element of the Administration's innovation agenda. For the NSC2 challenge, the NCI is again working with the CAI, building upon successful collaborations between the two institutions on the Breast Cancer Startup Challenge and Neuro Startup Challenge.

OECD Tour de Table Documents Cover Developments In 2014 And 2015: OECD has posted two Tour de Table documents. The documents, dated October 26, 2015, cover activities from January to July 2014 and before September 2015:

  • Current Developments in Delegations on the Safety of Manufactured Nanomaterials -- Tour de Table: The document compiles information, provided by delegations, including the EC, together with non-member economies, on current developments on the safety of manufactured nanomaterials. OECD intends the document to provide delegations with background information on activities related to manufactured nanomaterials, as well as other activities on nanotechnologies at the international level. The purpose of the Tour de Table is to provide delegations the opportunity to describe recent or planned national initiatives and/or events related to the safety of manufactured nanomaterials. OECD states that this will facilitate delegations to share their experiences and preoccupations with respect to safety, and will identify opportunities for future cooperation and coordination. The information provided in this document captures activities that occurred in delegations between January and July 2014.
     
  • Developments in Delegations on the Safety of Manufactured Nanomaterials -- Tour de Table: The document compiles information, provided by delegations, including the EC, together with other organizations, on current developments on the safety of manufactured nanomaterials. OECD intends the document to provide background information on activities related to manufactured nanomaterials at the national and international level. According to OECD, the purpose of the information exchange is to facilitate delegations to share their experiences and preoccupations with respect to safety, and serve as the basis to identify opportunities for future cooperation and coordination. The information provided in the document captures activities that occurred in delegations before September 2015.

Denmark Posts Several Publications Concerning Nanomaterials: On November 10, 2015, the Danish Environmental Protection Agency posted the following publications concerning nanomaterials:

  • Environmental assessment of nanomaterial use in Denmark: This is the concluding report of the project "Nanomaterials -- occurrence and effects in the Danish environment" (NanoDEN). The projects in NanoDEN aimed to investigate and generate new environmentally relevant knowledge concerning nanomaterials on the Danish market and to assess the possible associated risks to the environment. The report summarizes the results from the sub-projects and assesses whether and how nanomaterials may pose a risk for the environment in Denmark. The assessment is based on investigations of nine selected nanomaterials that are expected to be environmentally relevant based on knowledge of consumption quantities, or how they are used: titanium dioxide; zinc oxide; silver; carbon nanotubes; copper oxide; zero valent iron; cerium dioxide; quantum dots; and carbon black.
     
  • Consumer risk assessment for nanoproducts on the Danish market: The report:
     
    • Assesses consumer risks associated with 20 selected consumer exposure/use scenarios;
       
    • Integrates the learnings from these assessments with findings from previous activities of the project;
       
    • Discusses and puts into perspective what we know about the overall exposure and risks for Danish consumers, also considering other sources of nanomaterials exposure; and
       
    • Identifies main gaps in knowledge and methodologies for assessing consumer exposure.
       
  • Dermal Absorption of Nanomaterials Titanium Dioxide and Zinc Oxide Based Sunscreen: Role of Size and Surface Coating: The conclusion states:
     
    Based on our results using in vitro and in vivo mouse and human skin models we conclude that dermal penetration of TiO2 and ZnO NPs did not occur at or above the limit of detection of the used experimental methods. Should absorption of TiO2 and ZnO nanoparticles occur at levels below the detection limit of the assays used herein, the systemic dose would be very small (far lower than the doses used in the studies discussed above) and so highly unlikely to cause systemic toxicity based on toxicological evidence in rodents. This is in accordance with the conclusions that were made by the SCCS that stated that both kind of nanoparticles are safe to use for dermal applications up to a concentration of 25% in cosmetic products [SCCS (Scientific Committee on Consumer Safety), 2012; SCCS (Scientific Committee on Consumer Safety), 2014].
     
  • Environmental effects of engineered nanomaterials: Estimations of Predicted No-Effect Concentrations (PNECs): The report provides the following key findings:
     
    • Investigations have shown that currently accepted PNEC estimation approaches within the present European legislation in principle can be used for nanomaterials. This concerns the assessment factor (AF) and species sensitivity distribution (SSD) approaches. These methods do not take nano-specific processes during the testing of nanomaterials into account, and the tests may therefore not always be representative for natural conditions. Through a literature review carried out within the current project, three other methods were suggested: the probabilistic species sensitivity distribution (PSSD); the dissolved metal ion; and the indicative no effect concentration (INEC).
       
    • The current approach to select data for PNEC estimation favors effect studies conducted according to Good Laboratory Practice (GLP) and accepted guidelines. A consequence is that effect studies conducted according to guidelines for soluble chemicals may be unreliable as they do not take into account the specific nature of engineered nanomaterials (ENM).
       
    • Within the current project, an approach was developed for transparent evaluation of the suitability of effect studies to test ENMs and to what extent they are adequate for risk assessment. The approach focused on nano-specific parameters and highlights knowledge gaps and limitations in relation to data availability and relevance.
       
    • More than 1,200 scientific papers on effect studies of ENMs were found in the open literature. 500 of these revealed data on effects that potentially could be used for PNEC derivation. 50 percent of these studies used daphnia as the test organism, 30 percent used fish, and 20 percent used algae. Hardly any chronic studies were performed with fish. Nevertheless, no single study obtained the best score for risk assessment adequacy.
       
    • The number of sufficient effect studies adequate for risk assessment was, despite the large number of effect studies found, so low that PNEC estimation only could be made according to the AF approach.
       
    • Using the available data, silver nanoparticles were found to be the most toxic ENM (PNEC = 12 nanograms per liter (ng/L)), while titanium dioxide was found to be the least toxic (PNEC = 18 micrograms per liter (µg/L)). Due to a lack of adequate data it was not possible to derive PNEC values for carbon black and quantum dots; and
       
    • The derived PNEC values in this report were generally on the same level or slightly lower than the PNEC values found in the open literature or in the EU's Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) registrations. Compared with ion and bulk PNEC values in REACH registrations, the derived nano PNEC values in this report were in the same order of magnitude (silver) or one order of magnitude lower (titanium dioxide, zinc oxide, and copper oxide).
BIOBASED/RENEWABLE PRODUCTS

BRAG Biobased Products News And Policy Report: B&C's 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.

Public Meeting Announced To Discuss Modernizing The Regulatory System For Biotechnology Products Memorandum: On October 30, 2015, a public meeting was held to discuss Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology (Framework). FDA's role in responding to the July 2015 memorandum issued by OSTP, the Office of Management and Budget (OMB), the U.S. Trade Representative (USTR), and the Council on Environmental Quality (CEQ) entitled "Modernizing the Regulatory System for Biotechnology Products" was discussed. The July 2015 memorandum and the October 6, 2015, OSTP-issued Request for Information (RFI) to solicit relevant data and information to update the Framework are discussed in our memorandum Biotechnology: OSTP Seeks Comment on Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology. The Executive Office memorandum directs FDA, EPA, and the U.S. Department of Agriculture (USDA) -- the three agencies responsible for regulating biotechnology products -- to: establish a working group to update the Coordinated Framework to clarify roles and responsibilities, and develop a long-term strategy to ensure that the federal regulatory system is equipped to assess any risks while supporting innovation, protecting health and the environment, maintaining public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens. This meeting was another important step in the process to update the Framework, first issued in 1986 and last updated in 1992, to reflect better promising technologies routinely entering the market and, as the July 2015 memorandum provides, "to prevent unnecessary barriers to future innovation and competitiveness by improving the transparency, coordination, predictability, and efficiency of the regulation of biotechnology products while continuing to protect health and the environment."

LEGISLATIVE DEVELOPMENTS

House Subcommittee Passes Resolutions That Would Block EPA Clean Power Plan Rule: The House Energy and Commerce Subcommittee on Energy and Power on November 3, 2015, passed two resolutions that would block implementation of EPA's proposed rules to regulate carbon dioxide emissions from existing and new fossil fuel-fired power plants. On August 3, 2015, EPA announced two final rules to regulate carbon dioxide emissions from fossil fuel-fired power plants. The rules were published in the Federal Register on October, 23, 2015, and would impose limits on existing and new power plants. The resolutions -- H.J. Res 71 and H.J. Res 72 -- were introduced pursuant to the Congressional Review Act on October 26, 2015, and would provide for Congressional disapproval of each rule and state that the rules shall have no force and effect. If the resolutions pass, EPA may not issue the same or a substantially similar rule unless authorized by subsequent legislation. Companion resolutions were introduced in the Senate.

MISCELLANEOUS

ATSDR Announces Availability Of New Tox Profiles: On October 16, 2015, the Agency for Toxic Substances and Disease Registry (ATSDR) announced the availability of Set 27 Toxicological Profiles for review and comment. 80 Fed. Reg. 62533. The profiles include: Polybrominated Biphenyl Ethers (PBDEs) (UPDATE); N,N-Diethyl-meta-toluamide (DEET); Toluene Diisocyanates (mixture). Methylenediphenyl Diisocyanates (NEW); Nitrates/Nitrites (NEW); and Toluene (UPDATE). The Set 27 Toxicological Profiles are available online. Comment is due by January 14, 2016.

GAO Issues Chemicals Management Report: On October 9, 2015, the Government Accountability Office (GAO) issued a report entitled "Chemicals Management: Observations on Human Health Risk Assessment and Management by Selected Foreign Programs" (GAO-16-111R). The foreign programs GAO reviewed -- Canada's Chemicals Management Plan (CMP), Australia's Inventory Multi-tiered Assessment and Prioritisation (IMAP) framework, and the WHO's IARC Monographs Program and International Program on Chemical Safety (IPCS) -- assess the human health risks of chemicals using similar analytic approaches, such as using specific criteria to determine which assessments to prioritize. There are some notable differences emphasized in these programs, however. Canada's and Australia's programs emphasize the use of screening assessments -- assessments that vary in complexity ranging from a rapid screen of information to using more complex approaches, depending on what officials determine is needed to understand adequately relevant risks, and WHO's IARC Monographs Program and IPCS emphasize expert review by selecting internationally recognized experts to conduct or review assessments. Specifically:

  • Canada completed a process through its CMP of prioritizing roughly 23,000 chemicals and other substances to identify those that warranted further assessment. That multiyear process identified about 4,300 substances for further review, and Canadian officials told us they aim to address them all by 2020. Officials reported that, as of June 2015, they have completed screening assessments for about 2,700 substances (about 63 percent).
     
  • Australia prioritized a list of about 38,000 industrial chemicals through its IMAP framework to identify those for further assessment. Program officials committed to assessing a list of 3,000 priority chemicals between 2012 and 2016, and they recently told us that they have met this deadline, having completed 3,185 assessments of individual chemicals by July 2015.
     
  • WHO's IARC Monographs Program appoints expert working groups composed of internationally recognized experts to evaluate existing information on selected chemicals and other agents to form a conclusion about their carcinogenic risks to humans. According to its website, the IARC Monographs Program has assessed the carcinogenic risks of more than 900 chemicals and other agents since 1971.
     
  • WHO's IPCS uses a panel of international peer reviewers selected for their scientific expertise to review an initial draft assessment of the human health risks of selected chemicals, then sends the draft to a second set of experts who determine, among other things, whether peer review comments were appropriately addressed. According to its website and a program official, since 1976, IPCS has completed about 287 assessments.

Canada uses various approaches to manage the human health risks of toxic chemicals under the Canadian Environmental Protection Act, 1999 (CEPA 1999). Specifically, for all chemicals and other substances determined to be toxic under CEPA 1999, and proposed for CEPA 1999's List of Toxic Substances, officials may use a variety of mechanisms to manage identified human health risks, such as regulations, pollution prevention plan notices, and Significant New Activity provisions.

Reportedly, Senator Edward Markey (D-MA) requested the report.

This Update is provided as a complimentary service to our clients and is for informational purposes. This Update may be copied or quoted, provided proper attribution is given. The contents are not intended and cannot be considered as legal advice.

 
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