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March 1, 2016

Monthly Update for March 2016

Bergeson & Campbell, P.C.


EPA Extends Comment Period On Chlorinated Paraffins Risk Assessments: On February 22, 2016, the U.S. Environmental Protection Agency (EPA) extended the comment period on the draft risk assessments it has prepared for certain medium and long chain chlorinated paraffins. 81 Fed. Reg. 8712. This is an important opportunity to comment on the risk assessments prepared by EPA following the submission of Premanufacture Notifications (PMN) on certain chlorinated paraffins long manufactured and used by many industrial sectors that EPA deemed “new” chemicals and thus the subject of several new chemical notifications required to be submitted under the terms of a Consent Agreement. EPA reluctantly made available the risk assessments supporting its determination that the chemicals pose risks. Comments are now due on March 23, 2016.

Agencies Convene Second Meeting On Modernizing Regulatory System For Biotechnology Products: On March 2, 2016, EPA and other federal agencies announced that the second public meeting on the July 2, 2015, memorandum entitled “Modernizing the Regulatory System for Biotechnology Products” would be held March 9, 2016, in Dallas, Texas. 81 Fed. Reg. 10858. According to EPA, the March 9, 2016, meeting was convened to solicit comment on the current federal roles and responsibilities regarding biotechnology products. The July 2, 2015, memorandum was jointly issued by the Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality, and directs EPA, the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to update the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework). Last updated in 1992 and first rolled out in 1986, the Coordinated Framework outlines a comprehensive federal regulatory policy for products of biotechnology, and describes the federal regulatory policy intended to ensure the safety of biotechnology products. The Administration’s initiative has three key components. First, the Administration will update the Coordinated Framework, after accepting public comment, to clarify the “roles and responsibilities” of the federal agencies that now regulate the products of biotechnology: EPA, FDA, and USDA. It is hoped that this process will clarify which biotechnology product areas are within the authority and responsibility of each agency, and will better outline how the agencies can work together to regulate products that fall within the respective jurisdictional scope of each agency. Second, the Administration will commission an external, independent analysis of the future landscape of biotechnology products. The Administration has asked that the National Academies of Sciences, Engineering, and Medicine (The Academies) conduct such an analysis. Candidates for inclusion on The Academies’ panel were solicited in January 2016. Third, the Administration will formulate a long-term strategy to ensure that the federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology. This component is essential and holds considerable promise in developing a game plan for achieving success.

The first public engagement session took place on October 30, 2015, at the FDA’s White Oak Campus in Silver Spring, Maryland. Opening remarks were given by John Holdren, Ph.D., Assistant to the President for Science and Technology and Director of OSTP. Roberto Barbero, Ph.D., Assistant Director for Biological Innovation at OSTP, gave an overview on what OSTP is doing and how, as well as the principles that have led up to OSTP’s current efforts. Representatives from USDA’s Animal and Plant Health Inspection Service (APHIS), EPA, and FDA also delivered statements on the federal regulation of biotechnology products. Interested parties in attendance included a number of non-governmental organizations (NGO) that spoke out against the use of biotechnology, academic institutions that were supportive of continued research, and industry participants that were supportive of reasonable risk-based regulation to oversee biotechnology’s continued growth. A transcript from the meeting is available online. More information regarding the Coordinated Framework is available in our October 6, 2015, memorandum OSTP Seeks Comment on Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and in our July 6, 2015, memorandum White House Directs EPA, FDA, and USDA to Update the Coordinated Framework for the Regulation of Biotechnology. The Administration’s efforts to modernize the Coordinated Framework are essential, laudable, and timely. It is imperative that stakeholders participate actively and effectively in sharing their experiences under the Coordinated Framework with the Administration. There is only one remaining public meeting opportunity after Dallas. After the third and final meeting, the Administration will assess all the comments provided in response to the public meetings, and then will seek the public’s comments on its thoughts on modernizing the Coordinated Framework. Stakeholders are urged to attend or participate virtually in the third public meeting, and to help develop a more timely, efficient, and current governance framework for products of biotechnology.

EPA Issues New Guidance On CDR Reporting: EPA issued six helpful guidance documents on Toxic Substances Control Act (TSCA) chemical data reporting (CDR) to assist entities in fulfilling their reporting obligations under the CDR rule. The most recent guidance is intended to assist toll manufactures that operate production facilities. Other guidance has been prepared for importers and reporting obligations after changes to company ownership or legal entity status. The documents are available online.

EPA Makes Available 1-Bromopropane TSCA Work Plan Chemical Risk Assessment: On March 8, 2016, EPA announced the availability of and opening the public comment period for the draft TSCA Work Plan Chemical risk assessment for 1-Bromopropane (1-BP). 81 Fed. Reg. 12098. 1-BP is a colorless liquid with a sweet hydrocarbon odor that is used as a solvent in degreasing applications, spray adhesives, and in dry cleaning. 1-BP is produced or imported to the U.S. in large quantities (over 15 million pounds in 2011). This draft assessment focuses on human health risks to workers and consumers from acute (short-term) and chronic inhalation exposures associated with 1-BP use in spray adhesives, dry cleaning, and degreasing uses. EPA reviewed the evidence for 1-BP toxicity and identified risks for cancer (in workers) and adverse developmental effects (in consumers and workers). Other health risks identified for workers with chronic 1-BP exposures include adverse neurologic effects, as well as kidney, liver, and reproductive effects. Based on the final TSCA risk assessment, EPA may either initiate risk reduction actions that EPA believes are necessary to address the potential risks identified, or may conclude its work on the chemical uses being assessed if no risks are found. Comments must be received on or before May 9, 2016.

House Committee On Oversight And Government Reform Launches EPA IRIS Investigation: On March 8, 2016, the U.S. House of Representatives Committee on Oversight and Government Reform (the Committee) sent a letter to EPA requesting documents and information regarding its Integrated Risk Information System’s (IRIS) implementation of recommendations that were made by the National Academy of Sciences (NAS) in reports published by the National Research Council (NRC) in 2011 and 2014. The 2011 report, which reviewed the IRIS draft health assessment on formaldehyde, addressed deficiencies in the specific assessment but provided general suggestions for improving the IRIS process and a roadmap for its revision in case EPA decided to move forward with changes to the process. NAS’ subsequent 2014 report acknowledged that EPA has made progress regarding the IRIS process, but made further recommendations on conducting a systematic review. In a November 2015 progress report to Congress on IRIS, EPA listed additional measures it has taken in response to NRC’s recommendations, including the development of: (1) a draft IRIS Handbook of Operating Procedures; (2) draft methods for evaluating study quality relating to types of bias and to the appropriateness of study design and conduct; and (3) case studies and comparative analyses of approaches used to evaluate epidemiology and experimental animal studies.

The Committee’s letter requests documents related to the draft IRIS handbook, as well as other documents and information related to IRIS’ progress in implementing NAS’ recommendations, including:

  • Documents sufficient to identify all recommendation from the 2011 and 2014 NAS reports that have been fully implemented;
  • Documents referring or relating to the timeline for implementation of all outstanding NAS recommendations;
  • Documents referring or relating to the draft IRIS handbook, the timeframe for its completion, and/or plans to peer review the handbook;
  • Documents referring or relating to the peer review process for guidance documents or other reference materials developed to guide EPA staff in the implementation of the NAS recommendations (i.e., assessment protocol); and
  • Documents referring or relating to EPA’s process for the initial nomination of substances for review by IRIS, and/or the process for reevaluation of substances that have completed an IRIS assessment review.

EPA has until March 22, 2016, to provide this information. In the letter, the Committee also directs EPA to make arrangements for staff from EPA’s Office of Research and Development (ORD) to provide a briefing for Committee staff no later than March 22, 2016.

EPA Seeks Comment On IRIS Draft Assessment Of Hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX): On March 10, 2016, EPA announced a 60-day public comment period for the draft IRIS Toxicological Review of Hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX). 81 Fed. Reg. 12727. The draft document was prepared by the National Center for Environmental Assessment (NCEA) within EPA’s ORD. Comments are due May 9, 2016.

NAFTA TWG On Pesticides Releases Proposed Five-Year Strategy: On February 2, 2016, the Executive Board of the North American Free Trade Agreement (NAFTA) Technical Working Group on Pesticides (TWG) released details of its proposed strategic framework for the next five years. The environmental regulatory authorities in the U.S., Canada, and Mexico comprise the TWG and developed the strategy, and include EPA, Health Canada’s Pest Management Regulatory Agency (PMRA), and Mexico’s Secretaría de Agricultura, Ganadería, Desarrollo Rural, Pesca y Alimentación (SAGARPA) and its Secretaría de Medio Ambiente y Recursos Naturales (SEMARNAT). The message from the Executive Board states that the main goal is to “align the North American registration systems for pesticides and products treated with pesticides and make work-sharing a way of doing business.” There are three strategic objectives listed in the message, as described below.

Objective 1: Identify trade barriers and approaches to promote equal access and simultaneous introduction for pest management tools, which includes alignment of maximum residue limits (MRL) to encourage registrants to consider potential export markets of agricultural commodities intended for treatment with proposed new pesticides or new uses as a way to reduce the number of use expansion submissions and reduce potential trade barriers and continue ongoing work, through the International Crop Grouping Consulting Committee (ICGCC) for harmonizing crops, on the process for developing new/additional crop groups and to revise the existing guidance document as new scientific information becomes available.

Objective 2: Encourage cooperation on joint reviews of new pesticides and uses, and the reevaluation/reregistration review of pesticides to increase efficiency and quality of decision making.

Objective 3: Include working cooperatively on priority science and regulatory issues and practices, including data requirements, science approaches and policies for data interpretation, and risk assessment and communications of regulatory decisions.

The objectives and specific focus areas are ambitious. To achieve some of these objectives will require addressing some controversial issues, for example, the confidential treatment of data that underlie these programs (e.g., MRLs, residue studies, biopesticide registrations). More information on the strategy is available on Health Canada’s website.

EPA Releases Phase 2 Of Pesticide Submission Portal: On February 23, 2016, EPA released Phase 2 of the Pesticide Submission Portal, the Web-based system for electronic submission of pesticide applications to EPA. This action is the second step in a phased approach that will lead to EPA’s ability to accept all pesticide applications electronically. EPA has expanded the functionality of the portal by increasing the types of actions associated with distributor product applications that can be submitted to include: adding an alternate brand name; cancelling a distributor product; cancelling all distributor products; and reinstating a distributor product. Phase 2 also allows submission of responses to Data Call-Ins (DCI). The following activities responding to product-specific DCIs (PDCI) and generic DCIs (GDCI) issued under pesticide reregistration or registration review can now be submitted to EPA using the portal: acknowledgment of receipt of DCI (new DCIs issued after release of Phase 2 only); initial 90-day response to DCI (new DCIs issued after release of Phase 2 only); and data submissions responding to DCI requirements (for all DCIs). EPA will continue to accept DCI-response submissions via paper but encourages applicants to take advantage of this new, more efficient option. The portal is accessed through EPA’s Central Data Exchange (CDX) network and requires user registration. Registrants currently submitting CDs or DVDs using the e-Dossier downloadable tool or their own tools based on EPA’s XML guidance may use the portal instead of incurring courier costs by sending submissions to EPA. Additional information on the portal is available online.

EPA Publishes Notice Of Intent To Cancel Flubendiamide: On March 4, 2016, EPA published notice of its intent to cancel the pesticide flubendiamide. 81 Fed. Reg. 11558. Four pesticide products are affected: EPA Reg. No. 264-1025 — BELT SC Insecticide; EPA Reg. No. 71711-26 — FLUBENDIAMIDE Technical; EPA Reg. No. 71711-32 — VETICA Insecticide; and EPA Reg. No. 71711-33 — TOURISMO Insecticide. The cancellation notice, which was issued by EPA pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(e), expresses EPA’s intent to cancel the registration of these four products based on the registrants’ alleged failure to comply with a required condition of their registrations. Under this condition, which EPA alleges was agreed to by the registrants, each flunbendiamide registrant is required to submit a voluntary cancellation request if EPA finds that the product causes unreasonable adverse effects on the environment. EPA made such a finding of unreasonable adverse effects in a decision memorandum issued on January 29, 2016, but BCS/NAI has rejected EPA’s request to submit a voluntary cancellation. More information on BCS/NAI’s refusal to submit a request for voluntary cancellation is available in our blog item Bayer Announces That It Will Not Submit Voluntary Cancellation Requests for Flubendiamide. EPA’s finding of unreasonable adverse effects is based on the purported risk to aquatic invertebrates associated with flubendiamide. Each registrant will have 30 days from the date of receiving the Notice of Intent to Cancel to request a hearing concerning the notice. FIFRA Section 6(e) provides that the only matters that may be considered in the resulting hearing are whether the registrants have complied with the condition in question and whether EPA’s determination on existing stocks is consistent with FIFRA. In contrast, the registrants have stated that EPA is required to provide an adjudicatory hearing concerning the substantive basis for EPA’s determination that the products in question cause unreasonable adverse effects on the environment. Whether EPA can effectively circumvent the adjudicatory hearing that would otherwise be available on the substance is a key issue. EPA can be expected to argue that the registrants accepted the condition in question when the registrations for flubendiamide were first issued. The registrants can be expected to argue that EPA may not use such a condition to constrain hearing rights because this contravenes the intent of FIFRA. More information on EPA’s rationale, including the decision memorandum, is available on EPA’s website.

IARC Classifies Seven Chemicals: On February 24, 2016, The International Agency for Research on Cancer (IARC) classified seven widely used chemicals as either probably or possibly carcinogenic to humans. IARC’s conclusions on these chemicals were published online in the Lancet on February 23, 2016. The seven chemicals IARC classified are:

  • dimethylformamide (CAS No. 68-12-2), classified as probably carcinogenic to humans (group 2A), based on limited evidence in humans that it causes testicular cancer and sufficient evidence of carcinogenicity in experimental animals;
  • 2-mercaptobenzothiazole (CAS No. 149-30-4), classified as probably carcinogenic to humans based on limited human evidence that it causes urinary bladder cancer and sufficient evidence in experimental animals;
  • hydrazine (CAS No. 302-01-2), classified as probably carcinogenic to humans based on limited evidence it causes human lung cancer and sufficient evidence in experimental animals;
  • tetrabromobisphenol A (CAS No. 79-94-7), classified as probably carcinogenic to humans based on sufficient evidence in experimental animals and strong biological activity or “mechanistic” evidence;
  • 1-bromopropane (CAS No. 106-94-5), classified as possibly carcinogenic to humans (group 2B) based on sufficient evidence in experimental animals;
  • 3-chloro-2-methylpropene (CAS No. 563-47-3), classified as possibly carcinogenic to humans based on sufficient evidence in experimental animals; and
  • dimethyl-p-toluidine (CAS No. 99-97-8), classified as possibly carcinogenic to humans based on sufficient evidence in experimental animals.

A summary of IARC’s conclusions are published in “Carcinogenicity of some industrial chemicals” in the Lancet, where the summary can be purchased online.


EPA Likely To Expand SPCC Program To Hazardous Substances Under Terms Of Consent Decree: On February 16, 2016, the U.S. District Court for the Southern District of New York approved a consent decree between EPA and three environmental organizations that requires EPA to revisit its Spill Prevention, Control, and Countermeasure Program (SPCC) under the Clean Water Act (CWA). Under the decree, EPA must promulgate final regulations no later than August 16, 2019, to address storage and spill containment requirements for CWA hazardous substances. These changes could broaden significantly the scope of the SPCC program. The consent decree requires EPA to issue proposed and final rules to effectuate language in CWA Section 311(j)(1), calling for EPA to issue regulations “establishing procedures, methods, and equipment and other requirements for equipment to prevent discharges of … hazardous substances … from onshore facilities … and to contain such discharges.” There are over 300 hazardous substances regulated by the CWA stored at thousands of facilities across the country. The consent decree is a settlement of a July 21, 2015, legal challenge brought against EPA by the Environmental Justice Health Alliance for Chemical Policy Reform, People Concerned About Chemical Safety, and the Natural Resources Defense Council. The suit alleges that EPA has failed to implement its non-discretionary duty under CWA Section 311(j)(1)(C) to issue regulations to prevent and contain discharges of oil and hazardous substances from onshore facilities, including above-ground storage tanks. The environmental groups filed the suit after several recent chemical spills, including Freedom Industries’ January 2014 spill of 5,000 gallons of 4-methylcyclohexane methanol (MCHM) into the Elk River in West Virginia. Under the decree, EPA must issue a proposed regulation within 18 months, i.e., by August 16, 2017. This deadline can be extended to June 16, 2018, however, if EPA notifies the plaintiffs in the case within 60 days that it intends to publish an Information Collection Request (ICR) on hazardous substances stored in non-transportation related onshore facilities. EPA then must promulgate a final rule no later than 14 months after it issues the proposed rule. Based on the consent decree schedule, the earliest deadline for EPA’s promulgation of a final rule is October 16, 2018. If EPA issues an ICR, the deadline for the final rule would be August 16, 2019.

U.S. And Canada Agree To 40 Percent Reduction Of Phosphorus In Lake Erie: On February 22, 2016, EPA Administrator Gina McCarthy and Canada’s Environment and Climate Change Minister Catherine McKenna announced that Canada and the U.S. have adopted targets to reduce phosphorus entering Lake Erie by 40 percent. The targets will minimize the extent of low oxygen dead zones in the central basin of Lake Erie; maintain algae growth at a level consistent with healthy aquatic ecosystems; and maintain algae biomass at levels that do not produce toxins that pose a threat to human or ecosystem health, EPA stated. Through the Great Lakes Water Quality Agreement, Canada and the United States committed to combat nuisance algae development in Lake Erie, and agreed to develop updated binational phosphorus reduction targets for Lake Erie by February 2016. The 40 percent reduction targets are based on 2008 loading levels. Canada and the United States have committed to develop domestic action plans, by no later than February 2018, to help meet the new targets.

EPA Proposes Revisions To RMP Regulations: On March 14, 2016, EPA issued a proposed rule to revise its Risk Management Program (RMP) regulations to improve chemical process safety, assist local emergency authorities in planning for and responding to accidents, and improve public awareness of chemical hazards at regulated sources. 81 Fed. Reg. 13638. The RMP regulations require covered facilities to develop and implement a risk management program. EPA shares RMP information with state and local officials to help them plan for and prevent chemical accidents and releases. The proposed revisions are the result of a review undertaken to modernize the existing EPA RMP and information gathered from feedback obtained during listening sessions, webinars, meetings with stakeholder groups, stakeholder conferences, and public comments in response to EPA’s Request for Information (RFI). The proposed amendments are intended to improve existing risk management plan requirements to enhance chemical safety at RMP facilities and include the following elements:

  • Third Party Audits: This provision would require a facility that has an RMP reportable accident to use an independent third party to conduct its next scheduled audit. The proposal contains criteria for auditor competence and independence;
  • Incident Investigations and Root Cause Analysis: The proposal would require an incident investigation after any incident that resulted in or could have resulted in a catastrophic release. The facility would identify the root cause of (i.e., the fundamental reason for) the incident and submit a report;
  • Safer Technology Alternatives Analysis: Program 3 facilities in three industry categories (paper manufacturing, coal and petroleum products manufacturing, and chemical manufacturing) would be required to evaluate safer technology and alternatives when conducting the process hazard assessment already required by the current RMP rule;
  • Local Coordination: The proposal would increase communication with Local Emergency Planning Committees (LEPC) by requiring annual coordination by facilities with LEPCs to clarify response needs, emergency plans, roles, and responsibilities;
  • Emergency Response Exercises: The proposal would require responding facilities to conduct annual tabletop emergency response exercises with a field exercise every five years. All facilities would perform annual notification exercises;
  • Information Sharing to LEPCs: The proposal would add new disclosure requirements for facilities to LEPCs. LEPCs would receive Incident Investigation Reports, a summary of inherently safer technology adopted according to a Safer Technology Alternatives Analysis, and emergency response exercise reports. The public would receive chemical hazard information, summaries of emergency response exercises, and LEPC contact information; and
  • Increasing Access to Existing Public Information: The proposal seeks input on increasing the public’s access to existing public information to assist participation in accident preparedness planning, including chemical hazard information, summaries of emergency response exercises, and LEPC contact information.

Additional resources, including Frequently Asked Questions (FAQ), are available on EPA’s website. Comments and additional material must be received by May 13, 2016, however, under the Paperwork Reductio Act, comments on the information collection revision are best assured of consideration if OMB receives them on or before April 13, 2016. A public hearing is scheduled for March 29, 2016.

Hazardous Materials Transportation (HMT)

ICAO Issues Interim Ban On Transport Of Lithium Batteries On Passenger Aircraft: On February 22, 2016, the International Civil Aviation Organization (ICAO) banned the transport of lithium ion batteries as cargo on passenger aircraft. The prohibition applies to cargo shipments of lithium batteries; batteries shipped in personal electronic devices are not affected. The prohibition takes effect on April 1, 2016. It will remain in force while ICAO continues its work on a revised packaging performance standard for lithium ion batteries. ICAO anticipates issuing the standard in 2018.


Senate Confirms New FDA Commissioner: On February 24, 2016, the Senate approved President Obama’s nomination to head FDA, Robert M. Califf, M.D. Califf was a cardiologist at Duke University when he was appointed Deputy Commissioner for Medical Products and Tobacco in January 2015. The Senate confirmed Califf over comments expressed by some regarding FDA’s role in the prescription painkillers epidemic.

FDA Re-Opens Comment Period For Proposed Rule On Gluten-Free Labeling Of Fermented Or Hydrolyzed Foods: On February 23, 2016, the FDA Center for Food Safety and Applied Nutrition (CFSAN) re-opened the comment period on its proposed rule “Food Labeling: Gluten-Free Labeling of Fermented or Hydrolyzed Foods.” 81 Fed. Reg. 8869. The proposed rule would establish requirements concerning ”gluten-free” labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients to help ensure that individuals with celiac disease are not misled and receive truthful and accurate information with respect to fermented or hydrolyzed foods labeled as ”gluten-free.” The comment period ends April 25, 2016.

FDA To Hold Public Meeting On FSMA Final Rules And Progress: On February 26, 2016, FDA’s CFSAN issued a notice that it would be hosting a public meeting entitled “FDA Food Safety Modernization Act: Prevention-Oriented Import System Regulations and Implementation” on March 21, 2016, from 8:30 a.m. until 5:00 p.m., at CFSAN’s Wiley Auditorium, 5100 Paint Branch Parkway, in College Park, Maryland. 81 Fed. Reg. 9761. The meeting will provide importers and other interested persons an opportunity to discuss two recent final rules issued by FDA as part of the modern food safety system envisioned by Congress when the Food Safety Modernization Act (FSMA) was passed in 2011: Foreign Supplier Verification Programs; and Accredited Third-Party Certification.

FDA has issued a total of five final rules under FSMA and more are pending. In this meeting, FDA will also provide an update on the status of the Voluntary Qualified Importer Program, still in development, and an opportunity to discuss FDA’s comprehensive planning effort for the next phase of the FSMA implementation relating to import safety programs, including establishing the operational framework for these programs and plans for guidance documents, training, education, and technical assistance. Registration for in-person attendance is at capacity, but registration for the webcast is available here. After the meeting, a transcript will be accessible on FDA’s FSMA website.

FDA Issues Guidance For Industry On Acrylamide In Foods: On March 11, 2016, FDA’s CSFAN announced the availability of guidance for industry on “Acrylamide in Foods,” intended to provide information that may help growers, manufacturers, and food service operators reduce acrylamide levels in certain foods. 81 Fed. Reg. 12907. The announcement states that reducing acrylamide levels in foods may mitigate potential human health risks from exposure to acrylamide, a potential human carcinogen. The guidance is intended to suggest a range of possible approaches to reducing acrylamide levels. It is the final version of draft guidance dated November 2013, as modified in response to comments received. Comments may be submitted at any time. Please consult the Federal Register notice for submission details.

FDA Announces Availability Of Draft EA And Preliminary FONSI Concerning Investigational Use Of Oxitec OX513A Mosquitoes: On March 14, 2016, FDA announced the availability of the draft environmental assessment (EA) submitted by Oxitec Ltd. and a preliminary finding of no significant impact (FONSI) in support of a proposed investigational release (i.e., field trial) of OX513A Aedes aegypti genetically engineered (GE) mosquitoes (OX513A mosquitoes), as part of an existing mosquito control program in Key Haven, FL. 81 Fed. Reg. 13371. OX513A is a strain of Ae. Aegypti mosquito whose recombinant DNA (rDNA) construct encodes a conditional lethality trait such that the offspring of the matings of male OX513A mosquitoes and wild type Ae. Aegypti do not survive to adulthood. The intended result is a decrease in the overall population of Ae. aegypti in the environment. Only male OX513A mosquitoes are intended to be released. Comments are due by April 13, 2016.


The Netherlands Describes Tool For Risk Assessment Of Nanomaterials In Cosmetics: On January 25, 2016, the Netherlands National Institute for Public Health and the Environment (RIVM) published a report that describes the content of a computer program that can be used for a risk assessment. According to RIVM, the NanoCosmetics tool will need to cover all aspects of the risk assessment, including: the physicochemical characterization of the nanomaterials; the estimation of the consumer exposure; the possible hazards (toxicity) induced by the nanomaterials; and the risk assessment itself. The report concludes that it is feasible to develop an electronic tool that allows an estimation of the risk of the use of nanomaterials as cosmetic ingredients. In cases where only limited information is available, however, the tool will use default values as input data for the risk assessment. These default values will generally result in a conservative outcome.

Danish EPA Assesses Nano-Enabled Technologies In Cosmetics: On February 16, 2016, the Danish Environmental Protection Agency (Danish EPA) posted a report entitled Assessment of Nano-enabled Technologies in Cosmetics. The report reviews the available literature on nano-enabled technologies for cosmetic products, specifically addressing soluble nano-transporters. Accompanying the report is an appraised database summarizing the literature that formed the basis of the review. The database addresses the following areas: types and uses of soluble nano-transporters in cosmetic applications; assessment of the extent of dermal absorption/ penetration of nano-transporters; evidence of dermal/systemic toxicity arising from interactions with nano-transporters; identification of nano-specific characteristics that may influence dermal absorption/toxicity of nano-transporters; and assessment of the specific research areas that require more knowledge and to discuss to which extent provisions on nanomaterials in the cosmetic regulation are to be applied for nano-transporters.

OECD Publishes Reports On Physical-Chemical Properties And Categorization Of Nanomaterials: The Organization for Economic Cooperation and Development (OECD) recently published the following reports:

  • Physical-chemical properties of nanomaterials: Evaluation of methods applied in the OECD-WPMN testing programme: The Netherlands volunteered to lead an initial detailed evaluation of the applicability of the test methods applied to determine the physico-chemical properties of different types of nanomaterials in the Testing Program. The evaluated dossiers include information on multi-walled carbon nanotubes, single-walled carbon nanotubes, silver, silicon dioxide, cerium dioxide, zinc oxide, titanium dioxide, fullerenes, dendrimers, gold, and nanoclay. According to the recommendations, the evaluations showed that many of the methods have limitations, which to some extent could be addressed by developing standardized methods. The report recommends prioritizing some of the methods for further work towards standard test methods. To develop and validate standard test methods, the report recommends developing reference materials.
  • Categorisation of manufactured nanomaterials workshop report: This is the report of the September 17-19, 2014, OECD Expert Meeting on categorization of manufactured nanomaterials, which was hosted by EPA. The expert meeting concluded that discussion and conclusions can be used to develop fit-for-purpose decision frameworks for categorization that can be used under different regulatory systems for manufactured nanomaterials. To support this, the expert meeting recommended:
    1. Identifying and developing, where needed, methods for characterization of relevant physical-chemical properties for toxicokinetics, fate, hazard, and exposure assessments;
    2. Use of methods that enable comparability, are reliable, and use the OECD Guidance on Sample Preparation and Dosimetry; and
    3. Agreeing on or developing experimental models (e.g., in-vitro and in-vivo assays) that are predictive of human health and environment effects and that support categorization.

EFSA Begins Public Consultation On Draft Guidance On The Preparation And Presentation Of An Application For Authorization Of A Novel Food: The European Food Safety Authority (EFSA) has begun a public consultation on its draft guidance on the preparation and presentation of an application for authorization of a novel food. The European Commission (EC) promulgated a final novel foods regulation in December 2015. Under the regulation, food consisting of engineered nanomaterials should be considered a novel food. EFSA intends the draft document to provide guidance on the data needed to carry out the safety assessments of novel foods. The draft guidance states that, for foods consisting of “engineered nanomaterials,” the parameters for characterization and identification of engineered nanomaterials outlined in the EFSA Scientific Committee Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain should be provided. According to the draft guidance, where the novel food contains or consists of “engineered nanomaterials,” the applicant should consider the Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain from EFSA’s Scientific Committee. Comments are due April 21, 2016.

OECD Claims Urgent Research Needed Into Risks From Nanomaterials In Household Waste: According to a February 22, 2016, OECD press release, an OECD report states that “rgent research is needed to assess the possible risks to human health and ecosystems from the ever-increasing amounts of engineered nanomaterials going into household waste and ending up in the environment.” The OECD report, Nanomaterials in Waste Streams: Current Knowledge on Risks and Impacts, states that engineered nanomaterials are entering landfill sites, incinerators, and wastewater treatment facilities that are not designed to filter out particles as tiny as a millionth of a millimeter in size. Nanoparticles thus end up in sewerage sludge used as agricultural fertilizer and in sewage plant effluent that flows into rivers and lakes, as well as in recycled goods. While state-of-the-art waste treatment plants may collect a large share of nanomaterials from waste, according to the report, less efficient processes “mean a significant amount is likely released into the environment as exhaust gas from incineration, as ash applied on roads, as treated wastewater or leaches into soil and water sediment.” The report calls for research into the type and amount of nanomaterials entering waste streams, what happens to it inside treatment facilities, and the potential impacts of residual waste containing nanomaterials. It recommends greater safety measures for workers at recycling facilities.

French Ministry Publishes Report On Nanomaterial Registrations Received In 2015: The Ministry for the Environment, Energy, and the Sea has posted a report, available only in French, entitled Éléments issus des déclarations des substances à l’état nanoparticulaire: Rapport d’etude 2015. The report analyzes nanomaterial registrations received in 2015 for reporting year 2014. Under Decree No. 2012-232, companies that manufacture, import, and/or distribute a “substance with nanoparticle status” in an amount of at least 100 grams per year must submit an annual report with substance identity, quantity, and use information. According to the report, 14,584 declarations were submitted in 2015, compared to 10,417 declarations submitted in 2014, and 3,409 declarations submitted in 2013.

EPA Defends Conditional Nanosilver Registration: On March 8, 2016, EPA filed its brief in the U.S. Court of Appeals for the Ninth Circuit responding to two petitions for review of its conditional registration of a nanosilver pesticide product. NRDC v. EPA, No. 15-72308. The Natural Resources Defense Council (NRDC), as well as the Center for Food Safety (CFS) and International Center for Technology Assessment (ICTA), filed suit, asking the court to set aside EPA’s final order granting a conditional registration for a nanosilver-containing antimicrobial pesticide product named “NSPW-L30SS,” or “Nanosilva.”

In the consolidated case, EPA argues that when the petitioners commented on EPA’s proposed decision, they failed to raise most of the arguments they brought before the court, denying EPA an opportunity to address those issues. EPA provides the following summary of the issues presented:

  1. Whether substantial evidence supports EPA’s finding that the applicant Nanosilva lacked sufficient time to submit the required data, when EPA first imposed requirements on Nanosilva in the final order granting registration, and when data requirements in another entity’s registration did not apply to Nanosilva and other prior EPA actions never imposed the same requirements; and
  2. Whether EPA’s public-interest finding is supported by substantial evidence when data and other information in the record demonstrate that use of the pesticide could reduce the amount of silver in the environment and risks associated with silver.

EPA argues that it properly determined that Nanosilva had insufficient time to generate data. According to EPA, it imposed new data requirements simultaneously with its grant of NSPW-L30SS’s registration, and Nanosilva did not have sufficient time to satisfy those requirements. EPA rejects petitioners’ assertion that EPA imposed the data requirements at one of three earlier points: (1) in 2011 when it required data as a condition to AGS-20’s registration; (2) in 1984 when it promulgated regulations for data requirements; or (3) in 2010 when it communicated with Nanosilva about certain data. EPA states that conditioning HeiQ’s AGS-20 registration on the submission of certain data “does not ‘first impose’ those requirements on everyone else,” and that “[t]his interpretation is entitled to Chevron deference.” According to EPA, the 1984 regulations “require substantively different data from what EPA demanded of Nanosilva in 2015.” In its 2010 communications with Nanosilva, EPA states that it recommended the submission of additional data, but different data than what it “demanded” in 2015.

According to EPA, it “properly found that use of NSPW-L30SS is in the public interest because it could reduce the environmental silver load and risks associated with silver.” EPA cites evidence in the record showing that NSPW-L30SS’s nanosilver is applied at much lower rates than conventional silver; that NSPW-L30SS is expected to release silver ions at a controlled rate; and that the amount of silver that leaches from material treated with NSPW-L30SS into the environment is so low that it cannot be detected by measuring instruments. According to EPA, it further confirmed its conclusion after considering nanosilver’s toxicity. EPA rejects petitioners’ arguments regarding mobility, stating that petitioners misunderstand EPA’s review of leaching data. EPA states that its assumption that the use of NSPW-L30SS by manufacturers who start silver treatment after registration will not increase the overall environmental silver load needed no substantiation. Nothing in the record supports the petitioners’ claim, and EPA “was not obliged to embark on a wild goose chase to prove a negative proposition.” EPA describes petitioners’ final two arguments as “equally unconvincing.” EPA states: “One nonsensically demands that EPA’s public-interest finding be made with absolute certainty. The other urges the Court to review an allegation that EPA failed to comply with its non-binding guidance, an invitation that this Court has long rejected; moreover, the underlying argument lacks merit.” EPA asks the court to deny the petitions.


BRAG Biobased Products News And Policy Report: Bergeson & Campbell, P.C.’s (B&C®) consulting affiliate, B&C® Consortia Management, L.L.C. (BCCM), manages the Biobased and Renewable Products Advocacy Group (BRAG®). For access to a weekly summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to


Legislation To Protect Children From Lead Exposure Introduced In House And Senate: Senators Dick Durbin (D-IL) and Robert Menendez (D-NJ) joined Representatives Keith Ellison (D-MN) and Mike Quigley (D-IL) on March 7, 2016, to introduce legislation to protect children from lead poisoning. The Lead-Safe Housing for Kids Act of 2016 (H.R. 4694 and S. 2631) would require the Department of Housing and Urban Development (HUD) to adopt prevention measures and update its lead regulations to protect children from the risk of lead exposure. “We know that there is no safe level of lead for children, yet the Department of Housing and Urban Development regulations seem to ignore this fact,” stated Durbin. “We have to bring . . . outdated lead standards up to date and consistent with the latest science,” he added. The Centers for Disease Control and Prevention (CDC) calls for a public health intervention when a child’s blood level is 5 µg/dL (micrograms of lead per deciliter). Under current HUD regulations, however, intervention to reduce lead hazards in a home is not required until the amount of lead in a child is 20 µg/dL. Among other things, the legislation would bring HUD’s policies in line with the CDC recommendations and the current science on lead exposure. Specifically, the bill would ensure that federal lead standards are updated in accordance with the best available science by requiring HUD to align the definition of lead poisoning with the CDC’s blood level reference value or the most current CDC lead poisoning prevention definitions and guidance. The legislation also would require EPA and HUD to update outdated lead-contaminated dust and lead-contaminated soil standards, used to identify lead hazards in homes and the environment, to conform to the prevailing science.

House Bill Would Delete International Regulatory Provisions From Clean Air Act: Stating that “this assault on our Constitution and states’ rights must be stopped,” Representative Scott Perry (R-PA) on February 11, 2016, introduced a bill that would deny EPA “the ability to bypass Congress and take control of every states’ energy program.” The Energy Sovereignty Act (H.R. 4544) seeks to do so by eliminating Section 115 of the Clean Air Act (CAA). This provision addresses international air pollution and has been cited by some as legal grounds for implementation of the Clean Power Plan and other Obama Administration climate change initiatives. The bill’s introduction comes on the heels of the U.S. Supreme Court’s February 9, 2016, stay of the Clean Power Plan. In the wake of this decision, some are calling on EPA to exercise its authority under CAA Section 115 to address climate change. Section 115 would appear to authorize EPA to require states to reduce air pollution emissions that cross international boundaries if other countries are taking reciprocal action. Some argue that this “reciprocal action” has been taken via the climate agreement reached in Paris in December 2015. Perry’s legislation, if implemented, would remove this authority.

House Bill Seeks To End Fossil Fuel Leasing On Public Lands And The Outer Continental Shelf: Representative Jared Huffman (D-CA) on February 11, 2016, introduced legislation that would ban new fossil fuel leases on public lands and waters and in the outer continental shelf (OCS). The Keep It in the Ground Act of 2016 (H.R. 4535) would amend the Outer Continental Shelf Lands Act (43 U.S.C. 1337) to prohibit the U.S. Department of the Interior (DOI) from issuing a new lease or renewing, reinstating, or extending any nonproducing lease for the exploration, development, or production of oil, natural gas, or any other fossil fuel in the OCS. The bill would also require DOI to cancel leases in the Beaufort Sea, Cook Inlet, or Chukchi Sea within 60 days of the bill’s enactment. The bill is not limited to the OCS. It would prohibit DOI from conducting any lease sale, entering into any new lease, reoffering for lease any land covered by an expiring lease, or renewing, reinstating, or extending any nonproducing lease for onshore fossil fuels on public lands and waters.


OSHA Issues Draft WoE Guidance: On February 16, 2016, the U.S. Occupational Safety and Health Administration (OSHA) released a draft Weight of Evidence (WoE) guidance document for comment. The draft WoE guidance is intended to assist manufacturers, importers, and employers in evaluating scientific studies and data on potential health hazards of a chemical substance and to determine what information must be disclosed on the label and safety data sheet (SDS) for compliance with the Hazard Communication Standard (HazCom). HazCom 2012 introduced important changes, one of which authorizes manufacturers to consider the WoE as part of the process for assessing health hazards of a chemical and what must be disclosed on the label and SDS. Prior to HazCom 2012, one positive health effect study was deemed sufficient for purposes of classification and labeling. This draft WoE guidance sets forth OSHA’s expectations as to how best to conduct a WoE evaluation and provides illustrative examples to assist in this regard. The draft guidance was released as a companion to a recently posted hazard classification guidance, which OSHA has also made available. Comments are due by May 2, 2016.

EPA Announces National Enforcement Initiatives For Fiscal Years 2017-2019: EPA on February 18, 2016, announced seven National Enforcement Initiatives (NEI) for fiscal years (FY) 2017-2019. EPA announced that it will retain four of its current NEIs, add two new initiatives, and expand one to include a new area of focus. The FY 2017-2019 NEIs are:

  • Keeping Industrial Pollutants Out of the Nation’s Waters (new initiative);
  • Reducing Risks of Accidental Releases at Industrial and Chemical Facilities (new initiative);
  • Cutting Hazardous Air Pollutants (expanded initiative);
  • Reducing Air Pollution from the Largest Sources;
  • Ensuring Energy Extraction Activities Comply with Environmental Laws;
  • Keeping Raw Sewage and Contaminated Stormwater Out of the Nation’s Waters; and
  • Preventing Animal Waste from Contaminating Surface and Ground Water.

EPA is expanding its initiative focused on reducing toxic air pollution by adding large storage tanks and hazardous waste facilities to its work to address public health threats. NEIs reinforce EPA’s core enforcement work. One of EPA’s top enforcement priorities is to protect safe drinking water, and three of its initiatives include a focus on keeping pollutants out of drinking water sources. EPA selects NEIs every three years to focus resources on national environmental problems where there is significant non-compliance with laws, and where federal enforcement efforts can make a difference. The initiatives will cover three FYs, and focus on employing Next Generation Compliance strategies to enhance enforcement cases and build compliance.

New York Issues Emergency Regulation Classifying PFOA As Hazardous Substance: On February 17, 2016, the New York State Department of Environmental Conservation (NSDEC) published in the New York State Register an emergency rulemaking listing perfluorooctanoic acid (PFOA) as a hazardous substance under state law. As we reported last month, on February 3, 2016, New York Governor Andrew Cuomo (D) directed NYSDEC to issue the emergency regulation in response to the presence of PFOA in the drinking water supply of the village of Hoosick Falls, NY. This action vests NYSDEC with the legal authority to pursue New York State Superfund designation and remediation of the village using state Superfund resources.

ATSDR Makes Available Tox Profiles: On February 24, 2016, the Agency for Toxic Substances and Disease Registry (ATSDR) announced the availability of two new draft toxicological profiles on unregulated hazardous substances for review and comment. 81 Fed. Reg. 9198. The profiles are on Jet Fuels and 1-Bromopropane. Comments may include additional information or reports on studies about the health effects of Jet Fuels and 1-Bromopropane. Comments on the draft Toxicology Profiles must be received on or before May 24, 2016.

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