Wrap-Up of Federal and State Chemical Regulatory Developments, October 2016

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Bergeson & Campbell, P.C.

TSCA/FIFRA/IRIS/NTP/TRI

EPA Issues Statements Of Findings For September 2016: On September 23, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice announcing its findings after its review of Toxic Substances Control Act (TSCA) Section 5(a) notices when EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment. 81 Fed. Reg. 65636. Such statements apply to premanufacture notices (PMN), microbial commercial activity notices (MCAN), and significant new use notices (SNUN) submitted to EPA under TSCA Section 5. The notice presents statements of findings made by EPA on TSCA Section 5(a) notices during the period from June 22, 2016, to September 19, 2016. EPA issued findings for 18 new chemical substances. The Federal Register notice lists the statements of findings made by EPA after review of notices submitted under TSCA Section 5(a) that certain new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment.

Syngenta Settles With EPA On Alleged Label Violations: On September 16, 2016, EPA announced it settled an enforcement matter with Syngenta Crop Protection, LLC via a Consent Agreement and Final Order (CAFO) concerning EPA’s allegations that Syngenta violated the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and EPA’s Pesticide Container and Containment Rule (PCCR). The investigation took place over three years, starting in August 2012 and concluding in January 2015. The CAFO listed the alleged violations in three parts:

  1. Failure to have repackaging agreements and failure to maintain records concerning the repackaging agreements: In the CAFO, EPA states that it identified numerous and separate occasions when Respondent distributed or sold approximately 19 registered pesticides to approximately 222 refillers “prior to having written repackaging agreements in place with such refillers,” “and/or failed to maintain records of the repackaging agreements with the refillers.” The requirements for such agreements and recordkeeping are set forth at 40 C.F.R. §§ 165.67(b)(3), 165.67(d), and 165.67(h).
  2. Distribution and sale of misbranded pesticides: In the CAFO, EPA states that at least seven inspections conducted at different facilities that were refillers of Respondent’s pesticides found pesticides affixed with outdated labels, as well as sales of such products with outdated labels. EPA states that Syngenta was the registrant of all the products at issue and had provided the refillers with the outdated labels for repackaging the pesticide products in refillable containers or bulk tanks on at least 19 separate occasions.
  3. Failure to maintain data submitted for pesticide registration: In the CAFO, EPA states it conducted an inspection at two laboratories to review compliance with Good Laboratory Practice (GLP) requirements, and to audit the data for studies submitted by Respondent to EPA to support one of its pesticide registrations. In both cases, Respondent informed EPA that it did not maintain records or raw data associated with the studies and the laboratories confirmed they did not maintain the records at their facilities.

Syngenta neither admits nor denies these allegations, but has agreed to pay a civil penalty of $766,508, and to complete an environmental compliance promotion Supplemental Environmental Project (SEP) within four years at a cost of not less than $436,990. The SEP will involve a four-year educational awareness training and campaign to educate the regulated community on FIFRA regulatory compliance requirements pertaining to the PCCR. The training will focus on the requirements relevant to bulk pesticide containers, containment, labels, storage, transportation, delivery, clean-out, repackaging agreements, and recordkeeping. The training is intended to increase awareness across a broad array of businesses that handle pesticides, including registrants, refillers, retailers, commercial applicators, and custom blenders of pesticides. EPA in recent years has focused on labeling violations between registrant and supplemental distributor labels and the issues in this case have some similarities, particularly the need for written contacts between registrants and refillers or supplemental distributors, and also the need to ensure that current pesticide labels are provided before repackaging and relabeling take place. More information concerning supplemental distributors and repackaging is available in our blog item Registrants Penalized for Actions of Third-Party Pesticide Distributor, our memorandum EPA’s Enforcement Efforts Regarding FIFRA Supplemental Distribution and How to Avoid Noncompliance, and in the materials from our webinar EPA's Supplemental Distribution: Enforcement Actions Are Buzzing: How to Avoid Getting Stung.

Results Of EPA OIG’s Review Of EPA’s Antimicrobial Testing Program: On September 19, 2016, EPA’s Office of Inspector General (OIG) issued a report, EPA Needs a Risk-Based Strategy to Assure Continued Effectiveness of Hospital-Level Disinfectants, the result of OIG’s review of EPA’s Antimicrobial Testing Program (ATP) to “determine whether the program ensures the efficacy of EPA-registered hospital sterilants, disinfectants, and tuberculocides (“hospital-level disinfectants”); and to evaluate options for improving the ATP.” OIG found that the ATP “does not assure that hospital-level disinfectant products continue to be effective after they are registered,” specifically that:

  • Once EPA tests a product and it passes, it is listed as Agency Confirmed Efficacy on the Agency’s website and is typically not tested again; the long-term efficacy of the product cannot be assured.
  • EPA relies on manufacturers to submit voluntarily product samples for testing. In the last three years, out of the approximately 300 registered hospital disinfectant products that have not been tested, manufacturers submitted only 12 samples to EPA for ATP efficacy testing.

Importantly, however, OIG concludes: “Although the program as currently designed and conducted does not assure that most hospital disinfectant products continue to be effective, at this point it is redundant and unnecessary to make adjustments, since the EPA is concurrently having the products re-registered.” More information is available at http://pesticideblog.lawbc.com/entry/results-of-epa-oigs-review-of-epas-antimicrobial-testing-program.

PPDC To Meet: On October 5, 2016, EPA announced that the Pesticide Program Dialogue Committee (PPDC) would convene on November 2-3, 2016, at EPA’s Crystal City offices. 81 Fed. Reg. 69058. Topics to be considered at the meeting include pesticide regulatory development and reform initiatives and program implementation issues, among other issues. Please consult the Federal Register notice for more details.

EPA Seeks Comment On Two Proposed Test Methods And Guidance For Antimicrobial Efficacy Testing: On October 4, 2016, EPA announced the availability for public comment of two proposed test methods and associated testing guidance for evaluating antimicrobial pesticides against two biofilm bacteria, Pseudomonas aeruginosa and Staphylococcus aureus. Bacterial biofilms excrete a slimy, glue-like substance (extracellular polymeric substances, called the biofilm matrix) that facilitates attachment to many hard surfaces such as glass, metals, and plastics, including those in health-care settings. The biofilm matrix provides embedded bacteria with protection from dehydration and other environmental stresses, and interferes with the action of chemical disinfectants. Under FIFRA, the registrant of an antimicrobial product with a public health claim is required to submit efficacy data to EPA in support of the product's registration. EPA is soliciting comments on the clarity of the standard operating procedures and the regulatory guidance. Comments are due by December 5, 2016.

EPA Seeks Applications For Safer Choice Partner Awards: On October 11, 2016, EPA announced that it was seeking 2017 Safer Choice Partner of the Year Awards nominations. 81 Fed. Reg. 70110. The award recognizes Safer Choice stakeholders who have advanced the goals of the Pollution Prevention Act and the Safer Choice Program by reducing pollution at its source though safer chemistry. Applications are due by December 16, 2016.

Hearing Set For EPA Motion For Summary Judgment In Neonicotinoid Treated Seed Proceedings: Certain documents have been filed in the Anderson v. McCarthy proceedings in the U.S. District Court for the Northern District of California: EPA’s Notice of Motion and Motion for Summary Judgment; Defendant-Intervenors CropLife America, et al.’s Notice of Motion and Motion for Summary Judgment; and Plaintiffs’ Memorandum of Points and Authorities in Support of Motion for Summary Judgment. EPA’s documents are of particular interest to those who have been following this case and are concerned about the assertions in the case regarding the treated article exemption. In its motion, EPA argues that the Ninth Circuit lacks jurisdiction to hear Plaintiffs’ claims, as the “EPA guidance document they challenge is not a judicially reviewable agency action -- much less a final action -- regarding the regulatory status of treated seed,” and Plaintiffs “have not identified any discrete, mandatory duty or action that EPA has failed to perform under FIFRA.” EPA’s main arguments in support of its motion include: Plaintiffs have not identified any final agency actions. The Inspection Guidance is not an agency action, and even if the Inspection Guidance were an agency action, it is not final; and Count II (Plaintiffs’ allegation of EPA’s failure to regulate and enforce FIFRA with respect to pesticide-treated seeds) must be dismissed because there is no nondiscretionary duty identified by Plaintiffs that is unreasonably delayed or unlawfully withheld. Enforcement of FIFRA is a discretionary action not subject to review.

In its motion, Defendant-Intervenors argue: “Each of Plaintiffs’ claims constitutes an impermissible programmatic attack on EPA’s existing pesticide regulatory program --specifically, the interplay between EPA’s regulation of pesticides registered to be applied as seed treatments and what Plaintiffs characterize as its categorical application of the treated article exemption to the treated seed. As a result, each of these claims is non-justiciable as a matter of law, entitling Defendants to summary judgment in their favor.” Defendant-Intervenors note that pesticides used for seed treatments are subject to “rigorous, scientifically robust review and approval under FIFRA,” making Plaintiffs’ attempt to impose a regulatory process “entirely duplicative of EPA’s existing exercise of its authority under FIFRA, while having no impact on human health or environmental safety.”

Plaintiffs’ memorandum sets forth arguments for why the court should “find in favor of Plaintiffs on their four claims for relief: that EPA failed to enforce FIFRA against an entire class of pesticides; that EPA improperly amended the treated article exemption without following proper [Administrative Procedure Act (APA)] rulemaking procedures; that EPA’s exemption of neonicotinoid-coated seeds was ultra vires and/or arbitrary and capricious under the APA; and that EPA’s labeling requirements for unregistered pesticide-coated seed bags was arbitrary and capricious under the APA and FIFRA.” Specifically, Plaintiffs address why they believe EPA has failed to enforce FIFRA against neonicotinoid-coated seeds, why this asserted failure amounts to what they believe is “an unlawful abdication of [EPA’s] statutory responsibilities” and why they believe “EPA’s failure to enforce FIFRA against neonicotinoid-coated seeds and pesticidal dust-off is a ‘consciously and expressly adopted general policy,’ which ‘amounts to an abdication of its statutory responsibilities’ that this Court has the power to remedy.” A hearing on EPA’s motion was set for October 27, 2016, but due to scheduling conflicts has been rescheduled for November 3, 2016. It will be important to monitor the court’s consideration of these issues closely. More information on these proceedings can be found in our pesticide blog items District Court Declines to Rule on Jurisdictional Issues in Neonicotinoid Case until Summary Judgment and EPA Requests Dismissal of Complaint For Lack of Subject Matter Jurisdiction.

RCRA/CERCLA/CWA/CAA

President Directs Federal Agencies To Take Action To Address The National Security Implications Of Climate Change: On September 21, 2016, President Obama signed a Presidential Memorandum (PM) on Climate Change and National Security, establishing a policy that the impacts of climate change must be considered in the development of national security-related doctrine, policies, and plans. To achieve this, 20 federal agencies and offices with climate science, intelligence analysis, and national security policy development missions and responsibilities will collaborate “to ensure the best information on climate impacts is available to strengthen our national security.” The PM was released alongside a report from the National Intelligence Council identifying pathways through which climate change will likely pose significant national security challenges for the United States over the next two decades, including threatening the stability of other countries. The PM calls for establishing a dedicated Federal Climate and National Security Working Group, led by representatives from the National Security Council staff and the White House Office of Science and Technology Policy, and including over 20 federal agencies and offices with climate science, intelligence, and national security responsibilities. The Working Group will identify the U.S. national security priorities related to climate change and national security, and develop methods to share climate science and intelligence information to inform national security policies and plans. The Climate and National Security Working Group will create a Climate Change and National Security Action Plan within 90 days to identify specific steps that are required to perform the Working Group’s functions, which includes facilitating the exchange of climate data and information with the intelligence community and identifying gaps; recommending research guidelines concerning the Federal Government’s ability to detect climate intervention activities; identifying the most current information on regional, country, and geographic areas most vulnerable to current and projected impacts of climate variability for the next 30 years; and developing recommendations for the Secretary of State to help ensure that the work of U.S. embassies, including their planning processes, are better informed by relevant climate change-related analyses.

Leaders From 100 Countries Call For Ambitious Amendment To Montreal Protocol To Phase Down HFCs: The White House on September 22, 2016, hosted a gathering of countries in New York to provide a boost of momentum to the upcoming international negotiations to adopt an amendment to the Montreal Protocol to phase down the potent greenhouse gases (GHG) known as hydrofluorocarbons (HFC). The event highlighted two significant announcements. First, more than 100 countries called for securing an ambitious amendment with an “early freeze date.” This group includes the United States, Argentina, Chile, Colombia, all 28 countries in the European Union (EU), all 54 countries in Africa, and several island states that are the most vulnerable to the impacts of climate change. Complementing this announcement, more than 500 companies and organizations and hundreds of sub-national governments called upon world leaders to take strong action on HFCs. Second, a group of donor countries and philanthropists announced their intent to provide $80 million in support to help countries in need of assistance. After the meeting, representatives from the 100 nations released the New York Declaration of the Coalition to Secure an Ambitious HFC Amendment.

EPA Policy Assessment Calls For Retaining Current NO2 NAAQS: EPA’s Office of Air Quality Planning and Standards (OAQPS) on September 27, 2016, released a draft Policy Assessment (PA) recommending that EPA retain its current National Ambient Air Quality Standard (NAAQS) for nitrogen dioxide (NO2). The PA was prepared as part of EPA’s ongoing review of the primary (health-based) NAAQS for NO2. The PA presents analyses and preliminary staff conclusions regarding the policy implications of the key scientific and technical information that informs this review. When final, the PA is intended to bridge the gap between the relevant scientific evidence and technical information and the judgments required of the EPA Administrator in determining whether to retain or revise the current standards. The PA reaches the preliminary conclusion that the available scientific evidence, in combination with the available information from quantitative analyses, supports the adequacy of the public health protection provided by the current primary NO2. The PA further reaches the preliminary conclusion that it is appropriate to consider retaining the current standards, without revision, in this review. The PA recognizes, however, the “uncertainties that are inherent in the scientific evidence and technical analyses.” The PA states that “n staff’s view, there is appreciable uncertainty in the extent to which reductions in asthma exacerbations or asthma development would result from alternative NO2 standards with levels lower than those of the current standards. Thus, the basis for any consideration of alternative lower standard levels would reflect different public health policy judgments as to the appropriate approach for weighing uncertainties in the evidence.” Despite these uncertainties, OAQPS reached the preliminary conclusion that “consideration should be given to retaining the current standard, without revision.”

EPA Releases RCRA Strategy For Retail Sector: On September 12, 2016, EPA released its Strategy for Addressing the Retail Sector under RCRA’s Regulatory Framework (Strategy). EPA recognizes that regulation of hazardous waste generated by the retail sector under the Resource Conservation and Recovery Act (RCRA) presents unique challenges not found in more “traditional” RCRA-regulated industries. The retail sector handles a large number of diverse products, which change over time and may, in many instances, become regulated as hazardous waste under RCRA when discarded. As a result, retailers are required to make hazardous waste determinations for products at stores located across the country. Additionally, the reverse distribution process where retail stores generally send unused goods to reverse logistics centers and rely upon arrangements with suppliers/vendors to determine the ultimate disposition of these goods is a well-established business practice in the retail sector. Nevertheless, how the reverse distribution processes is regulated, or should be regulated, under RCRA has resulted in a number of questions from both retailers and regulators. This issue becomes more complicated for retail chains with store locations in many different states, where states have taken various positions on how RCRA regulations apply. EPA began a review of how RCRA hazardous waste regulations apply to the retail sector in 2008. On February 14, 2014, EPA issued a Notice of Data Availability (NODA) for the retail sector to understand better concerns from stakeholders and to gather information and feedback on issues impacting the sector. 79 Fed. Reg. 8926. The Strategy is intended to address the retail sector’s unique RCRA issues. The Strategy consists of a three-pronged approach:

  • Issue policy, guidance, and rulemaking to ensure a better fit between RCRA regulations and the retail sector;
  • Research retail hazardous waste management practices and related issues in the area of reverse distribution, universal waste, and other challenges; and
  • Identify additional approaches to address outstanding RCRA retail sector issues if needed.

Prior to issuing the NODA in 2014, EPA had already begun developing the Pharmaceuticals rule and the Generator Improvements rule, as well as the Definition of Solid Waste (DSW) rule. EPA is trying to ensure these rules address, at least in part, some of the unique retail sector RCRA issues. In addition, EPA states that it will add aerosol cans to the Universal Waste regulations and issue guidance on recycling aerosol cans. The Strategy states that EPA also will develop a policy that addresses the reverse distribution process for the retail sector.

EPA’s release of the Strategy comes on the heels of a landmark settlement with Whole Foods over alleged RCRA violations. EPA Region 6 and Whole Foods on September 19, 2016, entered into a compliance agreement for RCRA violations at 29 Whole Foods locations. The consent agreement states that Whole Foods locations failed to make hazardous waste determinations and did not comply with Universal Waste requirements. In addition to paying a $2 million penalty, Whole Foods must implement an electronic hazardous waste identification system. It also agreed to implement a SEP that consists of financing, developing, and hosting a series of compliance promotion activities through several different media. The objective of the SEP is to educate the retail industry, particularly smaller retailers, in Texas about the hazardous waste laws and regulations that apply to their operations.

EPA Implements New, Streamlined Approach For Approving RCRA Test Methods: EPA on September 27, 2016, announced that it is implementing a new, streamlined approval process for non-regulatory RCRA test methods in the “Test Methods for Evaluating Solid Waste, Physical/Chemical Methods” manual, also known as SW-846. 81 Fed. Reg. 66272. SW-846 has for decades served as the compendium of test methods EPA has approved for use to demonstrate compliance with RCRA regulations. EPA’s new process will use Internet site postings and “an extensive email list” to notify users of the SW-846 of methods being released for public comment. This approach differs from EPA’s traditional approval process, where EPA publishes proposed test methods in the Federal Register and takes comment on them. This new process is limited only to SW-846 methods published as guidance where there are no changes to the RCRA regulations. The process for updating or publishing SW-846 analytical methods that are required in the RCRA regulations (referred to as Method Defined Parameters or MDP) will not change. For years, many in the regulated community have decried EPA’s approach for approving test methods, arguing that EPA does not make available in a timely manner the use of analytical methods that take advantage of technological advancements. Because most SW-846 methods are guidance and not required under the regulations, these comments prompted EPA to seek a more efficient approach to announce the availability of methods for public use and to solicit comment prior to incorporating new or revised methods in the SW-846 compendium. EPA receives requests to add or update SW-846 methods from various sources. EPA considers these requests if the new method or revision addresses a national emergency (such as an oil spill), is necessary because of regulatory changes, addresses an emerging environmental contaminant (e.g., perfluorinated compounds), makes available new or updated technology (e.g., collision cell mass spectrometry), is a collaborative effort with other federal agencies, and provides an opportunity for greener chemistry or increased safety (e.g., decreased solvent use). Once EPA selects a method for possible revision or inclusion in SW-846, it is sent to a workgroup of experts for consideration and, if approved by the workgroup, is announced for comment in the Federal Register. EPA’s new approach seeks to streamline this process. EPA will post new test methods on its “Validated Methods” and “Hazardous Waste Test Methods” web pages. EPA will also notify the SW-846 analytical community via e-mails and web postings of new test methods. EPA will take comment on the test methods for 30 days and catalog and respond to these comments. Once EPA approves a new test method, it will add it to the SW-846 Compendium web page. EPA believes that this new approach will allow it to make available new advancements in technologies in a timely manner and provide increased accessibility to analytical procedures, guidance, and updates to SW-846, while still taking public comment on test methods. EPA is not requesting public comment on its new approach and will implement the new approach with all methods beginning from its Update VI to SW-846.

FDA

FDA Issues Guidance On Use Of The Term “Healthy”: On September 28, 2016, the U.S. Food and Drug Administration (FDA) issued a notice of availability of a guidance for industry, “Use of the Term “Healthy” in the Labeling of Human Food Products.” 81 Fed. Reg. 66527. FDA states that the guidance advises manufacturers who wish to use the implied nutrient content claim “healthy” to label their food products as provided by its regulations. FDA is also announcing its intent to exercise enforcement discretion relative to foods that use the implied nutrient content claim “healthy” on their labels that:

  • Are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or
  • Contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.

Comments can be submitted at any time.

FDA Issues Guidance On Necessity Of The Use Of Food Product Categories In Food Facility Registrations And Updates To Food Product Categories: On September 26, 2016, FDA announced that it was updating the food facility registration product categories in its guidance, which will “enhance FDA’s ability to respond quickly and accurately to food-related emergencies by updating the food product categories that companies can select when registering with the agency.” The updates include:

  • Acidified foods and low acid canned foods are no longer listed as food product categories because they are now activity types;
  • Additions to animal food categories of botanicals and herbs, direct fed microbials, animal protein products, forage products, human food by-products not otherwise listed and technical additives; and
  • Molluscan shellfish is now a food product category.

Food companies will be required to select appropriate food product categories from the updated categories during the October – December 2016 registration renewal period. The guidance also describes certain Food Safety Modernization Act (FSMA) amendments that allow FDA to determine appropriate food product categories through guidance.

FDA Posts FSMA Update -- What to Expect Now that the First Big FSMA Compliance Dates Are Here: On September 19, 2016, FDA posted Questions and Answers with Joan Givens, the Co-chair of the FSMA Operations Team Steering Committee and Director of FDA’s Food and Feed Program in the Office of Regulatory Affairs, regarding the first major compliance dates that have arrived for the preventive controls rules for human and animal food under FSMA. Ms. Givens addresses the following questions:

  1. What happens next in terms of FDA enforcement of these new standards?
  2. Does the focus on education mean that companies won’t really be held to these standards yet?
  3. What is the best thing covered food facilities can be doing now?
  4. Where can companies go wrong?
  5. What is the ultimate goal?

September 19, 2016, was the deadline for large businesses to comply with certain new standards under FMSA: (1) human food facilities must meet preventive controls and Current Good Manufacturing Practice requirements (CGMP); and (2) animal food facilities must meet CGMPs.

NANOTECHNOLOGY

EPA Researches How Sunscreens Containing Engineered Nanomaterials Might Change When Exposed To Chemicals In Pool Water: An August 15, 2016, EPA blog item describes EPA’s research on sunscreens containing engineered nanomaterials and how they might change when exposed to chemicals in pool water. According to EPA, many sunscreens contain titanium dioxide engineered nanomaterials, which are often coated with other materials such as aluminum hydroxide to shield skin from reactive oxygen species. EPA researchers are testing to see whether swimming pool water degrades the aluminum hydroxide coating, and if the extent of the degradation is enough to allow the production of potentially harmful reactive oxygen species. Results show that after three days, pool water caused the aluminum hydroxide coating to degrade, which can reduce the coating’s protective properties and increase the potential toxicity. EPA notes that even with degraded coating, the toxicity measured from the coated titanium dioxide was significantly less than the uncoated material, and “these sunscreens still provide life-saving protection against UV radiation.” According to EPA, the study provides evidence that when released into the environment, nanomaterials undergo physical and/or chemical transformations -- “an important consideration when measuring the impact of these materials on public health and the environment.”

Minnesota Adds Several Nanomaterials To List Of Chemicals Of High Concern: On September 13, 2016, the Minnesota Department of Health (MDH) announced the availability of an updated list of chemicals of high concern. Chemicals added to the list of chemicals of high concern include silicon carbide whiskers (Chemical Abstracts Service (CAS) Number 409-21-2), carbon nanotubes, multi-walled MWCNT-7 (CAS Number 308068-56-6), and silicon carbide, fibrous (CAS Number 308076-74-6). MDH added these nanomaterials based on their International Agency for Research on Cancer (IARC) classifications. As reported in our November 3, 2014, blog item, the IARC Working Group met on September 30-October 7, 2014, to review the carcinogenicity of fluoro-edenite, silicon carbide fibers and whiskers, and carbon nanotubes. The Working Group classified carbon nanotubes, multi-walled MWCNT-7 as Group 2B (possibly carcinogenic to humans); carbon nanotubes, multi-walled, other than MWCNT-7 as Group 3 (not classifiable as to its carcinogenicity to humans); carbon nanotubes, single-walled as Group 3; silicon carbide, fibrous as Group 2B; silicon carbide whiskers as Group 2A (probably carcinogenic to humans); Acheson process, occupational exposure associated with as Group 1 (carcinogenic to humans); and fluoro-edenite fibrous amphibole as Group 1. MDH reviewed chemicals classified as Group 1, 2A, or 2B for addition to the list of chemicals of high concern.

NNCO Holds Webinar On Nanotechnology And The Insurance Industry: On September 22, 2016, the National Nanotechnology Coordination Office (NNCO) held a webinar on the insurance industry and the challenges of underwriting nanotechnology and other emerging technologies. NNCO Director Dr. Michael Meador moderated the webinar discussion. Speakers included:

  • Allen Gelwick, Executive Vice President of the Lockton Companies;
  • Christie Sayes, Associate Professor of Environmental Science and Toxicology at Baylor University;
  • David Swatzell, Managing Partner at Knowtional; and
  • Madhu Nutakki, Digital Chief Technology Officer, Innovation & Mobile Delivery, at AIG.

NNCO encouraged representatives of the insurance industry, the nanotechnology business community, and interested members of the general public, media, academia, industry, non-governmental organizations, and federal, state, and local governments to participate.

Germany Publishes Review Of The Joint Research Strategy Of The Higher Federal Authorities: On September 19, 2016, the Federal Institute for Occupational Safety and Health (BAuA) published a report entitled Review of the joint research strategy of the higher federal authorities -- Nanomaterials and other advanced materials: Application safety and environmental compatibility. The report states that in a long-term research strategy, the higher federal authorities responsible for human and environmental safety -- the German Environment Agency (UBA), the Federal Institute for Risk Assessment (BfR), BAuA, the Federal Institute for Materials Research and Testing (BAM), and the National Metrology Institute (PTB) -- are accompanying the rapid pace of development of new materials from the points of view of occupational safety and health, consumer protection, and environmental protection. The report states that the goals of application safety and environmental compatibility for advanced materials and derived products are intended to reduce significantly unacceptable risks to humans and the environment. According to the report, this can be achieved by:

  1. Using safe materials without hazardous properties for humans and the environment (direct application safety); or
  2. Product design for low emissions and environmental compatibility over the entire product lifecycle (integrated application safety); or
  3. Product stewardship, where producers support users in taking technical, organizational, and personal safety measures for the safe use and disposal of products (supported application safety).

As a comprising part of the federal government’s Nanotechnology Action Plan 2020, the update of the joint research strategy aims to contribute to governmental research in the following main areas:

  • Characterizing and assessing the human and environmental risks of advanced materials;
  • Supporting research institutions and business enterprises;
  • Science-based revision of legal requirements and recommendations; and
  • Public acceptance.

The report states that the research strategy will be implemented in projects and other research-related activities, including governmental research, tendering and extramural research funding, and participation in mostly publicly supported projects with third-party funding. Agencies will use interdisciplinary and transdisciplinary approaches to connect better risk and safety research with innovation research and material development. To keep up with the pace of development, the time horizon for the research strategy extends to 2020. The research objectives in the report address the research approaches likely to be actionable in this period. The research strategy will be supported by a working group and be evaluated and revised by the end of the Nanotechnology Action Plan 2020.

ISO Publishes Standard For Compilation And Description Of Sample Preparation And Dosing Methods For Engineered And Manufactured Nanomaterials: The International Organization for Standardization (ISO) published ISO/TR 16196:2016, “Nanotechnologies -- Compilation and description of sample preparation and dosing methods for engineered and manufactured nanomaterials.” The goal of the standard is to assist scientists and experts to understand, plan, choose, and address issues relevant to nanomaterials before and during toxicological testing. The descriptions of sample preparation method factors for both in vitro and in vivo toxicological testing of engineered and manufactured nanoscale materials include considerations about physico-chemical properties, media, methods for transformation and accumulation studies, health effects, and dosimetry. According to ISO, the standard focuses on factors that might lead to results that are not relevant to safety evaluations. When featured, the standard considers referenced methods for their general interest and potential applicability. ISO states that it is likely that most of the described methods are not generally applicable to all nanomaterials, but they do demonstrate important factors and limitations that are common for a variety of nanomaterials. ISO notes that the standard is not intended to be a literature review nor a thorough assessment of the quality of the methods or data generated. The standard is intended to complement other international efforts.

NIOSH Announces Recent Publications On Nanotechnology And Certain Types Of Carbon Nanotubes: The National Institute for Occupational Safety and Health (NIOSH) recently announced the availability of the following publications:

  • Nanotechnology: Delivering on the Promise is a two-volume American Chemical Society symposium report that discusses advances in nanotechnology and the value of precautionary risk management. Editors include NIOSH Associate Director for Nanotechnology Charles L. Geraci, Ph.D., CIH. Lynn L. Bergeson wrote a chapter entitled “Opportunities and Challenges for Health, Safety, and the Environment: The Regulatory Void?,” which surveys the governance approaches that are emerging, with particular emphasis on the need for regulatory measures in targeted areas to ensure the integrity of core governance principles and provide some measure of commercial predictability; and
  • NIOSH scientists and external partners authored a critical review, update, and expansion of whether certain types of carbon nanotubes pose a risk of cancer in “Evaluating the mechanistic evidence and key data gaps in assessing the potential carcinogenicity of carbon nanotubes and nanofibers in humans,” published in Critical Reviews in Toxicology. When IARC evaluated carbon nanotubes in October 2014, it concluded the mechanistic evidence was considered to be not strong enough to alter the evaluations based on the animal data. The authors examine the in vivo and in vitro experimental studies according to current hypotheses on the carcinogenicity of inhaled particles and fibers. The authors cite additional studies of carbon nanotubes that were not available at the time of the IARC meeting, and extend their evaluation to include carbon nanofibers. The authors identify key data gaps and suggest research needs to reduce uncertainty. The abstract states: “The findings of this review, in general, affirm those of the original evaluation on the inadequate or limited evidence of carcinogenicity for most types of [carbon nanotubes] and [carbon nanofibers] at this time, and possible carcinogenicity of one type of [carbon nanotube] (MWCNT-7).” According to the authors, the key evidence gaps to be filled by research include: investigation of possible associations between in vitro and early-stage in vivo events that may be predictive of lung cancer or mesothelioma, and systematic analysis of dose-response relationships across materials, including evaluation of the influence of physico-chemical properties and experimental factors on the observation of nonmalignant and malignant endpoints.

EPA Submits Final TSCA Rule On Nanomaterials To OMB For Review: On October 7, 2016, EPA submitted to the Office of Management and Budget (OMB) a final rule that would require reporting and recordkeeping information on certain chemical substances when they are manufactured or processed as nanoscale materials. EPA issued a proposed rule, under TSCA Section 8(a), on April 6, 2015. EPA proposed to require persons that manufacture or process certain chemical substances when manufactured or processed at the nanoscale to report electronically to EPA certain information, including the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing data concerning environmental and health effects. EPA also proposed to require any persons who intend to manufacture or process chemical substances as discrete nanoscale materials after the effective date of the final rule to notify EPA of the same information at least 135 days before the intended date of commencement of manufacture or processing. As reported in our May 19, 2016, blog item, OMB’s Office of Information and Regulatory Affairs (OIRA) issued a December 17, 2015, memorandum concerning “Regulatory Review at the End of the Administration,” which states that “agencies should strive to complete their highest priority rulemakings by the summer of 2016 to avoid an end-of-year scramble that has the potential to lower the quality of regulations that OIRA receives for review and to tax the resources available for interagency review.”

Webinar Will Announce NSI On Water Sustainability Through Nanotechnology: On October 19, 2016, NNCO will hold a webinar to announce the Nanotechnology Signature Initiative (NSI): Water Sustainability through Nanotechnology. The webinar will highlight the activities of several participating federal agencies. NNCO states that the webinar will be the first in a series exploring the confluence of nanotechnology and water. Subsequent webinars will each focus on one of the NSI’s technical focus areas: increase water availability; improve the efficiency of water delivery and use; and enable next-generation water monitoring systems. Speakers will include:

  • Nora Savage, National Science Foundation;
  • Daniel Barta, National Aeronautics and Space Administration;
  • Paul Shapiro, EPA;
  • Jim Dobrowolski, U.S. Department of Agriculture (USDA) National Institute of Food and Agriculture; and
  • Hongda Chen, USDA National Institute of Food and Agriculture.

NNCO encourages participation from representatives of the National Nanotechnology Initiative (NNI) member agencies participating in the NSI, the nanotechnology business community, and interested members of the general public, media, academia, industry, non-governmental organizations, and federal, state, and local governments. Following speaker presentations, the panelists will answer questions from the audience. Questions for the panel can be submitted to webinar@nnco.nano.gov through the end of the webinar. Registration is limited to 500 and is open on a first-come, first-served basis.

BIOBASED/RENEWABLE PRODUCTS

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 http://www.braginfo.org.

White House Releases Proposed Update To The Coordinated Framework And National Strategy For Modernizing The Regulatory System For Biotechnology Products: On September 16, 2016, the White House posted a blog item, "Building on 30 Years of Experience to Prepare for the Future of Biotechnology," releasing two documents intended to modernize federal regulation of biotechnology products. See 81 Fed. Reg. 65414 for related information. In July 2015, the White House directed EPA, FDA, and USDA to develop a long-term strategy to ensure that the system is prepared for the future products of biotechnology, and commission an expert analysis of the future landscape of biotechnology products to support this effort. The proposed Update to the Coordinated Framework updates the 1986 Coordinated Framework for the Regulation of Biotechnology and provides a comprehensive summary of the roles and responsibilities of EPA, FDA, and USDA with respect to the regulation of biotechnology products. The National Strategy for Modernizing the Regulatory System for Biotechnology Products (National Strategy) sets forth a long-term strategy intended to ensure that the federal regulatory system is equipped to assess efficiently the risks, if any, of the future products of biotechnology. Comments are due by November 1, 2016, at 5:00 p.m. (EDT). More information is available in our memorandum online.

EPA Announces Public Meeting To Comment On Algae Guidance Documents: On October 12, 2016, EPA announced a public meeting on the draft Algae Guidance for the Preparation of TSCA Biotechnology Submissions (Algae Guidance). 81 Fed. Reg. 70419. This meeting will receive public input and comments on the draft Algae Guidance that describes EPA’s data needs for supporting risk assessments of genetically engineered algae and cyanobacteria that are manufactured, imported, or processed, and are subject to regulations under TSCA Section 5. The meeting will be held in Tempe, Arizona, on October 27, 2016. Registrants not able to attend in person can access the meeting through a live web stream and teleconference capabilities. Registration is available through the Eastern Research Group (ERG) website. EPA will hear oral comments on October 27, 2016, and accept written comments and electronic materials submitted on or before November 30, 2016.

HAZARDOUS MATERIALS TRANSPORTATION

PHMSA Issues Interim Final Rule To Implement Expanded Authority
To Issue Emergency Orders:
The U.S. Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) on October 14, 2016, issued an interim final rule to implement PHMSA’s expanded authority to address unsafe pipeline conditions or practices. 81 Fed. Reg. 70980. The rule adopts Section 16 of the Protecting our Infrastructure of Pipelines Enhancing Safety Act of 2016 (PIPES Act). This provision vests PHMSA with the authority to impose emergency restrictions, prohibitions, and safety measures on owners and operators of gas or hazardous liquid pipeline facilities to address imminent hazards. The interim final rule creates a new 49 C.F.R. § 190.236 that describes the steps PHMSA will take to determine if an “imminent hazard” exists that warrants issuance of an emergency order. The rule defines an “imminent hazard” as a condition that presents “a substantial likelihood that death, serious illness, severe personal injury, or a substantial endangerment to health, property, or the environment may occur before the reasonably foreseeable completion date of a formal administrative proceeding begun to lessen the risk of such death, illness, injury or endangerment.” Examples of when PHMSA intends to exercise its new authority include instances where a serious manufacturing flaw has been discovered in pipe, equipment, or other materials, or when an accident reveals a specific industry practice that is unsafe and needs immediate correction. If PHMSA determines that an imminent hazard exists, it can issue an emergency notice without advance notice or the opportunity for a hearing. PHMSA is taking comment on the interim final rule for 60 days, until December 13, 2016.

OSHA And PHMSA Issue Joint Guidance On Labeling Bulk Shipments: The Occupational Safety and Health Administration (OSHA) and PHMSA on September 19, 2016, issued joint guidance on the labeling of hazardous chemicals for bulk shipments. PHMSA and OSHA are responsible for enforcing distinct and separate safety standards that address appropriate labeling of chemical hazards in transportation (PHMSA) and in the workplace (OSHA). PHMSA’s labeling requirements are contained in the Hazardous Materials Regulations (HMR) and apply to transportation of hazardous materials in commerce. OSHA’s labeling requirements are specific to the workplace and are found in the Hazard Communication Standard (HCS). PHMSA and OSHA are aware of questions from stakeholders concerning the labeling required by each agency. The purpose of the joint memorandum is to provide clarity on the general applicability of, and overall relationship between, DOT’s labeling requirements under the HMR and OSHA’s labeling requirements for bulk shipments under the HCS. The memorandum states that PHMSA’s HMR requires labeling to be displayed or provided with a shipment during transportation in commerce. The HMR provides a comprehensive labeling system to communicate to personnel involved in the transportation of hazardous materials, including emergency responders and the general public, the potential dangers of handling packages containing hazardous materials or a sudden uncontrolled release of hazardous materials during transportation. During transportation, DOT’s HMR governs hazard communication labeling requirements. OSHA’s HCS 2012 labeling is not required on shipping containers in transport, even when DOT’s HMR does not require labeling in transportation. Regarding OSHA HCS 2012 labeling requirements for bulk shipments in DOT containers (e.g., tanker trucks, rail cars), the memorandum states that OSHA’s HCS requires labeling of hazardous chemicals in the workplace, both before and after transportation in commerce. OSHA requires labeling on the immediate container of hazardous chemicals. Regarding bulk shipments of hazardous chemicals, the HCS requires either labeling the immediate container with hazard information or transmitting the required label with shipping papers, bills of lading, or by other technological or electronic means so that it is immediately available to workers in printed form on the receiving end of a shipment. The OSHA HCS requirements for shipped material apply independently of whether the same material is subject to HMR labeling requirements during transportation. The memorandum also addresses bulk shipments bearing both DOT and OSHA HCS labels. The HMR prohibits the display on a package of any marking or label that could be confused or conflict with a label required by the HMR. According to the memorandum, however, this prohibition does not apply to HCS marking or labeling. Specifically, the guidance states “the display of a marking or label not required by DOT’s HMR, but conforming to OSHA’s HCS . . . is not a violation of the HMR.” In other words, an HCS-compliant OSHA label and a DOT HMR label or marking may both appear on the same package.

LEGISLATIVE DEVELOPMENTS

House Passes Legislation Suspending Regulations Challenged In Courts; White House Threatens Veto: Along party lines, the House of Representatives on September 21, 2016, passed the Require Evaluation Before Implementing Executive Wishlists (REVIEW) Act. Sponsored by Representative Tom Marino (R-PA), the bill (H.R. 3438) would require federal agencies to postpone the implementation of any rule imposing an annual cost on the economy of at least $1 billion if a petition seeking judicial review of that regulation is filed within 60 days of the rule taking effect. Under the bill, implementation of the regulation would be postponed until any judicial review is resolved. The White House on September 20, 2016, issued a veto threat on the bill. In its Statement of Administration Policy, the White House stated that “H.R. 3438 would promote unwarranted litigation, introduce harmful delay, and, in many cases, thwart implementation of statutory mandates and execution of duly enacted laws. The legislation also would increase business uncertainty and undermine much-needed protections for the American public, including critical rules that provide financial reform and protect public health, food safety, and the environment. For these reasons, the Administration strongly opposes H.R. 3438.”

Senator Boxer Introduces Bill To Ban Asbestos: On September 28, 2016, Senator Barbara Boxer (D-CA) introduced a bill that would require EPA to take action to eliminate human exposure to asbestos. The Alan Reinstein Ban Asbestos Now Act of 2016 (S. 3427) would amend TSCA by adding a new Section 702 entitled “Elimination of Asbestos Exposure.” Under the bill, EPA would have 90 days to assess the current and reasonably anticipated importation, distribution in commerce, uses of, and exposures to asbestos. The bill would also require EPA to “impose, by rule, prohibitions, restrictions, and other conditions, including prohibitions on the manufacture, processing, use, distribution in commerce, and disposal of asbestos and mixtures and articles containing asbestos.” EPA would have 18 months from the bill’s enactment to promulgate such a regulation. The overarching goal of the regulation must be the permanent elimination of the possibility of exposure to asbestos. One year after the regulation is promulgated, no person would be allowed to manufacture, process, use, distribute in commerce, or dispose of any form of asbestos, asbestos mixtures, or articles containing asbestos.

Senate Republicans Launch Attack On WOTUS Rule: Senate Republicans on the Environment and Public Works (EPW) Committee on September 20, 2016, issued a report assailing EPA and the Army Corps of Engineers’ (Corps) Waters of the United States (WOTUS) rule. Issued on April 21, 2014, the WOTUS rule is intended to clarify which waters are subject to jurisdiction under the Clean Water Act (CWA). 79 Fed. Reg. 22188. The report, “From Preventing Pollution of Navigable and Interstate Waters to Regulating Farm Fields, Puddles and Dry Land: A Senate Report on the Expansion of Jurisdiction Claimed by the Army Corps of Engineers and the U.S. Environmental Protection Agency under the Clean Water Act,” releases findings from the majority staff’s investigation into how EPA and the Corps are interpreting and implementing their authority under the CWA. “This new majority committee report demonstrates in detail that the EPA and the Army Corps of Engineers, under the Obama administration, are running rogue,” stated EPW Chair Jim Inhofe (R-OK). The report summarizes case studies that EPW Republicans claim demonstrate that EPA and the Corps have and will continue to advance very broad claims of jurisdiction based on discretionary authority to define their own jurisdiction. The report also alleges that the WOTUS rule would codify the agencies’ broadest theories of “ominous” jurisdiction. The report further argues that landowners will not be able to rely on current statutory exemptions or the new regulatory exemptions because the agencies have narrowed the exemptions in practice and simply regulate under another name.

House Bill Would Rewrite Safe Drinking Water Act: A bill introduced in the House on September 22, 2016, by Representatives Frank Pallone, Jr. (D-NJ) and Paul Tonka (D-NY) seeks to overhaul the Safe Drinking Water Act (SDWA). The Safe Drinking Water Act Amendments of 2016 (H.R. 6116) has six main goals: to regulate “dangerous” drinking water contaminants; reduce lead in drinking water; promote climate resiliency, security, and source water protection; provide funding for drinking water system upgrades; increase compliance and community right to know; and foster research. To regulate drinking water contaminants, the bill would remove procedural hurdles that have prevented EPA from setting needed drinking water standards and require EPA to make regulatory determinations for ten potential contaminants every three years. It also sets aggressive deadlines for the completion of four drinking water standards to address risks from lead, perchlorate perfluorinated compounds, and algal toxins. The bill also identifies several requirements for the final Lead and Copper Rule (LCR) based on recommendations of the National Drinking Water Advisory Council and lessons from the Flint crisis. The LCR revisions include re-evaluation of corrosion control when source water or treatment is altered, testing technique requirements to ensure valid results, school monitoring, clear and effective communication of lead issues, and lead service line replacement requirements. Reducing lead in drinking water is another aim of the bill. It would authorize $100 million for each of five years for a grant program to remove lead service lines controlled by public water systems. Applications would be prioritized for systems that serve an area that has experienced high lead levels in drinking water within the past three years, address vulnerable populations, and include assistance for low-income homeowners. The legislation also would require EPA to provide guidance for public water systems trying to inventory their lead service lines. Some $5 million a year would be authorized for schools to replace drinking water fountains that were manufactured prior to 1988. These fountains are likely to contain lead and pose a health risk to students and staff. And $50 million a year for five years would be appropriated for a grant program to replace lead service lines and solder in schools. The grant program prioritizes schools that have experienced lead level exceedances in the past three years. To ensure climate resiliency, security, and source water protection, H.R. 6116 would require drinking water systems to assess their vulnerabilities to upstream contamination (from industrial activities, oil and gas production, and other threats), climate change (including extreme weather and drought), and terrorism (including intentional contamination and sabotage). Those water systems will then be required to develop plans to mitigate those vulnerabilities and respond to emergencies. EPA would be tasked with providing guidance to systems for both the vulnerability assessments and response plans. The bill would also delete from the SDWA the so-called “Halliburton loophole,” which exempted hydraulic fracturing from regulation under the Underground Injection Control Program, and require disclosure of the chemicals used in fracking fluids.

Flint Crisis Spurs Introduction Of Several Bills To Amend SDWA: The Flint, Michigan, drinking water crisis has prompted lawmakers to introduce several pieces of legislation intended to strengthen the SDWA. Representative Lois Capps (D-CA) on September 22, 2016, introduced the Climate Resiliency, Security, and Source Water Protection Act (H.R. 6121). The bill would amend the SDWA to help community water systems be better prepared to protect drinking water and source water from the effects of climate change as well as from security threats from accidental or intentional contamination. H.R. 6121 includes and expands upon drinking water provisions authored by Capps in her Water Infrastructure Resiliency and Sustainability Act (H.R. 1278), which would create a competitive grant program to help drinking water system operators prepare for the impacts of climate-related risks to water supplies. H.R. 6121 builds upon this effort and also addresses possible risks to drinking water and source waters from homeland security threats, including terrorism, and contamination from industrial and agricultural activity. H.R. 6121 is also included as a component of H.R. 6116 (summarized above). Representative Brendan Boyle (D-PA) has introduced a bill (H.R. 6125) that would require EPA to develop an SDWA Maximum Contaminant Level Goal (MCLG) for perfluorinated compounds. On September 22, 2016, Representative Brenda Lawrence (D-MI) introduced H.R. 6127, which is intended to improve consumer confidence reports under the SDWA. Also on September 22, 2016, Representative Jan Schakowsky (D-IL) introduced the Water, Cosmetics, and Unwanted Pharmaceuticals (Water CUPS) Act (H.R. 6128). The bill is intended to study the impacts of prescription drugs and cosmetics entering the water supply. The Water CUPS Act would require EPA within four years to identify the types and sources of pharmaceuticals and personal care products in drinking water sources, study the effects of these products on human health and the environment, and determine methods to mitigate the risks of pharmaceuticals and personal care products in drinking water sources. Representative Tony Cardenas (D-CA) introduced a bill (H.R. 6140) that would require EPA to set an MCLG and a national primary drinking water regulation (NPDWR) for perchlorate. H.R. 6143, introduced by Representative Marcia Fudge (D-OH), would require EPA to publish revised guidance for school officials seeking to reduce lead in drinking water. Legislation introduced by Representative Marcy Kaptur (D-OH) would require EPA to set an MCLG and NPDWR for microcystin toxin. California Democrat Jerry McNerney introduced H.R. 6154, a bill that would amend the SDWA to reduce lead in drinking water.

Safety Over Secrecy Act Introduced In Senate:Senator Sheldon Whitehouse (D-RI) on September 21, 2016, introduced legislation intended to help protect public health and safety by limiting the use of confidentiality agreements in lawsuits involving health hazards. The Safety Over Secrecy Act (S. 3370) would curtail the ability of corporations to demand as a condition of settlements that plaintiffs never disclose their experiences. Settlements involving “industrial chemicals” would be covered under the bill.

Senate Bill Would Create “Green” Banks: Senators Chris Murphy (D-CT), Richard Blumenthal (D-CT), and Sheldon Whitehouse (D-RI) on September 22, 2016, introduced the Green Bank Act of 2016. The bill would create a national green bank to utilize public seed money to attract larger, private investments in clean energy and energy efficiency projects. The first green bank in the country, Connecticut’s Clean Energy Finance and Investment Authority (CEFIA), was founded in 2011. Since then, Connecticut Green Bank has leveraged more than $800 million in clean energy business investments, created the equivalent of more than 3,000 jobs, and reduced approximately 1.4 million tons of carbon dioxide (CO2) emissions over the lifetime of its financed projects. Companion legislation (H.R. 5802) was introduced in the House of Representatives by Representative Chris Van Hollen (D-MD). Both bills charge the Treasury Department with setting up the bank and appropriating $50 billion for its operations.

Accountability In Rulemaking Act Introduced In House: Representative Peter DeFazio (D-OR) on September 27, 2016, introduced legislation intended to improve transparency and accountability in the federal rulemaking process. Calling federal rulemaking a “notoriously slow and opaque process,” Mr. DeFazio introduced the Accountability in Rulemaking Act (H.R. 6177). The bill would require the White House OIRA and all federal agencies to include on the Unified Agenda more information about proposed rules. The bill is intended to allow the public to know the current status of proposed rules and would keep both OIRA and federal agencies accountable to timelines and to the public. Federal agencies are required to submit to OIRA for review any proposed rules that have an estimated annual impact on the economy of $100 million or more. OIRA has 90 days to review these rules, but that deadline is routinely extended.

Senate Bill Would Require Air Force Report On PFOA And PFOS: Senator Charles Schumer (D-NY) on September 27, 2016, introduced legislation seeking more information on contamination at U.S. Air Force installations caused by perfluorooctanoic acid (PFOA) and perfluorooctane sulfanate (PFOS). The bill (S. 3396) was referred to the Armed Services Committee. In May of this year, Senator Schumer had called upon EPA to update its “long overdue” drinking water guidelines for PFOA and PFOS. Several towns in New York -- most notably Hoosick Falls, Petersburgh, and North Bennington -- have had their drinking water contaminated by PFOA and PFOS. EPA in May set drinking water guidelines for PFOA and PFOS at 70 parts per trillion (ppt). PFOS contamination in Newburgh, New York, was allegedly caused by activities at the Stewart Air National Guard base. Senator Schumer’s bill would require the Air Force to conduct immediately tests to determine the extent of possible ground water contamination in Newburgh. Schumer stated these tests will help determine who is responsible for the contamination and, therefore, who should be held accountable for cleaning it up. The bill would further require the Air Force, if found culpable, to pay for the cleanup of the contamination. Senator Schumer’s legislation would also require the Air Force to release an expedited timeline detailing the immediate steps that will be taken to mitigate the contamination in Newburgh. Schumer stated this is needed to ensure the critical water supplies residents rely upon are no longer impacted.

Bipartisan Bill Would Create GHG Commission: Congressmen John Delaney (D-MD) and Chris Gibson (R-NY) on September 28, 2016, introduced legislation that seeks to find bipartisan consensus on climate change and drive economically viable solutions that reduce emissions of GHGs. The Climate Solutions Commission Act (H.R. 6240) would create a commission comprised of ten members: five Democrats and five Republicans. The commission would be charged with undertaking a comprehensive review of economically viable public and private actions or policies that would reduce GHG emissions. The commission would then make recommendations to the President, Congress, and states. It would use as its goals for emissions reductions the estimated rates of reduction that reflect the latest scientific findings of what is needed to avoid serious health and environmental consequences.

Representative Sessions Introduces Bill That Would Limit Federal Agency Guidance On Economically Significant Rules: Representative Pete Sessions (R-TX) on September 28, 2016, introduced the Truth in Regulations Act of 2016 (H.R. 6283). The bill is intended to limit how federal agencies issue guidance on economically significant rules, defined as regulations that have an annual impact on the economy of $100 million or more. Federal agencies would be required to release written procedures for the approval of “significant guidance documents.” The bill would prohibit these guidance documents from containing mandatory language such as “shall,” “must,” “required,” or “requirement.” Agencies would also be required to take public comment on significant guidance documents.

MISCELLANEOUS

OEHHA Issues Notice Of Intent To List PFOA And PFOS: On September 16, 2016, the California Environmental Protection Agency's Office of Environmental Health Hazard Assessment (OEHHA) issued a notice of intent to list PFOA and PFOS as known to the state to cause reproductive toxicity under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop 65). OEHHA is proposing the action under the authoritative bodies' listing mechanism. Comments are due October 17, 2016. If PFOA and PFOS are listed, warning requirements under the new regulatory scheme would be triggered one year from the date of OEHHA’s listing. More information is available in B&C’s memorandum “OEHHA Issues Notice of Intent to List PFOA and PFOS.”

OECD Launches First Five Endorsed AOPs: On September 20, 2016, the Organization for Economic Cooperation and Development (OECD) announced the availability of the first five endorsed Adverse Outcome Pathways (AOP) in a new series, free of charge from the OECD website. OECD has also released a user guide for developing AOPs. OECD describes an AOP as an “analytical construct that describes a sequential chain of causally linked events at different levels of biological organisation that lead to an adverse health or ecotoxicological effect,” and “the central element of a toxicological knowledge framework being built to support chemical risk assessment based on mechanistic reasoning.” The first five endorsed AOPs are:

OECD launched its knowledge base on AOPs in collaboration with EPA and the European Commission Joint Research Centre in 2014. These publications are the result of joint efforts between AOP developers and AOP reviewers through an established OECD AOP development and review process. OECD states that in the future, the publication of AOPs is likely to happen on a yearly basis, following the cycle of annual reviews and publications.

OEHHA Adopts Revisions To Its Proposition 65 Warning Regulations: On August 28, 2016, OEHHA adopted revisions to its Prop 65 Article 6 regulations covering "clear and reasonable warnings" requirements. B&C prepared a memorandum discussing OEHHA's November 27, 2015, proposed rule, “OEHHA Repeals and Re-Proposes Revisions to Proposition 65 Warning Regulations,” and the March 25, 2016, revisions to those proposed changes, “OEHHA Proposes Revisions to Its Proposed Proposition 65 Warning Regulations.” Other information related to OEHHA’s past actions modifying Prop 65 warning regulations is available on our website, key phrase Proposition 65. The final regulations are effective on August 30, 2018. In the interim, businesses may comply with the regulation that came into effect on August 30, 2016, or the provisions of the revised regulation. For the next two years, companies have the choice of whether to comply with the clear and reasonable warning requirements that will be operative until August 30, 2018, or the clear and reasonable warning requirements that must be operative by August 30, 2018. More information is available at http://www.lawbc.com/regulatory-developments/entry/proposition-65-oehha-adopts-revisions-to-its-proposition-65-warning-regulat?2016c21.

Chemical Safety Board Releases Final Report On 2014 Freedom Industries Spill Into Elk River: On September 28, 2016, the U.S. Chemical Safety and Hazard Investigation Board (CSB) released its final report on the 2014 Freedom Industries (Freedom) release of chemicals into the Elk River near Charleston, West Virginia. CSB concludes that the main cause of the release was Freedom’s failure to inspect or repair corroding tanks. CSB further concluded that “as hazardous chemicals flowed into the Elk River, the water company and local authorities were unable to effectively communicate the looming risks to hundreds of thousands of affected residents, who were left without clean water for drinking, cooking and bathing.” On the morning of January 9, 2014, an estimated 10,000 gallons of methylcyclohexanemethanol (MCHM) mixed with propylene glycol phenyl ethers (PPH) were released into the Elk River when a 46,000-gallon storage tank located at the Freedom site in Charleston, West Virginia, failed. The release flowed towards West Virginia American Water’s intake, which was located approximately 1.5 miles downstream from the Freedom site. CSB’s investigation found that Freedom’s inability to provide immediately information about the chemical characteristics and quantity of spilled chemicals resulted in significant delays in the issuance of the “Do Not Use Order” and informing the public about the drinking water contamination. For example, Freedom initially reported that 1,000 gallons of MCHM was released. Over the following days and weeks, the quantity increased to 10,000 gallons. Also, the presence of PPH in the released chemical was not made public until 13 days after the initial leak was discovered. CSB’s investigation further found that no comprehensive aboveground storage tank law existed in West Virginia at the time of the release, and while there were regulations covering industrial facilities that required Freedom to have secondary containment, Freedom ultimately failed to maintain adequate pollution controls and secondary containment as required. The Freedom spill prompted West Virginia lawmakers to pass the Aboveground Storage Tank Act. That law, which took effect in June 2014, requires an inventory and registration of aboveground storage tanks, the submittal of spill prevention response plans, and certified inspections of tanks.

Paris Agreement On Global Warming Takes Effect: On October 5, 2016, the 75th country ratified the Paris Agreement on Global Warming, reaching the threshold for entry into force of the Agreement. The accord will now enter into force on November 4, 2016. The Paris Agreement builds upon global accords to reduce climate change and brings all nations into a common cause to take ambitious efforts to combat climate change and adapt to its effects. The agreement charts a new course and has as its central aim the strengthening of the global response to the threat of climate change. It seeks to keep a global temperature rise this century to well below 2 degrees Celsius above pre-industrial levels. It also strives to limit the temperature increase even further to 1.5 degrees Celsius. Additionally, the agreement aims to strengthen the ability of countries to deal with the impacts of climate change.

United Nations Approves First Ever Global Emissions Controls For Airline Industry: On October 6 2016, the United Nations’ (UN) International Civil Aviation Organization (ICAO) overwhelmingly agreed on a new global measure to control CO2 emissions from international aviation. This is the first climate change pact to set global limits on an entire industry. The historic move came as ICAO’s Plenary Session’s 39th Assembly agreed to recommend adoption of a final resolution text for the GMBM. ICAO’s Carbon Offsetting and Reduction Scheme for International Aviation (CORSIA) is designed to complement the basket of mitigation measures the air transport community is already pursuing to reduce CO2 emissions from international aviation. These include technical and operational improvements and advances in the production and use of sustainable alternative fuels for aviation. Implementation of the CORSIA will begin with a pilot phase from 2021 through 2023, followed by a first phase, from 2024 through 2026. Participation in both of these early stages will be voluntary and the next phase from 2027 to 2035 would see all UN members on board. So far, 65 countries, including the U.S., have indicated they will participate in the agreement.

[View source.]


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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