Monthly Update for April 2018
EPA Issues Draft Guidance On Expanded Access To Confidential Business Information: On March 16, 2018, the U.S. Environmental Protection Agency (EPA) released three draft guidance documents for public comment clarifying the circumstances under which EPA may disclose Toxic Substances Control Act (TSCA) confidential business information (CBI) with an expanded set of people. 83 Fed. Reg. 17748. Amended TSCA Section 14(d) expanded the categories of people to whom EPA may disclose TSCA CBI by specifically authorizing EPA to disclose TSCA CBI to state, tribal, and local governments; environmental, health, and medical professionals; and emergency responders, under certain conditions, including consistency with guidance that EPA is required to develop. The draft guidance documents are:
- Draft Guide for Access to TSCA CBI for State, Local, and Tribal Governments, TSCA Section 14(d)(4);
- Draft Guide for Access to TSCA CBI for Medical and Environmental Professionals in Non-Emergency Situations, TSCA Section 14(d)(5); and
- Draft Guide for Access to TSCA CBI in Emergency Situations, TSCA Section 14(d)(6).
EPA states the conditions for access vary under each of the new provisions, but generally include the following: requesters must show that they have a need for the information related to their employment, professional, or legal duties; recipients of TSCA CBI are prohibited from disclosing or permitting further disclosure of the information to individuals not authorized to receive it (physicians/nurses may disclose the information to their patient); and, except in emergency situations, EPA must notify the entity that made the CBI claim at least 15 days prior to disclosing the CBI. In addition, under these new provisions, requesters (except in some emergency situations) are required to sign an agreement and may be required to submit a statement of need to EPA. In accordance with the requirements of TSCA Section 14(c)(4)(B), each guidance document covers the content and form of the agreements and statements required under each provision and include information on where and how to submit requests to EPA. Comments are due by April 16, 2018. On March 12, 2018, EPA also announced that it is collecting comments on burden and other information required by the Paperwork Reduction Act related to these documents in the form of an Information Collection Request (ICR), as detailed in a separate notice. 83 Fed. Reg. 10719. Comments on the ICR are due May 11, 2018. EPA states that it anticipates using comments received in response to the guidance document notice and the ICR notice to inform the development of final guidance documents, which it anticipates to be released in June 2018.
EPA To Convene National Leadership Summit To Take Action On PFAS: On March 19, 2018, EPA announced that it will hold a National Leadership Summit on May 22-23, 2018, to discuss Per- and Polyfluoroalkyl Substances (PFAS). EPA states that following the Summit, it will travel to states with communities impacted by PFAS to engage further on ways EPA can best support the work being done at the state, local, and tribal levels. Using information from the National Leadership Summit and community engagement, EPA plans to develop a PFAS Management Plan for release later in 2018. Additional information is available online.
EPA Releases New PR Notice On Minor Use Determination: On March 21, 2018, EPA released Pesticide Registration Notice (PR Notice) 2018-1, issued by the Office of Pesticide Programs (OPP) titled “Determination of Minor Use under Federal Insecticide, Fungicide, and Rodenticide Act Section 2(ll)” (PR Notice 2018-1). 83 Fed. Reg. 12385. The PR Notice states that it “describes the revised approach to interpreting economic minor use based on the concept of the registration of a pesticide as an investment.” Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 2(ll)(1) defines a minor use of a pesticide as a use on a crop grown on 300,000 acres or less in the United States. More information on other PR Notices is available on our blog under key phrase Pesticide Registration Notice.
EPA Appoints Additional Members To Science Advisory Committee On Chemicals; NGO Scientists Decline Appointment: On March 22, 2018, EPA Administrator Scott Pruitt appointed 11 additional members to the Science Advisory Committee on Chemicals. Under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the purpose of the Committee is to provide independent advice and expert consultation, at the request of the EPA Administrator, with respect to the scientific and technical aspects of risk assessments, methodologies, and pollution prevention measures or approaches supporting implementation of the Act. According to EPA, these additional members “will increase the balance of scientific perspectives and add experts with experience in labor, public interest, animal protection and chemical manufacturing and processing to the committee.” The additional 11 members — three from non-governmental organizations (NGO), four from industry, and four from academia or governmental organizations — will supplement the 18 expert members that were appointed on January 19, 2017. The Committee will meet three to four times a year for two years, and its charter can be extended. EPA has not yet scheduled the Committee’s first meeting.
Two of the members have reportedly declined the appointment. Dr. Michael Wilson, National Director for Occupational and Environmental Health at the BlueGreen Alliance, “notified EPA that he was unable to accept the appointment,” according to a spokesperson for the BlueGreen Alliance. Dr. Jennifer McPartland, Senior Scientist at the Environmental Defense Fund, has also declined the appointment. Ruthann Rudel, Director of Research at the Silent Spring Institute, stated that she is “collecting some advice and information” and has not decided whether to accept the appointment.
EPA Announces OPPT Management Changes: On April 4, 2018, EPA announced the following management changes in its Office of Pollution Prevention and Toxics (OPPT):
- Maria Doa, Ph.D., Director of the Chemical Control Division (CCD) at OPPT since 2011, will move to the Office of Research and Development’s (ORD) Office of Science Policy. Prior to leading CCD, Dr. Doa was director of the National Program Chemicals Division (NPCD).
- Lynn Vendinello, Deputy Division Director of the CCD since 2014, will serve as the CCD Acting Director on an interim basis. Ms. Vendinello has held a number of management and supervisory positions in OPPT and EPA’s Office of Compliance.
- Tanya Mottley, Acting Deputy Director of OPPT, will resume her leadership role as Director of NPCD. Prior to leading NPCD, Ms. Mottley was the Director of OPPT’s Pollution Prevention Division (PPD).
- Bryan Symmes will resume his duties as NPCD Deputy Director.
- Tala Henry, Ph.D., Director of OPPT’s Risk Assessment Division (RAD) since 2013, will be the next Acting Deputy Director for OPPT. Prior to leading RAD, Dr. Henry led NPCD after serving as a toxicologist in RAD and the Office of Water.
- Cathy Fehrenbacher, now RAD Deputy Director, will serve as RAD Acting Director. Ms. Fehrenbacher has held exposure assessment-related supervisory positions with OPPT; she began her career at EPA as a senior industrial hygienist.
These are significant leadership changes and are likely intended to maximize OPPT efficiency. We applaud OPPT’s continuing efforts to implement TSCA and the changes occasioned by the enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act almost two years ago.
Industry And EPA Discuss FIFRA Hot Topics: On April 10, 2018, Bergeson & Campbell, P.C. (B&C®) held a complimentary webinar, “FIFRA Hot Topics.” Co-hosted with Bloomberg BNA, the webinar featured Richard P. Keigwin, Jr., Director, OPP, Office of Chemical Safety and Pollution Prevention (OCSPP), EPA; Daniella Taveau, former International Trade Negotiator for EPA and now Regulatory and Global Trade Strategist, King & Spalding; and William L. Jordan, former senior toxics lawyer with EPA’s OPP and Office of General Counsel. The timely and fascinating conversation was augmented by B&C’s Senior Government Affairs Consultant, James V. Aidala , and moderated by Lisa M. Campbell, Partner. The materials and recording from the webinar are available on-demand from the Bloomberg Next website. To access the complimentary resources, click “+Add to Cart” from the webpage. You will need to register for a Bloomberg Next account during the checkout process, but once done, the recording and slides will be available for you to view or download free of charge.
EPA Seeks Comment On Draft Interim Science Policy To Reduce Animal Testing For Skin Sensitization: On April 10, 2018, EPA announced the availability of a draft Science Policy document intended to reduce the use of animals in testing chemicals to evaluate whether they cause an allergic reaction, inflammation, or sensitization of the skin. According to EPA, the document, Draft Interim Science Policy: Use of Alternative Approaches for Skin Sensitization as a Replacement for Laboratory Animal Testing, “describes the science behind the non-animal alternatives that can now be used (in vitro, in silico, in chemico) to identify skin sensitization.” The draft Science Policy states that OPP and OPPT will immediately begin to accept submissions of new approach methodologies (NAM) and defined approaches (DA) as described in the draft Science Policy. EPA notes that there are multiple domestic and international activities ongoing that will allow for refinement and expansion of this draft Science Policy to other DAs and additional NAMs and support global harmonization of DAs for skin sensitization. According to the draft Science Policy, OPP and OPPT “will continue to be active participants in these activities to ensure regulatory acceptance and will continue to support cross-sector collaborations that enhance animal welfare, and accelerate the implementation of NAMs.” Comments on the draft Science Policy document must be submitted to Docket Number EPA-HQ-OPP-2016-0093 by June 9, 2018.
EPA Includes Active-Inactive Designations On Updated TSCA Inventory: EPA’s April 2018 TSCA Chemical Substance Inventory is now available. For the first time, the Inventory includes a field designating substances that are “active” in U.S. commerce based on the following:
- Reporting from the 2012 and 2016 Chemical Data Reporting cycles;
- Notices of Commencement received by EPA since June 21, 2006; and
- Notice of Activity Form A’s received by EPA through the February 7, 2018, deadline, per the TSCA Inventory Notification (Active-Inactive) Rule.
EPA states that it “carefully processed and conducted a quality check of the data to ensure duplicate entries and confidential business information were removed” from the large number of notices received under the Active-Inactive Rule. EPA also posted a list of substances reported in a Notice of Activity Form A from February 8 through March 30, 2018. According to EPA, this list should assist processors in determining which of their substances on the Inventory have not yet been designated as “active” to date. Based on our review, the Inventory lists approximately 38,303 total active substances, or about 44.5 percent. The deadline for voluntary submission of a Notice of Activity Form A by processors is October 5, 2018.
EPA Releases New Educational Primer On Chemical Regulations In The U.S. And Canada: EPA, Environment and Climate Change Canada (ECCC), and Health Canada (HC) have released an educational primer on U.S. and Canadian regulations regarding chemical substances. EPA states that the purpose of the primer is to compile easy-to-use information for stakeholders potentially regulated under similar U.S. and Canadian regulations — Significant New Use Rules (SNUR) in the U.S. and Significant New Activity (SNAc) provisions in Canada. EPA, ECCC, and HC previously collaborated in the implementation of a Regulatory Cooperation Council (RCC) Work Plan on Chemicals Management that focused on SNURs and SNAcs. The primer states that an overarching issue identified during the roundtable discussions was the need for improved outreach and education, ranging from the basics of the SNUR/SNAc programs to specific requirements for various stakeholders, especially for potentially less-informed stakeholder groups, such as foreign suppliers, and small, niche companies in the U.S. and Canada. According to EPA, information in the primer will assist the regulated community to determine how to comply and engage their supply chains to help facilitate compliance for meeting SNUR and SNAc requirements. The primer notes that it does not substitute for any SNUR or SNAc provisions, nor is it a rule itself. The primer does not impose legally binding requirements on the regulated community or on EPA, ECCC, or HC.
EPA Proposes To Add Hazardous Waste Aerosol Cans To Universal Wastes Regulated Under RCRA: On March 16, 2018, EPA proposed to add hazardous waste aerosol cans to the category of universal wastes regulated under the federal Resource Conservation and Recovery Act (RCRA) regulations. 83 Fed. Reg. 11654. EPA states the streamlined Universal Waste regulations are expected to: ease regulatory burdens on retail stores and other establishments that discard aerosol cans by providing a clean, protective system for managing discarded aerosol cans; promote the collection and recycling of aerosol cans; encourage the development of municipal and commercial programs to reduce the quantity of these wastes going to municipal solid waste landfills or combustors; and result in an annual cost savings of $3.0 million to $63.3 million. As aerosol cans are “widely used for dispensing a broad range of products,” including pesticides, the proposed rule may have implications for chemical companies that create and distribute pesticide products marketed in aerosol cans. Hazardous waste aerosol cans that contain pesticides are also subject to FIFRA requirements, including compliance with the instructions on the product label. Under 40 C.F.R. Section 156.78, a flammability label statement is required for pressurized pesticide products that states “Do not puncture or incinerate container,” but EPA’s 2004 determination (that will be posted to Docket No. EPA-HQ-OLEM-2017-0463 on www.regulations.gov for this proposed rule) allows for the puncturing of cans. The proposed rule states EPA anticipates that this 2004 FIFRA determination would not be affected by the proposed addition of hazardous waste aerosol cans to the Universal Waste rules. Comments are due by May 15, 2018.
Presidential Memorandum Orders EPA To Reform NAAQS Implementation: Calling the process for implementing the National Ambient Air Quality Standards (NAAQS) “outdated and unnecessary barriers to growth,” the President on April 12, 2018, issued a memorandum ordering EPA to undertake “long-overdue reforms in implementation of NAAQS.” The memorandum is available in the April 16, 2018, Federal Register and is also available online. 83 Fed. Reg. 16761. The intent of the reform is to reduce regulatory uncertainty and decrease permitting delays to provide states with a more efficient process and to promote economic growth. At the President’s direction, EPA will take a series of actions designed to make the NAAQS program more efficient and cost-effective. These reforms will help responsibly protect the environment while reducing unnecessary barriers that are holding back manufacturing and business growth, the White House stated. The reforms laid out in the President’s memorandum are intended to provide states regulatory certainty and more flexibility in their implementation of NAAQS.
- State Implementation Plan (SIP) Reform — The memorandum directs EPA to take final action on SIPs within 18 months of submission of the SIP. This deadline applies to all SIPs and SIP revisions submitted pursuant to Section 110 of the Clean Air Act (CAA). With respect to Regional Haze Plans, EPA must undertake a process to review all full or partial Federal Implementation Plans (FIP) issued under the 2007 planning period of the Regional Haze Program and to develop options, at the request of affected states, to replace FIPs with approvable SIPs. EPA must also take “timely” action on the processing of preconstruction permit applications.
- Preconstruction Permit Application Review — The memorandum orders EPA to “endeavor to take final action on applications for preconstruction permits” within one year of the date of receiving a complete application. This one-year goal applies to all completed applications for preconstruction permits for which EPA is the direct permitting authority under the CAA. EPA also must seek to ensure that determinations relating to the completeness of an application are not “unduly delayed.”
- Exceptional Events — EPA is directed to take several actions providing relief for emissions caused by exceptional events. Specifically, EPA must reform how it handles demonstrations or petitions submitted pursuant to CAA Sections 319 and 179(b) relating to emissions beyond the control of state and local air agencies. With respect to all exceptional event demonstrations submitted pursuant to Section 319 of the CAA and all demonstrations or petitions relating to international emissions submitted pursuant to Section 179(b), EPA must “endeavor” to take final action within 120 days of a complete submission. EPA also must “endeavor” to use available monitoring data and modeling tools to assist states in identifying potential exceptional events and international emissions that may affect concentrations of criteria pollutants. EPA is also directed to ensure that it continues to take into consideration a state’s ability to meet and attain NAAQS that may be affected by international transport of criteria pollutants.
- Monitoring and Modeling Data — The memorandum orders EPA to base attainment and nonattainment designations on EPA-approved air quality monitors. Where modeling is necessary for permitting decisions, SIPs, or exceptional event or international emissions demonstrations, EPA must seek to ensure that its applicable modeling tools are sufficiently accurate for their intended application, and that the relevant state or local air agency, or permit applicant as applicable, is consulted regarding whether the use of modeling projections in lieu of monitored data is appropriate. EPA is further directed to seek to streamline its processes for considering and approving inputs to models and updates to modeling techniques, including updates to account for site-specific conditions. Where EPA-approved models are not representative of site conditions or planned activities, EPA is ordered to streamline the process for approving alternative models and to provide for other methods that promote innovative state approaches.
- Offsets — EPA is directed to provide flexibility to states with regard to identifying and achieving offsets, including by allowing intrastate and regional inter-precursor trading. These efforts should include development and implementation of flexible offset policies in rural areas where few facilities exist to generate offsets, to promote their economic expansion. State requests for regulatory relief due to emissions beyond their control, including exceptional events and international emissions, will be timely processed by EPA.
- Future NAAQS Reviews — EPA must evaluate whether it is complying fully with the requirements of CAA Section 109(d)(2)(C) relating to the scope and characterization of advice provided by its Clean Air Act Scientific Advisory Committee, including requirements that the Committee advise EPA regarding background concentrations and adverse public health or other effects that may result from implementation of revised air quality standards. In addition, EPA must examine the current NAAQS review process and develop criteria to ensure transparency in the evaluation, assessment, and characterization of scientific evidence in such reviews. Also, EPA must develop clear guidance for differentiating the role of science and policy considerations in establishing NAAQS.
- Timely Issuance of Implementing Regulations and Guidance — When issuing any final rule establishing or revising NAAQS, EPA must concurrently issue regulations and guidance necessary for implementing the new or revised standards. The regulations and guidance must detail the information that is relevant to the submission and consideration of SIPs and preconstruction permit applications.
- Review of Rules, Guidance, Memoranda, and Procedures Relating to SIPs and Permitting — The memorandum directs EPA to evaluate its rules, guidance, memoranda, and other public documents relating to the implementation of NAAQS, including documents that relate to the submission and consideration of preconstruction permit applications. EPA must determine whether any such documents should be revised or rescinded to ensure more timely permitting decisions under the NAAQS. Any resulting revisions or rescissions should seek to provide states with additional implementation flexibility.
FDA Releases Guidance For Industry To Help Businesses Determine Their Size Under FSMA Preventive Controls Regulations: On March 20, 2018, the U.S. Food and Drug Administration (FDA) announced the release of its draft guidance for industry “Determining the Number of Employees for Purposes of the ‘Small Business’ Definition in Parts 117 and 507” under the Food Safety Modernization Act’s (FSMA) Preventive Controls Regulations. 83 Fed. Reg. 12143. FDA states that the purpose of the draft guidance is to help industry entities subject to 21 C.F.R. Part 117 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food) and/or Part 507 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals) determine the number of employees for purposes of the “small business” definition under Parts 117 and 507. The draft guidance explores key terms such as “subsidiary,” “affiliate,” and “full-time equivalent employee (FTC),” offers a method for calculating FTCs, and provides examples of the types of situations businesses might encounter when trying to determine their number of employees. FDA is requesting comments on the draft guidance by May 21, 2018, to be filed in Docket No. FDA-2018-D-0671-0001 via www.regulations.gov to ensure that all comments are considered before it begins work on the final version of the guidance.
FDA Releases Guidance For Industry To Make Importation Of Certain Live Animals Less Burdensome: On March 22, 2018, FDA released guidance for industryentitled “Application of the Foreign Supplier Verification Program Regulations to the Importation of Live Animals.” 83 Fed. Reg. 12483. FDA states the purpose of the industry guidance is to communicate its intent to exercise enforcement discretion regarding application of the regulation on foreign supplier verification programs (FSVP) to importers of certain live animals; and this enforcement discretion would apply to importers of live animals that are required to be slaughtered and processed at U.S. Department of Agriculture- (USDA) regulated establishments subject to USDA-administered Hazard Analysis and Critical Control Point (HACCP) requirements, or at state-inspected establishments subject to requirements equivalent to the federal standard. FDA is accepting comments at any time in Docket No. FDA-2018-D-0721-0002 via www.regulations.gov.
FDA Updates Inflation Adjusted Cut-Offs Under FSMA: On March 30, 2018, FDA announced it was updating the applicable inflation adjusted values for six of the FSMA regulations covering 2015-2017, the most recent three years for which these values are available. These baseline values were set in 2011, when FSMA became law, but have changed every year because of inflation. FDA states these values “are particularly noteworthy for smaller businesses that may not be covered, may receive an exemption, or have later compliance dates based on their sales being less than the indicated value.” FDA provided the following as an example of how these values are utilized: For instance, farms or farm mixed-type facilities with an average annual monetary value of produce sold during the previous 3-year period of $25,000 or less (adjusted for inflation) are not subject to the Produce Safety Rule. That number, $25,000, was set as the baseline in 2011, however, the three-year inflation-adjusted average from 2015-2017 is $26,999. Therefore, if a farm or farm mixed-type facility’s three-year average is $26,999 or less, it is not subject to the Produce Safety Rule.
EC Ombudsman Issues Recommendation In Case Regarding Lack Of Access To Catalog Of Nanomaterials Used In Cosmetics: On March 13, 2018, the European Commission (EC) Ombudsman issued its recommendation in a case concerning the EC’s refusal to grant access to its catalog of nanomaterials used in cosmetics, as well as to related notification from cosmetics manufacturers. The EC Ombudsman found that while the final version of the catalog had not been published when ClientEarth made its access request, the EC failed to consult ClientEarth as to whether it would want access to any of the existing draft versions. As the catalog of nanomaterials used in cosmetics has been published, “the Ombudsman does not consider it necessary to recommend the disclosure of any drafts.” ClientEarth’s March 23, 2018, press release states: “We welcome this support from the European Ombudsman and expect the Commission to fully comply with the recommendations and restore trust.” The EC’s opinion on the Ombudsman’s recommendation is due June 15, 2018.
NIOSH Draft NORA For Respiratory Health Recommends Preventing Dust-Induced Lung Diseases, Including Those Associated With Nanomaterials: On March 15, 2018, the National Institute for Occupational Safety and Health (NIOSH) announced the availability of the draft National Occupational Research Agenda for Respiratory Health for public comment. 83 Fed. Reg. 11537. The draft National Occupational Research Agenda (NORA) for Respiratory Health is the first NORA to address respiratory health, and it is intended to identify the research, information, and actions most needed to prevent occupational injuries. The objectives include preventing and reducing work-related interstitial/dust-induced lung diseases. This will be achieved in part by preventing and reducing coal workers’ pneumoconiosis “and other dust-induced lung diseases, including those associated with nanomaterials.” According to the draft NORA, since there is no known effective treatment for any of the pneumoconioses, “primary prevention to control workplace fibrogenic dust exposures, medical surveillance for early disease detection, and other interventions from across the hierarchy of controls are essential.” Comments on the draft NORA for Respiratory Health are due May 14, 2018.
New ECHA Website Includes Information On Nanomaterials: The European Chemicals Agency (ECHA) announced on March 15, 2018, a new website, “Chemicals in our life.” The website is available in 23 European Union (EU) languages and “provides useful information on the benefits and risks of using chemicals and explains how the EU legislation on chemicals protects us.” In its press release, ECHA notes that the website allows users to explore parts of the EU Observatory for Nanomaterials (EUON). Several articles on nanomaterials related to health, the workplace, and consumer products are available. The website also includes a 360-degree interactive apartment that “shows where and why nanomaterials are used in our lives.”
EC Committee’s Preliminary Opinion On Colloidal Silver (Nano) Available For Comment: The EC Scientific Committee on Consumer Safety (SCCS) announced on March 20, 2018, that its preliminary opinion on colloidal silver (nano) is available for comment. The EC asked SCCS for its opinion on the safety of the nanomaterial colloidal silver as used in notified products, taking into account reasonably foreseeable exposure conditions. Due to a number of major data gaps, SCCS states that it is not able to draw a conclusion on the safety of nanosilver when used in oral and dermal cosmetic products. The EC asked SCCS to address any further scientific concerns with regard to the use of colloidal silver in nano form in cosmetic products. SCCS states: “In addition to safety assessment of nano silver, consideration should also be given to the likely presence of ionic silver in different type of final products.” Comments are due May 15, 2018.
EC Requests Scientific Opinion On Two Coatings For Titanium Dioxide (Nano Form) As A UV-Filter In Dermally Applied Cosmetic Products: SCCS announced on March 20, 2018, that the EC requested a scientific opinion on two coatings for titanium dioxide (nano form) (methicone and perfluorooctyl triethoxysilane) as an ultraviolet (UV)-filter in dermally applied cosmetic products. The EC asks SCCS to evaluate the safety of the materials when used as coatings on titanium dioxide (nano) for use as a UV-filter in dermally applied cosmetic products. The EC also asks whether SCCS has any further scientific concerns regarding the use of titanium dioxide (nano) coated with the materials when used as a UV-filter in dermally applied cosmetic products. The deadline is October 2018.
Australia Begins Public Consultation On Draft Documents To Implement New Industrial Chemicals Scheme: The Australian government is reforming the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) to make regulatory effort more proportionate to risk; promote safer innovation by encouraging the introduction of lower risk chemicals; and continue to protect workers, the public, and the environment from any harmful effects of industrial chemicals. NICNAS has begun a public consultation on the following draft documents that, together with the Industrial Chemicals Bill 2017, will form the Australian Industrial Chemicals Introduction Scheme (AICIS):
- Industrial Chemicals (General) Rules 2018 (General Rules): The General Rules contain details on how the introduction of industrial chemicals will be regulated under the new framework. Introductions that are considered to be medium to high risk and are not exempted or reported include certain industrial chemicals at the nanoscale;
- Industrial Chemicals Categorization Guidelines (Categorization Guidelines): The Categorization Guidelines contain the technical details and requirements that industrial chemical importers and manufacturers will need to categorize their chemical introductions under the new scheme; and
- Industrial Chemicals (Consequential Amendments and Transitional Provisions) Rules 2018 (Transitional Rules): The Transitional Rules describe how processes under the previous laws will transition to the new scheme.
Comments are due May 4, 2018. More information is available in our March 26, 2018, blog item, “Australia Begins Public Consultation on Draft Documents to Implement New Industrial Chemicals Scheme.”
OECD Evaluates Application Of In Vitro Methods For Human Hazard Assessment In OECD Testing Program For Safety Of Manufactured Nanomaterials: The Organization for Economic Cooperation and Development (OECD) has published a March 23, 2018, report entitled Evaluation of in vitro methods for human hazard assessment applied in the OECD Testing Programme for the Safety of Manufactured Nanomaterials. The Testing Program for the Testing of Manufactured Nanomaterials tested 11 manufactured nanomaterials to generate information, including their physico-chemical properties, environmental fate, and environmental and mammalian toxicity. The purpose of the evaluation was to review the Testing Program dossiers and evaluate which of the existing in vitro OECD Test Guidelines were used, what other non-guideline methods were applied, and what were the potential limitations of each assay used for testing manufactured nanomaterials. More information is in our March 27, 2018, blog item, “OECD Evaluates Application of In Vitro Methods for Human Hazard Assessment in OECD Testing Program for Safety of Manufactured Nanomaterials.”
Swedish National Platform For Nanosafety Launches New Website: On March 26, 2018, the Swedish National Platform for Nanosafety (SweNanoSafe) launched a new website intended to facilitate communication and knowledge exchange on the safety aspects of nanomaterials. According to the press release, the website is targeted toward regulators, scientists, industry, non-governmental organizations, and other stakeholders interested in nanotechnology. The website provides information on how nanomaterials are regulated in various areas, including work environment, chemicals, and cosmetics. It also contains information about research on the environmental, health, and safety aspects of nanomaterials. The website includes a knowledge bank, questions and answers, a calendar, and links to other sources of nanosafety information.
ISO Publishes In Vitro MTS Assay For Measuring The Cytotoxic Effect Of Nanoparticles: In April 2018, the International Standardization Organization (ISO) published standard ISO 19007:2018, “Nanotechnologies — In vitro MTS assay for measuring the cytotoxic effect of nanoparticles.” The standard specifies a method for evaluating the effects of nano-objects and their aggregates and agglomerates on cellular viability using the MTS assay. The assay design includes performance requirements and control experiments to identify and manage variability in the assay results.
Dr. Chuck Geraci Appointed NIOSH Associate Director For Emerging Technologies: Effective April 15, 2018, Chuck Geraci, Ph.D., CIH, will be the NIOSH Associate Director for Emerging Technologies. As Associate Director for Emerging Technologies, Dr. Geraci will be responsible for the planning, direction, and execution of emerging technology research activities at NIOSH, advising the NIOSH Director. Emerging technologies with potential to impact the U.S. workplace include the evolution of advanced and nano materials and manufacturing, advanced biotechnology, robotics, digital manufacturing, and new work organizational models. These responsibilities extend to nationally based projects and programs within NIOSH, and to international interactions that promote worker protection. Dr. Geraci will also assist in the formation of the Emerging Technologies Branch in the Education and Information Division, where he will serve as Acting/Interim Chief. In that capacity, he will continue to provide management direction to the Nanotechnology Research Center and will develop a project portfolio focused on addressing workplace challenges of key emerging technologies. Dr. Geraci has served as NIOSH Associate Director for Nanotechnology since October 2014.
TechConnect World Innovation Conference Includes Panel On Safety In Advanced Manufacturing: The May 13-16, 2018, TechConnect World Innovation Conference and Expo will include a panel discussion on “Safety in Advanced Manufacturing: A Profit Maker or a Profit Taker?” as part of the advanced manufacturing symposium. The panel discussion, which will be held on May 16, 2018, will provide a forum to examine existing health and safety approaches that enable Industry 4.0 and the advanced manufacturing ecosystem. It will consider the challenges and opportunities to incorporate new safety paradigms into business operations, and explore options for flexibility and scalability of a health and safety program for startups through small, medium, and large corporations. The session Co-Chairs include Chuck Geraci, Ph.D., CIH, Associate Director for Nanotechnology, NIOSH; Sally Tinkle, Ph.D., Senior Strategy and Policy Advisor, IDA/Science and Technology Policy Institute, and former Deputy Director of the National Nanotechnology Coordination Office; and Michael Fancher, Director, New York State Center for Advance Technology in Nanomaterials and Nanoelectronics, Associate Professor, SUNY Polytechnic Institute.
BRAG Biobased Products News And Policy Report: 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.
Spending Bill Includes Exemption For Reporting Emissions From Farms: The spending bill approved by lawmakers on March 21, 2018, includes an exemption from release reporting requirements under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) for emissions from farms. Lawmakers grafted the language of the Fair Agricultural Reporting Method Act (FARM Act; S. 2421) into the spending measure. Introduced by Senator Deb Fischer (R-NE), the bill would amend CERCLA Section 103 to exempt emissions from animal wastes at farms from CERCLA release reporting requirements.
Budget Bill Contains Language Revamping Brownfields Program: The omnibus spending bill contains compromise text based on H.R. 3017 that has been agreed to by all the authorizing Committees and that makes several additional improvements to the brownfields law to ensure more sites are remediated and returned to use. EPA estimates that more than 450,000 brownfields exist across the U.S., each of which has the capability to be remediated through the Brownfields Program, which in turn will encourage economic development in the local community. In November 2017, the House of Representatives passed Committee-led legislation — H.R. 3017, the Brownfields Enhancement, Economic Redevelopment Act of 2017 — by a vote of 409-8.
Senators Introduce Package Of Bills Intended To Streamline Permitting For Federal Highway Projects: On March 21, 2018, Senators John Cornyn (R-TX), Orrin Hatch (R-UT), Dan Sullivan (R-AK), and Deb Fischer (R-NE) introduced three bills intended to streamline the permitting process for proposed federal highway projects. The Senators stated that the bills would lower costs and reduce the length of the environmental review process without diminishing federal environmental protections or historic preservation standards by allowing states to assume certain permitting and review responsibilities. The bills would amend the Clean Water Act (CWA) to increase the ability of a state to administer the CWA permit program (S. 2586), amend the Endangered Species Act to authorize states to assume certain responsibilities (S. 2587), and establish a program to allow states to assume certain federal responsibilities under Title 54 of the United States Code (S. 2588).
Omnibus Spending Bill Funds EPA At $8 Billion: Lawmakers on March 22, 2018, reached agreement on a sprawling $1.3 trillion spending bill that funds the government through September 30, 2018. The bill has President Trump’s support, at least for now. Lawmakers largely rejected the President’s efforts to slash EPA funding in the bill. The measure funds EPA at $8 billion, which is only slightly less than EPA’s funding for Fiscal Year (FY) 2017. President Trump had proposed about a 30 percent reduction in EPA’s funding.
Senate Confirms Andrew Wheeler As EPA Deputy Administrator: On April 12, 2018, the Senate confirmed Andrew Wheeler as EPA Deputy Administrator. The Senate voted 53-45 to confirm Mr. Wheeler. Nominated by the President in October 2017, Mr. Wheeler is a principal and the head of the energy and environment team at Faegre Baker Daniels Consulting. Prior to joining Faegre Baker Daniels, Mr. Wheeler worked at the U.S. Senate Environment and Public Works Committee for 14 years serving in various roles, including as the majority and minority staff director and chief counsel. He started his career at EPA as a special assistant in the toxics office where he received three bronze medals. He has a B.A. from Case Western Reserve University, a J.D. from Washington University in St. Louis, and an M.B.A. from George Mason University.
California DFA Ordered To Suspend Chemical Activities: On February 22, 2018, the Superior Court of the State of California, County of Sacramento, issued a judgment granting petition for writ of mandate and declaratory and injunctive relief (Judgment) to suspend further chemical activities undertaken by the California Department of Food and Agriculture (CDFA) to control or eradicate pests under the Statewide Plant Pest Prevention and Management Program (the Project) until CDFA has certified a Program Environmental Impact Report (PEIR) that corrects violations of the California Environmental Quality Act (CEQA) identified in the court’s ruling. CDFA is charged with promoting and protecting the state’s agricultural industry, and preventing the introduction and spread of injurious insect or animal pests, plant diseases, and noxious weeds. Cal. Food & Agr. Code §§ 4011 401.51 403. CDFA developed the Project to control targeted pests or pathogens, and includes activities such as pest rating (evaluation of a pest’s environmental, agricultural, and biological significance); identification, detection, and delimitation of new pest populations; pest management response (which may include eradication and/or control of new or existing pest populations); and prevention of the movement of pests into and within California. The present case was brought after CDFA sought to comply with CEQA by preparing a single PEIR that provides a consolidated set of management practices rather than prepare Environmental Impact Reports (EIR) specific to particular pest management activities. Petitioners alleged that CDFA violated CEQA by certifying the PEIR for the Project and in related proceedings that CDFA violated CEQA by subsequently expanding the Statewide Plant Pest Prevention and Management Program to allow increased use of certain pesticides (Merit 2F and Acelepyrn) for the treatment of Japanese beetles without adequate environmental review. More information is available online.
EPA, OSHA, DHS Agree To Create New Protocols Requiring Notification And Coordination With First Responders: U.S. Senate Minority Leader Charles E. Schumer (D-NY) on March 20, 2018, announced that, after his intervention, representatives from the U.S. Occupational Safety and Health Administration (OSHA), EPA, and the Department of Homeland Security (DHS) are working to create new protocols for communicating and training with local governments and first responders. OSHA, EPA and DHS will convene the Chemical Facility Security and Safety Working Group (Working Group), which will coordinate strategies, activities, policies, and communication to address concerns that there should be an immediate and more thorough improvement of OSHA’s coordination and communication systems to local municipalities and their respective stakeholders. Specifically, the Working Group is moving forward with a new partnership between the agencies regarding the coordination of communication between state and local governments when there is a serious violation cited. The protocol will address the lack of communication with local first responders, safety and training agreements, and coordination on information sharing about all the relevant agencies when a local company is cited for serious violations — like the reported mishandling of Verla International’s (Verla) use of flammable liquids.
The new protocol is intended to ensure that emergency response agencies are notified when a facility receives a serious health or environmental violation, so that they can proactively prevent accidents and prepare to respond when accidents and fires occur. Specifically, the Working Group is tasked with:
- Developing appropriate means for sharing information with first responders to enhance their ability to safely and effectively plan for and respond to incidents in their jurisdiction;
- Developing tools, training, and resources to strengthen State Emergency Response Commissions and Local Emergency Planning Committees;
- Coordinating with agencies beyond DHS, EPA, and OSHA, by working with the U.S. Department of Justice, the U.S. Department of Transportation, and, in this instance, FDA, as appropriate, to address incidents involving hazardous materials and the effects these incidents have on workers and communities;
- Coordinating information sharing across the interagency community and with state, local, tribal, territorial, and private sector partners; and
- Leveraging limited resources across all levels of government by conducting and facilitating cross-training to raise awareness of other programs.
In April 2017, OSHA cited Verla’s cosmetic factory in New Windsor, New York, for improper storage of flammable liquids that resulted in several serious violations, and in November 2017 there was an explosion and fire at the factory where one worker was killed and 40 people, including seven firefighters, were injured — a tragedy that may have been avoided had the first responders been notified of the violations and known better how to handle the situation. Senator Schumer’s concerns about the lack of communication and notification stem from these events. He states the new protocols “will provide technical expertise and tighter coordination with federal and regional first responder operations to try to make sure the lack of communication and awareness of preexisting issues faced by first responders back in November is a thing of the past.”
EPA Convenes Safer Choice Partner & Stakeholder Summit 2018 Public Meeting: On April 11, 2018, EPA announced that it will hold its third Safer Choice Partner & Stakeholder Summit 2018. 83 Fed. Reg. 15561. Safer Choice partners with manufacturers to label cleaning and other products so consumers and commercial buyers can easily find products with chemical ingredients that are safer for people and the environment. The Summit provides an opportunity for partners, purchasers, retailers, NGOs, trade associations, chemical manufacturers, and other interested stakeholders to collaborate on exploring issues and developing solutions that can advance Safer Choice. The meeting will include informational and breakout sessions, with a focus on dialogue and active participation. The Safer Choice Partner & Stakeholder Summit 2018 will be held on May 14, 2018, from 8:00 a.m. to 5:00 p.m. (EDT).
Federal Agencies Sign MOU To Accelerate NEPA Reviews Of Infrastructure Projects: On April 9, 2018, the White House released a Memorandum of Understanding (MOU) signed by EPA and 11 other federal agencies to establish a cooperative relationship for the timely processing of environmental reviews and authorization decisions for proposed major infrastructure projects under the One Federal Decision (OFD) policy established in Executive Order (E.O.) 13807.E.O. 13807 requires the Office of Management and Budget (OMB) and the Council on Environmental Quality (CEQ), in consultation with the Federal Permitting Improvement Steering Council (Permitting Council), to develop a framework for implementation of the E.O. On April 9, 2018, OMB and CEQ issued an OMB/CEQ Memorandum to Heads of Federal Departments and Agencies titled “One Federal Decision Framework for the Environmental Review and Authorization Process for Major Infrastructure Projects under Executive Order 13807” (OFD Framework) pursuant to which the agencies entered into this MOU. The MOU paves the way for the federal government to limit National Environmental Policy Act (NEPA) reviews of major infrastructure projects to two years and to assign a lead agency to each review.
National Academies Find IRIS Program Has Made “Substantial Progress”: The National Academies of Sciences, Engineering, and Medicine released a new report on April 11, 2018, that finds that EPA’s Integrated Risk Information System (IRIS) Program has made “substantial progress” in implementing recommendations outlined by the National Academies in previous reports. According to the April 11, 2018, press release, the transformation of IRIS began several years ago, after the release of a 2011 National Academies report that provided suggestions for creating a more systematic and transparent IRIS process. In a 2014 report, the National Academies reviewed the changes implemented by EPA since 2011 and concluded that the improvements were considerable. Under the Program’s new leadership, EPA asked the National Academies to review again its progress toward addressing past recommendations. The press release states that the National Academies’ latest review, Progress Toward Transforming the Integrated Risk Information System (IRIS) Program, finds that the IRIS Program has made substantial progress in incorporating systematic-review methods into its process and assessments. The IRIS Program has also established a systematic-review working group and engaged subject-matter experts. According to the report, these groups should increase efficiency and consistency among assessments and improve the scientific rigor of the assessments. Although the National Academies Committee to Review Advances Made to the IRIS Process “offers some refinements and identifies a few possibilities for further development,” the report states that “its overall conclusion is that EPA has been responsive and has made substantial progress in implementing National Academies[’] recommendations.”
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