Monthly Update for October 2017
EPA Schedules PPDC Meeting: On October 13, 2017, the U.S. Environmental Protection Agency (EPA) announced the scheduling of a Pesticide Program Dialogue Committee (PPDC) meeting for November 1-2, 2017. 82 Fed. Reg. 47733. An agenda is expected to be made available by October 18, 2017.PPDC meetings provide the EPA Administrator with advice and information on pesticide issues from stakeholders, including the public, states, and others.
EPA Issues Test Methods And Guidance For Testing The Efficacy Of Antimicrobials Against Spores Of Clostridium Difficile: On September 29, 2017, EPA announced the availability of two final test method Standard Operating Procedures (SOP) for evaluating the efficacy of antimicrobials against spores of Clostridium difficile (C. diff):
- EPA Microbiology Laboratory Branch (MLB) SOP MB-28: Procedure for the Production and Storage of Spores of Clostridium difficile for Use in the Efficacy Evaluation of Antimicrobial Agents; and
- EPA MLB SOP MB-31: Procedure for the OECD Quantitative Method for Testing Antimicrobial Products against Spores of Clostridium difficile (ATCC 43598) on Inanimate, Hard, Non-porous Surfaces.
EPA also released regulatory guidance for test criteria and pesticide claims for these products, specifically “Methods and Guidance for Testing the Efficacy of Antimicrobial Products Against Spores of Clostridium difficile on Hard Non-Porous Surfaces.” EPA states that these test methods and guidance “provide a framework for registrants who seek to make a claim for antimicrobial pesticide products to control C. difficile spores on hard, non-porous surfaces.” C. diff is an anaerobic, spore-forming bacterium and a frequent cause of hospital-acquired infections. The spores survive on hard surfaces such as glass, metals, and plastics that are commonly found in health care settings. Hospitals and other health care facilities often use antimicrobial pesticides to reduce the number of spores on environmental surfaces. Registrants seeking antimicrobial product registrations with claims to control C. diff will need to review carefully these documents as they consider the efficacy data that EPA will likely require to support these claims, as well as the claims that can be made and supported for these products. EPA MLB SOP MB-28 describes the test methodology for producing and storing standardized spore suspensions of C. diff based on ASTM International (ASTM) E2839, Standard Test Method for Production of C. difficile Spores for Use in Efficacy Evaluation of Antimicrobial Agents (ASTM International). A spore suspension should be developed and qualified according to EPA MLB SOP MB-28 before an efficacy evaluation can be performed using method EPA MLB SOP MB-31. EPA MLB SOP MB-31 describes a quantitative method intended for evaluating the sporicidal efficacy of liquid disinfectants against spores of C. diff on inanimate, hard, non-porous surfaces. More information is available online.
EPA Schedules FIFRA Scientific Advisory Panel: On September 25, 2017, EPA announced the scheduling of a meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to review and consider the scope and clarity of the draft charge questions EPA prepared for the October 24-27, 2017, SAP meeting on physiologically-based pharmacokinetic (PBPK) modeling to address pharmacokinetic differences between and within species. 82 Fed. Reg. 44614. The meeting was held on October 2, 2017.
On October 12, 2017, EPA announced that it is postponing the SAP meeting scheduled for October 24-27, 2017, due to the unavailability of experts for the peer review panel. Given the importance of PBPK modeling in the review of the six chemical risk assessments being considered, EPA believes that additional expertise in modeling and human health risk assessment will benefit the panel. The postponement will also allow for a more robust review of these data. The SAP meeting on PBPK modeling will be postponed to 2018. EPA will issue another announcement once the new date for the SAP meeting on PBPK modeling has been determined.
EPA Extends Compliance Date For Formaldehyde Emission Standards For Composite Wood Products: On September 25, 2017, EPA extended the compliance dates for the formaldehyde emission standards for the composite wood products final rule issued pursuant to the Toxic Substances Control Act (TSCA) Title VI, issued on December 12, 2016. 82 Fed. Reg. 44533. EPA extended the December 12, 2017, manufactured-by date for emission standards, recordkeeping, and labeling provisions until December 12, 2018; extended the December 12, 2018, compliance date for import certification provisions until March 22, 2019; and extended the December 12, 2023, compliance date for provisions applicable to producers of laminated products until March 22, 2024. Additionally, the final rule extended the transitional period during which the California Air Resources Board (CARB) Third Party Certifiers (TPC) may certify composite wood products under TSCA Title VI without an accreditation issued by an EPA TSCA Title VI Accreditation Body, so long as the TPC remains approved by CARB, is recognized by EPA, and complies with all aspects of the December 12, 2016, final rule until March 22, 2019. EPA believes that extension of these compliance dates and the transitional period for CARB TPCs adds needed regulatory flexibility for regulated entities, reduces compliance burdens, and helps to prevent disruptions to supply chains while still ensuring that compliant composite wood products enter the supply chain in a timely manner. This final rule is effective on October 25, 2017.
EPA Extends Date For Substantiation Of CBI Claims: On September 20, 2017, EPA extended the period to substantiate confidential business information (CBI) claims asserted by entities between June 22, 2016, and March 22, 2017. 82 Fed. Reg. 43964. Substantiations are now due by October 19, 2017. EPA is considering candidates for Science Advisory Committee on Chemicals (SACC) membership listed in the August 26, 2016, notice pool of requested nominees; the 29 candidates for membership identified in the December 9, 2016, Federal Register notice; and the additional candidates provided in the August 3, 2017, Federal Register notice. More information on the background, qualification ofmembers, and the process of obtaining nominees is available in our memorandum “EPA Seeks Comment on Nominations to “Augmented” Science Advisory Committee on Chemicals.”
EPA Announces Updates To Pesticide Label Review Manual: On September 19, 2017, EPA announced an update to Chapters 15 and 16 of the Office of Pesticide Programs’ (OPP) Label Review Manual. Updates to Chapter 15: Company Name and Address include removing non-label related instructions on submitting address change requests and updating the National Pesticide Information Center’s contact information, including new hours of operation. Updates to Chapter 16: Graphics and Symbols, include adding hyperlinks to graphic and logo examples and allowing a QR (Quick Response) code as an acceptable symbol when used only for retail pricing. EPA states that the Label Review Manual, which began as a guide for EPA label reviewers, serves as a tool to assist registrants in understanding the pesticide labeling process and assists registrants in understanding approaches for how labels should generally be drafted. Pesticide product labels provide critical information about how to handle safely and legally and apply pesticides. EPA directs registrants to submit questions or comments on the Label Review Manual by using its Pesticide Labeling Questions & Answers — Form.
EPA Announces Availability Of Integrated Risk Information System Assessment Plans For Nitrate/Nitrite, Chloroform, And Ethylbenzene: On September 18, 2017, EPA announced a 30-day public comment period on the draft Integrated Risk Information System (IRIS) Assessment Plans for Nitrate/Nitrite, Chloroform, and Ethylbenzene. 82. Fed. Reg. 43539. These documents communicate information on the scoping needs identified by EPA program and regional offices and the IRIS Program’s initial problem formulation activities. Specifically, the assessment plans outline the objectives for each assessment and the type of evidence considered most pertinent to address the scoping needs. EPA is releasing these draft IRIS Assessment Plans for public comment, which are due October 18, 2017.
EPA OIG Releases Report On EPA’s Management Of Pesticide Funds: On September 18, 2017, EPA’s Office of Inspector General (OIG) issued a report on an evaluation conducted by OIG entitled “EPA Needs to Manage Pesticide Funds More Efficiently.” OIG states that it conducted the audit “to determine whether EPA manages the Pesticides Reregistration and Expedited Processing Fund (known as the FIFRA Fund) and the Pesticide Registration Fund (known as the [Pesticide Registration Improvement Act (PRIA)] Fund) effectively to minimize reliance on appropriated funds.” In the report, OIG states its finding that “EPA should manage the FIFRA and PRIA Funds more effectively by reducing excess fund balances to within a target range. As of September 30, 2016, [OIG] identified excess funds of approximately $21.4 million for FIFRA and $8.5 million for PRIA, for a total of $29.9 million. A reduction in fund balances would increase the availability of appropriated funds for other environmental purposes.” More information is available online.
EPA Requests Transfer Of TSCA Framework Suit To Fourth Circuit: On September 14, 2017, EPA filed a motion in the two Ninth Circuit Court of Appeals cases regarding review of the EPA TSCA framework rule Procedures for Chemical Risk Evaluation under TSCA: Safer Chemicals Healthy Families v. EPA, Case Nos. 17-72260 (filed August 10, 2017); and Environmental Defense Fund v. EPA, Case No. 17-72501 (filed September 6, 2017), requesting that the cases be transferred to the Fourth Circuit and to hold the cases in abeyance. In the motion, EPA states it is in the interest of judicial economy for the same court to hear the challenges to both EPA rules, that it would be more convenient for the parties and conserve travel resources for these cases to be heard in the Fourth Circuit, because all counsel of record are located in Washington, D.C., or New York, and the Fourth Circuit may be able to resolve the petitions for review more quickly than this court given the respective complexity of the courts’ dockets. The court has not yet responded to the request. More information on these petitions for review is available in our blog under key phrases framework rules and petition for review.
EPA Proposes To Repeal Clean Power Plan: On October 10, 2017, EPA Administrator Scott Pruitt issued a Notice of Proposed Rulemaking (NPRM), proposing to repeal the Clean Power Plan (CPP). After reviewing the CPP, EPA stated that the Obama-era regulation exceeds EPA’s statutory authority. EPA added that repealing the CPP will also facilitate the development of U.S. energy resources and reduce unnecessary regulatory burdens associated with the development of those resources, in keeping with the principles established in President Trump’s Executive Order on Energy Independence. “The Obama administration pushed the bounds of their authority so far with the CPP that the Supreme Court issued a historic stay of the rule, preventing its devastating effects to be imposed on the American people while the rule is being challenged in court,” stated EPA Administrator Scott Pruitt. “We are committed to righting the wrongs of the Obama administration by cleaning the regulatory slate.” Although the proposed rule does not specify what new approaches, if any, EPA may take, Pruitt stated that “any replacement rule will be done carefully, properly, and with humility, by listening to all those affected by the rule.” EPA sent the NPRM to the Federal Register for publication. Upon publication, the public will have 60 days to submit comments. EPA estimates that the proposed repeal could provide up to $33 billion in avoided compliance costs in 2030. In the proposal and its accompanying technical documents, EPA states that “this administration is, in a robust, open, and transparent way, presenting a wide range of analysis scenarios to the public.”
Senate Committee Approves PHMSA Administrator Nominee: The Senate Committee on Commerce, Science and Transportation on October 4, 2017, approved the nomination of Howard “Skip” Elliott to serve as Administrator of the Department of Transportation’s Pipeline and Hazardous Materials Safety Administration (PHMSA). The nomination now goes to the full Senate for a vote. From 2004 until this year, Mr. Elliott served as Vice President of public safety, health, and environment at CSX. He also has more than four decades of experience in the railroad industry.
EPA Amends NESHAP For Phosphoric Acid Manufacturing And Phosphate Fertilizer Production: On September 28, 2017, EPA issued a final rule revising the Clean Air Act (CAA) National Emission Standards for Hazardous Air Pollutants (NESHAP) for the phosphoric acid manufacturing and fertilizer production sectors. 82 Fed. Reg. 45193. The revisions became effective upon publication. EPA promulgated the amendments in response to two petitions for reconsideration filed by The Fertilizer Institute (TFI) and the Phosphate Corporation of Saskatchewan. EPA focused the revisions to the rule on three issues raised in the petitions: compliance deadlines for air oxidation reactors used in superphosphoric acid (SPA) lines; compliance deadlines for revised low-energy absorber monitoring provisions; and monitoring options for low-energy absorbers. EPA also addressed a fourth issue, which was identified after the close of the public comment period: the restoration of the 20 percent variability allowance for the minimum liquid flow rate to the absorber. The compliance deadline for air oxidation reactors used in SPA lines is now August 19, 2018. EPA also revised the compliance deadline for revised low-energy absorber monitoring to August 19, 2018. Regarding monitoring options for low-energy absorbers, EPA added a new option and provided an option for regulated entities to request an alternative monitoring method. EPA also clarified that owners and operators must establish the minimum liquid-to-gas ratio operating limit by dividing the minimum liquid flow rate to the absorber determined during a performance test by the maximum possible gas flow rate through the absorber determined using blower design capacity. EPA also addressed what it described as an “omission” by restoring provisions to account for the variability in absorber pressure drop and the variability in minimum liquid flow rate to the absorber. Specifically, owners/operators are required to conduct a performance test to determine the baseline average value for both the pressure drop and for the minimum liquid flow rate of the absorber, and are then allowed to operate within a range that is within 20 percent of this rate.
D.C. Circuit Rejects Stay Of Coal Combustion Residue Rule: On September 27, 2017, the U.S. Court of Appeals for the District of Columbia Circuit issued an order denying EPA’s request to stay litigation over EPA’s 2015 coal combustion residue (CCR) rule issued under the Resource Conservation and Recovery Act (RCRA). In the rule, Hazardous and Solid Waste Management System; Disposal of Coal Combustion Residuals from Electric Utilities, 80 Fed. Reg. 21302 (Apr. 17, 2015), EPA established management standards for CCRs under RCRA Subtitle D. Industry and environmental groups filed suit on the rule, which was consolidated in Utility Solid Waste Activities Group et al., v. EPA, et al. EPA sought a stay of the litigation after in announced on September 13, 2017, that it would reconsider the CCR rule. The court rejected, without explanation, EPA’s effort to stay the litigation. The court did, however, delay oral arguments on the case from October 17, 2017, to November 20, 2017. The court ordered to parties to “be prepared to address at oral argument whether an additional period of abeyance in whole or in part is appropriate for this matter.”
EPA Proposes Amendments To NESHAP For Portland Cement Manufacturing Industry: On September 21, 2017, EPA proposed revisions to the NESHAP for the Portland Cement Manufacturing Industry. 82 Fed. Reg. 44254. The proposed rule addresses the results of the residual risk and technology review (RTR) EPA is required to conduct in accordance with CAA Section 112. EPA stated that as a result of the RTR, it found risks due to emissions of air toxics to be acceptable from this source category with an ample margin of safety. EPA thus proposed no new cost-effective controls to achieve further emissions reductions, nor did it propose revisions to the numerical emission limit. EPA did, however, propose amendments clarifying the NESHAP’s requirements and provisions. Comments on the proposed rule are due by November 6, 2017.
EPA Proposes ICR To Lay Groundwork For CWA Hazardous Substances Regulations: On September 21, 2017, EPA published a proposed information collection request (ICR), “Survey on Clean Water Act (CWA) Hazardous Substances and Spill Impacts” (hereinafter “Proposed Survey”) in the Federal Register. 82 Fed. Reg. 44178. The Proposed Survey, which would be sent to states, tribes, and U.S. territories, will assist EPA with gathering information and data to inform a future EPA rulemaking that will propose requirements to prevent the discharge of listed hazardous substances from facilities permitted under the CWA’s National Pollutant Discharge Elimination System (NPDES). The Proposed Survey requests information on the number and type of Emergency Planning and Community Right-to-Know Act (EPCRA) Tier II facilities with CWA hazardous substances onsite, historical discharges of CWA hazardous substances, ecological and human health impacts of those discharges, and existing state and tribal programs that address spill prevention of hazardous substances. At this stage in the pre-rulemaking process, EPA is seeking comments on the value, utility, and resource burden implications of the proposed ICR.
Nearly 40 years ago, pursuant to CWA Section 311(b)(2)(A), EPA promulgated a list of hazardous substances codified at 40 C.F.R. Section 116.4. At that same time, EPA proposed prevention and spill requirements for these listed substances for facilities required to obtain NPDES permits. EPA never finalized these regulations, which prompted a 2015 lawsuit for EPA’s “unreasonable delay/failure to perform a non-discretionary duty to establish regulations for hazardous substances under CWA section 311 (j)(1)(C).” The parties ultimately reached a settlement finalized in February 2016, which requires EPA to issue a regulatory proposal no later than June 2018. The comment period for the proposed ICR, a mere preliminary step, closes on November 20, 2017. EPA will then consider comments and submit a final ICR package to the Office of Management and Budget (OMB) for review and approval. EPA will announce the submission to OMB in the Federal Register, which will include an additional opportunity to comment on scope and value, and any associated resource burdens, of the ICR. Given this timeline, it is likely that EPA will not be able to meet the June 2018 deadline, and will need to seek an extension from the court to provide additional time to develop and propose the regulations.
EPA Requests Comment On Two Documents Related To Review Of Sulfur Oxides NAAQS: On September 19,2017, EPA announced the release of two draft documents related to the review of the National Ambient Air Quality Standards (NAAQS) for sulfur oxides (SOx). 82 Fed. Reg. 43756. The documents are titled Risk and Exposure Assessment for the Review of the Primary National Ambient Air Quality Standard for Sulfur Oxides, External Review Draft (Draft REA) and Policy Assessment for the Review of the Primary National Ambient Air Quality Standard for Sulfur Oxides, External Review Draft (Draft PA). EPA prepared the documents as part of its current review of the primary NAAQS for SOx. The Draft REA describes draft quantitative exposure and risk analyses for this NAAQS review. The PA, when final, serves to bridge the gap between the currently available scientific information and the judgments required of EPA in determining whether to retain or revise the existing primary NAAQS for SOx. EPA is requesting comments on the draft documents; the comment period closes on October 18, 2017. Both documents are available online.
EPA Incorporates Updated Reference To CERCLA All Appropriate Inquiries Standard: On September 15, 2017, EPA issued a final rule revising the “All Appropriate Inquiries Rule” under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund) to incorporate by reference an updated standard. 82 Fed. Reg. 43310. EPA amended the rule to reference ASTM International’s E2247-16 “Standard Practice for Environmental Site Assessments: Phase I Environmental Site Assessment Process for Forestland or Rural Property.” The revision allows for parties seeking to satisfy the CERCLA Section 107 limited liability for bona fide prospective purchasers to use this updated reference as a means for doing so. The rule becomes effective on March 14, 2018.
RCRA Hazardous Waste Electronic Manifest System Advisory Board Schedules Public Meeting And Adds New Member: EPA’s Hazardous Waste Electronic Manifest System (e-Manifest) Advisory Board held its second public meeting on September 26-28, 2017, at the EPA Conference Center. The meeting theme was “Implementing e-Manifest: User Registration and Account Activation.”The purpose of the meeting was to address critical e-Manifest user registration and account activation issues that need resolution prior to the launch of the e-Manifest system. All meeting materials are available in the e-docket (Docket no. EPA-HQ-OLEM-2017-0368). This meeting provided an opportunity for public comment. EPA also announced that Jonathan Alboum is the newest member of the e-Manifest Advisory Board. Mr. Alboum is the former CIO of the U.S. Department of Agriculture (USDA), and currently serves as the Deputy Director of the USDA Office of Procurement and Property Management.
FDA Announces Meeting, Calls For Comments On FDA/USDA Agricultural Biotechnology Education And Outreach Initiative: On October 13, 2017, the U.S. Food and Drug Administration (FDA) announced two public meetings regarding its Agricultural Biotechnology Education and Outreach Initiative in the Federal Register and requested comments. 82 Fed. Reg. 47750. The meetings will be held in Charlotte, North Carolina, on November 7, 2017, from 8:00 a.m. to 1:00 p.m. (EST) and in San Francisco, California, on November 14, 2017, from 8:00 a.m. to 1:00 p.m. (PST). FDA states the purpose of the public meetings is “to provide the public with an opportunity to share information, experiences, and suggestions to help inform the development of this education and outreach initiative.” This initiative, which Congress appropriated $3 million to fund, calls upon FDA to work with USDA to provide education and outreach to the public on agricultural biotechnology and food and animal feed ingredients derived from biotechnology. FDA is specifically requesting comments on questions listed in the Federal Register notice. Comments are due by November 17, 2017, and can be filed in Docket FDA-2017-N-5991 on www.regulations.gov. More information on the initiative and information on how to register for the meetings is available on FDA’s website.
FDA Releases Guidance Addressing FDA And EPA Jurisdiction Over Mosquito-Related Products: On October 5, 2017, FDA issued a notice in the Federal Register announcing the availability of final guidance that helps to clarify FDA and EPA jurisdiction over the regulation of mosquito-related products intended to function as pesticides, including those produced through the use of biotechnology. 82 Fed. Reg. 46500. Guidance for Industry #236, “Clarification of FDA and EPA Jurisdiction Over Mosquito-Related Products” (Guidance), provides information for industry and other stakeholders regarding the regulatory oversight of articles, including substances, for use in or on mosquitoes (mosquito-related products). FDA states that it is providing the Guidance to clarify circumstances under which such products are regulated by FDA as new animal drugs under the Federal Food, Drug, and Cosmetic Act (FFDCA) and other circumstances under which such products are regulated by EPA as pesticides under FIFRA. FDA notes that the Guidance is important in light of the public health urgency of countering the spread of mosquito-borne disease such as that caused by the Zika virus. While novel mosquito control technologies have gained greater attention, there has been confusion regarding FDA and EPA jurisdiction over such products. FDA, working collaboratively with EPA, is providing the Guidance to clarify the regulatory oversight of mosquito-related products. This includes, but is not limited to, those produced through biotechnology. The Guidance includes the following examples of new animal drugs regulated by FDA:
- Products intended to reduce the virus/pathogen load within a mosquito, including reduction in virus/pathogen replication and spread within the mosquito and/or reduction in virus/pathogen transmissibility from mosquitoes to humans; and
- Products intended to prevent mosquito-borne disease in humans or animals.
Examples of pesticide products regulated by EPA are “[p]roducts intended to reduce the population of mosquitoes (for example, by killing them at some point in their life cycle, or by interfering with their reproduction or development).” More information is available online.
FDA Proposes To Extend Compliance Dates For Nutrition Facts Label Final Rules: On October 2, 2017, FDA issued a notice in the Federal Register proposing to extend the compliance dates for the Nutrition Facts and Supplement Facts label final rule and the Serving Size final rule from July 26, 2018, to January 1, 2020, for manufacturers with $10 million or more in annual food sales. 82 Fed. Reg. 45753. Manufacturers with less than $10 million in annual food sales would receive an extra year to comply — until January 1, 2021. FDA states that it is proposing to extend the compliance dates “in response to the continued concern that companies and trade associations have shared with us regarding the time needed for implementation of the final rules [including] … concerns about their ability to update all products by the original compliance dates and the importance of obtaining clarification from the FDA on a number of technical issues relating to the final rules.” Comments on the extension are due by November 1, 2017.
FDA, CDC, And USDA Announce 2017 Scientific Meeting Of The National Antimicrobial Resistance Monitoring System: On September 20, 2017, FDA, along with its National Antimicrobial Resistance Monitoring System partners, the Centers for Disease Control and Prevention (CDC) and USDA, announced that it will be holding the 2017 Scientific Meeting of the National Antimicrobial Resistance Monitoring System (NARMS) on October 24-25, 2017, from 8:30 a.m. to 5:00 p.m. (EST) at the USDA’s South Building, in the Jefferson Auditorium, 14th & Independence Avenue S.W., Washington, DC 20250. FDA states that the purpose of this public meeting will be to “summarize NARMS progress since the last public meeting in 2014, present recommendations made by the recent FDA Science Board review of NARMS in 2017, and to explore new possible directions for NARMS within a One Health paradigm.”
FDA Releases Training Module For Carriers Subject To The Sanitary Transportation Rule: On September 20, 2017, FDA announced the availability of an online food safety training module for carriers engaged in the transportation of food by rail or motor vehicle in the United States. FDA states that it is offering this training free of charge to help carriers meet the requirements of the Food Safety Modernization Act (FSMA) rule on Sanitary Transportation of Human and Animal Food (Sanitary Transportation Rule), which requires rail and motor vehicle carriers covered by the rule to provide food safety training to their personnel engaged in transportation operations. The training must provide personnel with an awareness of potential food safety problems; basic sanitary practices; and carrier responsibilities. The carrier training requirement applies when the shipper and carrier have agreed, in a written contract, that the carrier is responsible, in whole or part, for sanitary conditions during transportation operations. The first compliance date for businesses covered by the Sanitary Transportation rule was April 6, 2017; the compliance date for small businesses covered by the rule is April 6, 2018.
FDA Proposes To Extend Dates For Compliance With The Agricultural Water Provisions In The Standards For The Growing, Harvesting, Packing, And Holding Of Produce For Human Consumption Rule: On September 13, 2017, FDA issued a proposed rule in the Federal Register to extend, for covered produce other than sprouts, the dates for compliance with the agricultural water provisions in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule under the FSMA. 82 Fed. Reg. 42963. FDA states it is proposing to extend the compliance dates to “address questions about the practical implementation of compliance with certain provisions and to consider how we might further reduce the regulatory burden or increase flexibility while continuing to achieve our regulatory objectives, in keeping with the Administration’s policies.” Comments on the extension are due by November 13, 2017.
EU Nanosafety Cluster Will Hold Webinar On November 20: The European Union (EU) NanoSafety Cluster will hold the first in a series of webinars on November 20, 2017. The series will introduce the EU NanoSafety Cluster’s work and the key outcomes from its projects. The first webinar will present the EU NanoSafety Cluster, what it does, and provide examples of its work. Future webinars, which will be held every four months, will cover important project outcomes and their impact on the safe development of nanomaterials to consumers across all sectors. The webinars are open to all interested participants. Registration for the November 20, 2017, webinar is available online.
Registration Open For NNI Workshop On Open Technology Development Pathways: The “Technology Development Pathways: Case Studies from the [National Nanotechnology Initiative (NNI)]” workshop will be held November 1, 2017. Keynote presentations will highlight the pathways companies have taken to get from research to commercialization. Panel discussions will focus on specific steps of the development pathway, such as scale up and quality control/measurement systems. NNI notes that federal government representatives will also participate, enabling attendees to learn of ongoing research activities, agency needs, and funding opportunities. Registration is on a first-come, first-served basis, but space is limited.
NIA Will Hold Webinar On Safe By Design For Nanomaterials: On October 24, 2017, the Nanotechnology Industries Association (NIA) will hold a webinar on Safe by Design for nanomaterials. NIA states that the webinar is free and open to all actors interested in nanomaterials and their safe management throughout their lifecycle, using the principles of Safe by Design from the earliest development stages. According to NIA, the webinar will bring together projects active in the creation of Safe by Design across Europe to inform participants of the long-term benefits and commercial sustainability that Safe by Design brings to product development. Registration is available online.
OECD Releases Test Guidelines Specifically Developed To Address Nanomaterials: On October 12, 2017, the Organization for Economic Cooperation and Development (OECD) announced the release of 17 new, updated, corrected, or deleted Test Guidelines. The Test Guidelines include three specifically developed for nanomaterials. OECD states that Test Guideline 318: Dispersion Stability of Nanomaterials in Simulated Environmental Media provides a simple and effective tool that can analyze the dispersion stability of nanomaterials in aqueous media. It is one of the prerequisites for a subsequent robust and reliable safety testing of nanomaterials. The Test Guideline allows users to understand their fate in natural waters and their potential behavior in test media. OECD updated Test Guideline 412: 28-Day (Subacute) Inhalation Toxicity Study and Test Guideline 413: 90-Day (Subchronic) Inhalation Toxicity Study to allow testing and hazard identification of inhaled nanomaterials. According to OECD, the updates concern bronchoalveolar lavage measurements; particle-size distribution for test atmospheres; post-administration duration; and lung burden measurements.
EC Proposes To Amend REACH Annexes To Address Nanomaterials: On October 9, 2017, the European Commission (EC) began a public consultation on a draft regulation that would amend Annexes I, III, VI, VII, VIII, IX, X, XI, and XII of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to address nanoforms of substances. The draft regulation states that:
- Manufacturers and importers should assess and, where relevant, generate the necessary information and document in the chemical safety report that the risks arising from the identified uses of the substance with nanoforms are adequately controlled;
- All different nanoforms and sets of nanoforms should be considered by the registrant in the demonstration of safety;
- A number of specific physico-chemical properties, in addition to those used to identify the different nanoform or sets of nanoforms, may be considered relevant for scientific understanding of the properties of a nanomaterial, with the necessary parameters depending on the individual case. For reasons of workability and proportionality, only registrants for higher volume substances than 100 tonnes per year should be required to consider explicitly such further information in case other particle properties significantly influence hazard or exposure to those nanoforms; and
- Compliance with the provisions of the proposed amendment should not be required immediately to allow all registrants and downstream users adequate time to adapt to the more specific requirements for substances with nanoforms. The amendment would apply from January 1, 2020.
Comments are due November 6, 2017. More information is available in our October 11, 2017, blog item, “EC Proposes to Amend REACH Annexes to Address Nanomaterials.”
EPA Promulgates Final SNUR For Bimodal Mixture Consisting Of MWCNTs And Other Classes Of CNTs: On October 3, 2017, EPA promulgated a final significant new use rule (SNUR) under TSCA Section 5(a)(2) for the chemical substance identified generically as bimodal mixture consisting of multi-walled carbon nanotubes (MWCNT) and other classes of carbon nanotubes (CNT), which was the subject of premanufacture notice (PMN) P-11-482. 82 Fed. Reg. 45990. According to the June 8, 2017, proposed SNUR, the generic use of the PMN substance will be as a specialty additive. This final rule is effective November 2, 2017. More information on the SNUR is available in our October 4, 2017, blog item, “EPA Promulgates Final SNUR for Bimodal Mixture Consisting of MWCNTs and Other Classes of CNTs.”
Switzerland Intends To Require Notification Of Fibrous Nanomaterials Placed On The Market: On September 29, 2017, Switzerland notified the EC of a draft amendment to the Ordinance on Protection against Dangerous Substances and Preparations. According to the notification, the draft amendment introduces a risk-based obligation for the manufacturer/importer to communicate fibrous nanomaterials placed on the market. The obligation must be fulfilled within three months after the first placing on the market. The notification includes the following grounds for the fibrous nanomaterials requirement: “The new obligation should give an overview to the authorities and the public over the fibrous nanomaterials placed on the market. Regulatory risk reduction measures are possible if special risks are recognized.”
ECHA Announces RAC Conclusion On Opinion For Harmonized Classification And Labeling For Titanium Dioxide: The European Chemicals Agency (ECHA) announced on September 27, 2017, that the Committee for Risk Assessment (RAC) concluded on ten opinions for harmonized classification and labeling (CLH), including titanium dioxide. RAC did not agree to the proposal to classify titanium dioxide as category 1B, presumed to have carcinogenic potential for humans, but “agreed to classify titanium dioxide in category 2 as a suspected human carcinogen Carc. 2; H350 (inhalation), i.e. not by the oral or dermal routes.” ECHA states that the opinion will be available on RAC’s web page “in the near future.”
OECD Tour de Table Highlights International Developments On The Safety Of Manufactured Nanomaterials: On September 27, 2017, OECD published a corrected version of the Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour De Table, which covers developments on the safety of manufactured nanomaterials that were provided by OECD delegations from March to August 2017. It summarizes relevant information on activities related to manufactured nanomaterials, as well as other activities on nanotechnologies at the international level. Highlights of the reported activites are available in our September , 2017, blog item, “OECD Tour de Table Highlights International Developments on the Safety of Manufactured Nanomaterials.”
JRC Publishes NANoREG Toolbox For The Safety Assessment Of Nanomaterials: The EC Joint Research Center (JRC) has published the NANoREG Toolbox for the Safety Assessment of Nanomaterials. The Toolbox supports the implementation of the NANoREG framework by providing an overview of available tools (test methods, datasets, models, guidance documents, and decision trees) useful to regulators and other stakeholders in the European REACH context. The tools consist not only of those released in the scientific deliverables of NANoREG, but include those from other initiatives, at the European level and beyond, that have addressed one or more “nano-specific hurdles” in safety assessment. The dataset “is freely available to the global nanoEHS community, be it regulators or industry, for further expansion and exploitation.”
EPA Issues Direct Final SNURs For CNT (Generic) And Nanocarbon (Generic): EPA promulgated on September 21, 2017, SNURs for 37 chemical substances that were the subject of PMNs. 82 Fed. Reg. 44079. Six of the chemical substances, including CNT (generic) and nanocarbon (generic), are subject to consent orders issued by EPA under TSCA Section 4. The promulgated SNURs include:
- CNT (generic) (PMN Number P-15-672): The generic (non-confidential) use of the PMN substance will be in filtration media; and
- Nanocarbon (generic) (PMN Number P-16-170): The substance will be used as an additive to composite materials.
Both SNURs would designate as a “significant new use” the absence of specified protective measures. The notice includes recommended testing for each substance. The SNURs will take effect November 20, 2017. More information on the SNURs is available in our September 21, 2017, blog item, “EPA Issues Direct Final SNURs for Carbon Nanotube (Generic) and Nanocarbon (Generic).”
EC Begins Consultation On Revising Recommendation On Definition Of Nanomaterial: On September 15, 2017, the EC began a public consultation on the revision of the 2011 EC Recommendation on the definition of nanomaterial. According to the Roadmap, the intention is to prepare a revised Recommendation to be adopted by the EC, accompanied by a Staff Working Document that will report on the review undertaken and the rationale for the modifications. The Roadmap states that it is envisaged that the EC will then:
- Promote the revised Recommendation within the EU and, as appropriate, in the international community;
- Develop guidance (including technical requirements), sector-specific guidance, and implementation tools;
- Support the uptake of the Recommendation in the relevant policy areas, such as chemicals, cosmetics, and food; and
- Set up a system of continuous monitoring of implementation across sectors, facilitate quick dissemination and uptake of any relevant scientific/technical developments, and if considered appropriate, trigger actions to support quality assurance and control of the measurements and their application in the nanomaterial definition.
Comments on the Roadmap were due October 13, 2017.
BRAG Biobased Products News And Policy Report: Bergeson & Campbell, P.C. (B&C®) consulting affiliate, B&C® Consortia Management, L.L.C. (BCCM), manages the Biobased and Renewable Products Advocacy Group (BRAG®). For access to a weekly summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to http://www.braginfo.org.
California Governor Brown Signs Cleaning Product Right To Know Act Of 2017 (S.B. 258); New York State To Release Household Cleaning Product Disclosure Program:On October 15, 2017, California Governor Jerry Brown signed California Senate Bill (S.B.) 258, the Cleaning Product Right to Know Act of 2017, which would require manufacturers of cleaning products to disclose certain chemical ingredients on the product label and on the manufacturer’s website. The final version of S.B. 258 was passed by the California Senate on September 13, 2017, by a vote of 27 to 13. The California Assembly passed the bill by a vote of 55 to 15, with nine votes not recorded, on September 12, 2017. The online disclosure requirements would apply to a designated product sold in California on or after January 1, 2020, and the product label disclosure requirements would apply to a designated product sold in California on or after January 1, 2021. More information on S.B. 258 is available in our memorandum “California Bill Would Require Disclosure of Cleaning Product Ingredients.” The State of New York’s Department of Environmental Conservation’s (DEC) Division of Materials Management will soon release formally a similar initiative, the Household Cleaning Product Information Disclosure Program. This program will require manufacturers of domestic and commercial cleaning products distributed, sold, or offered for sale in New York State to furnish information regarding such products in a certification form prescribed by the Commissioner, and is expected to require disclosure of many more chemicals than S.B. 258. The period for comments on the draft certification form and guidance document related to the program ended on July 14, 2017.B&C will soon be releasing a detailed memorandum on both developments to be available on our regulatory developments web page.
Pruitt Appoints Jim Gulliford As Regional Administrator For Region 7: On October 12, 2017, EPA Administrator Pruitt announced the appointment of Jim Gulliford of Missouri to become Regional Administrator for Region 7. Gulliford will oversee environmental protection efforts in Iowa, Kansas, Missouri, and Nebraska. He previously held the position of Regional Administrator for Region 7 from 2001-2006. Guilliford most recently held the position of Executive Director of the Soil and Water Conservation Society, where he led the organization from 2009-2016 and he also brings extensive experience at EPA and at the state level. Guilford served as Assistant Administrator for the Office of Prevention, Pesticides, and Toxic Substances (now the Office of Chemical Safety and Pollution Prevention) from 2006-2009. Guilliford will be joining EPA on October 23, 2017.
EPA Requesting Comments On Fiscal Year 2018-2022 Strategic Plan: EPA on October 5, 2017, announced that it is seeking comments on its Draft Fiscal Year (FY) 2018–2022 EPA Strategic Plan. 82 Fed. Reg. 46490. EPA states that the plan reflects Administrator Scott Pruitt’s priorities for advancing EPA’s mission to protect human health and the environment by setting three strategic goals:
- Core Mission: Deliver real results to provide Americans with clean air, land, and water.
- Cooperative Federalism: Rebalance the power between Washington and the states to create tangible environmental results for the American people.
- Rule of Law and Process: Administer the law, as Congress intended, to refocus the Agency on its statutory obligations under the law.
This plan includes objectives and strategies for achieving the strategic goals, and establishes strategic measures and FY 2018–2019 priority goals by which EPA will hold itself accountable to monitor progress in improving significantly the way EPA does business and environmental benefits, engaging closely with public sector partners at all levels and the regulated community. Comments are due October 31, 2017.
EPA Launches Smart Sectors Program: On September 26, 2017, EPA announced that it has launched the Smart Sectors program in the Office of Policy. 82 Fed. Reg. 44783. Based on EPA’s Sector Strategies program, the Smart Sectors program “will re-examine how EPA engages with industry in order to reduce unnecessary regulatory burden, create certainty and predictability, and improve the ability of both EPA and industry to conduct long-term regulatory planning while also protecting the environment and public health,” according to the notice. The industry sectors EPA will initially seek to work with are: aerospace; agriculture; automotive; cement and concrete; chemical manufacturing; construction; electronics and technology; iron and steel; oil and gas; ports and shipping; and utilities and power generation. A notice published on September 29, 2017, identified also the industry sectors of forestry and paper products; mining; and ports and marine (and deleted ports and shipping). 82 Fed. Reg. 45586. Under this program, EPA will designate staff-level points of contact who will act as liaisons among industry trade associations and companies, EPA program and regional offices, state and local governments, and other stakeholder groups. The sector liaisons will focus their attention primarily on three main areas: building relationships and improving customer service to sectors; developing additional expertise in each industry’s operations and environmental performance; and informing the planning of future policies, regulations, and EPA processes. EPA anticipates that participating industries will benefit from coordinated, cooperative, and constructive problem-solving with government.
California Court Of Appeal Reverses Trial Court Decision Denying PANNA’s Petition Challenging Approval By DPR Of Pesticides Containing Dinotefuran: On September 19, 2017, California’s Court of Appeal for the First Appellate District reversed a trial court decision denying a petition by the Pesticide Action Network North America (PANNA) challenging the approval by the California Department of Pesticide Regulation (DPR) of amended labeling for two previously registered pesticides containing the active ingredient dinotefuran, a neonicotinoid: Dinotefuran 20SG, manufactured by Mistui Chemicals Agro, Inc.; and Venom Insecticide, manufactured by Valent U.S.A. Corporation. PANNA’s petition alleged that DPR “violated the California Environmental Quality Act (CEQA) by approving the label amendments without sufficient environmental review.” The amended labeling for these two neonicotinoid products added some new registered uses and also increased the allowable application rates for certain existing uses. The court’s construction of CEQA was a critical element in its decision. Since the DPR regulatory program has been certified pursuant to CEQA, the court agreed that DPR can utilize its standard program documents for pesticide registration actions in lieu of the documents typically prepared under CEQA. The court disagreed, however, with DPR’s assertion that “its regulatory program ‘is exempt from the substantive portions of CEQA.’” The court found the DPR’s record supporting the dinoteferan registration actions to be deficient because DPR could not demonstrate that it properly considered certain factors specified in CEQA. In essence, the court concluded that certain CEQA requirements that DPR construed as procedural in nature were actually substantive standards that DPR must meet and adequately document in its administrative record. More information is available online.
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