Monthly Update for March 2017
Lynn L. Bergeson, Charles M. Auer, and Carla Hutton, “Practitioner Insights: A Review and Analysis of TSCA Reform Provisions Pertinent to Manufacturers and Processors of Nanoscale Materials,” Bloomberg BNA Daily Environment Report, January 26, 2017: On June 22, 2016, President Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act, Pub. L. No. 114-182, and in so doing significantly revised the Toxic Substances Control Act (TSCA) for the first time since its enactment in 1976. This article reviews and analyzes TSCA as amended and focuses narrowly on how new TSCA specifically impacts nanoscale materials. Although the new TSCA dramatically changes how the U.S. Environmental Protection Agency (EPA) evaluates and manages industrial chemicals, including nanoscale chemicals, the absence of words or phrases such as nano or nanoscale materials means that there are no specific or additional requirements that apply explicitly to such materials. This was a significant shift from many of the earlier TSCA reform bills, which explicitly addressed nanoscale materials by proposing new definitions such as “substance characteristics” and “special substance characteristics” that included concepts such as size or size distribution; shape; surface structure; and reactivity. The new TSCA is noticeably silent on this subject and does not distinguish nanoscale materials or treat such materials differently from other chemical substances regulated under TSCA.
EPA Extends Comment Deadline For Risk Evaluation Scoping Efforts Under TSCA: On March 6, 2017, EPA reopened the comment period on the risk evaluation scoping efforts under TSCA for the ten chemical substances that were designated on December 19, 2016. 82 Fed. Reg. 12589. The substances are: 1,4-Dioxane; Methylene Chloride; 1-Bromopropane; N-Methylpyrolidone; Asbestos; Pigment Violet 29; Carbon Tetrachloride; Trichloroethylene; Cyclic Aliphatic Bromide Cluster (HBCD); and Tetrachloroethylene. In a notice issued in the Federal Register on January 19, 2017, EPA announced a public meeting that took place on February 14, 2017, and solicited comments “to receive input and information to assist the Agency in its efforts to establish the scope of risk evaluations under development for the ten chemicals substances.” The March 6, 2017, notice extends the comment period from March 1, 2017, to March 15, 2017, in response to a requestfrom the interested public.More information is available in our blog items EPA To Hold Public Meeting on Uses and Conditions of Use for the Initial Ten Chemicals to be Evaluated under TSCA Section 6 and EPA Announces Initial List of TSCA Section 6 Chemicals for Risk Evaluation.
EPA Schedules Webinar For Use Of CDX For Upfront Substantiation Of Confidential Business Information In TSCA Submissions: On March 10, 2017, EPA announced the scheduling of a webinar for upfront substantiation of confidential business information (CBI) TSCA submissions. The webinar is in response to the January 19, 2017, Federal Register notice (https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01235.pdf) on CBI upfront substantiation requirements that will change effective March 21, 2017, for TSCA submissions.
To prepare for this change, EPA’s Office of Pollution Prevention and Toxics (OPPT) revised the Central Data Exchange (CDX) TSCA reporting applications to allow for upfront substantiation of CBI claims. OPPT will host two webinars covering the use of CDX for upfront CBI substantiation. The first will be at 1:00 p.m. (EDT) on March 15, 2017, and the second is scheduled for 1:00 p.m. on March 21, 2017. These webinars will cover technical aspects of making upfront substantiations within the CDX reporting applications. OPPT has noted that it would appreciate help in identifying participants that currently use CDX reporting applications or will do so under the new requirements to participate in these events. Participants will need to register for the webinars using the following link: https://tscacdxappchanges.eventbrite.com. The webinars will be limited to the first 1,000 registrants and registration will close at 11:00 a.m. (EDT) on the date of each webinar. For interested parties that are unable to attend either webinar, OPPT will post the webinar materials at https://www.epa.gov/tsca-cbi.
EPA Issues Status Report On New Chemical Reviews: On March 10, 2017, EPA issued a status report on new chemicals under OPPT review, receipt of notices of commencement, and related submissions. 82 Fed. Reg. 13339. The report covers the period beginning December 1, 2016, to December 30, 2016. Comments are due by April 10, 2017.
New Guidance Available For Review Of Developmental Neurotoxicity Studies: On March 15, EPA announced that it and Health Canada have developed new guidance for interpreting developmental neurotoxicity (DNT) data in support of a pesticide registration. This guidance will help scientists in EPA and Canada’s Pest Management Regulatory Agency (PMRA) evaluate these studies more consistently. The DNT study assesses behavioral and neurobiological parameters to ascertain the effects of chemicals on the developing animal. The basic purpose of DNT guideline testing is to screen for the potential of chemicals to cause adverse neurodevelopmental outcomes. The guidance was developed to resolve some inconsistencies in the way U.S. and Canadian regulators were evaluating DNT studies, but it may also be useful for other international regulatory agencies or those interpreting data generated under the auspices of the Organization for Economic Cooperation and Development (OECD) or EPA DNT guidelines. While the guidance was meant for government scientists, it is written to facilitate transparency and to ensure all stakeholders know how the data are evaluated.
EPA Administrator Pruitt Stays Effective Date Of RMP Final Rule: EPA Administrator Scott Pruitt on March 13, 2017, signed a rule delaying for 90 days the effective date of EPA’s final rule revising the Risk Management Program (RMP) under the Clean Air Act (CAA). EPA issued the final RMP rule on January 13, 2017. 82 Fed. Reg. 4594. It was met immediately with criticism by many industry sectors affected by the final rule. In a letter dated February 28, 2017, a group known as the RMP Coalition submitted a petition for reconsideration of the RMP final rule as provided for in CAA Section 307(d)(7)(B). Under that provision, the Administrator is to commence a reconsideration proceeding if in the Administrator’s judgment the petitioner raises an objection to a rule that was impracticable to raise during the comment period or if the grounds for the objection arose after the comment period but within the period for judicial review. In either case, the Administrator must also conclude that the objection is of central relevance to the outcome of the rule. The Administrator may stay the effective date of the rule for up to three months during such reconsideration. In a letter dated March 13, 2017, Administrator Pruitt announced the convening of a proceeding for reconsideration of the RMP rule. In summary, the letter states that having considered the objections raised in the RMP Coalition Petition, the Administrator determined that the criteria for reconsideration have been met for at least one of the objections. Administrator Pruitt on the same day stayed the effective date of the rule to June 19, 2017. EPA stated that “the 90-day extension will allow time for EPA to consider whether to further extend the effective date of the rule through a rulemaking action while the Agency reconsiders the rule in response to [the RMP] petition.”
EPA Extends Comment Period On HAP Petition: On March 6, 2017, EPA extended the comment period of its decision to grant a petition to add n-propyl bromide (nPB) to the list of hazardous air pollutants (HAP) under the CAA. 82 Fed. Reg. 12589. The comment period, which was originally scheduled to close on March 10, 2017, is now open until June 8, 2017.
EPA Extends Comment Period On Hardrock Mining Financial Rule: EPA on March 2, 2017, extended for 120 days the comment period on its proposed rule establishing financial assurance requirements for the hardrock mining industry. 82 Fed. Reg. 12333. The new comment period closes on July 11, 2017. EPA explained that it extended the comment period because “a number of parties . . . requested additional time to review the proposed rule and supporting information.” Most notably, on February 17, 2017, Chairs from three House committees sent a letter to EPA urging it to extend by 120 days the comment period on the proposed rule. Energy and Commerce Chair Greg Walden (R-OR), Natural Resources Chair Rob Bishop (R-UT), and Transportation and Infrastructure Chair Bill Shuster (R-OH) sent the letter reiterating their requests for a longer period of public comment to review the “extremely technical” proposed rule. EPA proposed the rule under Section 108(b) of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund) on January 11, 2017. 82 Fed. Reg. 3388. The rule proposes requirements on the hardrock mining industry to demonstrate financial responsibility for addressing environmental contamination caused by mining operations. The Chairmen state that the proposed rule is a “significant rulemaking that will have a considerable impact on the mining industry.” EPA’s Regulatory Impact Analysis estimates that the financial responsibility amount for the industry is approximately $7.1 billion. The Chairmen also argue that the rulemaking docket contains over 200,000 documents and the proposal contains a complex statistical model EPA developed to calculate financial assurance obligations. The letter states, however, that the model “was developed by EPA with no input from States, industry experts, or stakeholders.” Moreover, the lawmakers claim that since the proposal, over 2,300 technical documents were added by EPA to the docket. They argue that more time is needed to digest the rule and the hefty rulemaking docket. The letter is available online.
PHMSA Will Not Take Enforcement Actions Against Parties Using 2017-2018 Version Of ICAO Technical Instructions: The Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) on February 27, 2017, issued a notice stating that it will not take enforcement action against parties using the 2017-2018 standards for international dangerous goods shipments. Many companies are adhering to the requirements in the recently-adopted 2017-2018 International Civil Aviation Organization’s (ICAO) Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO Technical Instructions) and Amendment 38-16 of the International Maritime Dangerous Goods Code (IMDG Code). Currently, however, PHMSA’s Hazardous Materials Regulations (HMR) only authorize the use of the 2015-2016 versions of the standards. See 49 C.F.R. Sections 171.7(t) and 171.7(v). PHMSA’s notice states that “while it decides whether or not to adopt the 2017-2018 versions of these international standards, it will not take enforcement action against any offeror or carrier who is using the 2017-2018 versions of these standards.” The notice is available online.
Trump Orders Reconsideration Of “Waters Of The United States” Rule: On February 28, 2017, President Trump signed an Executive Order (E.O.) entitled “Restoring the Rule of Law, Federalism, and Economic Growth by Reviewing the “Waters of the United States (WOTUS) Rule.” The WOTUS definition in the Clean Water Act (CWA) identifies those waters and wetlands that are jurisdictional, and thus subject to CWA regulations and permitting requirements. The E.O. begins with a statement of the Trump Administration’s policy to “ensure that the Nation’s navigable waters are kept free from pollution, while at the same time promoting economic growth, minimizing regulatory uncertainty, and showing due regard for the roles of the Congress and the States under the Constitution.” President Trump instructs EPA and the U.S. Army Corps of Engineers (Corps) to review the Obama era rule entitled “Clean Water Rule (CWR): Definition of ‘Waters of the United States,’” and to publish for notice and comment a rule to rescind or revise the CWR. The E.O. includes the instruction that any future revision to the rule must consider interpreting “navigable water” in a manner consistent with the late Justice Scalia’s opinion in Rapanos v. United States, 547 U.S. 715 (2006). Immediately following the E.O., EPA and the Corps issued a “Notice of Intention to Review and Rescind or Revise the [CWR].” 82 Fed. Reg. 12532. Issued in 2015, the CWR is currently the subject of a nationwide judicial stay pending the outcome of litigation challenging the rule. In the CWR, EPA and the Corps attempted to add clarity to and codify Justice Kennedy’s “significant nexus” test from his concurring opinion in Rapanos. The statutory WOTUS definition includes as jurisdictional a category of waters/wetlands that are “adjacent” to navigable waters. The CWA does not go a step further to define “adjacency” for the purposes of jurisdiction. In Rapanos, Kennedy concurred with the majority in judgment only, and opined “[a]bsent more specific regulations, however, the Corps must establish a significant nexus on a case-by-case basis when it seeks to regulate wetlands based on adjacency to non-navigable tributaries.” Kennedy cites examples of hydrological and ecological functions that alone or in combination could establish a “significant nexus,” including sediment trapping and nutrient cycling, and contribution of flow to a downstream water. In contrast, Scalia interprets adjacency to require a surface water connection between the wetland at issue and a navigable water. In the CWR, EPA and the Corps attempt to add clarity by defining “adjacent” wetlands/waters as those that meet specific distance parameters of a navigable water.
With respect to the ongoing litigation, the E.O. instructs the Attorney General to inform the courts of the pending review and take any measures he deems appropriate concerning the litigation pending the completion of any future rulemaking proceedings. It is unclear at this time what legal measures will be pursued. The process to rescind the CWR and promulgate a final, revised WOTUS definition is likely to take at least two years. Until a replacement rule is in place, and absent other guidance, EPA and the Corps will continue to follow concepts included in the 2008 EPA Guidance interpreting Rapanos. More background on the CWR and the legal history is available in our memorandum titled “What’s Next for ‘Waters of the U.S.’ (WOTUS)?.”
President Trump Signs Bill Killing Stream Protection Rule: On February 16, 2017, President Trump signed a bill (H.J. Res. 38) killing the “Stream Protection Rule” issued on December 20, 2016, by the Department of Interior (DOI) (81 Fed. Reg. 93066). The regulation sought to require coal mining operations to rehabilitate damage to streams caused by coal mining operations. The joint resolution to disapprove the rule was passed under the Congressional Review Act (CRA), which has only been used three times in the past two decades to remove regulations; President Trump has signed two of those three CRA measures. In a statement accompanying his signature of the bill, Mr. Trump stated the regulation was “overly burdensome” and that it “threatened the coal industry with millions of dollars in compliance costs.” Mr. Trump stated that “complying with the regulation would have put an unsustainable financial burden on small mines, most of which are in the Appalachian Basin.” The bill is now Public Law Number 115-5.
EPA Withdraws ICR For Oil And Gas Industry: EPA announced on March 7, 2017, that it withdrew an Information Collection Request (ICR) compelling owners and operators of facilities in the oil and natural gas industry to provide information on equipment and emissions at oil and gas operations. 82 Fed. Reg. 12817. In 2016, EPA sent letters to more than 15,000 owners and operators in the oil and gas industry, requiring them to provide the information. The ICR was comprised of two parts: an “operator survey” that asked for basic information on the numbers and types of equipment at onshore oil and gas production facilities in the U.S. and a “facility survey” asking for more detailed information on sources of methane emissions and emissions control devices or practices in use by a representative sampling of facilities in several segments of the oil and gas industry. EPA is withdrawing both parts of the information request. EPA states that it is withdrawing the request because it would “like to assess the need for the information that the agency was collecting through these requests, and reduce burdens on businesses while the Agency assesses such need.” The withdrawal also comes in the wake of a March 1, 2017, letter from nine state Attorneys General and the Governors of Mississippi and Kentucky, expressing concern with the burdens on businesses imposed by the requests. The withdrawal became effective on March 2, 2017. Recipients of the request are no longer required to respond.
Addition Of Natural Gas Processing Facilities To The Toxics Release Inventory (TRI); Extension Of Comment Period: On March 8, 2017, EPA extended the comment period for 60 days, from March 7, 2017, to May 6, 2017, regarding EPA’s addition of natural gas processing facilities to the TRI. 82 Fed. Reg. 12924. The action responds to stakeholders’ requests to extend the comment period.
CWA Suit In Washington Federal District Court Implicates Pesticide Active Ingredients: On February 21, 2017, the Northwest Environmental Advocates (NWEA) filed a CWA lawsuit in the U.S. District Court for the Western District that involves a number of pesticide active ingredients in addition to other chemicals. The lawsuit seeks to compel EPA’s response to NWEA’s 2013 Petition for Rulemaking to Update the Water Quality Criteria for Toxics in the State of Washington (NWEA v. EPA, No.: 2:17-cv-00263). NWEA asserts that Washington’s aquatic life water quality criteria (ALC) and human health water quality criteria (HHC) for many chemicals that are classified as “toxic pollutants” are outdated and inadequate. The chemicals at issue include the pesticide active ingredients acrolein, carbaryl, copper, diazinon, demeton, malathion, and methoxychlor. NWEA alleges that Washington’s continued use of outdated criteria violates the CWA and poses a risk to species listed as threatened or endangered under the Endangered Species Act (Act), specifically Chinook Salmon and Southern Resident orca whales. More information is available in our blog entitled “Clean Water Act Suit in Washington Federal District Court Implicates Pesticide Active Ingredients.”
FDA Announces Amendment To U.S.-EU Mutual Recognition Agreement: On March 2, 2017, the U.S. Food and Drug Administration (FDA) announced that the United States and the European Union (EU) have completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under this agreement, U.S. and EU regulators will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities. As part of the Mutual Reliance Initiative, the amended agreement represents the culmination of nearly three years of FDA and EU cooperation, and will allow FDA and EU drug inspectors to rely upon information from drug inspections conducted within each other’s borders. FDA states that ultimately this will enable FDA and the EU to avoid the duplication of drug inspections, lower inspection costs, and enable regulators to devote more resources to other parts of the world where there may be greater risk.
FDA To Issue PDF Export Certificates For Food Products: On February 15, 2017, FDA announced that certificates of free sale (COFS) for food products regulated by FDA’s Center for Food Safety and Applied Nutrition (CFSAN) would be issued online as downloadable PDFs beginning on February 20, 2017. FDA issues COFS for certain CFSAN-regulated food products upon request by an exporter. FDA states that CFSAN COFS will have a new look, including an updated letterhead and image of the U.S. Department of Health and Human Services (HHS) seal; and the change from paper to PDF certificates will make the process of issuing COFS more efficient for both exporters and the agency. FDA also states that if exporters are unable to use the new PDF system, they may contact FDA for assistance.
FDA Holds Public Meeting On And Requests Comments Regarding Use Of The Term “Healthy” In The Labeling Of Human Food Products: On February 16, 2017, FDA issued a notification of public meeting and a further request for comments regarding use of the term “healthy” in the labeling of human food products. 82 Fed. Reg. 10868. The purpose of the public meeting, held on March 9, 2017, was to give interested persons an opportunity to discuss the use of the term “healthy” in the labeling of human food. Comments are due by April 26, 2017.
FDA Reopens Comment Period For Guidance On Fruit Juice And Vegetable Juice As Color Additives In Food: On March 1, 2017, FDA reopened the comment period for the notice entitled “Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry” that was published in the Federal Register on December 14, 2016. 82 Fed. Reg. 12184. The draft guidance, when final, will help manufacturers determine whether a color additive derived from a plant material meets the specifications under certain FDA color additive regulations. The notice states that FDA is taking this action in response to requests to allow interested persons additional time to submit comments. Comments are now due by May 1, 2017.
GAO Calls For A National Strategy To Address Fragmentation In Federal Oversight Regarding Food Safety: In January, the U.S. Government Accountability Office (GAO) issued a report entitled Food Safety: A National Strategy Is Needed to Address Fragmentation in Federal Oversight in response to a request to examine efforts toward and options for addressing fragmentation in the federal food safety oversight system. GAO’s report describes the actions that HHS (including FDA), the U.S. Department of Agriculture (USDA), and the Office of Management and Budget (OMB) have taken since 2014 to address fragmentation; evaluates the extent to which these agencies have addressed two prior GAO recommendations for government-wide planning; and assesses actions that food safety and other experts suggest are needed to improve the federal food safety oversight system. In this report, GAO recommends that the appropriate entities within the Executive Office of the President, in consultation with stakeholders, develop a national strategy to guide the federal food safety oversight system and address ongoing fragmentation.
ISO Publishes Standard On Vocabulary For Nano-Enabled Electrotechnical Products And Systems: In January 2017, the International Organization for Standardization (ISO) published International Electrotechnical Commission (IEC)/Technical Specification (TS) 80004-9:2017, “Nanotechnologies -- Vocabulary -- Part 9: Nano-enabled electrotechnical products and systems.” IEC/TS 80004-9:2017 specifies terms and definitions for electrotechnical products and systems reliant on nanomaterials for their essential functionalities. ISO states that it is intended to facilitate communications between organizations and individuals in industry and those who interact with them. It includes sections on general terms related to nano-enabled electrotechnical products and systems; terms related to nano-enabled photovoltaics and thin-film organic electronics; and terms related to luminescent nanomaterials.
Report Claims OECD Dossiers On Nanomaterials Are Of “Little To No Value”: On February 23, 2017, the Center for International Environmental Law (CIEL) issued a press release announcing a new report, commissioned by CIEL, the European Environmental Citizens’ Organization for Standardization (ECOS), and the Oeko-Institute, that “shows that most of the information made available by the Sponsorship Testing Programme of the Organisation for Economic Co-operation and Development (OECD) is of little to no value for the regulatory risk assessment of nanomaterials.” CIEL states that the Institute of Occupational Medicine (IOM) screened 11,500 pages of raw data from the OECD dossiers on 11 nanomaterials, and analyzed all characterization and toxicity data on three specific nanomaterials -- fullerenes, single-walled carbon nanotubes, and zinc oxide. According to CIEL, while OECD’s Working Party on Manufactured Nanomaterials has yet to draw conclusions on the data quality, some stakeholders participating in EU policy-making -- “notably the European Chemicals Agency (ECHA) and the European Commission’s Joint Research Centre” -- have presented the dossiers as containing information on nano-specific human health and environmental impacts. CIEL states that industry associations and individual companies “have taken this a step further emphasizing that there is enough information available to discard most concerns about potential health or environmental risks of manufactured nanomaterials.” More information is available in our March 1, 2017, blog item, “Report Claims OECD Dossiers on Nanomaterials Are of ‘Little to No Value.’”
Another Draft REACH Guidance Document On Nanomaterials Moves To CARACAL For Review: According to the ECHA website, the draft Guidance on information requirements and Chemical Safety Assessment: Appendix R7-1 Recommendations for nanomaterials applicable to Chapter R7a Endpoint specific guidance and Appendix R7-2 Recommendations for nanomaterials applicable to Chapter R7c Endpoint specific guidance has been sent to the Competent Authorities for Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and Classification, Labeling, and Packaging (CLP) (CARACAL) on February 23, 2017. The guidance focuses on specific recommendations for testing materials that are nanomaterials. The guidance notes that part of the advice provided is not strictly nanospecific (e.g., it may also be applicable to other particulate materials). When included, however, it has been considered that the issue is especially relevant for nanomaterials and should be part of the nanospecific guidance. In other instances, no additional guidance for the endpoint has been provided, including when the endpoint is not relevant for nanomaterials (e.g., flash point or surface tension), the guidance already provided is considered to be equally applicable to nanomaterials, or because more research is needed before developing advice.
NIOSH Publishes Draft Chapter On Analysis Of Carbon Nanotubes And Nanofibers On Filters By Transmission Electron Microscopy: On February 27, 2017, the National Institute for Occupational Safety and Health (NIOSH) announced the availability of a draft chapter to be published in the NIOSH Manual of Analytical Methods entitled “Analysis of Carbon Nanotubes and Nanofibers on Mixed Cellulose Ester Filters by Transmission Electron Microscopy” for public comment. 82 Fed. Reg. 11919. The draft chapter provides standardized approaches for the analysis of carbon nanoparticles. NIOSH states that these standardized approaches are intended to harmonize analytical techniques, enabling comparison of results between studies and fostering optimal data quality. According to NIOSH, its scientists published studies on the microanalysis of airborne carbonaceous nanomaterials, and this research led to the procedures described in the chapter. The chapter provides detailed guidance on effective means to perform transmission electron microscopic analysis on carbon nanotubes and nanofibers that are sampled from occupational atmospheres. NIOSH notes that the draft chapter has previously undergone scientific peer review. Comments are due April 28, 2017.
ECHA Board Of Appeal Annuls Contested Decision Concerning Titanium Dioxide: On March 2, 2017, ECHA announced that its Board of Appeal issued its decision in Case A-011-2014, which concerns a REACH dossier evaluation for titanium dioxide. In its evaluation, ECHA considered only the substance identity information required and not the information requirements for human health and environmental effects. The Contested Decision required Huntsman P&A UK Ltd (formerly Tioxide Europe Limited), the lead registrant and one of the nine appellants, to provide detailed substance identity information on the crystal phases, nanoforms, and surface treatment of nanoforms covered by its registration. According to the Board of Appeal, the procedures available to ECHA allow for information concerning the toxicological and ecotoxicological properties, and potentially other information, to be considered to ensure that sufficient information is available regarding the hazards and risks posed by the substance. The toxicological and ecotoxicological information in the registration dossier must satisfy the registration requirements set out in REACH with regard to all the bulk forms and crystal phases and/or nanoforms of titanium dioxide covered by the registration. The Board of Appeal concluded that a literal interpretation of the wording of REACH Annex VI Section 2 does not lead to an unreasonable result. The alleged contradiction in this case between the purpose and the wording of Section 2 does not stem from the wording of that provision. It derives, according to the Board, from the compliance check in the present case being limited to substance identity information only. The Board of Appeal annulled the requests for information on the crystal phases and/or nanoforms of titanium dioxide. As the requirement to submit information on nanoforms must be annulled, the Board states that there is no need to examine the requirement to submit information on the surface treatment of such nanoforms. More information is available in our March 6, 2017, blog item, “ECHA Board of Appeal Annuls Contested Decision Concerning Titanium Dioxide.”
European NanoSafety Cluster Publishes 2017 Research Regulatory Roadmap: On March 9, 2017, the NanoSafety Cluster published its 2017 Research Regulatory Roadmap. The purpose of the Roadmap is to identify both ongoing and complete activities associated with the development of regulations promoting the safety of nanomaterials. The Roadmap identifies research areas or priorities that need to be addressed further to facilitate this process. According to the Roadmap, there remain significant gaps in knowledge and procedures that need to be addressed to generate “appropriate and proportionate regulation for nanomaterials that is informed by a sound evidence base.” The Roadmap outlines the current regulatory landscape pertaining to nanomaterials and then identifies the additional major areas that need to be considered, noting relevant activities that have or are being conducted in relation to each, but highlighting those for which more work is needed. The key activities include not only research, but also standardization and regulation development. The Roadmap states that the rapid evolution of the field of nanotechnology means that the content may need updating with time, and the NanoSafety Cluster plans to combine the outputs of the Roadmap with other activities such as Closer to the Market Roadmap and to consider these reports in generating a NanoSafety Cluster Research Agenda.
SCCS Seeks Comment On Opinion On Titanium Dioxide (Nano Form) As UV-Filter In Sprays: On March 10, 2017, the Scientific Committee on Consumer Safety (SCCS) began a public consultation on its opinion on titanium dioxide (nanoform) as an ultraviolet (UV)-filter in sprays. In July 2015, the European Commission (EC) received new data from industry to support the safe use of nano titanium dioxide when used as a UV-filter in sunscreens and personal care spray products at a concentration up to 5.5 percent. The EC asked SCCS whether, in light of the data provided, nano titanium dioxide is safe when used as a UV-filter in sunscreens and personal care spray products at a concentration up to 5.5 percent. SCCS concluded that, on the basis of the provided data, the information is insufficient to allow assessment of the safety of the use of nano titanium dioxide in sprayable applications. The opinion notes that exposure studies have not been conducted using representative sprayable products that may be intended for the EU market. The submission also does not contain a toxicological evaluation for nano titanium dioxide via the inhalation route, which SCCS states would allow deriving a point of departure for risk assessment using worst-case conditions. SCCS emphasizes that compliance with the specifications from its previous opinion on nano titanium dioxide, SCCS/1516/13, will not imply absence of effects after inhalation exposure. That opinion addressed only the safety of nano forms of titanium dioxide in dermal applications and excluded sprayable products. The draft opinion states: “In fact, that [earlier] Opinion expressed concerns over the safety of TiO2 nanomaterial applications that could lead to inhalation exposure of the consumer to TiO2 nanoparticles.” The EC also asked whether SCCS had any further scientific concerns regarding the use of nano titanium dioxide when used as a UV-filter in sunscreens and personal care spray products. The draft opinion does not include a response from SCCS. Comments are due May 14, 2017.
NanoMONITOR Workshop Will Examine Supporting The Risk Assessment Of Nanomaterials Under REACH: NanoMONITOR’s first stakeholders’ day, April 4, 2017, will include a workshop on “Development of a real-time information and monitoring system to support the risk assessment of nanomaterials under REACH.” The workshop will provide a forum for nanotechnology researchers, industry, and regulators to present and discuss the use of measured data on the concentration of engineered nanomaterials to support the risk assessment of nanomaterials and the implementation of safe exposure scenarios. Workshop topics will include:
- Workplace and environmental exposure to engineered nanomaterials;
- Data acquisition and data sharing technologies;
- Air quality monitoring;
- Impact of nanotechnologies on human health and the environment; and
- Risk governance of nanotechnologies.
The registration deadline is March 24, 2017. Due to the capacity limitations of the venue, the maximum number of attendees to be accepted is limited to 70. Registration will be on a first-come, first-served basis.
TechConnect Conference Will Include Panel On Safety And Innovation As Partners For Success In Advanced Manufacturing: The TechConnect World Innovation Conference and Expo, which will be held May 14-17, 2017, in Washington, D.C., will include a panel discussion on May 16, 2017, on “Safety and Innovation as Partners for Success in Advanced Manufacturing” as part of the Advanced Manufacturing Symposium. The session description states that as emerging and novel technologies, materials, and information are integrated into increasingly automated and networked manufacturing processes, the elements of effective health, safety, and environmental practice will need to evolve. The goals of the session are to: (1) provide a forum for stakeholders to explore the changes advanced materials and manufacturing innovation bring to the workplace and the environment; (2) examine existing health and safety approaches that enable the advanced manufacturing ecosystem; and (3) identify challenges and opportunities for new safety paradigms. The session will incorporate perspectives from technology leaders, manufacturing operations experts, and occupational health and safety practitioners. The session will also provide an opportunity to discuss and present research on managing process hazards and exposures, life cycle assessment, risk management, new models of occupational safety and health, and effective risk management practices. More information is available in our February 21, 2017, blog item, “TechConnect Conference Will Include Panel on Safety and Innovation as Partners for Success in Advanced Manufacturing.”
BRAG Biobased Products News And Policy Report: Bergeson & Campbell, P.C.’s (B&C®) consulting affiliate, B&C® Consortia Management, L.L.C. (BCCM), manages the Biobased and Renewable Products Advocacy Group (BRAG®). For access to a weekly summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to http://www.braginfo.org.
National Academies Report Finds Future Biotechnology Products May Overwhelm Agencies: On March 9, 2017, the National Academies of Sciences, Engineering, and Medicine (National Academies) published a report entitled Preparing for Future Products of Biotechnology, prepared by the Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System (Committee). The Committee was asked to describe the possible future products of biotechnology that will arise over the next five to ten years, as well as provide some insights that can help shape the capabilities within EPA, FDA, and USDA as they move forward. According to the Committee, agencies may be overwhelmed by the number and diversity of new biotechnology products. The Committee states that the agencies should increase their scientific capabilities, tools, and expertise in key areas of expected growth. The report reflects the Committee’s deliberations regarding the future products of biotechnology that are likely to appear on the horizon, the challenges that the regulatory agencies might face, and the opportunities for enhancing the regulatory system to prepare for what might be coming. The Committee reached consensus on conclusions and recommendations that are based on extensive information gathering, Committee discussions, and input from a wide variety of communities interested in biotechnology. A copy of the slides used during a National Academies webinar on the report can be found on the National Academies’ website. More information can be found in our memorandum online.
House Resolution Urges Action To Address Hexavalent Chromium In Drinking Water: Representative Al Green (D-TX) on February 17, 2017, introduced a resolution (H. Res. 147) encouraging EPA to complete its health review and establish standards under the Safe Drinking Water Act (SDWA) for hexavalent chromium in drinking water. The resolution also encourages state and local governments to collaborate and set “reasonable standards for hexavalent chromium in drinking water to ensure the safety of their constituents.”
House Passes CRA Resolution To Kill OSHA Rule On Recordable Injuries And Illnesses: On February 21, 2017, Representative Bradley Byrne (R-AL) introduced a resolution under the CRA disapproving of the Occupational Safety and Health Administration’s (OSHA) rule clarifying an employer’s continuing obligation to make and maintain an accurate record of recordable injuries and illnesses. The House on March 10, 2017, passed the resolution. OSHA on December 19, 2016, issued a final rule that clarifies an employer’s continuing obligation to make and maintain an accurate record of each recordable injury and illness. 81 Fed. Reg. 91792. The final rule became effective on January 18, 2017. OSHA’s longstanding position has been that an employer's duty to record an injury or illness continues for five years; this position has been upheld by the Occupational Safety and Health Review Commission in cases dating back to 1993. In 2012, however, the D.C. Circuit issued a decision in AKM LLC v. Secretary of Labor (Volks) reversing the Commission and rejecting OSHA’s position on the continuing nature of its prior recordkeeping regulations. The final rule more clearly states employers’ obligations. OSHA claims that the final rule adds no new compliance obligations and does not require employers to make records of any injuries or illnesses for which records are not already required. Representative Byrne, Chair of the Subcommittee on Workforce Protections, introduced the resolution of disapproval (H. J. Res 83) under the CRA “to overturn an unlawful power grab by the Obama administration and reject a failed approach to workplace safety.” Byrne also claims that the rule does nothing to improve worker safety and health and creates confusion for small businesses.
Safe Drinking Water Act Amendments Bill Introduced: On February 16, 2017, Congressman Frank Pallone, Jr. (D-NJ), Ranking Member on the House Energy and Commerce Committee, introduced the Safe Drinking Water Act Amendments of 2017 (H.R. 1068). The bill would be the first major update to the SDWA in over 20 years. According to Mr. Pallone, when Congress last updated the SDWA in 1996, “particularly high procedural hurdles were created that have prevented . . . EPA from setting drinking water standards.” He claims that H.R. 1068 “removes those onerous procedural hurdles and sets deadlines for the development of standards on . . . lead, perchlorate, perfluorinated compounds, and algal toxins.” The bill would also provide grants for replacement of lead service lines, as well as grants to make water systems more resilient to climate change and extreme weather. The legislation also would require water systems to address risks to their source water from climate change, industrial activity, and terrorism. The bill is an amalgam of ideas drawn from a number of House Democrats who have introduced bills and put forward ideas on drinking water over the past few years.
AQUA Act Introduced In House: On February 16, 2017, Representative Paul Tonko (D-NY) introduced the AQUA Act (H.R. 1071), which would increase funding for local communities with water systems in need of repair. The bill specifically authorizes significantly higher funding levels for the Drinking Water State Revolving Fund (SRF) and increases funding for a grant program to remove lead pipes from public water systems. The AQUA Act is also included as part of the Safe Drinking Water Act Amendments of 2017 (H.R. 1068).
House Passes SCRUB Act: The House on March 1, 2017, passed the Searching for and Cutting Regulations That Are Unnecessarily Burdensome Act (SCRUB Act; H.R. 998). The bill would establish the Retrospective Regulatory Review Commission to review the Code of Federal Regulations to identify rules that should be repealed to lower the cost of regulation. The Commission is to give priority to the major reviews that have been in effect for more than 15 years, that impose paperwork burdens or unfunded mandates that could be reduced substantially without significantly diminishing regulatory effectiveness, that impose disproportionately high costs on small entities, or that could be strengthened in their effectiveness while reducing regulatory costs. The Commission’s goal is to achieve a reduction of at least 15 percent in the cumulative costs of regulation with a minimal reduction in the overall effectiveness of such regulation. The Commission would terminate after five years. The bill requires enactment of a joint resolution of approval of recommendations of the Commission for the repeal of a rule or rules. If a regulation is repealed, the agency that promulgated it is prohibited from reissuing substantially similar rules without Congressional approval or issuing a new rule that results in the same adverse effects of a repealed rule.
Regulatory Integrity Act Passed In House: The House on March 1, 2017, passed the Regulatory Integrity Act (H.R. 1004). Introduced by Representative Tim Walberg (R-MI), the bill would require agencies to disclose actions on pending rules and public communications about those rules. Agencies would be banned under the bill from trying to lobby the public about rulemakings.
House Lawmakers Pass Bill To Reform OIRA: On March 1, 2017, the House of Representatives passed H.R. 1009, the Office of Information and Regulatory Affairs (OIRA) Insight Reform and Accountability Act. Under the bill, OIRA, which is currently under the White House OMB, would be subject to Congressional oversight. The bill would require OIRA to report to Congress on proposed regulations and the progress in eliminating regulations that are unnecessary or outdated.
Flake Kicks Off “Earth, Wind, And Fire” Week With Three Bills Curbing EPA Regulations: On February 27, 2017, Senator Jeff Flake (R-AZ) kicked off what he calls “Earth, Wind, and Fire Week” by introducing legislation intended to “rein in harmful EPA regulations in Arizona.” Senator Flake,Chairman of the Senate Energy and Natural Resources Subcommittee on Water and Power, said that he will use the week as an opportunity to introduce seven land, air, and forestry bills that “will ease burdensome regulations and provide for more economic development and infrastructure investment in rural Arizona.” The first three bills he introduced are “Wind” bills intended to “rein in overreaching and economically harmful EPA air regulations.” The Agency PAYGO for Greenhouse Gases Act (S. 453) would limit EPA’s ability to impose the costs of greenhouse gas (GHG) rules on other federal agencies without first providing an offset from EPA’s own budget. It would also prohibit EPA from passing the federal costs of a GHG rule onto consumers of federal power generating agencies. The Commonsense Legislative Exceptional Events Reform (CLEER) Act (S. 454) would ensure that states and localities are not considered in violation of federal air quality standards due to uncontrollable, naturally occurring events, such as dust storms and wildfires. The Ozone Regulatory Delay and Extension of Assessment Length (ORDEAL) Act (S. 452) would revise EPA’s existing timeline for reviewing National Ambient Air Quality Standards (NAAQS) and air quality criteria from five-year intervals to ten-year intervals. The bill would also delay the implementation and enforcement of the 2015 ozone NAAQS until 2025. Senator Flake has introduced these bills in the 113th and 114th Congresses.
Senator Inhofe Introduces CRA Resolution To Kill RMP Rule: On March 2, 2017, Senator Jim Inhofe (R-OK) introduced a bill under the CRA to scuttle EPA’s final rule implementing changes to the RMP. The resolution (S.J. Res. 28) is similar to one introduced in the House in February (H.J. Res. 59). EPA issued the revised RMP rule on January 13, 2017. 82 Fed. Reg. 4594.
House Democrats Introduce Bill To Protect Scientific Integrity In Federal Research: On March 2, 2017, House Science Committee members Representative Paul Tonko (D-NY) and Ranking Member Eddie Bernice Johnson (D-TX) introduced the Scientific Integrity Act. The bill would require federal agencies to adopt or strengthen policies to insulate government-directed research from the influence of political pressure and special interests. The bill (H.R. 1358) quickly garnered 77 co-sponsors. When introducing the bill, Mr. Tonko stated “Not since the Scientific Revolution has there been a more important moment to stand for the basic ideas that inquiry must be free and facts and evidence matter.” Under the bill, federal agencies that conduct or fund scientific research would be required to develop clear written scientific integrity policies that can guarantee research is being done and published without undue influence, censorship, or distortion. Over 20 federal agencies have developed scientific integrity policies to date; the legislation would also codify and strengthen these policies within a common framework. A companion bill was introduced in the Senate last month by Senator Bill Nelson (D-FL).
Senator Introduces Quartet Of Bills To Improve Rulemaking Process: Senator James Lankford (R-OK) on March 8, 2017, introduced a package of regulatory improvement bills aimed at improving the federal rulemaking process. Senator Lankford chairs the Senate Subcommittee on Regulatory Affairs and Federal Management. The Early Participation in Regulations Act of 2017 (S. 579) would require agencies to publish an Advance Notice of Proposed Rulemaking (ANPRM) for major rules at least 90 days before an agency publishes a Notice of Proposed Rulemaking, with a few exceptions. Currently, the Administrative Procedure Act (APA) does not require ANPRMs. It also would require agencies to hold the comment period open for 60 days and include a written statement with the ANPRM identifying the significance of the problem the rule seeks to address, legal authority for writing the rule, and the specific desired measurement to determine success. The Better Evaluation of Science and Technology (BEST) Act (S. 578) would amend the APA to apply the same scientific standards found in TSCA to the federal government. This bill is based on the “Scientific Standards” provision in the Frank R. Lautenberg Chemical Safety for the 21st Century Act (P.L. No. 114-182), which amended TSCA. The Truth in Regulations Act of 2017 (S. 580) attempts to “end agency abuse of guidance documents” by outlining what may and may not be included in guidance documents. It would require agencies to seek notice and comment for all regulations issued under the “good cause” exception to the APA. The Providing Accountability Through Transparency Act (S. 577) of 2017 would require that agencies provide a 100-word plain language summary with each proposed rule.
Bipartisan Legislation Would Codify OSHA VPP: On March 9, 2017, Representatives Todd Rokita (R-IN), Martha Roby (R-AL), and Gene Green (D-TX) introduced a bill that would make permanent OSHA’s Voluntary Protection Program (VPP). This is the second consecutive Congress in which the lawmakers have introduced the Voluntary Protection Program Act (H.R. 1444). The bill would codify VPP, a successful partnership between private industry and OSHA. VPP was created in 1982 but has never been authorized in law. The program requires implementation of comprehensive health and safety worksite protocols, which when certified compliant by OSHA, yield fewer injuries and illnesses and allows OSHA to focus on higher risk workplaces. Currently more than 2,200 worksites participate in the program, covering approximately 900,000 employees. A 2007 report noted that VPP saves at least $89 million in public sector costs annually due to reduced injuries. Additionally, private sector employers report a 100-300 percent return on investment on their VPP participation. Mr. Rokita stated that “I’ve seen across Indiana the successes of VPP at worksites like Cintas in Frankfort, and RR Donnelley and Nucor in Crawfordsville. Rather than promoting a Washington-knows-best approach, VPP works with the private sector to create safe work environments. This is sound policy that is not only good for the employers and employees, but for the American economy overall.” Representative Green added that the VPP “is one of the few programs that has achieved unified support from both union and non-unionized labor, small and large businesses, and government.” Ms. Roby noted that Texas has 371 VPP sites that employ tens of thousands of workers.
Senate Confirms Scott Pruitt As EPA Administrator: The Senate on February 17, 2017, approved the nomination of Oklahoma Attorney General Scott Pruitt as the next EPA Administrator. In his tenure as Attorney General, Pruitt was a frequent critic of EPA and filed several legal challenges to Obama EPA regulations. The debate over his nomination was bitter, as those opposed to his nomination argued he was a poor choice to head EPA. The 52-46 vote reflected the opposition to his nomination. Pruitt’s ascension to the EPA post likely is a harbinger heralding a rollback of several of Obama’s regulatory initiatives. President Trump has vowed to sign an E.O. killing the Clean Power Plan and on February 28, 2017, he signed an E.O. entitled “Restoring the Rule of Law, Federalism, and Economic Growth by Reviewing the ‘Waters of the United States (WOTUS) Rule.’” See related item under the CWA Section above.
President Issues Order Requiring Creation Of Regulatory Reform Task Forces: President Trump on February 24, 2017, issued an E.O. entitled “Presidential Executive Order on Enforcing the Regulatory Reform Agenda.” The E.O. states that “it is the policy of the United States to alleviate unnecessary regulatory burdens placed on the American people.” It requires each federal agency to designate a Regulatory Reform Officer (RRO). RROs are to oversee the implementation of regulatory reform initiatives and policies to ensure that agencies effectively implement regulatory reforms. Federal agencies also must establish a Regulatory Reform Task Force that is to evaluate existing regulations and make recommendations regarding their repeal, replacement, or modification. At a minimum, the task forces must attempt to identify regulations that eliminate jobs, or inhibit job creation; are outdated, unnecessary, or ineffective; impose costs that exceed benefits; create a serious inconsistency or otherwise interfere with regulatory reform initiatives and policies; are inconsistent with the requirements of Section 515 of the Treasury and General Government Appropriations Act; or derive from or implement E.O.s or other Presidential directives that have been subsequently rescinded or substantially modified.
OSHA Proposes To Delay Effective Date Of Beryllium Rule: OSHA on March 2, 2017, delayed until May 20, 2017, its final rule amending the standards for occupational exposure to beryllium. 82 Fed. Reg. 12318. OSHA promulgated the rule on January 9, 2017 (82 Fed. Reg. 2470); it was to take effect on March 21, 2017. OSHA is delaying the rule’s effective date in accordance with the White House memorandum, entitled “Regulatory Freeze Pending Review,” issued on January 20, 2017. That memorandum directed federal agencies to review new or pending regulations and temporarily postpone the date that they would take effect. OSHA states that the proposed delay will allow it to review further and consider the rule. The proposed extension of the effective date will not affect the compliance dates of the beryllium rule. Comments regarding the additional proposed extension were due on March 13, 2017.
California Extends Registration Filing Deadline For Pesticide Impregnated Products: On February 22, 2017, the California Department of Pesticide Regulation (DPR) announced it was extending the filing date for applications to register products made from pesticide impregnated materials bearing pesticide claims from March 1, 2017, to July 1, 2017. Specifically, each retailer (or authorized representative) of an affected product must submit an Application for Pesticide Registration (DPR-REG-030) to DPR by July 1, 2017. DPR’s California Notice 2015-13, issued on December 11, 2015, informed pesticide product registrants and stakeholders of DPR’s intention to register products made with pesticide impregnated materials and bearing pesticide claims.
The February 22 notice also states the following in terms of the requirements:
- Each company with products made from pesticide impregnated material and sold under their own company name into or within California is required to register the product(s) as a pesticide;
- The product must bear a federally approved pesticide label; DPR will assign a separate California-only registration number for purposes of tracking sales and use of the products in California;
- Each company will need to obtain at least one registration for each use category of product sold (e.g., the apparel use category includes wearable items such as jackets, shirts, hats, socks, pants, and shorts; the non-apparel use category includes non-wearable items such as bedding, tents, seat covers, chopping blocks, shower curtains, and mouse pads); and
- If items are impregnated with different pesticides or different percentages of the same pesticide, separate registrations will be required.
The requirements set forth in this notice do not apply to products that satisfy the requirements to be a treated article, including the requirement that any claims be related to protection of the article/substance itself. The notice applies instead to those pesticide impregnated materials that include pesticidal claims that are not limited to protection of the material. More information on the December 2015 notice is available in our blog item “California Issues Notice Requiring Registration for Products Made From Pesticide Impregnated Materials and Bearing Pesticide Claims.”
President Signs E.O. Calling For Reorganization Of The Executive Branch: President Trump on March 13, 2017, signed an E.O. requiring a program-by-program examination of federal agencies. Entitled “Comprehensive Plan for Reorganizing the Executive Branch,” the order “is intended to improve the efficiency, effectiveness, and accountability of the executive branch by directing the Director of the Office of Management and Budget (OMB) to propose a plan to reorganize governmental functions and eliminate unnecessary agencies . . . components of agencies, and agency programs.” The heads of federal agencies are given six months to submit to OMB a proposed plan to reorganize “to improve the efficiency, effectiveness, and accountability of that agency.” OMB then will have six months to prepare the overall plan for shrinking the federal government. The proposed plan must include recommendations to eliminate unnecessary agencies, components of agencies, and agency programs, and to merge functions. The proposed plan also must include recommendations for any legislation or administrative measures necessary to achieve the proposed reorganization. In developing the plan, the order requires OMB to consider several factors:
- Whether some or all of the functions of an agency or a program should remain in the federal government or would be better devolved to State or local governments or to the private sector;
- Redundancy in agency functions and programs;
- Whether the costs of continuing to operate an agency or a program are justified by the public benefits it provides; and
- The costs of shutting down or merging agencies or programs, including the costs of addressing the equities of affected agency staff.