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Pesticide Labels Copyrights, Clean Air Act Abeyance, Nutrition Information Compliance: Recent Federal Developments

On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The law substantially amends the Toxic Substances Control Act (TSCA), and in so doing, fundamentally alters the domestic management of industrial chemicals, the lifeblood of many manufacturing processes. This article, “TSCA Reform: Key Provisions and Implications,” summarizes key changes and explains their likely impacts on the manufacturing sector. For the purposes of this article, reference is made to the amended TSCA as “new TSCA.”

U.S. District Court Finds FIFRA Precludes Copyright Protection For Required Elements Of Pesticide Labels: In a two-page order issued on April 10, 2017, the U.S. District Court for the Middle District of North Carolina partially granted a motion for summary judgment filed by “me-too” registrants, Willowood, LLC, Willowood USA, LLC, Willowood Azoxystrobin, LLC, and Willowood Limited (Defendants), regarding Syngenta Crop Protection, LLC’s (Plaintiff) claims of copyright infringement. Syngenta Crop Protection, LLC v. Willowood, LLC, Case No. 1:15-CV-00274. The claims at issue (Counts V and VI of Plaintiff’’s complaint) were based on the Defendants’ use of Syngenta’s label. The court stated that it was granting this part of Defendants’ motion “because the Federal Insecticide Fungicide and Rodenticide Act (FIFRA) precludes copyright protection for the required elements of pesticide labels . . . of me-too registrants.” More information is available in our blog entitled “U.S. District Court Finds FIFRA Precludes Copyright Protection for the Required Elements of Pesticide Labels.”

EPA Issues TSCA Notices On Several New Chemical Notifications: On April 25, 2017, the U.S. Environmental Protection Agency (EPA) issued two notices in the Federal Register expressing its determination that several new chemical notifications are “not likely to present an unreasonable risk of injury to health or the environment.” 82 Fed Reg. 19044 (Statements of Findings for December 2016); 82 Fed. Reg. 19046 (Statements of Findings for February 2017). The statements of findings list premanufacture notices (PMN) and microbial commercial activity notices (MCAN) regarding new polymer and biodegradable chemicals submitted to EPA under TSCA Section 5.

EPA Schedules Pesticide Program Dialogue Committee (PPDC) Meeting: On April 18, EPA announced in the Federal Register the scheduling of a meeting to provide advice and recommendations to EPA on issues associated with pesticide regulatory development and reform initiatives, evolving public policy and program implementation issues, and science issues associated with evaluating and reducing risks from use of pesticides. 82 Fed. Reg. 18292. The meeting was convened on May 3-4, 2017, and materials are available here

EPA Requests Comment On Assignment And Application Of The Unique Identifier Under TSCA Section 14; Public Meeting Is Scheduled: On May 8, 2017, EPA issued a Federal Register notice requesting comment on approaches for assigning and applying unique identifiers. 82 Fed. Reg. 21386. TSCA requires EPA to assign a “unique identifier” whenever it approves a Confidential Business Information (CBI) claim for the specific chemical identity of a chemical substance, to apply this unique identifier to other information or submissions concerning the same substance, and to ensure that any nonconfidential information received by EPA identifies the chemical substance using the unique identifier while the specific chemical identity of the chemical substance is protected from disclosure. EPA is requesting written comments and will hear oral comments at the meeting. The meeting is scheduled for May 24, 2017; advance registration must be completed by May 22, 2017. On-site registration will be permitted, but seating and speaking priority will be given to those who pre-register by the deadline. Written comments are due by July 7, 2017.

EPA Reopens Comment Period On TSCA Section 6 Proposals: On May 1, 2017, EPA reopened the comment period on two proposed rules under TSCA Section 6 pertinent to trichloroethylene for use in vapor degreasing and N-methylpyrrolidone (NMP) for consumer uses and most types of commercial paint and coating removal applications. 82 Fed. Reg. 20310. The comment period was extended in response to a request from the public. Comments on these proposals are now due by May 19, 2017.

EPA Hosts Meeting On Negotiated Rulemaking: On May 5, 2017, EPA announced it would convene a public meeting to clarify and discuss the process of negotiated rulemaking on changes to Chemical Data Reporting (CDR) requirements for inorganic byproducts. 82 Fed. Reg. 21228. The meeting was held on May 9-10, 2017, in Washington, D.C. On December 15, 2016, EPA published a notice in the Federal Register of its intention to establish a Negotiated Rulemaking Committee (NRC) under the Federal Advisory Committee Act (FACA) and the Negotiated Rulemaking Act. 81 Fed. Reg. 90843. The NRC will implement the amended TSCA Section 8(a)(6) requirement that EPA “enter into a negotiated rulemaking … to develop and publish, not later than 3 years after the date of enactment … a proposed rule providing for limiting the reporting requirements under this subsection for manufacturers of any inorganic byproducts, if the byproducts, whether by the byproduct manufacturer or by any other person, are subsequently recycled, reused, or reprocessed.” EPA states that it is holding this public meeting prior to the establishment of that NRC to “exchange information and clarify a number of aspects of inorganic byproduct identification and reporting.” EPA states that written comments can be submitted at any time during the negotiated rulemaking process.

EPA Hosts Events Soliciting Information On Regulatory Reforms: EPA hosted several events to gather input on regulatory actions that could be repealed, replaced, or modified as part of EPA’s regulatory reform efforts under Executive Order (EO) 13777. The Office of Pesticide Programs (OPP) hosted a public meeting of the PPDC on May 3, 2017, and May 4, 2017 (see item above). The session on May 4, 2017, focused on receiving public feedback on pesticide regulatory reform issues. The Office of Water (OW) hosted a listening session on May 2, 2017. In the pesticide space, EPA’s OW is responsible for the National Pollutant Discharge Elimination System (NPDES) Pesticide General Permit (PGP), which requires NPDES permitting for pesticide applications into, over, and near “Waters of the United States” (WOTUS), including mosquito abatement activities. The U.S. Court of Appeals for the Sixth Circuit issued a 2009 decision requiring EPA to regulate pesticides under the NPDES program. Both industry and state co-regulators have criticized PGP requirements as duplicative, burdensome, and unnecessary for pesticides applied in accordance with FIFRA. Attempts to pass legislation that would eliminate NPDES permitting for FIFRA-compliant pesticides applications have not been successful to date. EPA’s actions under EO 13777 may offer an administrative mechanism to repeal the PGP. It is unclear, however, if a repeal would be legally defensible in light of the Sixth Circuit ruling. Alternatively, EPA could modify the PGP to eliminate the reporting and recordkeeping requirements that opponents find overly burdensome. Written comments on all regulatory reforms, including OW and OPP issues, will be accepted in docket EPA-HQ-OA-2017-0190, Evaluation of Existing Regulations, currently open through May 15, 2017. More details on the NPDES permit for pesticides are available in our blog item “EPA Issues Final 2016 NPDES Pesticide General Permit.”

Congressional Democrats Request Inquiry Into EPA’s Chlorpyrifos Decision: On April 27, 2017, Senator Elizabeth Warren (D-MA) and Representative Frank Pallone (D-NJ) sent a letter to Inspector General Arthur Elkins, Jr. at the Office of Inspector General (OIG) at EPA requesting the OIG to conduct an investigation into EPA’s March 29, 2017, order denying the September 2007 petition of the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) requesting that EPA revoke all tolerances and cancel all registrations for the pesticide chlorpyrifos. The letter refers to the March 29, 2017, order as “Administrator Scott Pruitt’s order,” and asks OIG to address questions specifically targeting the rationale, communications, and consideration that Administrator Pruitt took prior to reaching the decision. The letter states that Administrator Pruitt's “hasty reversal of this decision … appears not to be based on EPA’s existing recent scientific findings about the risk, or any new information that contradicts the findings about the health and safety risks of chlorpyrifos.” Further, the letter asserts that “it does not appear to be consistent with the law, which requires that pesticide products cannot be used unless ‘there is reasonable certainty that no harm will result from the aggregate exposure to the pesticide chemical residue.’”

EPA Reopens Comment Period On TSCA Reporting And Recordkeeping Requirements For Small Manufacturers And Processors: On May 9, 2017, EPA reopened the comment period on its request for public comment on whether revision to the current size standards for small manufacturers and processors, which are used in connection with reporting regulations under TSCA Section 8(a), is warranted. 82 Fed. Reg. 21542. The comment period is being reopened to allow the public to consider feedback received by EPA from the Small Business Administration (SBA) as a result of a consultation request on EPA’s preliminary determination on whether revision to these standards is warranted. Comments are due by May 24, 2017.

EPA Proposes To Delay Certification Of Pesticide Applicators Rule; Requests Comments: On May 15, 2017, EPA published a notice in the Federal Register proposing to further delay the effective date of its Certification of Pesticide Applicators Rule and requesting comments. 82 Fed. Reg. 22294. EPA’s final rule issued January 4, 2017, revises the regulation concerning the certification of applicators of restricted use pesticides (RUP). In this notice, EPA proposes to further delay the effective date from May 22, 2017, to May 22, 2018. Comments are due by May 19, 2017.

RCRA/CERCLA/CWA/CAA/HMT

D.C. Circuit Orders Holds On Three Clean Air Act Cases: The U.S. Court of Appeals for the District of Columbia Circuit is holding in abeyance three of EPA’s most important Clean Air Act (CAA) rules. On April 27, 2017, the court granted EPA’s request to hold in abeyance indefinitely oral arguments on two lawsuits over EPA’s regulation for utilities. Oral arguments were to be held on May 18, 2017. On April 28, 2017, the court issued an order delaying for 60 days litigation on EPA’s Clean Power Plan. In a separate order it also held for 60 days EPA’s final rule establishing New Source Performance Standards (NSPS) for new power plants.

EPA To Reconsider And Stay Portions Of NSPS For Oil And Gas Sector: On April 18, 2017, EPA Administrator Scott Pruitt agreed to reconsider and stay administratively for 90 days portions of EPA’s final rule issued on June 3, 2016, under the CAA establishing NSPS for the oil and natural gas sector. 81 Fed. Reg. 35824. Shortly after EPA promulgated the rule, the American Petroleum Institute, Texas Oil and Gas Association, Independent Associations, and the GPA Midstream Association filed petitions asking EPA to reconsider and administratively stay portions of the rule. The April 18 letter responds to those petitions. The scope of the stay and reconsideration, however, is narrow. Mr. Pruitt states that “the petitions have raised at least one objection to the fugitive emissions monitoring requirements . . . that arose after the comment period or was impracticable to raise during the comment period.” EPA, therefore, will be convening a proceeding for reconsideration of the fugitive emissions monitoring standards found in 40 C.F.R. Section 60.5397a. The letter states that EPA will also issue a 90-day stay of the compliance date for the fugitive emissions monitoring requirements and that sources need not comply with these requirements while the stay is in effect. EPA on April 4, 2017, stated that it is conducting a review of the entire oil and gas NSPS. 82 Fed. Reg. 16331.

Court Puts SSM SIP Call Case On Hold: On April 24, 2017, the U.S. Court of Appeals for the D.C. Circuit issued an order to postpone indefinitely oral argument and hold in abeyance for 90 days a case regarding the EPA rule forcing 36 states to remove CAA regulatory exemptions for periods of startup, shutdown, and malfunction (SSM). This decision essentially clears the way for the Trump Administration to reconsider the rule. The SSM provisions thus remain on the books in those states that have them. In the litigation, industry groups and states are challenging EPA’s June 2015 rule requiring states to modify their state implementation plans (SIP) for air law compliance, or SIP Call. States in the suit argue that EPA overstepped its authority in seeking to strip all SSM exemptions from state plans, and industry groups argue that continuous compliance with air law emissions limits is impossible.

EPA Provides Update On RCRA e-Manifest Development: On April 20, 2017, EPA provided an update on the development of its electronic manifest (e-Manifest) under the Resource Conservation and Recovery Act (RCRA). EPA added functionality to the system so that states can approve their own users. In addition, manifest data will now save to the database, allowing persons associated with a manifest to save, edit, and make changes as needed. EPA also published the final meeting minutes of the e-Manifest Advisory Board’s first public meeting, held on January 10-12, 2017. EPA held a webinar on April 26, 2017, to provide a system demonstration and an update on the user fee rule and advisory board. Slides and other information from the webinar are available online. The e-Manifest team also made a presentation to the American Petroleum Institute on April 26, 2017. The presentation provided industry stakeholders with a system demonstration and an update on the user fee rule and advisory board. The team also made a presentation to the RCRA Division Directors and the Association of State and Territorial Solid Waste Management Officials (ASTSWMO) on April 24, 2017. EPA continues to develop the e-Manifest user fee final rule under EPA’s Action Development Process. EPA expects to issue a final rule in December 2017. This rule will include a methodology for determining and revising user fees and a process for publishing fee schedules.

PHMSA Adjusts Civil Penalty Levels: On April 19, 2017, the U.S. Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) revised the maximum and minimum civil penalties for a knowing violation of the federal Hazardous Materials Regulations (HMR). 82 Fed. Reg. 18397. The maximum civil penalty for a knowing violation is now $78,376, except for violations that result in death, serious illness, or severe injury to any person or substantial destruction of property, for which the maximum civil penalty is $182,877. The minimum civil penalty amount is now $471. The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 required federal agencies to update their civil monetary penalties. The rule was immediately effective.

Latest WOTUS Rule Developments: In response to President Trump’s February 28, 2017, EO, EPA and the U.S. Army Corps of Engineers (Corps) have moved swiftly to begin the process of rescinding the 2015 Clean Water Rule (CWR), which redefined jurisdictional waters under the Clean Water Act (CWA) known as WOTUS. In late April, the EPA OW convened a meeting with associations representing state and local government interests to provide an opportunity for early input on key concepts that EPA and the Corps expect to clarify in the replacement WOTUS rule. At that time, the agencies stated that the rulemaking would be bifurcated into two steps. The first step will rescind the CWR and recodify the earlier definition of WOTUS. The former definition had been in place since 1986. The recodification will maintain the status quo while EPA and the Corps develop and propose a replacement rule. On May 2, 2017, the Office of Management and Budget (OMB) received for interagency review the proposed rescission of the CWR and recodification of the former WOTUS definition. OMB’s review process is expected to proceed relatively quickly, and the proposal will likely appear in the Federal Register by July 2017 for public notice and comment. In the interim, EPA and the Corps are crafting the replacement rule language. On May 9, 2017, EPA and the Corps sent a letter to state governors soliciting input on “new definition of protected waters that is in-line with Supreme Court Justice Antonin Scalia’s opinion in the 2006 Rapanos v. United States case.” Scalia held in Rapanos that WOTUS includes those waters and wetlands that possess a “relatively permanent” and “continuous surface connection” to traditionally navigable rivers and streams. The future proposed WOTUS rule is likely to define the terms “relatively permanent” and “continuous surface connection.” These concepts are of particular relevance in the arid west and southwestern portions of the U.S. where the majority of streams are ephemeral or perennial and only contain water during rain events or at certain times of the year.

EPA Administrator Pruitt Revises CERCLA Delegations Of Authority For Remediations Estimated To Exceed $50 Million: In a May 9, 2017, memorandum, EPA Administrator Scott Pruitt revised the delegations of authority under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund) for high price remediations. With this revised delegation, authority previously delegated to the Assistant Administrator for the Office of Land and Emergency Management and the Regional Administrators to select remedies estimated to cost $50 million or more “shall be retained by the Administrator.” The memorandum takes away the authority previously vested with Regional Administrators to approve CERCLA Records of Decision above the $50 million threshold. Mr. Pruitt now retains the sole authority for signing off on such remediation projects. Mr. Pruitt’s memorandum assured staff that “Superfund and the EPA’s land and water cleanup efforts will be restored to their rightful place at the center of the agency’s core mission.” The memorandum states that the intent of the revised delegation is to “facilitate the more-rapid remediation and revitalization of contaminated sites and to promote accountability and consistency in remedy selection.” It also directs staff to “involve the Administrator’s Office early on and throughout the process of developing and evaluating alternatives and remedy selection.”

FDA 

FDA To Extend Compliance Date Of Final Rule Requiring Disclosure Of Nutrition Information: On May 4, 2017, the U.S. Food and Drug Administration (FDA) issued a notice stating that it is extending the compliance date for the final rule requiring disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments by one year. 82 Fed. Reg. 20825. The original compliance date for the final rule was May 5, 2017; it is now May 7, 2018. The notice states FDA is taking this action to “enable us 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.”

FDA Revokes Food Additive Approval For The Use Of Perchlorate In Sealing Gaskets For Food Containers Because Its Use Has Been Abandoned: On May 4, 2017, FDA issued a final rule amending the food additive regulations under 21 C.F.R. Part 177, Indirect Food Polymers, to no longer provide for the use of potassium perchlorate as an additive in closure-sealing gaskets for food containers. 82 Fed. Reg. 20829. FDA states that upon the review of submitted data and information submitted in a petition by the Society of the Plastics Industry, Inc. and other available relevant material, it concluded that the use of potassium perchlorate has been abandoned for use as an additive in closure-sealing gaskets for food containers and does not anticipate that industry will resume this intended use in the future. Objections to this final rule or requests for a hearing must be filed by June 5, 2017, to the FDA docket FDA-2016-F-1805.

FDA Denies Food Additives Petition Regarding Perchlorates: On May 4, 2017, FDA issued a notification that it was denying a petition submitted by NRDC, et al., requesting that FDA: (1) revoke the Threshold of Regulation (TOR) exemption No. 2005-006 to no longer exempt from its food additive regulations the use of sodium perchlorate monohydrate as a conductivity enhancer in antistatic agents for use in finished articles in contact with dry foods; (2) issue a new FDA regulation to prohibit the use of perchlorates in antistatic agents for use in food-contact articles; and (3) amend its food additive regulations to no longer provide for the use of potassium perchlorate as an additive in closure-sealing gaskets for food containers. 82 Fed. Reg. 20847. In the notice, FDA states the following in terms of its determinations on the requests: (1) “we have determined that the dietary exposure to sodium perchlorate monohydrate as a result of the use allowed by the TOR exemption No. 2005-006 does not exceed the TOR exemption criteria in § 170.39(a)(2)(i) and that the data and information provided do not support a conclusion that TOR exemption No. 2005-006 is no longer supportable”; (2) “we decline to propose a regulation under part 189 prohibiting the use of perchlorates as a food contact substance in antistatic agents because proposing such a regulation would be inconsistent with our conclusion that the data and information provided in the petition do not support a conclusion that TOR exemption No. 2005-006 is no longer supportable”; and (3) “the food additive use of potassium perchlorate has been removed from § 177.1210 in a final rule [also] published [May 4, 2017; see above 82 Fed. Reg. 20829] … and we decline to address the petitioners’ assertions regarding the safety of the food additive use.” Electronic or written objections and requests for a hearing must be submitted by June 5, 2017.

FDA Takes Action On Violations Of Current Good Manufacturing Practice: On May 4, 2017, the U.S. District Court for the Southern District of Florida entered a consent decree of permanent injunction between the United States and Syfrett Feed Company Inc. of Okeechobee, Florida (Syfrett Feed), and its owner/President, Vice President, and Operations Manager. On behalf of FDA, the U.S. Department of Justice (DOJ) had filed a complaint related to Syfrett Feed’s multiple violations of the current good manufacturing practice (cGMP) regulations for medicated feeds, which included failure to establish and maintain adequate procedures for the identification, storage and inventory control of drugs intended for use in medicated feeds; failure to establish and use adequate procedures for all equipment used in the production and distribution of medicated feeds to avoid unsafe contamination of medicated and non-medicated feeds; and failure to ensure that correct labels are used for all manufactured medicated feeds. The consent decree prohibits Syfrett Feed from “processing, manufacturing, preparing, packing and distributing the medicated animal feed it produces until the defendants hire an expert to ensure that they are following all cGMP regulations in the manufacture of medicated feed and until the FDA provides Syfrett Feed with written permission that they may resume the manufacture and distribution of their medicated feed.”

FDA Acting Commissioner Stephen M. Ostroff, M.D. Delivered Speech On FDA, Past And Future: On May 4, 2017, FDA Acting Commissioner Stephen M. Ostroff, M.D. made remarks at the Food and Drug Law Institute Annual Conference in a speech titled “FDA: Looking Back, Looking Forward.” Dr. Ostroff discussed the topics of food safety, specifically the Food Safety Modernization Act; medical products, including the 21st Century Cures Act; opioid misuse and abuse, and how FDA is committed to addressing the epidemic; the extension of FDA’s authority over all tobacco products; and FDA’s program alignment initiative, which has allowed for better vertical integration within its field offices and labs by commodity category, such as food and feed, drugs, and devices.

FDA Recognizes Australia As Having A Comparable Food Safety System To The U.S.: On April 19, 2017, FDA announced it had signed an arrangement with the Australian Department of Agriculture and Water Resources recognizing each other’s food safety systems as comparable to each other, the third time that FDA has recognized a foreign food safety system as comparable, the first being New Zealand in 2012 and Canada in 2016. By recognizing each other’s systems, FDA and Australian Department of Agriculture and Water Resources have confidence that they can leverage each other’s science-based regulatory systems to help ensure food safety. Systems recognition establishes a framework for regulatory cooperation in a variety of areas that range from scientific collaboration to outbreak response. 

Nanotechnology

NIOSH BSC Meeting Includes Presentation On Nanotoxicology: On April 12, 2017, the National Institute for Occupational Safety and Health (NIOSH) Board of Scientific Counselors (BSC) held its 68th meeting. Dr. Jenny Roberts, Nanotechnology Research Center (NTRC) Toxicology and Internal Dose Critical Area Coordinator, gave a presentation on the Nanotoxicology Program

EC4safenano Conducts Survey On Demand And Supply Of Services For Safe Use Of Nanomaterials And Nanotechnology: The European Center for Risk Management and Safe Innovation in Nanomaterials and Nanotechnologies (EC4safenano) has sent a survey to different stakeholders, including European Union (EU) Member States, the EC and EC agencies, industry, and bodies representing the general public. Responses will influence the design of EC4safenano and ensure that issues important to stakeholders will be addressed; the catalog of services will be relevant; and services can be provided through EC4safenano. EC4safenano will be developed over the next three years to bridge the gap between scientific knowledge and daily practice by providing services to help others to manage this new technology safely. EC4safenano will anonymize and summarize the survey responses in a report that will be made available to all respondents.

Charles Geraci Receives NIOSH Director’s Distinguished Career Scientist Award: On April 27, 2017, Dr. Charles Geraci, Associate Director for Nanotechnology at NIOSH, received the Director’s Distinguished Career Scientist Award. Dr. Geraci provides overall strategic guidance to the nanotechnology research program at NIOSH and is recognized internationally for his leadership in the field. Dr. Geraci has made major contributions in the form of developing policy documents, refining research methods, developing field investigation strategies, and directly applying research outputs to effective worker health and safety approaches needed to develop emerging technologies responsibly. Dr. Geraci is also active on the International Organization for Standardization Technical Committee 229 on Nanotechnology, as well as the Organization for Economic Cooperation and Development (OECD) Working Party on Manufactured Nanomaterials, and serves on the executive committee of the American Industrial Hygiene Association Nanotechnology Working Group. Speaking for all in the nano community, the honor is richly deserved as Dr. Geraci’s service to the community and his scholarship and leadership are without equal.

EPA TechDirect Reports Availability Of Nanorem Toolbox: The May 1, 2017, issue of EPA’s TechDirect includes an item on the availability of the Taking Nanotechnological Remediation Processes from Lab Scale to End User Applications for the Restoration of a Clean Environment (NanoRem) Toolbox. NanoRem is a research project funded through the European Commission’s Seventh Framework Program for Research and Technological Development. EPA describes the NanoRem Toolbox as the primary gateway to the NanoRem Project’s results. EPA states that the Toolbox focuses on the needs of decision makers, consultants, and site owners. The April 1, 2017, issue of TechDirect reported on the availability of 12 NanoRem Bulletins that were created to transfer the knowledge developed within NanoRem to end-users.

JRC Publishes NANoREG Framework For The Safety Assessment Of Nanomaterials: The EC Joint Research Center (JRC) has published a Science for Policy report entitled NANoREG framework for the safety assessment of nanomaterials. The report was developed within the NANoREG project, “A common European approach to the regulatory testing of nanomaterials.” The NANoREG framework represents the project’s proposal for a common understanding in the field of environmental health and safety (EHS) assessment of nanomaterials under the current European regulatory framework, with focus on REACH. The report is also intended to contribute to the ongoing debate on the need to facilitate the implementation of REACH for nanomaterials. The report notes that the NANoREG partners, including JRC, “believe that the proposed framework will be useful for scientific experts and stakeholders, such as regulatory authorities and industry.”

NanoMONITOR Begins Survey To Refine Design Of Real-Time Information And Monitoring System: NanoMONITOR announced on May 3, 2017, the launch of a survey intended to refine the design of the real-time information and monitoring system to support the risk assessment of nanomaterials under REACH. NanoMONITOR states that the ten-minute survey will help it:

  1. Elicit stakeholders’ requirements on the NanoMONITOR web platform;

  2. Elicit stakeholders’ requirements on the NanoMONITOR station prototype; and

  3. Evaluate the current use of the measured data to evaluate the potential environmental, health, and safety risk posed by the use of nanomaterials.

ACS Publishes Study Finding That Nanoparticles Can Travel From Lungs To Blood, Possibly Explaining Risks To Heart: The American Chemical Society (ACS) announced on May 3, 2017, publication of an article entitled “Inhaled Nanoparticles Accumulate at Sites of Vascular Disease” in ACS Nano. ACS states: “Importantly, the nanoparticles appeared to preferentially accumulate at inflamed vascular sites, including carotid plaques in patients at risk of a stroke. The findings suggest that nanoparticles can travel from the lungs into the bloodstream and reach susceptible areas of the cardiovascular system where they could possibly increase the likelihood of a heart attack or stroke, the researchers say.”

NanoImpact Publishes Special Issue Based On Eighth International Congress Of Nanotoxicology: NanoImpact has published a special issue based on work presented at the Eighth International Congress of Nanotoxicology, which was held June 2-4, 2016, in Boston, Massachusetts. The theme was “A Decade of Nanotoxicology: Impact on Human Health and the Environment.” The Editorial by the associate guest editors, Dhimiter Bello and David T. Leong, states that the special issue brings together a collection of 12 original research papers and three review papers. The collection reflects issues discussed at the Congress -- challenges, emerging themes, and concrete outcomes that can be translated to practice. Of note, according to the guest editors, are the number of papers in the special issue focused on engineered nanomaterials in food and their impact on the gastrointestinal system. In addition, two papers focus on exposures to engineered nanoparticles from printing and photocopying, providing an example of real world exposure scenarios from nano-enabled products during their life cycle. The guest editors state that “[s]uch applications along the life cycle of nano-enabled products highlight a number of additional complexities that nanotoxicology had to deal with -- limited availability of nanomaterials for testing, physico-chemical and morphological (PCM) properties of released nanoparticles differing from the input nanomaterials, background nano aerosols, lower exposures and dosimetry conversions, and most importantly, chronicity of exposures.”

EPA Delays Effective Date Of TSCA Section 8(a) Rule Concerning Nanoscale Materials; Will Publish Draft Guidance For Comment: EPA published on May 12, 2017, a Federal Register notice delaying the effective date of the January 12, 2017, rule concerning TSCA Section 8(a) reporting requirements from May 12, 2017, to August 14, 2017. 82 Fed. Reg. 22088. EPA notes that Section 553(b)(1)(B) of the Administrative Procedure Act (APA) allows EPA to take action without providing an opportunity for notice or comment when it for good cause finds that “notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.” APA Section 553(d)(3) allows the effective date of an action to be less than 30 days when a good cause finding is made. EPA states that because of the complex issues regarding the reporting requirements of the rule and the “immediate pendency” of the effective date of the reporting requirements, “it would be impractical to make the effective date of this extension 30 days after its publication, and it would be impractical to get public comments on an extension of the effective date of the rule.” In addition, according to EPA, the public interest is served by complete and accurate reporting under the rule, “which would be greatly facilitated by publication of the guidance.” EPA states that it therefore finds good cause to extend the effective date of the rule without notice and comment. EPA is scheduled to publish a Federal Register notice on May 16, 2017, announcing the availability of and requesting public comment on a draft guidance document entitled “Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce.” EPA states in the pre-publication notice that the guidance provides answers to questions EPA has received from manufacturers (includes importers) and processors of certain chemical substances when they are manufactured or processed at the nanoscale as described in the January 12, 2017, final rule. EPA states that it will make the draft guidance available on EPA website, and will also be available in Docket ID number EPA-HQ-OPPT-2010-0572. EPA states that it will accept comments regarding the guidance, but not regarding the rule itself, “which has already been finalized.” Comments will be due 30 days after the notice is published in the Federal Register. More information regarding the final rule is available in our January 12, 2017, memorandum, “EPA Promulgates Final TSCA Reporting and Recordkeeping Rule for Nanoscale Materials.”

ECHA Creates Web Page For Nanomaterials Expert Group: The European Chemicals Agency (ECHA) has created a web page for the Nanomaterials Expert Group (NMEP), which was created in October 2012. NMEP aims to seek common ground among experts on scientific and technical issues regarding the implementation of REACH, the Classification, Labeling, and Packaging (CLP) regulation, and the Biocidal Products Regulation (BPR) for nanomaterials. ECHA states that the page includes information on NMEP’s mandate and activities, the list of the members, and the meeting schedule, which will also include the minutes of the meetings in the future. According to the web page, NMEP will meet May 16-17, 2017, and November 7-8, 2017.

Nanosensor Manufacturing Workshop Will Be Held In June: On June 13-14, 2017, a “Nanosensor Manufacturing Workshop: Finding Better Paths to Products” will be held at the National Science Foundation in Arlington, Virginia. The Workshop supports the goals of the National Nanotechnology Initiative’s (NNI) Nanotechnology Signature Initiative, “Nanotechnology for Sensors and Sensors for Nanotechnology.” According to NNI, the Workshop will identify key elements needed to achieve production-scale manufacturing of nanotechnology-enabled sensors. NNI will webcast the Workshop. According to NNI, the Workshop will culminate in a publicly available report and may inform future research priorities for achieving scalable manufacturing and commercialization of nanosensors.

Legislative Developments

Congress Passes Legislation On Funding; EPA Budget Left Largely Intact: Facing a government shutdown, late on April 30, 2017, lawmakers reached agreement on a spending bill that funds the federal government through September 2017, which is the end of Fiscal Year (FY) 2017. Both houses passed the bill the week of May 1, 2017. President Trump’s budget blueprint sought to slash EPA’s coffers by some 31 percent (and more if certain programs were eliminated from the base). The deal reached by lawmakers, however, would essentially fund EPA at its current levels and retain current staff levels. The bill appropriates $8.058 billion for EPA, paring a little over $80 million -- about one percent -- from EPA’s FY 2016 budget. Programs targeted for elimination by President Trump remain funded, at least through September, when Congress will face another budget showdown. For example, the bill funds the Great Lakes Restoration Initiative, the Chesapeake Bay Program, and lead elimination programs. While EPA’s budget is generally unchanged, the bill does contain several policy riders. It would require EPA to treat air emissions from forest biomass as carbon neutral. EPA also would not be allowed to regulate manure and similar agricultural byproducts as wastes under RCRA, and the bill would bar EPA from requiring CWA permits for certain agricultural practices. The legislation also prohibits funding to regulate lead content of ammunition, ammunition components, and fishing tackle under TSCA or any other law. Senate Report No. 114-281 on the pending FY 2017 budget deal and an accompanying explanatory statement also address specifically TSCA, the Integrated Risk Information System (IRIS), and nanomaterials. The specific language is below.

Toxic Substances Control Act Modernization: The Committee notes that legislation to modernize TSCA was recently approved by both the Senate and the House of Representatives. This bill includes language that will enable the EPA to collect and spend new fees to conduct additional chemical reviews, consistent with TSCA modernization legislation. Those fees are expected to be $25,000,000 per year once the program is fully implemented. The Congressional Budget Office estimates that in fiscal year 2017, fee collections will begin several months after the beginning of the fiscal year and will total $4,000,000. This bill also includes language ensuring that new fee collections will supplement, not supplant, appropriated resources for these activities.

Integrated Risk Information System: The Committee is aware of efforts by the Agency to implement the 2011 National Academy of Science’s [NAS] Chapter 7 and 2014 NAS report recommendations for the Integrated Risk Information System [IRIS] but remains concerned that the recommendations have not been fully implemented. In published appendices that accompany final IRIS assessments, EPA has detailed some of the Agency’s deficiencies in meeting the NAS high-priority reforms. The Committee directs the Agency to convene an interagency working group to be Co-Chaired with the Office of Information and Regulatory Affairs and to include relevant executive branch stakeholders to review compliance with the NAS recommendations in IRIS assessments issued since the 2014 NAS report. The working group shall focus specifically on transition from the use of single point estimates of hazard and exposure to presenting more complete information on the distribution of estimated hazards, exposures, and/or risks, including central tendency values; on processes for evaluating study quality, relevance, and risk of bias; the use of a transparent and reproducible weight-of-evidence process for applying scientific findings; the selection of an adverse outcome; and the use of default linear low-dose extrapolation and other default modeling approaches to hazard determinations. The Committee directs the Agency to issue a report to the Committees of Appropriations of the House and Senate on the findings of the working group and the implementation plans of its findings within 180 days of enactment of this act. The working group report shall also include a timetable for EPA’s full implementation of the NAS recommendations for all IRIS assessments issued since the 2014 NAS report.

Nanomaterials Research: The Committee notes the increased capabilities that the Food and Drug Administration [FDA] has developed to study environment, health, and safety of nanomaterials [nanoEHS] within FDA’s Jefferson Laboratory Campus, including the National Center for Toxicological Research, and its consolidated headquarters at White Oak, Maryland. The FDA can and should be more involved in nanoEHS research with other agencies, particularly in activities involving human health. Out of the amounts appropriated, the [EPA] Administrator shall seek to involve the FDA in nanoEHS research to the maximum extent possible, including participation in EPA funded research.

Senate Rejects Bid To Void Methane Rule: In a surprising move, the Senate voted to not consider a Congressional Review Act (CRA) resolution (H.J. Res. 36) that would have voided the Bureau of Land Management’s final rule establishing regulations to reduce waste of natural gas from venting, flaring, and leaks during oil and natural gas production activities on onshore federal leases. 81 Fed. Reg. 83008 (Nov. 18, 2016). Congress had passed 13 consecutive CRA resolutions before the Senate rejected H.J. Res. 36. Only 51 votes were needed to continue consideration and a vote on the resolution; only 49 Senators voted to move forward.

Lead-Free Schools Act Would Amend Safe Drinking Water Act: On April 14, 2017, Representative Josh Gottheimer (D-NJ) introduced the Lead-Free Schools Act (H.R. 2094). The bill redirects existing funding and amends the Safe Drinking Water Act (SDWA) to increase testing for lead and contaminants in water at schools and provide funding for a competitive grant program for the replacement of old fountains and infrastructure that may be leaching lead and other contaminants. The bill would also set deadlines for EPA to establish national primary drinking water standards for lead and other contaminants.

Bicameral Climate Change Adapt America Fund Act Introduced: On April 25, 2017, Senator Dick Durbin (D-IL) and Representative Ted Deutch (D-FL) introduced the Climate Change Adapt America Fund Act (S. 922, H.R. 2129). The bicameral legislation would create an Adapt America Fund that would be tapped to finance climate change adaptation and infrastructure resiliency projects. The bill would authorize DOT to issue up to $200 million annually in Climate Change Bonds to be purchased by Americans. The proceeds would be directed to the Adapt America Fund and support investments that help states and local communities prepare for the impacts of climate change. The bill would also authorize the formation of an 11-member Climate Change Advisory Commission, which would develop guidelines to award the funds.

Regulatory Reform Bill Introduced In Senate: On April 26, 2017, Senators Rob Portman (R-OH) and Heidi Heitkamp (D-ND) introduced the Regulatory Accountability Act (S. 951). The bipartisan legislation is intended to update the federal regulatory process. The bill is a companion to H.R. 5, which the House of Representatives passed on January 11, 2017, by a 238-183 vote. The measure is based on bipartisan EOs from the past five Presidents, and it would result in a more transparent, accountable regulatory process that would yield more effective regulatory outcomes for American businesses, workers, and their families. The bill would codify the duty to analyze the costs and benefits of new regulations. It would also require agencies to adopt the most cost-effective approach to achieve their objectives. To hold agencies accountable, the bill would permit a judicial check on an agency’s cost-benefit analysis of major rules. The bill would invite early public participation on major rules and require federal agencies to disclose the information they rely upon in an attempt to ensure greater transparency in the rulemaking process. It also would ensure that agencies use sound scientific and technical data to justify new rules, in keeping with calls for agencies to use the “best available science” to craft regulations. The bill would codify key regulatory EOs that have been in place from President Reagan through President Obama. It also would require federal agencies to build in an automatic review for the largest, most significant rules at least once every ten years to ensure that those rules are still meeting regulatory objectives and work as intended, and to consider whether they could be improved to produce better results or be more cost-effective. The measure would further require federal agencies to follow a more evidence-based approach in crafting rules that will cost more than $1 billion annually. This legislation would give those impacted by the regulations greater access to an agency hearing to test the key disputed facts underlying these mega-rules.

Senate Bill Seeks To Make America 100 Percent Clean Energy By 2050: On April 27, 2017, SenatorsJeff Merkley (D-OR), Bernie Sanders (I-VT), Edward J. Markey (D-MA)m and Cory Booker (D-NJ) introduced legislation that would transition the U.S to 100 percent clean energy by the y ear 2050. The bill is the first introduced in Congress that fully envisions a transition off of fossil fuels for the U.S. The 100 By ’50 Act (S. 967) bill has seven core components:

  • Greening the Grid -- Phase-out fossil fuel electricity by 2050 and replace it with clean and renewable energy, through a mandatory fossil fuel phase-out and major investments in clean and renewable energy, storage, and grid infrastructure to ensure reliability and affordability.

  • Electrifying the Energy Economy -- Electrify transportation and heating systems with power from the clean electrical grid, through a national zero emissions vehicle standard, major investments in zero emission vehicles and zero emission heating systems, as well as carbon taxing authority for commercial aviation, maritime, and rail.

  • Clean and Renewable Energy for All -- Ensure that low-income and disadvantaged communities share in the benefits of a transition to 100 by 2050, through grants to make clean energy, energy efficiency, and public transportation affordable and accessible, and to provide job training in the clean energy sector.

  • Just Transition for Workers -- Provide a just transition for the people who work in the fossil fuel economy to find good jobs in growth industries of the future, and get fair benefits between jobs or in retirement.

  • Ending New Fossil Fuel Investments -- Stop the approval of major fossil fuel projects and end fossil fuel subsidies.

  • Ensuring American Competitiveness -- Make sure that energy-intensive U.S. products maintain a level playing field with products imported from other countries by imposing a carbon tariff for imported carbon-intensive products.

  • Mobilizing American Resources -- Create a major new source of funding to ensure a rapid and smooth transition to 100 by 2050 by auctioning Climate Bonds and investing the funds in the new programs created by S. 967.

Senate Bill Seeks To Improve EPA Transparency: Senator John Thune (R-SD) on April 27, 2017, introduced a bill intended to increase transparency in EPA’s rulemakings. The Real EPA Impact Reviews (REPAIR) Act (S. 971) is intended to facilitate a more transparent EPA regulatory impact analyses (RIA) process. It would require EPA to include a scenario in each of its RIAs that does not contain additional proposed regulations. The REPAIR Act was prompted by EPA’s draft 2014 RIA for lowering the National Ambient Air Quality Standard (NAAQS) for ozone. The RIA assumed that the numerous other regulations would be fully implemented, despite the possibility that these regulations may have been subject to delay, modification, or dismissal prior to finalization. The RIA also included in its baseline assumptions that the existing ozone standard would be fully implemented, despite the fact that 227 U.S. counties had yet to meet the existing standard. Such inclusions likely caused the RIA to underestimate significantly the true cost of a lower ozone standard, Senator Thune argues. By prohibiting the inclusion of proposed rules and regulations in at least one RIA scenario, stakeholders will have a clearer understanding of a proposed regulation’s true compliance costs, he added.

Bipartisan Climate Solutions Bill Introduced In House: On May 3, 2017, Representatives John Delaney (D-MD) and John Faso (R-NY) introduced legislation intended to address climate change and “initiate a bipartisan solution to the environmental crisis of our time.” The Climate Solutions Commission Act (H.R. 2326) would create a National Climate Solutions Commission whose purpose would be to review economically viable public and private actions or policies to reduce greenhouse gas emissions. The National Climate Solutions Commission would be required to give the White House, Congress, and the states their recommendations within 18 months. The commission would have ten members, five Democrats and five Republicans. The bill also would direct the Government Accountability Office (GAO) to study and report on the financial tools, policies, and institutions most successful at reducing greenhouse gas emissions while protecting economic growth and employment.

Senate Bill Aims To Improve Federal Response To Emerging Contaminants In Drinking Water: On April 24, Senators Jeanne Shaheen (D-NH) and Rob Portman (R-OH) introduced the Safe Drinking Water Assistance Act (S.914), which is aimed at federal efforts to address unregulated, emerging contaminants in drinking water. The Senators’ home states, New Hampshire and Ohio, have faced issues with the presence of perflourinated chemicals (PFC) and cyanotoxins, respectively, in recent years. In August 2014, cyanotoxins in Lake Erie caused by harmful algal blooms led to the shutdown of Toledo’s public drinking water supply for several days. The SDWA requires EPA to identify and analyze routinely emerging contaminants and provide guidance to state and local officials on potential health risks. Most state and local entities lack the resources to monitor emerging contaminants of concern, and vast knowledge gaps exist on both the health effects and occurrence of these compounds in drinking water systems and source waters for drinking supplies.

S.914 would establish a national strategy to coordinate the federal response to emerging contaminants, and assist with state-level response through the following actions:

  • Creation of an EPA-led program to provide communities with federal resources and technical assistance when emerging contaminants are detected in their drinking water supplies;

  • Establishment of a comprehensive database of resources to assist with testing for emerging contaminants;

  • Creation of an EPA and Department of Health and Human Services interagency working group to improve federal identification and response efforts; and

  • Development of an interagency federal research strategy to improve identification, analysis, and treatment methods.

S. 914 was referred to the Committee on Environment and Public Works where it awaits further action. If enacted, the national strategy established under the Safe Drinking Water Assistance Act could accelerate EPA regulatory action on chemicals that are not currently regulated under the SDWA. The availability of occurrence data is a main driver in EPA’s selection of contaminants for Contaminant Candidate Lists (CCL), which is issued every five years. Listing contaminants on the CCL is the first step toward a potential SDWA regulatory determination. CCL4, which was issued in late 2016, includes several pesticide active ingredients and/or pesticide degradates, industrial solvents, and paint and coating ingredients. Any future strategy would likely require federal appropriations to move forward with technical assistance and research efforts.

 Environmental Council Of The States Adopts Several Resolutions At Spring Meeting: During its spring meeting in April, the Environmental Council of the States (ECOS) adopted several resolutions. ECOS is the national nonprofit, nonpartisan association of state and territorial environmental agency leaders. The resolutions ECOS adopted are:

OSHA Removes Regulations Clarifying Employers’ Continuing Obligations To Make And Maintain An Accurate Record Of Each Recordable Injury And Illness: The Occupational Safety and Health Administration (OSHA) on May 3, 2017, removed the regulations pertaining to employers’ continuing obligation to make and maintain an accurate record of each employee’s work-related injury and illness. 82 Fed. Reg. 20548. On December 19, 2016, OSHA promulgated a final rule entitled “Clarification of Employer’s Continuing Obligation to Make and Maintain an Accurate Record of Each Recordable Injury and Illness.” 81 Fed. Reg. 91792. The final rule amended OSHA’s recordkeeping regulations clarifying that the duty to make and maintain accurate records of work-related injuries and illnesses is an ongoing obligation. On March 1, 2017, the House of Representatives passed a resolution of disapproval (H.J. Res. 83) of the rule under the CRA. The Senate passed H.J. Res. 83 on March 22, 2017. President Trump signed the resolution into law on April 3, 2017. Accordingly, OSHA is removing the affected amendments to the recordkeeping regulations from 29 C.F.R. Sections 1904.29, 1904.32, 1904.33, 1904.34, 1904.35, and 1904.40.

Parties To Stockholm Convention Agree To New Restrictions: On May 5, 2017, parties to the Stockholm Convention agreed to ban the production, use, and trade of two toxic chemicals -- decabromodiphenyl ether (DecaBDE) and short-chain chlorinated paraffins (SCCP) -- and to reduce the unintentional release of a third, hexachlorobutadiene (HCBD). Parties to the Rotterdam Convention agreed to new obligations for four toxic substances that ensure countries will verify their trading partners’ consent to receive restricted chemical exports. Specifically, Rotterdam Convention parties agreed to list SCCPs, carbofuran, trichlorfon, and tributyltin compounds to Annex III of the treaty. India and five other asbestos-producing nations -- Russia, Kazakhstan, Kyrgyzstan, Syria, and Zimbabwe -- blocked the listing of chrysotile asbestos.

ICCVAM Invites Comments Regarding Its Preparation Of A Strategic Roadmap: New Approaches To Evaluation: On May 8, 2016, EPA announced its invitation for public input regarding the “Strategic Roadmap: New Approaches to Evaluate the Safety of Chemicals and Medical Products” (Roadmap), the development of which was coordinated by the National Toxicology Program’s (NTP) Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). ICCVAM states that the vision of the Roadmap is to “establish new approaches for evaluating the safety of chemicals and medical products in the United States that will increase confidence in alternative methods and improve their relevance to human health outcomes while maximizing efficiency and maintaining a commitment to replace, reduce, and refine animal use.” ICCVAM’s Roadmap effort was introduced in March 2016. A detailed presentation on the development of the Roadmap is available here.

ICCVAM, a permanent committee of the National Institute of Environmental Health Sciences (NIEHS) under the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), is composed of representatives from 16 U.S. federal regulatory and research agencies that require, use, generate, or disseminate toxicological and safety testing information. As a participating member of ICCVAM, EPA states that its role is to “encourage the development and use of alternatives to animal test methods, ensure that new methods are valid, review test method recommendations, and as appropriate, adopt these alternatives in our own regulatory programs.” Further information on the Roadmap is available on the NTP website. Comments can be submitted by e-mail to ICCVAMquestions@niehs.nih.gov by August 31, 2017.

Trump Announces Intention To Nominate Susan Bodine, EPW Committee Chief Counsel, For EPA Assistant Administrator For OECA: On May 12, 2017, President Trump announced his intention to nominate Susan Bodine to be an EPA Assistant Administrator for EPA’s Office of Enforcement and Compliance Assurance (OECA). Ms. Bodine has been the Chief Counsel for the Senate Environment and Public Works Committee (EPW) since January 2015. Prior to her position at the Senate EPW Committee, Ms. Bodine was a Partner at Barnes & Thornburg LLP from 2009-2015, and Assistant Administrator of EPA’s Office of Solid Waste and Emergency Response from 2006-2009.

©2017 Bergeson & Campbell, P.C.

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