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Recent Federal Developments- June 2017: TSCA Reform; EPA To Delay Agricultural WPS Indefinitely; Food Contact Sanitizing Solutions Model; FDA Posts Updates On FSVP Final Rule Under FSMA; Regulatory Treatment Of Unlisted Chemicals

Federal Issues

TSCA Reform -- One Year Later: Join the Environmental Law Institute (ELI) and the George Washington University Milken Institute School of Public Health on June 27, 2017, for "TSCA Reform, One Year Later," a day-long conference exploring the federal government’s implementation of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which significantly amended the Toxic Substances Control Act (TSCA), just over one year after it was signed into law. This event is free and open to the public. Speakers will discuss key components of the bipartisan legislation and will provide an overview of the current state of implementation. Afternoon breakout sessions will invite all participants to discuss ongoing law and policy issues.

Speakers include:

  • Hon. John ShimkusU.S. Representative (R-IL)

  • Bonnie Englebardt Lautenberg

  • Lynn R. Goldman, M.D., M.S., M.P.H., Michael and Lori Milken Dean, Milken Institute School of Public Health; Professor of Environmental and Occupational Health

  • Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C.

  • Dimitri J. Karakitsos, Partner, Holland & Knight

  • Scott Fulton, President, Environmental Law Institute

TSCA/FIFRA

EPA To Delay Agricultural WPS Indefinitely; Cites Issues With Guidance And Training: In a May 11, 2017, letter from U.S. Environmental Protection Agency (EPA) Acting Assistant Administrator Wendy Cleland-Hamnett to the Chief Executive Officer of the National Association of State Departments of Agriculture (NASDA), Cleland-Hamnett states that it is appropriate to grant NASDA’s request to delay implementation of all revised provisions to the agricultural Worker Protection Standard (WPS) “until the necessary guidance and training have been completed which would allow state lead pesticide agencies to successfully implement the rule changes.” EPA has not yet issued any formal delay notifications. The May 11, 2017, letter was sent in response to a February 17, 2017, letter from NASDA that requested EPA to extend the WPS “until at least January 2, 2018, or until adequate enforcement guidance, educational materials, and training resources have been completed and the state lead agencies have the tools, time, and resources necessary to effectively implement the rule changes and assist the regulated community with compliance activities.” This letter was not submitted in the WPS docket in response to a request for comment, but pursuant to a NASDA membership decision. NASDA states in the letter that the new WPS regulations require “significant additional staff time to provide sufficient outreach to workers, handlers, applicators, agricultural employers, trainers and other stakeholders,” and that “the enhanced compliance and record keeping requirements require a robust delivery and understanding of educational resources and training materials to assist [state lead agencies] and the regulated community in understanding, complying, and enforcing the new requirements.” The WPS final rule, including updates and revisions to the existing worker protection regulations for pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), became effective on January 1, 2016, and on January 4, 2017, agricultural employers and handler employers were required to comply with all of the new requirements set forth in the final rule -- with the exception of two requirements that would be implemented not before January 2018.

EPA Releases New Model To Calculate Exposure To Food Surface Sanitizers: On May 31, 2017, EPA announced the release of its Food Contact Sanitizing Solutions Model (FCSSM), a pesticide risk assessment model that has been developed to estimate indirect dietary exposure to components of sanitizing solutions used in commercial settings. The model consists of spreadsheets that automatically calculate dietary exposure and risk estimates based on data entered by the user. The model estimates exposures to antimicrobial active ingredients listed under 40 C.F.R. § 180.940(b) and 40 C.F.R. § 180.940(c), where 940(b) includes uses in dairy processing equipment and food processing equipment and utensils, while 940(c) excludes dairy processing equipment. FCSSM does not apply to active ingredients listed under 40 C.F.R. § 180.940(a), which are used on food contact surfaces in public eating places as well as dairy and food processing equipment. For this case, EPA’s established methodology remains in place. Compared to the simple calculation method used previously for these use scenarios, the major new feature of the FCSSM is the separate calculations of both acute and chronic dietary exposures for the general U.S. population and eight subpopulations. EPA also released a user guide that provides background information on the model and familiarizes users with the inputs required to run the model. More information about the FCSSM, as well as other models used for pesticide risk assessments, is available on EPA’s website.

EPA Releases Ecological Risk Assessments For Neonicotinoids And Announces Next Steps In Registration: On May 25, 2017, EPA announced the release of ecological risk assessments for four neonicotinoid active ingredients for public comment, as well as the Registration Review Update for Four Neonicotinoid Insecticides (Update). 82 Fed. Reg. 24113. The ecological risk assessments are: the preliminary aquatic risk assessment for imidaclopridthe combined preliminary bee risk assessment for clothianidin and thiamethoxam; and the draft assessment of the potential effects of dinetofuran on bees. EPA states that public comments “could address, among other things, the Agency’s risk assessment methodology and assumptions applied to its draft risk assessments, such as its methodology for estimating colony-level risk to bees from exposure to bee bread.”

The main focus of the Update document is EPA’s efforts to harmonize the risk assessment and management of the four neonicotinoids during registration review. EPA has identified additional pollinator exposure data and pollinator toxicity data needs; registrants have committed to producing the needed data, and most of the data will be submitted in 2017. EPA plans to produce final pollinator risk assessments for both agricultural and non-agricultural uses in 2018. Release of non-pollinator risk assessments (i.e., aquatic organisms, terrestrial mammals, and birds) is planned for 2017. Human health risk assessments are also scheduled to be issued in 2017. EPA has stated that mitigating risk from the uses of all neonicotinoids may be considered for all four compounds at the same time to ensure consistent risk management and to prevent unnecessary shifts in usage between the compounds without a reduction in risk. EPA intends to release final pollinator assessments and proposed interim decisions for registration review for all four neonicotinoids in 2018. Comments on the three ecological risk assessments are due by July 24, 2017. More information is available here.

EPA Releases Initial 2016 CDR Data: EPA released in June initial data collected under EPA’s Chemical Data Reporting (CDR) rule from the 2016 CDR reporting period. The initial release of the 2016 CDR data includes national production volume, other manufacturing information, and processing and use information, but does not include information that was claimed by the submitter to be confidential business information (CBI) or information that is being withheld to protect CBI. EPA anticipates releasing additional data in Fiscal Year (FY) 2018 after the completion of an ongoing CBI substantiation process required by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which amended TSCA. There are changes to reporting since the 2012 CDR, including the reporting of new information as a result of a new lower threshold for reporting chemicals subject to certain TSCA actions and changes to processing and use reporting. CDR data are collected every four years, with the latest submission period ending on October 31, 2016. Under the CDR rule, EPA collects basic exposure-related information on the types, quantities, and uses of chemical substances produced domestically and imported into the United States. The 2016 CDR data are available via ChemView at https://java.epa.gov/chemview. More information on the CDR is available at https://www.epa.gov/chemical-data-reporting.

EPA Announces Establishment Of Negotiated Rulemaking Committee:  On June 5, 2017, EPA announced the formal establishment of a Negotiated Rulemaking Committee under the Negotiated Rulemaking Act. 82 Fed. Reg. 25790. The Committee is intended to negotiate a proposed rule that would limit CDR requirements under TSCA Section 8(a) for manufacturers of inorganic byproduct chemical substances that are recycled, reused, or reprocessed. The rulemaking is required by TSCA Section 8(a)(6). The Committee met on June 8-9, 2017, and will meet again on August 16-17, 2017.

EPA Announces Availability Of Performance Testing Methods For Bed Bug Pesticide Products: On June 14, 2017, EPA announced the availability of a final test guideline, Laboratory Product Performance Testing Methods for Bed Bug Pesticide Products; OCSPP Test Guideline 810.3900. 82 Fed. Reg. 27254. The test guideline is part of a series of test guidelines established by the Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances. The test guidelines serve as a compendium of accepted scientific methodologies and protocols that are intended to provide data to inform regulatory decisions. This test guideline provides guidance for conducting a study to determine pesticide product performance against bed bugs, and is used by EPA, the public, and companies that submit data to EPA.

RCRA/CERCLA/CWA/CAA/HMT

EPA Delays Effective Date Of RMP Rule By 20 Months: On June 14, 2017, EPA delayed for 20 months the effective date of the Risk Management Program (RMP) rule revisions under the Clean Air Act (CAA). 82 Fed. Reg. 27133. EPA states that the extension will allow it time “to conduct a reconsideration proceeding and to consider other issues that may benefit from additional comment.” EPA received three petitions for reconsideration from two industry groups and the Attorneys General of Louisiana, Arizona, Arkansas, Florida, Kansas, Kentucky, Oklahoma, South Carolina, Texas, Wisconsin, and West Virginia. The industry groups include a coalition of the American Chemistry Council, American Forest & Paper Association, American Fuel & Petrochemical Manufacturers, American Petroleum Institute, U.S. Chamber of Commerce, National Association of Manufacturers, and Utility Air Regulatory Group. The Chemical Safety Advisory Group also filed a petition for reconsideration on the rule. The RMP revisions were published in the Federal Registeron January 13, 2017. 82 Fed. Reg. 4594. On January 26, 2017, and March 16, 2017, EPA delayed the effective date of the amendments until June 19, 2017. The new effective date of the rule is February 19, 2019.

EPA Extends Compliance Date For Formaldehyde Emissions Standards: On May 24, 2017, EPA issued a direct final rule, 82 Fed. Reg. 23735, and a proposed rule, 82 Fed. Reg. 23769, extending the TSCA Title VI final rule compliance dates, including: extending the December 12, 2017, date for emission standards, recordkeeping, and labeling provisions until March 22, 2018; extending the December 12, 2018, date for import certification provisions until March 22, 2019; and extending the December 12, 2023, date for provisions applicable to producers of laminated products until March 22, 2024. Additionally, this direct final action will extend the transitional period during which the California Air Resources Board (CARB) Third Party Certifiers (TPC) may certify composite wood products under TSCA Title VI without an accreditation issued by an EPA TSCA Title VI Accreditation Body so long as the TPC remains approved by CARB, is recognized by EPA, and complies with all aspects of the December 12, 2016, final rule. Extension of these compliance dates and the transitional period for CARB TPCs adds regulatory flexibility for regulated entities, reduces compliance burdens, and helps to prevent disruptions to supply chains. The final rule is effective on July 10, 2017, without further notice, unless EPA received adverse comment by June 8, 2017. If EPA received adverse comment, EPA will publish a timely withdrawal of the rule and inform the public that this rule will not take effect.

Administrator Pruitt Forms Task Force To Expedite Superfund Cleanups: On May 22, 2017, EPA Administrator Scott Pruitt established a task force to provide recommendations on an expedited timeframe on how EPA can restructure the cleanup process under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund). The task force will also be charged with realigning incentives to promote expeditious remediation, reduce the burden on cooperating parties, incentivize parties to remediate sites, encourage private investments, and promote the revitalization of properties. In the memorandum, Mr. Pruitt states that “Superfund programs take too long to start and too long to complete.” Pruitt vowed to restore Superfund cleanups “to their rightful place at the center of the agency’s core mission.” The task force will be chaired by Albert Kelly, a senior advisor to Mr. Pruitt. Within 30 days, the task force must prepare a set of recommendations on actions EPA can take to:

  • Streamline and improve the efficiency and efficacy of the Superfund program, with a focus on identifying best practices within regional Superfund programs, reducing the amount of time between identification of contamination at a site and determination that a site is ready for reuse, encouraging private investment at sites during and after cleanup, and realigning incentives of all involved parties to foster faster cleanups.

  • Overhaul and streamline the process used to develop, issue, or enter into prospective purchaser agreements, bona fide prospective purchaser status, comfort letters, ready-for-reuse determinations, and other administrative tools under the Agency’s existing authorities used to incentivize private investment at sites.

  • Streamline and improve the remedy development and selection process, particularly at sites with contaminated sediment, including to ensure that risk-management principles are considered in the selection of remedies at such sites. In addition, the task force should propose recommendations for promoting consistency in remedy selection and more effective utilization of the National Remedy Review Board and the Contaminated Sediments Technical Advisory Group in an efficient and expeditious manner.

  • Utilize alternative and non-traditional approaches for financing site cleanups, as well as improvements to the management and use of Superfund special accounts.

  • Reduce the administrative and overhead costs and burdens borne by parties remediating contaminated sites, including a reexamination of the level of agency oversight necessary.

  • Improve EPA’s interactions with key stakeholders under the Superfund program, particularly other federal agencies at federal facilities and federal potentially responsible parties, and expand the role that tribal, state, and local governments, local and regional economic development zones, and public-private partnerships play in the Superfund program. In addition, the task force should propose recommendations for better addressing the liability concerns of state, tribal and local governments.

EPA Extends Compliance Deadline For 2015 Ozone NAAQS Area Designations: On June 6, 2017, EPA announced that it is extending the deadline for promulgating initial area designations by one year for the 2015 ozone National Ambient Air Quality Standards (NAAQS). EPA is giving states more time to develop air quality plans and intends to provide greater flexibility to states as they develop their plans. Pursuant to language in the FY 2017 Omnibus funding bill, EPA Administrator Scott Pruitt is establishing an Ozone Cooperative Compliance Task Force to develop additional flexibilities for states to comply with the ozone standard.

EPA Extends For Two Years Stay Of Provisions Of Oil And Gas Methane Rule: On May 31, 2017, EPA proposed to stay for two years certain requirements of the 2016 final rule curbing emissions of methane from the oil and gas sector. The 2016 rule establishes New Source Performance Standards (NSPS) under the CAA for greenhouse gases and volatile organic compounds (VOC) emitted from the oil and natural gas sector. 81 Fed. Reg. 35824; June 3, 2016. The rule addresses, among other things, fugitive emissions at well sites and compressor stations and emissions from pneumatic pumps. For centrifugal compressors, reciprocating compressors, pneumatic pumps, and storage vessels, the rule also requires certification by a professional engineer of the closed vent system design and capacity, as well as any technical infeasibility determination relative to controlling pneumatic pumps at well sites. EPA stayed the rule in April for three months to allow it time to consider whether objections to the rule warranted reconsideration. On August 2, 2016, several interested parties submitted administrative petitions to EPA seeking reconsideration of various aspects of the 2016 rule pursuant to CAA Section 307(d)(7)(B). Those petitions included objections to the fugitive emissions requirements, well site pneumatic pump standards, and the requirements for certification by a professional engineer. On April 18, 2017, EPA Administrator Scott Pruitt launched a proceeding for reconsideration of the following objections relative to the fugitive emissions requirements: (1) the process and criteria for requesting and receiving approval for the use of alternative means of emission limitations (AMEL) for purposes of compliance with the fugitive emissions requirements in the 2016 rule; and (2) the applicability of the fugitive emissions requirements to low production well sites. EPA has since identified objections to two other aspects of the rule that meet the criteria for reconsideration under CAA Section 307(d)(7)(B). These objections relate to the requirements for certification of a closed vent system by a professional engineer and the well site pneumatic pump standards. The proposed two-year stay “would provide the EPA sufficient time to propose, take public comment, and issue a final action on the issues concerning the specific requirements on which EPA has granted reconsideration,” EPA stated, adding that during the stay, EPA also plans to complete its reconsideration process for all remaining issues raised in the reconsideration petitions. A copy of the pre-publication version of the notice is available online.

FDA

FDA Withdraws Draft Guidance On The Applicability Of Color Additive Regulations Authorizing The Use Of Certain Fruit Juice And Vegetable Juice:  On May 12, 2017, the U.S. Food and Drug Administration (FDA) announced that it would be withdrawing its 2016 draft guidance on the use of fruit juice and vegetable juice as color additives, based on public comments that raised substantive technical concerns, for example that the guidance “promoted practices that may be inconsistent with current industry practices intended to enhance food safety.” FDA states that even though it is withdrawing this draft guidance, the regulations authorizing certain plant-derived color additives remain in place it “will continue to respond on a case-by-case basis to industry questions on these topics … [and] intends to continue evaluating information submitted to its docket and consulting with stakeholders in considering next steps.”

FDA Posts Updates On FSVP Final Rule Under FSMA:  On May 26, 2017, FDA posted a constituent update on its website regarding the Foreign Supplier Verification Programs (FSVP) final rule, one of seven foundational rules of the FDA’s Food Safety Modernization Act (FSMA). In a posted question and answer (Q&A) interview, Sharon Mayl, Senior Advisor for Policy in the Office of Foods and Veterinary Medicine at FDA, explains what is ahead as FSVP implementation moves forward, as well as the answers to important questions regarding the first compliance date that has just passed -- May 30, 2017 -- such as who must be in compliance, what importers have to verify, and what can importers expect when an investigator reviews their FSVP, among others. The full list of compliance deadlines for the FSVP is available on FDA’s website. FDA also posted a fact sheet and other guidance and FSVP information in another constituent update issued May 11, 2017.

FDA Announces Opportunity To Comment On FDA’s Regulations For Submission Of Petitions, Including Food And Color Additive Petitions: 

On May 30, 2017, FDA issued a notice in the Federal Register announcing an opportunity for public comment on the information collection provisions of its regulations for submission of petitions, including food and color additive petitions (FAP and CAP) (including labeling), submission of information to a master file in support of petitions, and electronic submission using FDA Form 3503. 82 Fed. Reg. 24718. FDA is inviting comment on these topics:

  • Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility;

  • The accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

  • Ways to enhance the quality, utility, and clarity of the information to be collected; and

  • Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Comments are due July 31, 2017.

FDA Intends To Extend Compliance Dates For Agricultural Water Standards Under FSMA: On June 6, 2017, FDA announced it was intending to extend the compliance dates for agricultural water requirements in the Produce Safety Rule (PSR), a final rule promulgated under FDA’s FSMA which establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. FDA states that it intends to use the extended time period to “work with stakeholders as it considers the best approach to address their concerns while still protecting public health,” and the extended compliance dates, the length of which are still under consideration, will “also give farms an opportunity to continue to review their practices, processes and procedures related to agricultural water and how it is used on their farms.”

NANOTECHNOLOGY

France Publishes English Summary Of Study On Development Of Nanomaterials By 2030: On April 26, 2017, France’s National Research and Safety Institute (INRS) published a press release announcing the availability of an English summary of a foresight study conducted in 2014 on the development of nanomaterials by 2030 and the consequences on safety and health in small businesses in France. Four scenarios were envisioned. According to INRS, the possible future outcomes “should lead to a better apprehension of the risks associated with these promising materials.” The foresight study is one of three exercises that INRS has conducted to date. In 2017, INRS intends to begin a fourth exercise that will address the circular economy and its consequences on occupational safety and health.

Germany Publishes Final Report From Project On Methodology For Identifying Granular Biopersistent Particles At Workplaces: Germany’s Federal Institute for Occupational Safety and Health (BAuA) has published the final report for the project “Methodology for the Identification of Granular Biopersistent Particles (GBP) at Workplaces.” The final report states that the category includes respirable granular biopersistent particles without known significant specific toxicity. This category comprises various materials such as minerals, metals, metal oxides, or polymers that show a negligible solubility in lung fluids (extracellular lung lining fluid, intracellular lysosomal fluid). The abstract states:

Outlook

The inhalation exposure pathway will show lower effects as compared to intratracheal instillation as no bolus effects will occur. Therefore, the final setting of maximum tolerable clearance t1/2 and PMN levels to define the GBP category should await the outcome of the inhalation validation study.

EPA Seeks Comment On Draft Guidance For Nanoscale Materials Reporting Rule: EPA published 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.” 82 Fed. Reg. 22452. The promised 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 TSCA Section 8(a) rule. The 14-page draft guidance, in the form of Q&As, addresses questions within the following categories: what chemicals are reportable; who is required to report; information that is to be reported; when is reporting required; general questions; and confidentiality. Comments are due June 15, 2017. More information regarding the draft guidance is available in our May 16, 2017, memorandum, “EPA Seeks Comment on Draft Guidance for Nanoscale Materials Reporting Rule.”

IARC Publishes Monograph On Carbon Nanotubes, Fluoro-Edenite, And Silicon Carbide: The International Agency for Research on Cancer (IARC) announced on May 19, 2017, publication of Volume 111 of the IARC Monographs, Some Nanomaterials and Some Fibres. The Monograph contains evaluations of the carcinogenic hazard to humans of fluoro-edenite fibrous amphibole, silicon carbide fibers and whiskers, and carbon nanotubes. As reported in our November 3, 2014, blog item, a summary of the findings was published in The Lancet Oncology in 2014. The Working Group, which met September 30-October 7, 2014, classified fluoro-edenite fibrous amphibole as carcinogenic to humans (Group 1). Regarding silicon carbide fibers and whiskers, the Working Group classified occupational exposures associated with the Acheson process as carcinogenic to humans (Group 1), and fibrous silicon carbide as possibly carcinogenic to humans (Group 2B). Although not unanimous, the Working Group classified silicon carbide whiskers as probably carcinogenic to humans (Group 2A) rather than possibly carcinogenic to humans (Group 2B). The Working Group classified single-walled and multi-walled carbon nanotubes as not classifiable as to their carcinogenicity to humans (Group 3), with the exception of a specific multi-walled carbon nanotube. Multi-walled carbon nanotubes-7 were classified as possibly carcinogenic to humans (Group 2B).

ECHA Publishes REACH Guidance For Nanomaterials: The European Chemicals Agency (ECHA) announced on May 24, 2017, publication of five documents that it intends to help registrants preparing dossiers that cover nanoforms ahead of the 2018 registration deadline under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. ECHA published two new guidance documents:

  • Nano-specific appendix to Chapter R.6 of the Guidance on information requirements and chemical safety assessment (quantitative structure-activity relationships and grouping of chemicals); and

  • How to prepare registration dossiers that cover nanoforms -- best practices.

In addition, ECHA published updates to three of its existing guidances on nanomaterials -- the appendices for nanomaterials to Chapters R.7a, R.7b, and R.7c of the Guidance on IR&CSA (endpoint specific guidance). ECHA states that these three documents provide nano-specific advice to help registrants meet the information requirements set out in REACH Annexes VI-XI.

ISO Publishes Procedure For Detecting Reactive Oxygen Species Generated By Metal Oxide Nanomaterials: The International Organization for Standardization (ISO) recently announced publication of standard ISO/TS 18827:2017, “Nanotechnologies -- Electron spin resonance (ESR) as a method for measuring reactive oxygen species (ROS) generated by metal oxide nanomaterials.” To detect and quantify ROS formation on the surface of metal oxide nanomaterials, the standard suggests the ESR method. The standard provides a method to assess ROS generation on the metal oxide nanomaterials in a cell free condition. According to ISO, this method may provide valuable information for the prediction of ROS-mediated cytotoxicity without cytotoxicity assay at physico-chemical evaluation phase.

NanoEHS Webinar Held On Voluntary Standards And Their Role In Enhancing The Quality Of Scientific Research: A May 24, 2017, webinar was held on “An Introduction to Voluntary Standards and Their Role in Enhancing the Quality of Scientific Research.” According to the National Nanotechnology Coordination Office (NNCO), the safe development and commercialization of nanotechnology depends on the availability of internationally agreed upon standards. Such standards enable the use of consistent terminology, measurement protocols, and well-characterized reference materials, and are thus foundational for precise and reproducible measurements. The webinar provided an introduction to voluntary standards, the nanomaterial measurement infrastructure, and how the development and use of standards enhances the quality of scientific research.

Appellate Court Vacates Conditional Nanosilver Registration: On May 30, 2017, the U.S. Court of Appeals for the Ninth Circuit responded to two petitions for review of EPA’s conditional registration of a nanosilver pesticide product and vacated the conditional registration. NRDC v. EPA, No. 15-72308. The Natural Resources Defense Council (NRDC) as well as the Center for Food Safety (CFS) and the International Center for Technology Assessment (ICTA) filed suit in 2015 asking the court to set aside EPA’s final order granting a conditional registration for a nanosilver-containing antimicrobial pesticide product named NSPW-L30SS (NSPW). The court vacated the conditional registration because, according to the court, “EPA failed to support its finding that NSPW is in the public interest.” When EPA granted the conditional registration, EPA did so on the basis that NSPW had a lower application rate and a lower mobility rate when compared to conventional-silver pesticides, and thus had the potential to reduce environmental loading and risk caused by silver release. Petitioners disputed these facts. While the court found that substantial evidence supports EPA’s findings that NSPW has lower application and mobility rates, the court agreed that the third premise, that current users of conventional-silver pesticides will switch to NSPW and/or that NSPW will not be incorporated into new products, “impermissibly relies on unsubstantiated assumptions.” According to the court, the public interest finding is an “essential prerequisite to conditional registration,” and EPA failed to support that finding for NSPW with substantial evidence. The court vacated the conditional registration in whole, and did not consider the remaining issues raised by petitioners. An EPA spokesperson declined to state whether EPA will appeal the decision. More information is available in our May 31, 2017, memorandum, “Appellate Court Vacates Conditional Nanosilver Registration.”

KAN Reviews Nanotechnology Standardization Documents From Occupational Safety And Health Perspective: Germany’s Commission for Occupational Health and Safety (KAN) released in May 2017 a report entitled Standardization in nanotechnology -- Status review and requirements analysis from the occupational safety and health perspective. According to the report, which is in German but includes an English summary, the authors conducted a structured status review of the standardization situation in the field of nanotechnology. The evaluation of the findings focuses on a comparison with national and European rules and regulations and identifies loopholes. The results are then used as the basis for recommendations to help occupational safety and health experts exert a targeted influence on standardization in nanotechnology and prevent standards that conflict with established rules and regulations. More information is available in our June 6, 2017, blog item, “KAN Reviews Nanotechnology Standardization Documents from OSH Perspective.”

ISO Publishes Standard Providing Plain Language Explanation Of Selected Terms From ISO/IEC 80004 Series: ISO published standard ISO/TR 18401:2017, “Nanotechnologies -- Plain language explanation of selected terms from the ISO/IEC 80004 series.” The standard is intended to assist stakeholders who are making decisions about the direction, management, and application of nanotechnologies to understand better selected key terms and definitions in the ISO/IEC 80004 vocabulary series for nanotechnologies. The standard offers explanations, including examples, of selected nanotechnology terms and is intended to facilitate an understanding of the use and applications of nanotechnology. More information is available in our June 7, 2017, blog item, “ISO Publishes Standard Providing Plain Language Explanation of Selected Terms from ISO/IEC 80004 Series.”

SEMI Hosts Webcast On New TSCA Requirements For Nanoscale Materials: On June 1, 2017, in concert with industry partners, SEMI hosted an information-sharing webcast concerning the new regulatory requirements for nanoscale materials under TSCA. Jim Alwood, Program Manager in EPA’s Chemical Control Division, provided a summary and answered questions about the new TSCA Section 8(a) recordkeeping and reporting requirements for nanoscale materials. SEMI has posted the following materials for download:

  • Introductory Slides;

  • EPA Presentation;

  • Q&A Session and Next Steps; and

  • SEMI Questions (forwarded to EPA on May 30, 2017).

Australian Consultation Paper Addresses Regulatory Treatment Of Unlisted Chemicals Introduced At The Nanoscale: On June 1, 2017, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) published Consultation Paper 5, which seeks feedback from stakeholders on the detail to be included in delegated legislation made under the framework established by the Industrial Chemicals Bill. Part 7 of the Consultation Paper is a proposal for the categorization of industrial chemicals introduced at the nanoscale. It presents options for the properties of nanoscale chemicals that should be used as criteria to define the chemicals that require pre-introduction assessment. NICNAS proposes that it will not categorize introductions of unlisted chemicals consisting of particles at the nanoscale using the same hazard and exposure band criteria proposed for other chemicals. Instead, NICNAS will set criteria using properties important for establishing which nanoscale chemicals require pre-introduction assessment. NICNAS will hold the following public workshops:

  • Sydney public workshop, June 16, 2017, 9:30 a.m. to midday; and

  • Melbourne public workshop, June 28, 2017, 9:30 a.m. to midday.

Comments on Consultation Paper 5 are due July 12, 2017. More information is available in our June 9, 2017, blog item, “Australian Consultation Paper Addresses Regulatory Treatment of Unlisted Chemicals Introduced at the Nanoscale.”

Sweden To Require Information On Nanomaterials In Product Register Notifications: On June 7, 2017, Sweden notified the European Commission (EC) that it intends to amend the information requirements concerning the Swedish Chemicals Agency’s (KEMI) product register to require notifiers to provide information on nanomaterials contained in the product. Under the draft regulation, the requirement will apply to nanomaterials that have been intentionally added to the product, regardless of the concentration of the nanomaterials. The definition of nanomaterial will reflect the EC’s recommended definition, except that nanomaterials that are natural or incidental shall not be notified to the product register. Exemption from the notification obligation is proposed for nanopigments and for entities with an annual turnover of less than SEK 5 million. Those covered by the exemption will provide information only as to whether a component is a nanomaterial. Other information may be provided on a voluntary basis. These exceptions will be valid for an evaluation period of three years. Product groups that are already exempt from the required registration in the product register will remain exempt, including waste, foodstuffs and animal feed, medicinal products, cosmetics, and tattoo inks. KEMI intends the rules on notification of nanomaterials to the product register to enter into force on January 1, 2018. Information on the presence of nanomaterials will be reported to KEMI’s product register beginning in February 2019.

ECHA Committee Concludes Titanium Dioxide Should Be Classified As Suspected Of Causing Cancer When Inhaled: On June 9, 2017, ECHA announced that the Committee for Risk Assessment (RAC) “concluded that the available scientific evidence meets the criteria in the [Classification, Labeling and Packaging (CLP)] Regulation to classify titanium dioxide as a substance suspected of causing cancer through the inhalation route.” In May 2016, France submitted a proposal for harmonized classification and labeling (CLH). The proposal’s conclusions on classification and labeling state:

TiO2 should be considered as being potentially carcinogenic to humans when inhaled and thus be classified Carc. Cat 1B-H350i. This classification applied for both fine particles and nanomaterials of TiO2 without being able of any distinction in terms of morphology, crystal phase, and surface treatment.

RAC assessed the carcinogenic potential of titanium dioxide against the CLP criteria and, having considered the available scientific data, concluded that it meets the criteria to be classified as suspected of causing cancer (category 2, through the inhalation route). According to ECHA, RAC concluded that there was insufficient evidence to classify titanium dioxide in the more severe category for carcinogenicity (category 1B) as was originally proposed by France. This more severe category refers to a substance that is presumed to cause cancer. Following adoption, RAC’s opinion will go through a normal editorial check before it is sent to the EC for final decision making. The opinion will be made available on ECHA’s website at that time.

ECHA Launches EU Observatory For Nanomaterials: On June 14, 2017, ECHA announced the launch of the European Union (EU) Observatory for Nanomaterials (EUON). ECHA states that EUON “offers a unique web-based information point with factual and neutral content about nanomaterials on the EU market.” EUON is targeted at a wide audience, including consumers, workers, regulators, and scientists. EUON provides information on uses, health and safety issues, research, regulation, and international activities. According to ECHA, EUON will be further developed in the coming years with new content to meet the audiences’ needs. EUON will also carry out studies and make use of external databases and publications. ECHA is hosting EUON based on a formal delegation agreement between ECHA and the EC. The agreement, signed at the end of 2016, runs until 2020. ECHA notes that the EC concluded that EUON “is the most efficient and proportionate measure to increase transparency and availability of information regarding nanomaterials.”

BIOBASED/RENEWABLE PRODUCTS

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.

LEGISLATIVE DEVELOPMENTS

Senate Committee Approves Several Regulatory Overhaul Bills: On May 17, 2017, the Senate Homeland Security and Governmental Affairs Committee approved several bills intended to overhaul the federal regulatory process. The Committee sent to the Senate floor the Regulatory Accountability Act of 2017 (RAA; S. 951), the Midnight Rules Relief Act of 2017 (S. 34), the Regulations from the Executive in Need of Scrutiny Act of 2017 (REINS Act; S. 21), the Providing Accountability Through Transparency Act of 2017 (S. 577), and the Early Participation in Regulations Act of 2017 (S. 577). Among the package of bills, the RAA is garnering the most attention. It would require agencies to weigh the costs and benefits of new regulations and require the adoption of the most cost effective alternative. For regulations with a cost exceeding $1 billion, the bill would require agencies to take a more “evidence-based” approach than they typically follow. The Midnight Rules Relief Act would allow lawmakers to repeal multiple rules under a single Congressional Review Act (CRA) resolution. The REINS Act would require regulations with a cost of $100 million or more to be approved by Congress before they take effect. S. 577 would require agencies to publish a plain-language, 100-word summary of proposed regulations. The Early Participation in Regulations Act would require federal agencies to issue an advance notice of proposed rulemaking at least 90 days before proposing a rule.

Bicameral Legislation Seeks To Repeal CRA: Senators Cory Booker (D-NJ) and Tom Udall (D-NM) on May 16, 2017, introduced legislation (S. 1140) that would repeal the CRA. A companion bill (H.R. 2249) was introduced in the House by Representative David Cicilline (D-RI). In a statement, Senator Udall stated that “Republicans' abuse of the CRA this year was a gift to their special interest campaign donors, from billionaire bankers to big industry polluters.” Since February, House and Senate Republicans have successfully used the CRA to void 14 federal regulations. (President Trump has signed 13 of those into law.) In the previous 20 years, the CRA had only been successfully used once. In addition to repealing the CRA, the Sunset the CRA and Restore American Protections (SCRAP) Act would remove the prohibition on agencies reissuing a previously overturned rule and would give those agencies greater flexibility in reinstating such rules.

Senate Bill Would Reinstate OSHA Recordkeeping Rule: On May 16, 2017, Senators Patty Murray (D-WA) and Richard Blumenthal (D-CT) introduced legislation that would reinstate the Occupational Safety and Health Administration’s (OSHA) recordkeeping rule that was overturned under the CRA (H.J. Res. 83). Companion legislation was introduced in the House (H.R. 2428). The Accurate Workplace Injury and Illness Records Restoration Act (S. 1122) would reinstate OSHA’s authority to require employers to make and maintain accurate workplace injury records as an ongoing obligation. It also enables OSHA to issue a citation in those cases where the violation of the recordkeeping requirements continues for more than six months from the date the employer should have first recorded the injury.

Bill Would Ban Regulation Of Carbon Dioxide From Power Plants: On May 16, 2017, Representative Keith Rothfus (R-PA) introduced the Fighting Against Imbalanced Regulatory Burdens Act (H.R. 2438). The bill would ban EPA from imposing any restrictions on carbon dioxide emissions from power plants unless countries responsible for 80 percent of non-U.S. emissions have enacted similarly stringent policies. “For the past eight years, American workers have been hurt by unfair and ineffective rules from Washington while China and other countries continued to increase their emissions,” stated Congressman Rothfus. “This bill is about restoring fairness and balance to our environmental regulations and protecting our workers, businesses, and energy system from harmful and ineffective policies,” Rothfus stated.

Senate Bill Seeks To Provide Relief In Complying With Ozone NAAQS: On May 23, 2017, Senators Orrin Hatch (R-UT) and Claire McCaskill (D-MO) introduced a bill (S. 1203) under which state, local, and tribal governments may develop Early Action Compact (EAC) plans to achieve and maintain EPA’s NAAQS for ozone. The legislation directs EPA to implement a program that gives communities a voice to design locally crafted solutions to improve air quality so that they can comply with federal standards. On November 26, 2014, EPA proposed revisions to the NAAQS for ground-level ozone. EPA proposed lowering both the primary (health-based) and secondary (welfare-based) standards from the current 75 parts per billion (ppb) to somewhere in a range of 65 to 70 ppb. Many areas throughout the country are at risk of being designated as non-attainment under the NAAQS. When an area is designated as such, it can have significant, negative economic implications. In 2002, EPA initiated the EAC Program to make available an option that allowed for non-attainment areas to enter into a voluntary cooperative agreement with EPA to take early action to prevent a non-attainment designation and provide for cleaner air sooner than might have occurred by otherwise following the timelines in the CAA. This program had success: 13 out of the 14 areas that voluntarily opted into this program were successful in improving air quality and avoiding a non-attainment designation entirely. EPA scrapped the EAC Program in 2017 due to ligation, which argued that the program was outside EPA’s authority under the CAA. S. 1203 would give clear authorization and direct EPA to implement a similar program to the EAC so that other areas throughout the country can again have the option of taking early action to improve air quality and avoid a non-attainment designation.

Senate Bill Would Exempt Certain Farms From SPCC Requirements: On May 23 2017,Senator Deb Fischer (R-NE) introduced a bill that would exempt certain farms and ranches from the Spill Prevention Control and Countermeasures (SPCC) requirements under the Clean Water Act (CWA). The Farmers Undertake Environmental Land Stewardship (FUELS) Act (S. 1207) would carve out an SPCC exemption for farms with 10,000 gallons or less of aggregate above ground oil storage capacity. It would also allow farms with an aggregate above ground storage of 10,001 to 42,000 gallons and/or no history of spills to maintain a self-certified spill plan to respond to any potential spills. The bill would require full SPCC compliance -- including certification from a professional engineer -- for farms with an individual tank with an above ground storage capacity greater than 10,000 gallons and/or, an aggregate above ground storage capacity greater than 42,000 gallons and/or, reported discharge history. S. 1207 also would amend the threshold for individual tank and aggregate capacity on separate land parcels by increasing the individual tank capacity from 1,000 gallons to 1,320 gallons and increasing the aggregate capacity from 2,000 gallons to 3,000 gallons.

Senate Subcommittee Holds Hearing On Implementation Of Ozone NAAQS: On May 23, 2017, the Senate Committee on Environment and Public Works Subcommittee on Clean Air and Nuclear Safety held a hearing entitled, “Making Implementation of the National Ambient Air Quality Standards for Ground-Level Ozone Attainable: Legislative Hearing on S.263 and S.452.” The panel of witnesses testifying at the hearing included Misael Cabrera, Director of the Arizona Department of Environmental Quality; Ahron Hakimi, Executive Director, Kern Council of Governments; Kyle Zeringue, Senior Vice President, Business Development, Baton Rouge Area Chamber of Commerce; Shawn Garvin, Secretary, Delaware Department of Natural Resources and Environmental Control; and Dr. Monica Kraft, Past President of the American Thoracic Society, University of Arizona College of Medicine.

Bipartisan Senate Bill Exempts Ammunition And Fishing Tackle From TSCA Regulation: On May 24, 2017, Senators John Thune (R-SD) and Amy Klobuchar (D-MN) reintroduced legislation to prevent ammunition and fishing tackle from regulation under TSCA. The Hunting, Fishing, and Recreational Shooting Protection Act (S. 1214) would exclude ammunition and fishing tackle from TSCA, preventing EPA from regulating it and leaving any potential regulation up to state fish and game agencies and the U.S. Fish and Wildlife Service.

Pipeline Safety Legislation Introduced In Senate: On May 24, 2017, Senator Gary Peters (D-MI) introduced legislation intended to bolster pipeline safety in and around the Great Lakes and account for the unique needs of the Great Lakes ecosystem. The bill (S. 1226) would amend the Oil Pollution Act of 1990 to equalize liability and financial assurance requirements for onshore pipeline facilities that could discharge oil into the Great Lakes system. It would raise liability caps for Great Lakes pipeline operators; expand and clarify the U.S. Secretary of Transportation’s authority to suspend or shut down unsafe oil pipelines; strengthen federal review of oil spill response plans; increase transparency surrounding oil spill response and cleanup plans; and create a Center for Expertise in the Great Lakes region to study freshwater oil spills.

Lawmakers Introduce Environmental Justice Bill Package: On June 5, 2017, Representatives Donald McEachin (D-VA), Nanette Diaz Barragán (D-CA), and Pramila Jayapal (D-WA) introduced a trio of environmental justice bills intended to fight the impact of climate change. The Environmental Justice Small Grants Program Act of 2017 (H.R. 2695) would officially establish the Office of Environmental Justice at EPA. It would also codify the Environmental Justice Small Grants program, setting the appropriated amount to $16 million per year. (President Trump’s FY 2018 budget provides no funding for the Environmental Justice Office.) The Executive Office of Environmental Justice Act of 2017 (H.R. 2696) creates the Office of Environmental Justice within the Executive Office of the President. The director of the office would be tasked with conducting environmental justice assessments of executive orders, doing community and stakeholder outreach, and assessing the progress made on implementing environmental justice policies. The third piece of legislation is the environmental justice resolution (H.J. Res. 362) introduced by McEachin highlighting the importance of environmental justice. In April, McEachin, Diaz Barragán, and Jayapal formed the United for Climate and Environmental Justice Congressional Task Force, comprised of members of the Congressional Black Caucus, Congressional Hispanic Caucus, and the Congressional Asian Pacific American Caucus. The group aims to address the disproportionate impact of climate change and other environmental harms on communities of color, low-income families, and other marginalized groups.

House Passes Pesticide Spraying Legislation: On May 24, 2017, the U.S. House of Representatives passed H.R. 953, the Reducing Regulatory Burdens Act of 2017, by 256-165 vote. H.R. 953, which is similar to bills introduced in the past three congresses, would overturn a 2009 U.S. Court of Appeals for the Sixth Circuit decision requiring CWA National Pollutant Discharge Elimination System (NPDES) permits for pesticide spraying activities into, over, or near waters. The legislation would eliminate NPDES permitting for pesticide spraying that complies with FIFRA. Proponents of the legislation assert that the addition of CWA regulation is duplicative, burdensome, and costly for industry without resulting in any additional environmental benefits. Opponents argue that the bill would strip clean water protections for waters already listed as impaired for pesticides. Championed by Representative Bob Gibbs (R-OH), the recent vote received significant bipartisan support, with twenty-five Democrats voting in support of the bill. Senators Claire McCaskill (D-MO) and Mike Crapo (R-ID) introduced companion legislation in the Senate (S. 340), which currently awaits action by the Committee on Environment and Public Works. The prospects for a Senate vote are mixed in light of the number of confirmations in the queue for political appointees, as well as big ticket legislative priorities, such as health care and tax reform. If legislation is enacted, it would only apply to the four states (Idaho, New Hampshire, New Mexico, and Massachusetts), tribal lands, and other federally managed areas that are governed by the federal NPDES permit. Forty-six states administer state versions of pesticide permits. Many states would be expected to phase out permitting if the federal requirement is eliminated, however.

House Subcommittee Approves Three Environmental Bills: The House Energy and Commerce Subcommittee on the Environment on June 15, 2017, passed three environmental bills to the full Committee. The Ozone Standards Implementation Act of 2017 (H.R. 806) would allow states more time to adopt the NAAQS for ozone. According to a statement by the Subcommittee, the bill “would provide states the flexibility needed to implement the [NAAQS] . . . and will ensure the nation’s infrastructure and manufacturing permitting continue while maintaining improvements to air quality.” The Brownfields Enhancement Redevelopment and Reauthorization Act of 2017 (no bill number yet) seeks to improve EPA’s Brownfields program to spur the cleanup and reuse of the estimated 450,000 brownfields in the U.S. The Subcommittee also approved the Nuclear Waste Policy Amendments Act of 2017 (no bill number yet). The bill would require the use of Yucca Mountain for the disposal site for spent nuclear fuel and high-level radioactive waste.

MISCELLANEOUS  

Global Mercury Convention Enters Into Force: On May 18, 2017, the European Union (EU) and seven of its members -- Bulgaria, Denmark, Hungary, Malta, the Netherlands, Romania, and Sweden -- deposited their instruments of ratification at the UN Headquarters in New York, bringing to 52 the current number of Parties to the Minamata Convention on Mercury (the Convention). With over 50 nations ratifying the Convention, it became legally binding for all ratifying parties on August 16, 2017. Signed in 2013, the Convention protects human health and the environment from anthropogenic emissions and releases of mercury and mercury compounds. The Convention bans new mercury mines and requires the eventual closure of existing mines. It also calls for the phase out and phase down of mercury use in a number of products and processes, control measures on emissions to air and on releases to land and water, and the regulation of the informal sector of artisanal and small-scale gold mining. The Convention also addresses interim storage of mercury and its disposal once it becomes waste. The U.S. has not ratified the Convention.

EPA Requests Nominations Of Experts To Office Of Research And Development’s Board Of Scientific Counselors: On May 25, 2017, EPA announced that it was seeking nominations for technical experts to serve on its Board of Scientific Counselors (BOSC), a Federal Advisory Committee to the Office of Research and Development (ORD). 82 Fed. Reg. 24120. The BOSC is a chartered Federal Advisory Committee that was established by the EPA to provide independent scientific and technical peer review, advice, consultation, and recommendations about ORD. As a Federal Advisory Committee, the BOSC conducts business in accordance with the Federal Advisory Committee Act (FACA). EPA is seeking nominations of nationally and internationally recognized scientists and engineers having experience and expertise in one or more of the many areas identified in the notice. Comments are due June 30, 2017.
 

California Department Of Pesticide Regulation Issues Guidance: On May, 24, 2017, the California Department of Pesticide Regulation (DPR) issued guidance regarding its Notice 2015-13 to applicants registering pesticide impregnated materials bearing pesticide claims to be sold and distributed into or within California, per Notice 2015-13, issued December 11, 2015. 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. The guidance includes information on the registration requirements, as well as:

  • The actual application for pesticide registration (and includes a sample application);

  • Pesticide product labeling;

  • The California-only registration number that will be assigned to each pesticide-impregnated product;

  • Agent designation instructions;

  • Changes after product registration that may require notification or submission to DPR;

  • Labeling revisions relating to pesticide claims;

  • The renewal application and fees; and

  • The California mill assessment, a payment on each dollar sales of all pesticide products sold for use in California.

More information on the requirements is available in our blog item  “California DPR Extends Filing Date to Register Pesticide Impregnated Products.”

EPA Honors Winners Of The 2017 Green Chemistry Challenge Awards: On June 9, 2017,EPA recognized landmark green chemistry technologies developed by industrial pioneers and leading scientists that turn potential environmental issues into business opportunities, spurring innovation and economic development. The Green Chemistry Challenge Award winners were honored on June 12, 2017, at a ceremony in Washington, D.C. Find out more about the winners and their innovative technologies: https://www.epa.gov/newsreleases/epa-honors-winners-2017-green-chemistry-challenge-awards.

California DTSC Releases SCP AA Guide: On June 14, 2017, the California Department of Toxic Substances Control (DTSC) released its Safer Consumer Products (SCP) Alternatives Analysis (AA) Guide Version 1.0. Version 1.0 of the AA guide is a new version created by DTSC based on feedback received in response to the draft AA guide released in December 2016. The guide is intended to help people understand the process by describing the steps of the AA process and describing how they fit together to achieve the regulatory goals. It also provides a variety of resources, descriptions of the framework in the regulations, and examples of approaches the responsible entity could use to evaluate the effects associated with a Priority Product or an alternative. In particular, the guide provides information about:

  • The two stages of the AA process;

  • Approaches for conducting AA steps;

  • Tools and methods that may be useful for specific steps in the analysis;

  • Approaches for identifying and collecting needed data; and

  • Examples to illustrate steps in the analysis.

©2017 Bergeson & Campbell, P.C.

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