Federal Development Update for January 2018


Bergeson & Campbell, P.C.’s (B&C®) much anticipated and highly acclaimed annual Forecast, “Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018,” is now available. In the Forecast, the lawyers, scientists, and chemical regulatory specialists at B&C and its affiliated consulting firm, The Acta Group (Acta®), offer comprehensive and highly useful observations on the fast-changing and nuanced area of domestic and global chemical legal, scientific, and regulatory issues expected to be hot topics in 2018. This 38-page document is chock-full of insights, predictions, and useful information.

Happy New Year and enjoy reading our predictions!

TSCA/FIFRA/TRI

Lynn L. Bergeson, “Resetting The TSCA Inventory: Why This Is Important,” Environmental Quality Management, Volume 27, Issue 1, Fall 2017: On August 11, 2017, the U.S. Environmental Protection Agency (EPA) published the third Toxic Substances Control Act (TSCA) framework final rule in the Federal Register, the TSCA Inventory Notification (Active-Inactive) Requirements. This final rule is now in effect. This Washington Watch column explains why the rule is important, and what stakeholders should be doing to protect their interests.

Missouri Issues Fines Regarding Dicamba Applications: On December 14, 2017, the Missouri Department of Agriculture (MDA) announced that it issued and collected the first round of fines resulting from investigations regarding the pesticide dicamba. The news release states that the first wave of civil penalties issued to applicators, all from Dunklin County, were issued as “a result of investigations of complaints during the 2016 growing season,” and the “civil penalties, ranging from $1,500 to $62,250, were issued for pesticide misuse (off label use and drift).” This is the first group of what is anticipated to be a large number of dicamba-related enforcement cases, given the extensive number of, and publicity concerning, the reported incidents involving dicamba. More information on dicamba issues is available in our blog.

EPA Releases Draft Human Health And Ecological Risk Assessment For Glyphosate: On December 18, 2017, EPA announced the forthcoming release of the draft human health and ecological risk assessments for glyphosate. EPA’s Draft Human Health and Ecological Risk Assessments for Glyphosate website states that the “draft risk assessments and supporting documents will be available in glyphosate’s registration review docket EPA-HQ-OPP-2009-0361 on www.regulations.gov in early 2018,” and that EPA will “open a 60-day public comment period for the draft risk assessments, evaluate the comments received, and consider any potential risk management options for this herbicide.” Many of the assessment documents, including the draft human health risk assessment, are already available on EPA’s website, but not yet posted in the docket. EPA states the proposed interim registration review decision for glyphosate is scheduled to be published in 2019. For more information, see our blog.

Ninth Circuit Simultaneously Denies Motion To Dismiss Without Prejudice And Grants Motion To Expedite In Chlorpyrifos Litigation: On December 20, 2017, the U.S. Court of Appeals for the Ninth Circuit issued an order in LULAC v. Pruitt, Case No. 17-71636, a case challenging an order denying administrative petitions to revoke the tolerances and cancel the registrations for chlorpyrifos. The court denied a motion by EPA and Administrator Pruitt (Respondents) to dismiss the case for lack of jurisdiction while granting a motion by League of United Latin American Citizens (LULAC), et al. (Petitioners) to expedite briefing and hearing in the case. More information on these two motions is available in our blog item “NGOs and Farmworkers File Motion for Expedited Briefing and Hearing in Chlorpyrifos Litigation.” These two actions indicate that the court has decided to defer argument and resolution of the jurisdictional issues presented by the motion to dismiss until briefing and argument on the merits. The court also granted an October 13, 2017, motion by the Petitioners to expedite briefing and hearing in the case. The court set the following expedited briefing schedule: Petitioners’ opening brief is due January 23, 2018; Intervenors’ brief(s) are due February 6, 2018; Respondents’ answering brief is due March 8, 2018; Petitioners’ optional reply brief is due 28 days after service of Respondents’ brief; and Intervenors’ optional reply brief(s) are due 42 days after service of Respondents’ brief. The court also directed the Clerk to “calendar this case [for argument] as soon as possible upon completion of briefing.” More information is available in our blog.

EPA Releases Preliminary Ecological And Human Health Risk Assessments For Three Neonicotinoid Insecticides: On December 21, 2017, EPA released preliminary ecological and human health risk assessments for three neonicotinoid insecticides: clothianidin, thiamethoxam, and dinotefuran, and a preliminary ecological risk assessment for imidacloprid, assessing risks to birds, mammals, non-target insects, and plants. 82 Fed. Reg. 60599. EPA also released new cotton and citrus benefits assessments for foliar applications of the neonicotinoids, as well as its response to public comments on the 2014 Benefits of Neonicotinoid Seed Treatment to Soybean Production. EPA states that it is interested in public comment on the benefits for cotton and citrus, since previous assessments identified potential risks to pollinators. EPA states that it plans to release the final pollinator risk assessments and proposed interim decisions for these chemicals in mid-2018. Comments are due by February 20, 2018. For more information, see our blog.

EPA Signals New Rulemaking On Worker Protection Standard: On December 21, 2017, EPA announced that it is initiating a rulemaking to reconsider certain provisions of the Agricultural Worker Protection Standard (WPS). 82 Fed. Reg. 60576. The provisions at issue were identified as part of the public comments received in response to Executive Order 13777, Enforcing the Regulatory Reform Agenda. Three provisions in particular were the subject of public comment, and later considered by the Office of Pesticide Programs’ (OPP) Pesticide Program Dialogue Committee (PPDC) at its November 2, 2017, meeting. The three provisions are: minimum age (the 2015 WPS specifies a minimum age of 18 years, with an exemption for owners of agricultural establishments and their immediate family members); designated representative (the 2015 WPS requires employers to provide pesticide application information and safety data sheets (SDS) to a designated representative of a worker or handler under specified circumstances); and application exclusion zones (AEZ) (the 2015 WPS requires the establishment of AEZs with respect to outdoor production on farms, nurseries, and forests to reduce the number of incidents where workers or others are exposed to pesticides during agricultural pesticide applications). EPA also announced that the compliance dates in the revised WPS remain in effect and that EPA has no intent to extend them. This means that most provisions in the revised WPS went into effect on January 2, 2017, and compliance with two additional requirements began on January 2, 2018. The two requirements include compliance with the display of pesticide safety information, and pesticide handlers must temporarily suspend applications if workers or others enter into the application zone during pesticide applications. The only requirements in the revised WPS that were not effective as of January 2, 2018, are the requirements that the worker and handler pesticide safety training material cover the expanded content at 40 C.F.R. Sections 170.401(c)(3) and 170.501(c)(3). The 2015 revised WPS provided that compliance with the expanded pesticide safety content in these sections was not required until 180 days after EPA publishes in the Federal Register a notice of availability of certain training materials. While there are training materials available that meet the expanded content requirement, EPA has not yet published such a Federal Register notice and apparently does not intend to do so until after the rulemaking announced on December 21 has concluded.

In Case Of First Impression, Court Rules EPA Wrongly Dismissed Citizen Group’s TSCA Section 21 Petition: On December 21, 2017, the U.S. District Court for the Northern District of California ruled that EPA had wrongly dismissed a TSCA Section 21 petition submitted by Food & Water Watch, Inc. and other citizens seeking the regulation of fluoridation of drinking water supplies under TSCA Section 6(a) on grounds that the ingestion of fluoride poses an unreasonable risk to humans. Food & Water Watch, Inc. v. EPA, Case No. 17-cy-02162-EMC (N.D. Cal.) (Food & Water Watch). In 2017, EPA denied the Section 21 petition on the grounds that it failed to address conditions of use other than the fluoridation of drinking water. 82 Fed. Reg. 11878 (Feb. 27, 2017). In a fairly scathing rebuke of EPA’s legal positions, the court denied EPA’s motion to dismiss the petitioner’s judicial challenge of EPA’s administrative denial of the Section 21 petition and, in so doing, essentially rejected EPA’s interpretation that a citizen petition must evaluate all conditions of use of a chemical substance in a TSCA Section 6(b) risk evaluation. While we are hesitant to note that “we told you so” in our March 7, 2017, blog item, the analysis noted there was spot on. At issue in Food & Water Watch is EPA’s legal position that TSCA Section 6 requires that EPA consider all conditions of use in proceedings under that provision. The court rejected this view noting that the “argument has no basis in the statutory text,” and there “is no good reason to believe that the term’s [conditions of use] appearance … [in Section 21] … obligates all citizen petitioners to address all conditions of use.” The court also noted that EPA’s interpretation creates “a disparity between citizen petitions and manufacturer requests” for a Section 6(b) risk evaluation. Under the rules, a manufacturer’s request may be limited only to those particular conditions of use of interest to the manufacturer, citing 40 C.F.R. Section 702.37(b)(4). The court also noted EPA’s change of view on this issue between the proposed and final risk evaluation rule. EPA initially proposed that risk evaluations must consider all conditions of use, but concluded in the final rule that EPA may focus its review on fewer than all conditions of use. The court’s analysis is clear and well written, and goes into some detail on EPA’s legal reasoning and the problems it identified with it. This ruling raises interesting issues when viewed in the broader context of pending judicial challenges to EPA’s TSCA framework rules. In those challenges, citizen advocates challenge EPA’s view, as articulated in the final framework rules, that the Agency retains discretion to assess those conditions of use it believes are most relevant for a particular chemical evaluation. In other words, they challenge EPA’s view that fewer than all conditions of use must be considered in a risk evaluation, the very position the court in Food & Water Watch rejected for purposes of Section 21 petitions challenging EPA’s interpretation of a citizen’s legal burden under TSCA Section 6(a). Given that the judicial challenge to the risk evaluation final rule is being heard in the U.S. Court of Appeals for the Ninth Circuit, this district court decision is particularly relevant.

EPA Issues Final Rule Adopting NAICS Codes For TRI Reporting: On December 26, 2017, EPA issued a final rule adopting the North American Industry Classification System (NAICS) codes for Toxics Release Inventory (TRI) reporting to reflect the Office of Management and Budget’s (OMB) 2017 NAICS code revision. 82 Fed. Reg. 60906. EPA issued a direct final rule on August 17, 2017, and received an adverse comment, which has reportedly been addressed in the final rule. The final rule was effective on January 1, 2018.

Ninth Circuit Orders EPA To Revise Standard For Levels Of Lead In Paint And Dust: On December 27, 2017, a three-judge panel of the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) ordered EPA to revise its nearly 17-year-old standard for levels of lead in paint and dust within one year. A Cmty. Voice v. EPA, No. 16-72816. The Ninth Circuit held that “EPA was under a duty stemming from the Toxic Substances Control Act and the Residential Lead-Based Pain[t‍] Hazard Reduction Act of 1992 to update lead-based paint and dust-lead hazard standards in light of the obvious need, and a duty under the Administrative Procedure Act to fully respond to petitioners’ rulemaking petition.” The decision stems from a petition filed in June 2016 by environmental and health groups seeking this action. The order came in the form of a writ of mandamus, an unusual court order and extraordinary judicial remedy that requires an official or agency to perform a certain duty, in this case for EPA to issue a proposed rule within 90 days of this decision and to promulgate the final rule within a year of when the proposed rule is issued. The court stated that in doing so, it was mindful of the Agency’s arguments that officials needed more time to deliberate a complex new standard. More information is available in our blog.

Arkansas State Plant Board Votes To Keep Dicamba Ban In Place: On January 3, 2018, officials with the Arkansas State Plant Board (Plant Board) voted 11 to 3 to uphold its statewide ban of dicamba. The vote came after a subcommittee of the state’s legislative council asked the Plant Board to reevaluate its earlier decision. The subcommittee will revisit the Plant Board’s decision again on January 16, 2018. That the subcommittee plans to revisit the decision is noteworthy and illustrates the controversy surrounding this and other similar state bans. Given the panel will meet again soon, this may indicate that the legislature is urging some greater flexibility -- that is, a longer application window that would allow some growers to use the herbicide, along with consideration of any data about the newer formulations designed to reduce the likelihood of drift. Whether any “flexibility” or additional data will be sufficient to convince the Plant Board that the product can be used without expecting drift incidents in the future is not clear, especially since the issue has become a point of intense political debate. More information on dicamba issues is available on our blog under key word dicamba.

RCRA/CERCLA/CWA/CAA/EPCRA

EPA Prohibits CBI Claims For Hazardous Waste Export And Import Documents: On December 26, 2017, EPA issued a final rule stating that “no person can assert confidential business information (CBI) claims for documents related to the export, import, and transit of hazardous waste.” 82 Fed. Reg. 60894. The prohibition takes effect on June 26, 2018. After that date, no party may claim CBI for its notifications of intent to export or other information related to the export of hazardous waste. EPA also decided against requiring that confirmations of receipt, recovery, or disposal be posted on the Internet by exporters and importers. This is because that information will be available via EPA’s newly launched Waste Import Export Tracking System (WIETS). EPA’s rationale for disallowing CBI claims for hazardous waste exports rests primarily on its conclusion that denying CBI claims for these records is consistent with the non-CBI treatment of hazardous waste manifests. Manifests contain similar information as that required by the documents related to the export, import, and transit of hazardous waste, EPA explained. EPA also cited its February 7, 2014, final rule on electronic manifests, in which EPA staked out a categorical determination for individual Resource Conservation and Recovery Act (RCRA) hazardous waste manifest records and aggregate data. 79 Fed. Reg. 7518. In that rule, EPA concluded that information contained in individual manifested records and aggregate data are essentially public information and therefore ineligible for treatment as CBI. EPA states that because the information contained in RCRA hazardous waste manifests is largely similar to the information contained in hazardous waste export and import documents, EPA concluded that application of confidentiality determinations in this action is consistent with the categorical determination that electronic manifests are not CBI. Moreover, EPA stated that it believes that any CBI claim that might be asserted with respect to the hazardous waste documents within the scope of this action would be extremely difficult to sustain under the substantive CBI criteria set forth in EPA’s CBI regulations (40 C.F.R. Part 2, Subpart B). To substantiate a CBI claim, a business must also show that the information is not, and has not been, reasonably obtainable without the business’s consent by other persons (other than governmental bodies) by use of legitimate means. Because the export and import documents are shared with several commercial entities throughout the chain of custody of a hazardous waste shipment, EPA determined that the information is easily accessible to other parties without the business’s explicit consent. For these reasons, EPA believes that any CBI claim that might be asserted with respect to hazardous waste export and import documents would be difficult to sustain under the substantive CBI criteria.

EPA Seeks Comment On Replacement Of Clean Power Plan: EPA on December 28, 2017, issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking comment on the next steps to replace the Clean Power Plan (CPP). 82 Fed. Reg. 61507. The CPP established regulatory steps to limit greenhouse gas (GHG) emissions from existing electric utility generating units (EGU). The ANPRM is a separate, but related, action to the October 16, 2017, proposal to repeal the CPP. 82 Fed. Reg. 48035. EPA proposed to determine that the CPP exceeds EPA’s statutory authority under the Clean Air Act (CAA). In the ANPRM, EPA is specifically soliciting information on systems of emission reduction that are applicable to or at an EGU facility, information on compliance measures, and information on state-planning requirements under CAA Section 111(d). Comments are due on February 26, 2018.

EPA Information Collection Request (ICR) For National Study Of Nutrient Removal At Publicly Owned Treatment Works (POTW): On December 29, 2017, EPA announced in the Federal Register its submission of a POTW Screener Questionnaire (ICR No. 2553.01) to the Office of Management Budget (OMB) for review and approval. 82 Fed. Reg. 61756. The ICR will inform an EPA Office of Water multi-year study aimed at evaluating the nutrient removals and related technology performance of POTWs with conventional secondary treatment, with an end goal of producing a first of its kind comprehensive nationwide data set. The Questionnaire is the first phase of EPA’s study, which it expects will span four to five years. EPA plans to use the results of the study “to help set more realistic and achievable nutrient reduction targets.” EPA is accepting comments on the ICR until January 29, 2018.

The results of the study will be useful for informing nutrient management policy and watershed planning decisions across the country. The POTW community has long touted that it has reached the limits of practicable nutrient reduction without expensive, cost-prohibitive upgrades that would still be insufficient to reach nutrient reduction targets in waterbodies. The results of the study may bolster the policy argument that more efforts need to be undertaken by the non-point source community to reduce nutrient run-off from farms, ranches, and other working lands. Nutrient management stakeholders should monitor developments as the study progresses and EPA offers opportunities for public input.

EPA Issues Final Electronic Hazardous Waste Manifest User Fee Rule: EPA on January 3, 2018, issued a final rule establishing the methodology it will use to determine the user fees applicable to the electronic and paper hazardous waste manifests that EPA is developing under the Hazardous Waste Electronic Manifest Establishment Act. 83 Fed. Reg. 420. The final rule specifically establishes the methodology EPA will use in setting and revising user fees to recover the full costs of the electronic hazardous waste manifest (e-Manifest) system. This includes costs incurred in developing, operating, maintaining, and upgrading the system, as well as any costs incurred in collecting and processing data from any paper manifest submitted to the e-Manifest system after the date on which the system begins to operate on June 30, 2018. The e-Manifest user fee final rule addresses several key issues, including who must pay e-Manifest user fees; what types of transactions give rise to fees; what formula is EPA using to set fees; what the available options are for users to make their fee payments; what process EPA will follow to revise user fees; and what the sanctions are for non-payment. EPA is also tailoring user fees according to whether manifests are submitted electronically or via paper to reflect the varying processing costs of these options. The final rule promulgates a new Subpart FF in 40 C.F.R. Parts 264 and 265. EPA estimates that the per manifest fees for paper manifests will range from $7 to $20, with mailed paper manifests incurring the higher fee. The estimated fee for electronic manifests is $4 per manifest. The rule takes effect on June 30, 2018.

EPA Promulgates Final Air Quality Designations For 2010 SO2 NAAQS: EPA on January 9, 2018, promulgated a final rule establishing the initial air quality designations for certain areas for the 2010 sulfur dioxide (SO2) primary National Ambient Air Quality Standard (NAAQS). 83 Fed. Reg. 1098. EPA designates areas as Nonattainment, Attainment/Unclassifiable, or Unclassifiable. EPA makes these determinations on the application of its nationwide analytical approach and technical analysis, including evaluation of monitoring data and air quality modeling. The CAA directs areas designated Nonattainment by this rule to undertake certain planning and pollution control activities to attain the NAAQS as expeditiously as practicable. This is the third of four expected actions planned by EPA to designate areas for the 2010 SO2 NAAQS. The designations become effective on April 9, 2018.

FDA

FDA Solicits Comments On Information Collection Provisions Of FDA's Consultation Procedures For Foods Derived From New Plant Varieties: On December 13, 2017, the U.S. Food and Drug Administration (FDA)announced an opportunity for public comment on the proposed collection of certain information of FDA’s consultation procedures for foods derived from new plant varieties, including the information collection provisions in the guidance entitled, “Guidance on Consultation Procedures: Foods Derived From New Plant Varieties,” and in Form FDA 3665 entitled, “Final Consultation For Food Derived From a New Plant Variety (Biotechnology Final Consultation),” which developers may use to prepare the final consultation in a standard format. 82 Fed. Reg. 58619. Comments are due by February 12, 2018.

FDA Terminates The Food Advisory Committee: On December 13, 2017, FDA announced that it was terminating the Food Advisory Committee and removing the Food Advisory Committee from its list of standing advisory committees, effective immediately. 82 Fed. Reg. 58553. FDA states that over the past several years, “the Committee has met very infrequently, and the effort and expense of maintaining the Committee are no longer justified.” Further, “[a‍]ny relevant food issues in the future could be addressed by FDA’s Science Board and/or FDA’s Risk Communication Advisory Committee, with additional augmentation of expertise by appropriate subject matter experts serving as temporary members on either of those committees.”

FDA Announces Availability Of Draft Guidance On Drug Products Containing Nanomaterials: On December 18, 2017, FDA announced the availability of a draft guidance for industry entitled “Drug Products, Including Biological Products, That Contain Nanomaterials: Guidance for Industry.” 82 Fed. Reg. 60019. According to the notice, FDA developed the guidance to provide industry with its current thinking for the development of human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage form. The draft guidance discusses both general principles and specific considerations for the development of drug products containing nanomaterials, including considerations for establishing the equivalence of such products with other drugs. The draft guidance discusses considerations for quality, nonclinical, and clinical studies as they relate to drug products containing nanomaterials throughout product development and production. The draft guidance does not limit or classify the types of nanomaterials that can be used in drug products. Instead, it focuses on the “deliberate and purposeful manipulation and control of dimensions to produce specific physicochemical properties” that may warrant further evaluation with regards to safety, effectiveness, performance, and quality. FDA notes that the draft guidance “does not address, or presuppose, what ultimate regulatory outcome, if any, will result for a particular drug product that contains nanomaterials.” FDA currently addresses issues such as the safety, effectiveness, public health impact, or the regulatory status of drug products that contain nanomaterials on a case-by-case basis using its existing review processes. FDA states that it may continue to develop guidance addressing “certain specific commonly-used types of nanomaterials, e.g., some liposomes, to better address the challenges in evaluating and characterizing the quality and performance of drug products that incorporate them.” The draft guidance includes recommendations for applicants and sponsors of investigational, pre-market, and post-market submissions for these products. FDA seeks comment on the terminology, including the term “nanomaterial,” as used in the draft guidance. Comments are due March 19, 2018.

FDA Releases Information On How VQIP Will Work: On January 2, 2018, FDA issued a Constituent Update regarding the Voluntary Qualified Importer Program (VQIP), a voluntary, fee-based program for importers that will allow expedited review and importation of human and animal foods into the United States for approved applicants who achieve and maintain a high level of control over the safety and security of their supply chains. FDA’s Food Safety Modernization Act (FSMA) required it to establish VQIP, and the agency expects to begin accepting applications from importers in early 2018. The update links to a conversation with Doriliz De Leon, a Consumer Safety Officer in the Food Adulteration Assessment Branch in FDA’s Center for Food Safety and Applied Nutrition (CFSAN), and Amelia Tetterton, a Consumer Safety Officer in the Import Program Development and Implementation Branch in FDA’s Office of Regulatory Affairs, in which they explain the role of this program in helping to ensure the safety and security of imported foods.

FDA To Exercise Enforcement Discretion As Related To FSMA: On January 4, 2018, FDA issued a Constituent Update announcing that it intends to exercise enforcement discretion for certain provisions in four of the rules that implement the FSMA, specifically provisions in the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule, the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule, the Foreign Supplier Verification Programs rule (FSVP), and the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule, and how they apply to:

  • Facilities that would be farms except for certain factors and activities;
     
  • Written assurances provisions in all four rules related to the control of identified hazards or microorganisms that are a potential risk to public health;
  •  
  • The animal food preventive controls requirements for certain manufacturing/processing activities performed on human food byproducts used as animal food; and
     
  • FSVP requirements for importers of food contact substances.
     

FDA states that this means that “during the enforcement discretion period, the agency does not intend to enforce these provisions as they currently apply to certain entities or activities,” and that it is exercising enforcement discretion to “allow time to consider changes or other approaches to address concerns regarding the application of these provisions to certain activities or entities.”

FDA Releases Guidance For Industry Related To Human Food Byproducts For Use As Animal Food: On January 5, 2018, FDA announced the availability of a guidance for industry entitled “Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs,” a compliance policy regarding certain entities and/or activities related to the “farm” definition, written assurances, food contact substances, and human food byproducts for use as animal food.83 Fed. Reg. 598. The guidance is effective immediately, but FDA will continue to accept comments on it.

FDA Releases Information On FSMA Collaborative Training Forum: On January 8, 2018, FDA issued a Constituent Update that provided more information on the FSMA Collaborative Training Forum, a forum established to provide a space for dialogue, information-sharing, alignment, and collaboration for all those providing FSMA training. FDA states that to help facilitate training, FDA, together with the U.S. Department of Agriculture (USDA), funded a network of public and private partners in state, federal, tribal and international governments, industry, and academia for the development and delivery of training. The update states that the new webpage, FSMA Collaborative Training Forum, provides descriptions of and links to all the members of the FSMA Collaborative Training Forum.

NANOTECHNOLOGY

UNEP Report On Emerging Issues Of Environmental Concern Includes Nanomaterials: In early December 2017, the United Nations Environment Program (UNEP) published Frontiers 2017: Emerging Issues of Environmental Concern. The report covers six key emerging issues, including nanomaterials. The report addresses nanodimensions -- new discoveries about familiar materials; specific forms, applications, and effects; environmental and health exposure to engineered nanomaterials; and applying regulations for health and environmental safety. According to the report, expanding the research, production, and use of engineered nanomaterials across the world will require “transformative policies to encourage innovation and industrial applications of green chemistry, and more critically, iterative and responsive regulatory frameworks that apply the precautionary principle to assure safety and non-polluting outcomes.”

NIOSH Plans To Support Implementation Of WHO Guidelines To Protect Workers From Nanomaterials: On December 15, 2017, the National Institute for Occupational Safety and Health (NIOSH) posted a blog item entitled “WHO Guidelines to Protect Workers from Nanomaterials.” As reported in our December 13, 2017, blog item, the World Health Organization (WHO) recently published WHO Guidelines on Protecting Workers from Potential Risks of Manufactured Nanomaterials. NIOSH Director John Howard, MD, describes the WHO Guidelines as “an important step in protecting workers worldwide from the potential risks of manufactured nanomaterials.” Vladimir Murashov, Ph.D., Senior Scientist, NIOSH Office of the Director, chaired the Guideline Development Group. NIOSH also contributed one of the eleven systematic reviews (Eastlake A, Zumwalde R, Geraci C. “Can Control Banding be Useful for the Safe Handling of Nanomaterials? A Systematic Review.” J Nanoparticle Res.) and participated in the external expert review. The blog item states that NIOSH “plans to continue supporting this WHO effort at the guideline implementation phase, which will focus on turning these guidelines into practice.”

EEB Finds Estonian EU Council Presidency Failed To Fill Regulatory Gaps On Nanomaterials: The European Environmental Bureau (EEB) announced on December 22, 2017, the availability of its assessment of the environmental performance of the Estonian Presidency of the European Union (EU). The assessment is based on the results of “Ten Green Tests” laid out at the beginning of Estonia’s Presidency. The eighth test is protecting the public from hazardous chemicals, including mercury. The test includes encouraging the European Commission (EC) “to develop a new strategy for a non-toxic environment that builds on a strengthened implementation of [the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation], fills regulatory gaps such as on nanomaterials and mixture effects, and sets out a way forward following the fitness checks of REACH and all other EU Chemical safety legislation.” EEB notes that while there were positive steps taken, “the Estonian Presidency did not work on the regulatory gaps on nanomaterials, but rather encouraged its development as a new revolutionary technology in several events.”

Germany Publishes Report On Scientific Stakeholder Meeting On Nanomaterials In The Environment: The German Environment Agency (UBA) has published a report summarizing the contents and outcomes of the October 2017 scientific stakeholder meeting on nanomaterials in the environment. The stakeholder meeting provided a forum for participants to present the state of the knowledge on environmental nanosafety in a regulatory context, as well as to discuss the scientific results and their regulatory relevance between affected stakeholders. The meeting included key note talks, platform presentations, and poster presentations. A Knowledge Café provided the opportunity for participants to discuss selected topics with regard to environmental safety of nanomaterials in smaller groups. The meeting closed with a discussion on the lessons learned highlighting the outcomes of the meeting from the perspectives of different stakeholders.

IOSH Publishes Research Report And Industry Guidance On Nanotechnology In Construction And Demolition: On January 8, 2018, the Institution of Occupational Safety and Health (IOSH) announced the availability of a research report on nanotechnology in construction and demolition, as well as guidance for industry. The aim of the research was to provide clarity regarding the current use of nanomaterials in the built environment and the potential benefits and risks arising for those working in the construction and demolition sectors. Research included review of academic and manufacturers’ literature; interviews with individuals working in various parts of the construction, demolition, and materials supply sectors; and laboratory testing of samples of nano-enabled construction products. More information is available in our January 10, 2018, blog item, “IOSH Publishes Research Report and Industry Guidance on Nanotechnology in Construction and Demolition.”

EFSA Begins Public Consultation On Guidance For The Risk Assessment Of Nanoscience And Nanotechnology Applications: The European Food Safety Authority (EFSA) opened a public consultation on its draft guidance for the risk assessment of nanoscience and nanotechnology applications in the food and feed chain. The guidance covers the relevant areas within EFSA’s remit, such as novel foods, food contact materials, food and feed additives, and pesticides. EFSA notes that the guidance takes account of scientific developments that have taken place since publication of the previous guidance in 2011, particularly studies that offer new insights into exposure assessment and hazard characterization of nanomaterials. The guidance also considers nano-specific considerations relating to in vivo/in vitro toxicological studies, outlines a tiered framework for toxicological testing, and proposes ways to carry out risk characterization and uncertainty analysis. Comments are due March 4, 2018.

BIOBASED/RENEWABLE PRODUCTS

BRAG Biobased Products News And Policy Report: B&C consulting affiliate, B&C® Consortia Management, L.L.C. (BCCM), manages the Biobased and Renewable Products Advocacy Group (BRAG®). For access to a weekly summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to http://www.braginfo.org.

LEGISLATIVE

White House Resubmits EPA Deputy Administrator And CEQ Chair To Senate: The White House on January 8, 2018, resubmitted to the Senate the nominations of Andrew Wheeler to be EPA Deputy Administrator and Kathleen Hartnett White to head the White House Council on Environmental Quality (CEQ). The White House resubmitted the nominations after Senate Democrats, led by Senator Tom Carper (D-DE), blocked unanimous consent in the Environment and Public Works Committee on the nominees. Under Senate rules, pending nominations are returned to the White House at the end of a calendar year unless there is unanimous consent to continue them.

MISCELLANEOUS

EPA Issues Final Rule Adjusting Statutory Civil Monetary Penalties: On January 10, 2018, EPA issued a final rule adjusting the level of statutory civil monetary penalty amounts under the statutes EPA administers. 83 Fed. Reg. 1190. The action is mandated by the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended through the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. The 2015 Act prescribes a formula for annually adjusting statutory civil penalties to reflect inflation, maintain the deterrent effect of statutory civil penalties, and promote compliance with the law. The rule does not necessarily revise the penalty amounts that EPA chooses to seek pursuant to its civil penalty policies in a particular case. EPA’s civil penalty policies, that guide enforcement personnel in how to exercise EPA’s statutory penalty authorities, take into account a number of fact-specific considerations, e.g., the seriousness of the violation, the violator’s good faith efforts to comply, any economic benefit gained by the violator as a result of its noncompliance, and a violator’s ability to pay. According to the helpful table that is part of the rule, under TSCA, the statutory civil penalty for violations that occurred after November 2, 2015, where penalties are assessed on or after January 15, 2018, is $38,892 (where the as enacted statutory amount was $25,000), and under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), penalties subject to the same limitations (where the as enacted statutory amount was $5,000) are $19,446 This rule was effective January 15, 2018.

This Update is provided as a complimentary service to our clients and is for informational purposes. This Update may be copied or quoted, provided proper attribution is given. The contents are not intended and cannot be considered as legal advice.

 
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