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July 1, 2016

Monthly Update for July 2016

Bergeson & Campbell, P.C.


EPA Launches Advisory Panels: On June 15, 2016, the U.S. Environmental Protection Agency (EPA) launched two advisory panels designed to facilitate small businesses to provide feedback to EPA on three solvents. EPA has established a Small Business Advocacy Review (SBAR) Panel for a proposed rulemaking seeking to limit trichloroethylene (TCE), a chemical used in commercial degreasing operations, dry cleaning operations, and consumer products. EPA also created a panel for a proposed rule that would limit n-methylpyrrolidone’s (NMP) and methylene chloride’s (MC) use in paint and coating strippers. Both rulemakings are a consequence of risk assessments EPA issued in 2014 and 2015, respectively, as part of its ongoing Toxic Substances Control Act (TSCA) Work Plan for Chemicals Program. The Small Business Regulatory Enforcement Fairness Act requires EPA to convene SBAR panels for most proposed rules unless EPA certifies that a rule will not significantly affect small companies. Stakeholders can track these panels’ activities through dockets. More information on the TCE panel is available online. More information on the NMP and MC panel is available online.

NTP Issues Draft Analysis Regarding PFOA And PFOS: In June 2016, the National Toxicology Program (NTP) released a draft hazard analysis of perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS), and concluded each can impair the immune system. NTP conducted a systematic review of human, animal, and detail biological or “mechanistic” studies of PFOA and PFOS because several experimental animal and epidemiological studies detected immune effects following exposure to the chemicals. A peer review Panel will convene on July 19, 2016, to consider the hazard analysis. NTP’s draft analysis and related information is available online.

EPA Issues White Paper On Proposed Modification Of Registration Procedures For Plant-Incorporated Protectants In Breeding Line Intermediates; Notice Of Availability: On June 30, 2016, EPA made available for comment a White Paper describing how EPA is proposing to modify its current approach to plant-incorporated protectants (PIP) in breeding line intermediates (BLI) under Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 81 Fed. Reg. 42704. A PIP is a type of pesticide intended to be produced and used in a living plant, or the produce thereof. A BLI is an intermediate used in plant breeding to bring together, or “stack,”‘ two or more PIPs that have each been individually engineered into different lines of a seed propagated plant. These proposed changes are intended to bring efficiencies to EPA’s approach to PIPs in BLIs while not reducing EPA’s ability to ensure that PIPs in BLIs meet the requirements of FIFRA. Comments are due on or before August 15, 2016.

Court Rules EPA Properly Exercised Discretion Regarding Inert Ingredients: On June 29, 2016, the U.S. District Court for the Northern District of California (court) issued an opinion dismissing the complaint and denying the motion for summary judgment of the Center for Environmental Health, Beyond Pesticides, and Physicians for Social Responsibility (CEH, et al.), and granting EPA’s motion for summary judgment. The case stems from a petition filed in 2006 requesting EPA to initiate a rulemaking requiring the labeling of 371 inert ingredients in pesticides. EPA issued an Advance Notice of Proposed Rulemaking (ANPR) in 2009, but did not proceed further with a rulemaking. CEH, et al. filed a second lawsuit in March 2014, alleging that EPA’s failure to complete the rulemaking process started by the ANPR violated FIFRA and the Administrative Procedure Act (APA). In May 2014, EPA responded by amending its response to the 2006 petition to explain that it had decided to pursue an approach different from requiring mandatory disclosure on the pesticide label of a hazardous inert ingredient. EPA announced that it would instead pursue a “‘combination of regulatory and focused non-regulatory actions that do not rely on rulemaking’ including potentially: (1) removing over ninety chemicals from the list of inert ingredients approved for pesticide use; (2) evaluating the effect of the 371 inert ingredients on food crops; (3) directing pesticide registrants to modify their registrations by replacing hazardous inert ingredients with less hazardous ones; and (4) seeking to expand the existing voluntary disclosure program.” The court granted EPA’s motion for judgment in the March 2014 lawsuit, “finding that there was no further relief that [the court] could offer to plaintiffs and that the action was moot.” CEH, et al.’s complaint in the case at issue challenges EPA’s May 2014 denial of its rulemaking petition, alleging that under FIFRA and APA, EPA’s decision to deny the rulemaking petition was “arbitrary, capricious, and contrary to [FIFRA].” CEH, et al. requested the court to “set aside the denial and to remand the decision to the EPA to consider ‘the evidence weighing in favor of disclosure of inert pesticide ingredients.'” Background on the complaint is available in our blog item NGOs File Suit Regarding Inert Ingredients’ Disclosure. In support of its ruling to grant EPA’s motion for summary judgment, the court stated: “EPA is not mandated to require disclosure of the inert ingredients at issue,” since “[p]laintiffs have provided no persuasive evidence that EPA’s decision to forego rulemaking is inconsistent with the ANPR.” The court noted, for example, that EPA’s regulation governing disclosure of inert ingredients, 40 C.F.R. § 156.10(g)(7), states that “[t]he Administrator may require the name of any inert ingredient(s) to be listed in the ingredient statement if he determines that such ingredient(s) may pose a hazard to man or the environment”; this allows EPA to require applicants to list hazardous inert ingredients, but “does not mandate it.” In addition, the court found that EPA’s decision “that a series of non-rule actions would achieve a greater reduction in the risks from the use of pesticides and could be implemented in a timelier manner,” was not arbitrary or capricious, even if it “conceivably offers a less effective remedy than what plaintiffs sought.” The decision supports EPA’s discretionary authority to determine how to manage and address any inert ingredients that may cause unreasonable adverse effects on the environment. EPA has set forth several actions that it is taking or intends to take in lieu of mandatory label disclosure of inert ingredients. On October 22, 2014, EPA proposed to remove 72 chemical substances from the current listing of inert ingredients approved for use in pesticide products because the inert ingredients are no longer used in any registered pesticide product. Registrants of any pesticides containing a potentially hazardous inert ingredient should monitor how EPA’s regulatory and focused non-regulatory actions affect such substances.

EPA Seeks Extension In Taking Final Action On Chlorpyrifos Registrations: On June 29, 2016, EPA submitted a status report in the Ninth Circuit Court of Appeals case concerning a petition by Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) to revoke the tolerances and cancel the registrations for chlorpyrifos. The Court of Appeals issued an order on December 10, 2015, requiring EPA to take final action concerning the PANNA and NRDC petition no later than December 30, 2016. To comply with an earlier order, EPA issued a proposed rule to revoke the tolerances for chlorpyrifos before it could complete a refined drinking water assessment or propose a new “point of departure” for chlorpyrifos based on biomonitoring data from an epidemiological study. EPA’s status report states that it has made “significant progress” towards meeting the December 30, 2016, deadline, but “extraordinary circumstances exist that make it impracticable for the Agency to meet the Court’s deadline.” EPA has requested a six-month extension for final action on the petition. EPA notes that a proposed new point of departure was presented to a FIFRA Scientific Advisory Panel (SAP), but was not favorably received. At the same time, EPA states that the SAP “raised concerns about the approach EPA adopted in the Proposed Rule, namely that the continued use of acetylcholinesterase inhibition as the point of departure may not be sufficiently health protective.” EPA infers that the SAP may be disposed to recommend a “hybrid approach,” but the written SAP report will not be issued until the end of July 2016. EPA states that it had planned to seek public comment on its refined drinking water assessment and new point of departure for chlorpyrifos immediately after the SAP meeting. EPA now believes that it would be best to obtain the final SAP report before deciding how to establish a point of departure. Accordingly, EPA proposes to seek comment on its refined drinking water analysis and analysis of the epidemiological data by early Fall 2016, and to take final action on the PANNA and NRDC petition by June 30, 2017. EPA expects that the refined drinking water assessment for chlorpyrifos will allow “tailored risk mitigation” that could eliminate one basis for the proposed revocation of chlorpyrifos tolerances. In contrast, EPA’s concerns about the potential neurodevelopmental effects of chlorpyrifos may not be as readily addressed by risk mitigation. If EPA decides either to retain the Food Quality Protection Act (FQPA) 10X safety factor for chlorpyrifos based on purported neurodevelopmental effects observed in epidemiological studies, or to adopt some “hybrid” risk assessment methodology for neurodevelopmental effects in response to the SAP recommendations, debate on the merits of doing so will likely be strong.

EPA Withdraws Significant New Use Rules: On July 14, 2016, EPA withdrew significant new use rules (SNUR) promulgated under TSCA for three chemical substances that were the subject of premanufacture notices (PMN). 81. Fed. Reg. 45416. EPA published the SNURs using direct final rulemaking procedures, which requires EPA to take certain actions if an adverse comment is received. The SNURs were applicable to the following chemical substances: Functionalized carbon nanotubes (generic) (PMN P-15-276), Diisocyanato hexane, homopolymer, alkanoic acid-polyalkylene glycol ether with substituted alkane (3:1) reaction products-blocked (generic) (PMN P-15-378), and Modified diphenylmethane diisocyanate prepolymer with polyol (generic) (PMN P-15-559). EPA received adverse comments regarding the SNURs and thus withdrew the SNURs as required under the direct final rulemaking procedures. EPA intends to publish proposed SNURs for the chemical substances later this year.


EPA Proposes Fee System For Electronic Hazardous Waste Manifest: EPA issued a pre-publication of a rule proposing its user fee methodology applicable to electronic and paper manifests submitted to the national electronic manifest system (or e-Manifest system). After the implementation date for the e-Manifest system, certain users of the hazardous waste manifest would be required to pay a prescribed fee for each electronic and paper manifest they use and submit to the system for EPA to recover its costs of developing and operating the national e-Manifest system. The hazardous waste manifest affects approximately 80,000 federally regulated entities and an equal or greater number of entities handling state-only regulated wastes in at least 45 industries. These industries are involved in shipping off-site, transporting, and receiving several million tons annually of wastes that are hazardous under the Resource Conservation and Recovery Act (RCRA) or state-only regulated wastes that are subject to the tracking of their movements with the RCRA hazardous waste manifest. EPA estimates that these entities currently use between three and five million hazardous waste manifests to track RCRA hazardous and state-only regulated wastes from generation sites to receiving facilities for their management. The affected entities include hazardous waste generators, hazardous waste transporters, and owners and operators of treatment, storage, and disposal facilities (TSDF), as well as the corresponding entities that handle state-only regulated wastes subject to tracking with the RCRA manifest. The proposed rule places the majority of the user fee burden commercial TSDFs that receive hazardous and state-only regulated wastes from off-site for management at their permitted or interim status facilities. Under this proposed rule, these commercial TSDFs would be the focal point for the payment and collection of the user fees. EPA tentatively concluded that payment of this proposal’s user fees by the several hundred commercial TSDFs is the most efficient and expedient means for implementing a user fee requirement for the national e-Manifest system. A copy of the pre-publication version of the proposed rule is available online.


EPA Issues Final Rule Establishing Sulfur Dioxide NAAQS Air Quality Designations: EPA on July 12, 2016, issued a final rule establishing the initial air quality designations for the 2010 primary sulfur dioxide (SO2) National Ambient Air Quality Standard (NAAQS). 81 Fed. Reg. 45039. EPA has designated areas as either nonattainment, unclassifiable/attainment, or unclassifiable, based on whether the areas do not meet the NAAQS or contribute to a nearby area that does not meet the NAAQS (nonattainment); meet the NAAQS (attainment); or cannot be classified on the basis of available information as meeting or not meeting the NAAQS (unclassifiable/attainment). The Clean Air Act (CAA) directs areas designated as nonattainment to undertake certain planning and pollution control activities to attain the SO2 NAAQS as expeditiously as practicable. The full listing of the air quality designations is available online. The effective date of this rule is September 12, 2016.

EPA Releases Preliminary 2016 Effluent Guidelines: On June 27, 2016, EPA released its Preliminary 2016 Effluent Guidelines Program Plan (2016 Preliminary Plan) under the Clean Water Act (CWA). 81 Fed. Reg. 41535. CWA Section 304(m) requires EPA to publish biennially a plan for new and revised effluent limitations guidelines. The Preliminary 2016 Plan identifies any new or existing industrial categories selected for effluent guidelines or pretreatment standards and provides a schedule for their development. The Preliminary 2016 Plan (available online) provides a summary of EPA’s review of effluent guidelines and pretreatment standards. EPA requests comments and information on the data and information used to support the findings, actions, and conclusions. EPA states in the Preliminary 2016 Plan that it is initiating or continuing to review wastewater discharges for the following industry categories: Iron and Steel Manufacturing; Organic Chemicals, Plastics, and Synthetic Fibers; Pulp, Paper, and Paperboard; Battery Manufacturing; and Electrical and Electronic Components Manufacturing. EPA is also continuing its study of Centralized Waste Treatment (CWT) facilities and transfers of wastewater originating from conventional oil and gas extraction facilities to Publicly Owned Treatment Works (POTW). The comment period on the Proposed 2016 Plan closes on July 27, 2016.

EPA Issues Final Rule Establishing Pretreatment Standards For Discharges From Oil And Gas Wells: On June 28, 2016, EPA issued a final rule under the CWA establishing pretreatment standards preventing the discharge of pollutants in wastewater from onshore unconventional oil and gas (UOG) extraction facilities to POTWs. 81 Fed. Reg. 41845. EPA states that UOG extraction wastewater can be generated in large quantities and contains constituents that are potentially harmful to human health and the environment. Certain UOG extraction wastewater constituents are not typical of POTW influent wastewater and can be discharged, untreated, from the POTW to the receiving stream, can disrupt the operation of the POTW, accumulate in biosolids, and facilitate the formation of harmful disinfection byproducts. The final rule applies to onshore extraction from shale and/or tight geologic formations (referred to by EPA as UOG resources). The final rule establishes technology-based categorical pretreatment standards under the CWA for discharges of pollutants into POTWs from existing and new onshore UOG extraction facilities in subpart C of 40 C.F.R. Part 435. EPA promulgated a zero discharge requirement for wastewater pollutants associated with onshore UOG extraction facilities to POTWs. The final rule is effective on August 29, 2016.

EPA Issues Final Rule Revising CAA Standards For Commercial And Industrial Solid Waste Incineration Units: On June 23, 2016, EPA issued a final rule under the CAA amending the New Source Performance Standards (NSPS) and Emission Guidelines for new and existing commercial and industrial solid waste incineration units. 81 Fed. Reg. 40955. EPA originally promulgated NSPS and EG for these units on March 21, 2011. 76 Fed. Reg. 15372. EPA received petitions for reconsideration on that rule and on February 7, 2013, issued a final rule responding to certain of the issues raised in the petitions. 78 Fed. Reg. 9112. Following that action, EPA again received petitions for reconsideration on several aspects of that rule. The June 23, 2016, final rule revises the NSPS and EG in response to those petitions. The final rule revises continuous emission monitoring (CEM) requirements during startup and shutdown, particulate matter limits for waste burning kilns, the definition of “kiln,” and fuel variability factors for coal-burning energy recovery units. The amendments in this rule to 40 C.F.R. Part 60, subpart DDDD, were effective immediately, and to 40 C.F.R. Part 60, subpart CCCC, are effective December 23, 2016.


FDA Issues Proposed Rule To Update GRAS/GRAE Determinations Of OTC Antiseptic Products: On June 30, 2016, the U.S. Food and Drug Administration (FDA) proposed to amend a previously proposed rule for over-the-counter (OTC) antiseptic drug products, and to establish conditions under which OTC consumer antiseptic products intended for use without water (consumer antiseptic rubs or consumer rubs, including hand sanitizers) are generally recognized as safe and generally recognized as effective (GRAS/GRAE). 81 Fed. Reg. 42912. The previously proposed rule used safety data evaluated by FDA as part of its ongoing review of OTC antiseptic drug products to propose GRAS determinations for certain antiseptic active ingredients in OTC products. In light of more recent scientific developments and changes in the use patterns of these products, however, FDA is now proposing that additional safety data are necessary to support the safety of antiseptic active ingredients for this use. FDA states that its request for more data is intended to help it ensure that regular use of these products does not present unknown safety and efficacy concerns, and does not mean FDA believes these products are ineffective or unsafe. Comments on the proposed rule are due by December 27, 2016. New data or information may be submitted by June 30, 2017, however, and comments on any new data or information may then be submitted to the docket for an additional 60 days.

FDA Issues Guidance For Industry On Policy On Declaring Small Amounts Of Nutrients And Dietary Ingredients On Nutrition Labels: On July 1, 2016, FDA issued a notice of availability of its Guidance for Industry that explains to manufacturers of conventional foods and dietary supplements its policy on determining the amount to declare on the nutrition label for certain nutrients and dietary ingredients that are present in a small amount, FDA’s Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels. 81 Fed. Reg. 43061. FDA states that the guidance specifically explains how FDA intends to consider exercising enforcement discretion when a conflict occurs between compliance with subsections (c) and (g) of 21 C.F.R. Section 101.9, Nutrition labeling of food, such that compliance with both sections is not possible. Comments may be submitted at any time.

FDA Hosts Webinar On FSMA Final Rule On Mitigation Strategies To Protect Food Against Intentional Adulteration: On June 21, 2016, FDA hosted a webinar regarding the Food Safety Modernization Act’s (FSMA) final rule on Mitigation Strategies To Protect Food Against Intentional Adulteration. FDA states that the purpose of the final rule is to protect food from intentional acts of adulteration where there is an intent to cause wide scale public health harm, and that the final rule establishes various food defense measures that an owner, operator, or agent in charge of a facility is required to implement to protect against the intentional adulteration of food.


NIOSH Explores Workplace Exposure To Multi-Walled Carbon Nanotubes: The May 2016 issue of NIOSH Research Rounds includes an item entitled “Research Explores Workplace Exposure to Carbon Nanotubes.” The National Institute for Occupational Safety and Health (NIOSH) summarizes the following two published papers by NIOSH investigators with partners at Kazan State Medical University, in Kazan, Russia, that explore whether workplace exposure to multi-walled carbon nanotubes could pose a risk for lung disease. For both studies, participants from the same facility in Kazan volunteered to participate.

  • Integrated Analysis of Dysregulated ncRNA and mRNA Expression Profiles in Humans Exposed to Carbon Nanotubes: NIOSH states that workers exposed to multi-walled carbon nanotubes were significantly more likely than unexposed workers to have abnormal changes related to various cell functions including cell growth and cell death. This study, published in the peer-reviewed journal PLOS ONE, is the first to look at these cellular changes in blood samples from workers exposed to multi-walled carbon nanotubes. According to NIOSH, since this study had only a small number of participants, large-scale studies are needed to determine whether the observed ribonucleic acid (RNA) changes are useful markers of exposure in workers. Additional work also is needed to determine if the effects observed are specific to the multi-walled carbon nanotubes and if this information can assist in developing good risk management practices. The investigators recommended that these findings be considered when comparing the results from similar studies in the U.S., such as an ongoing study at NIOSH; and
  • Fibrosis Biomarkers in Workers Exposed to MWCNTs: Workers exposed to multi-walled carbon nanotubes were significantly more likely than non-exposed workers to have cellular changes that correlated with lung inflammation and scarring. NIOSH states that these findings, published in the peer-reviewed journal Toxicology and Applied Pharmacology, underscore the importance of implementing strict control measures as a reasonable precaution to prevent exposure to workers handling multi-walled carbon nanotubes. The findings indicate that future studies should consider using the observed biomarkers to assess the health effects of workplace exposure to multi-walled carbon nanotubes. In addition, according to investigators, a repository of biological samples would be a valuable tool for future studies.

FSANZ Publishes Reports On The Use Of Nanotechnology In Food Additives And Packaging: In June 2016, Food Standards Australia New Zealand (FSANZ) announced the availability of two reports on the potential use of nanotechnologies in existing food additives and food packaging. FSANZ retained an expert toxicologist to review publicly available scientific literature on whether there is reasonable evidence of health risks associated with oral ingestion of titanium dioxide, silicon dioxide, and silver in food. These food additives may contain a proportion of material with at least one dimension in the nanoscale range. As an extension of this work, the consultant also investigated evidence of risks to health from nanomaterials used in food packaging. FSANZ states that the key findings include:

  • The consultant reviewed the evidence on nanoscale silicon dioxide, titanium dioxide, and silver in food and found the weight of evidence does not support claims of significant health risks for food grade materials;
  • Titanium dioxide and silicon dioxide are used internationally in a range of food products and have been used safely for decades. They are approved food additives in Australia and New Zealand. Silver is also an approved additive in Australia and New Zealand but is permitted in very few foods;
  • Overall, the findings of the report are consistent with recently published information in the Organization for Economic Cooperation and Development’s (OECD) Working Party on Manufactured Nanomaterials Sponsorship Program for the Testing of Manufactured Nanomaterials toxicological dossiers on silicon dioxide, titanium dioxide, and silver;
  • There is no direct evidence to suggest novel nanomaterials are currently being used in food packaging applications in Australia or New Zealand, with most patents found from the U.S.;
  • From the case studies on the use of nano-clay and nanosilver in packaging, the report concludes that there is no evidence from the literature of migration of nano-clay from packaging into food. The nanoscale nature of nanosilver (whether used in packaging or food) is also not likely to be dangerous to consumers’ health; and
  • An independent peer review agreed with the overall analysis and conclusions of both reports stating that they were appropriately balanced in their reporting and that none of the nanotechnologies described are of health concern.

nanoIndEx Publishes Guidance Document On Assessment Of Personal Exposure To Airborne Nanomaterials: In June 2016, the “Assessment of Individual Exposure to manufactured nanomaterials by means of personal monitors and samples” (nanoIndEx) project published a guidance document entitled Assessment of Personal Exposure to Airborne Nanomaterials. The three-year project was funded under the Safe Implementation of Innovative Nanoscience and Nanotechnology (SIINN) European Research Area Network (ERA-NET). Its aim was to determine the field readiness and usability of the instrumentation available for personal exposure assessment; use this information to generate reliable data on personal exposure in real workplaces; and distribute the findings to stakeholders. The guidance document summarizes the key findings of the project, and is intended to present the state of the art in personal exposure assessment for nanomaterials. The conclusions section states: “Unfortunately, many nanotoxicological studies have used excessive, unrealistically high doses of [manufactured nanomaterials] and it is therefore debatable what their findings mean for the lower real-world exposures of humans. Moreover, it is not clear how to establish realistic exposure dose testing in toxicological studies, as available data on occupational exposure levels are still sparse.” According to the guidance document, future studies should focus on the potentially adverse effects of low-level and realistic exposure to manufactured nanomaterials, especially through the use of exposure doses similar to those identified in environmental sampling.

NIOSH Publishes PPOP On Nanotechnology Research Center: On June 15, 2016, NIOSH posted a number of Program Performance One-Pagers (PPOP), including a May 2016 PPOP on the NIOSH Nanotechnology Research Center (NTRC). The PPOP states that the NTRC focuses on increasing understanding of hazards and related health risks to workers who make and use nanomaterials and preventing occupational exposures to nanomaterials. The PPOP includes the following future NIOSH actions:

  • Analyze biomarkers from research studies of nanomaterial workers;
  • Publish the first in a series of nanomaterial handling guidance, “Workplace Design Solutions: Protecting Workers during the Handling/Weighing of Nanomaterials”;
  • Use data on high volume nanomaterials to characterize the size and location of the nanomaterial workforce; and
  • Complete the draft “Current Intelligence Bulletin: Approaches to Developing Occupational Exposure Limits or Bands for Engineered Nanomaterials.”

EFSA Priority Topics For Guidance Development Include Nanotechnologies: On June 20, 2016, the European Food Safety Authority (EFSA) published a scientific opinion entitled “Priority topics for the development of risk assessment guidance by EFSA’s Scientific Committee in 2016-2018.” EFSA asked its Scientific Committee to review its cross-cutting guidance for scientific assessments to identify gaps requiring either new or revised guidance. The Scientific Committee identified topics to be included in its 2016-2018 work program without ranking their priority. According to the scientific opinion, work is already underway in three areas, including nanotechnologies, which are intended to lead to new or revised cross-cutting guidance. The Scientific Committee will continue to keep priorities for cross-cutting guidance across EFSA’s fields of responsibility under review. Regarding nanotechnologies, the scientific opinion states:

Future developments are expected in the field of nano-encapsulates and nano-composites in applications such as novel foods, food/feed additives, biocides, food contact materials, but especially as pesticides. In line with the revision of EFSA’s cross-cutting guidance documents (EFSA Scientific Committee, 2015), the Scientific Committee Nanomaterial Guidance (EFSA Scientific Committee, 2011) requires updating to stay aligned with fast developments in both scientific innovations and legal requirements in this area. The need for this update has been agreed as a priority for the new Scientific Committee in 2015. The guidance update should take into account the general extensions needed to cover also nanopesticides and nanoformulations, food contact materials, food and feed additives and novel foods; as well an update of the physico-chemical property measurements and the other data needed for food/feed assessment. In addition, a second guidance document should be produced on the environmental risk assessment for nanoparticles used in the food chain.

CRS Prepares “Policy Primer” On Nanotechnology: The Congressional Research Service (CRS) prepared a June 28, 2016, report, Nanotechnology: A Policy Primer. The report provides an overview of federal research and development (R&D) in nanotechnology, U.S. competitiveness in the field, environmental, health, and safety (EHS) concerns, nanomanufacturing, and public understanding of and attitudes toward nanotechnology. According to the report, while more than 60 nations established similar programs after the launch of the National Nanotechnology Initiative (NNI), “it appears that several have moved away from centralized, coordinated nanotechnology-focused programs (e.g., the United Kingdom, Japan, Russia), some in favor of market- or application-oriented topic areas (e.g., health care technologies).” Using the criteria of R&D expenditures and non-financial outputs such as scientific papers or patents, the U.S. “appears to be the overall global leader in nanotechnology, though some believe the U.S. lead may not be as large as it was for previous emerging technologies.” The report states that in recent years, China and the European Union (EU) Member States have surpassed the U.S. in the publication of nanotechnology papers. The report notes that there is general agreement that more research on EHS implications is needed to protect the public and the environment, assess and manage risks, and create a regulatory environment that “fosters prudent investment in nanotechnology-related innovation.” Nanomanufacturing may require the development of new technologies, tools, instruments, measurement science, and standards, while public understanding and attitudes may also affect the environment for R&D, regulation, and market acceptance of products incorporating nanotechnology.

IRSST Studies Efficacy Of N95 Respirators In Conditions Representative Of Human Breathing: On June 28, 2016, Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST) issued a press release announcing the availability of a study on “Efficiency Evaluation of N95 FFRs under Cyclic and Constant Flows.” Researchers tested the efficacy of N95 filtering facepiece respirators (FFR) in conditions of constant and cyclical air flow, simulating human breathing, from 42 to 360 liters per minute. According to the press release, N95 respirators “are the personal safety equipment most commonly used in Quebec by industrial and health-care workers to protect themselves against exposure to ultrafine particles” (UFP) (diameter of particles less than 100 nanometers). Researchers examined the impact of breathing frequency and inhalation flow rate on the efficacy of N95 respirators; compared the efficacy of N95 respirators in conditions of cyclical air flow with the results for constant air flow; and assessed the impact of the clogging time of the filter on the performance of N95 respirators as a function of relative humidity and air flow (cyclical and constant). The press release states that UFPs “are potentially toxic and liable to cause serious health problems. They may be of natural origin (sea spray, smoke from forest fires or volcanic activity) or human origin (welding, diesel or exhaust fumes) and, due to their nanometric size, these particles may, once inhaled, be deposited deep in the lungs’ alveoli.” According to the press release, the study results indicated that the influence of a high inhalation flow rate significantly affected the penetration of UFPs, while the impact of breathing frequency was moderate. Researchers established that with a constant air flow, the best assessment of UFP penetration levels is obtained using a moderate inhalation flow rate typical of the human respiratory cycle. The results also showed that filter clogging time and relative humidity have a major impact on particle penetration through N95 respirators.

EC Denies 2014 Petition Seeking EU-Wide Ban On Nanoparticles: On June 29, 2016, the European Commission (EC) provided a notice to the European Parliament regarding its response to a 2014 petition calling for an EU-wide ban on microplastics and nanoparticles. The petition summary states: “Nanoparticles are so small that they penetrate cells effortlessly and can damage them, causing cancer. Because the precautionary principle applies in the EU, the petitioner urges a ban on these small particles as soon as possible.” In its response, the EC states that nanoparticles “are ubiquitous in the environment,” and while some manufactured nanomaterials may potentially be carcinogenic, others are not. The EC states that the general regulatory framework on chemicals, along with the sectoral legislation, “are appropriate to assess and manage the risks from nanomaterials, provided that a case-by-case assessment is performed.” The EC notes that the need to modify the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to include more specific requirements for nanomaterials was identified. According to the EC, a final impact assessment of the proposed changes is being prepared, and the modification of technical REACH Annexes to include specific considerations for nanomaterials is planned for early 2017. The EC states that it created a web portal intended to improve communication regarding nanomaterials, and that this web portal will soon be superseded by the EU Nano Observatory, which will be managed by the European Chemicals Agency (ECHA). The EC concludes that it has “no plans for a generic ban of nanomaterials,” and as it states in the petition response, “[n]anotechnology has a considerable potential to develop tools that protect human health and the environment and address other societal challenges, and the Commission supports its responsible development and use.”

NanoSafety Cluster Publishes 2016 Edition Of Compendium Of Projects: On July 11, 2016, the NanoSafety Cluster (NSC) published the 2016 edition of the Compendium of Projects in the European NanoSafety Cluster. According to NSC, the focus of investment and research “has moved increasingly towards predictive and high throughput approaches to nanosafety, including safety-by-design, bioinformatics, as well as the utilisation of nano-characterisation and safety datasets to support regulation and nanoproduct commercialisation.” The 2016 Compendium contains entries from nine running Seventh Research Framework Program projects, and 11 Horizon 2020 projects (seven running and four in negotiations), offering “exciting insights” into the state-of-the-art collaborative research occurring across Europe. The Compendium also includes updates from the NSC Working Groups (WG) and provides introductions to two new WGs — Safety by Design (WG9) and the Industrial Innovation Liaison (WGi2L/WG10). According to the Compendium, it intends to bring the research community closer together and show the potential for synergy. To establish links and communication between researchers well before the publication of their results, the Compendium focuses on the projects’ strategic aims, covers specific work objectives and the methods used in research, and documents human capacities and partnerships.


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


PHMSA Proposes New Safety Oil Spill Response Plans And Information Sharing For High-Hazard Flammable Trains: On July 13, 2016, the Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA), in coordination with the Federal Railroad Administration (FRA), announced proposed regulations for Oil Spill Response Plans and Information Sharing for High-Hazard Flammable Trains (HHFTs). The rule would expand the comprehensive oil spill response plan requirements under the CWA to certain HHFT trains based on the amount of crude oil being transported. Under the proposal, certain HHFT trains would be required to have comprehensive plans rather than the basic plans that are currently required. The rule also proposes to require the operator to be prepared to respond to an incident involving a worst-case discharge, or the largest quantity of oil reasonably expected to be discharged during an incident. The rule would codify the requirement that railroads share information about all HHFT operations with state and tribal emergency response commissions to improve community preparedness, in accordance with the Fixing America’s Surface Transportation Act of 2015 (FAST Act). The rule proposes railroads be required to provide monthly notification or certification of no change to state and tribal emergency response commissions and relevant emergency responders for HHFTs, including: a reasonable estimate of the number of HHFTs that are expected to travel, per week, through each county within the state; the routes over which the affected trains will be transported; a description of the materials shipped and applicable emergency response information required by the hazardous materials regulations (HMR); at least one point of contact at the railroad (including name, title, phone number, and address); and for petroleum oil trains subject to the Comprehensive Oil Spill Response Plan under 49 C.F.R. Part 130, the contact information for the qualified individuals and description of response zones must also be provided to state and tribal emergency response commissions, or other appropriate state-delegated entities. The rule would also incorporate into the HMR an alternative test method for initial boiling point for flammable liquids (Hazard Class 3) to determine the proper Packing Group. PHMSA is proposing to incorporate by reference an initial boiling point test for flammable liquids from the ASTM D7900 method referenced in the American National Standards Institute/American Petroleum Institute Recommend Practices 3000, “Classifying and Loading of Crude Oil into Rail Tank Cars,” First Edition, September 2014, as an acceptable testing alternative to the boiling point tests currently specified in the HMR. The ASTM D7900 standard differs from the boiling point tests currently in the HMR in that it is the only test that ensures a minimal loss of light ends. The incorporation of the ASTM D7900 will not replace the currently authorized initial boiling point testing methods, but rather serve as a testing alternative if one chooses to use that method. A copy of the pre-publication version of the proposed rule is available online.


House Passes EPA Budget With Controversial Riders; White House Vows Veto: On July 14, 2016, by a 231-196 vote, the House of Representatives passed a bill (H.R. 5538) funding EPA for Fiscal Year (FY) 2017. The bill slashes EPA’s operating budget by $399 million below the Obama Administration’s FY 2017 request. Lawmakers also approved several policy riders that would block implementation of EPA rules that are the cornerstone of Obama’s environmental agenda. In a Statement of Administration Policy, the White House vowed to veto the legislation, arguing that the “unacceptable reduction in funding would significantly undermine key actions to address climate change and improve air quality.” The White House also strongly opposes the policy riders, which would block implementation of the Clean Power Plan (CPP), the CWA’s Waters of the United States jurisdictional rule, standards for methane releases from oil and gas wells, and the NAAQS for ozone. The legislation cuts funding in several key areas. Funding for State Categorical Grants would be reduced by $100 million; the bill also slashes appropriations for the e-Manifest EPA is developing under the RCRA program. The Administration also objects to the reductions made to the Hazardous Substance Superfund Account, arguing that “robust funding within the account is necessary to protect the public and address the release of hazardous substances.” But it is the inclusion of numerous policy riders in the bill that has raised the hackles of the White House. Section 431 of the bill would block the CPP regulating emissions from power plants. Although the CPP is currently stayed pending judicial review, “this provision seeks to derail this critical component of the Administration’s efforts to combat climate change regardless of the outcome of judicial review,” the White House stated. Section 438 of the bill would delay implementation of the 2015 ozone NAAQS, while Section 439 of the bill would block standards for sources of emissions of methane in the oil and natural gas industry. The Administration also “strongly objects” to Section 434 of the bill that would block the implementation and enforcement of a rule to prohibit certain uses of hydrofluorocarbons (HFC). Also stalled under the bill are EPA’s worker protection standards for the pesticide industry, revisions to EPA’s regulatory criteria for aquifer exemptions involving underground injection, and EPA’s current activities under the 2008 Lead Renovation, Repair, and Painting rule.

President Signs Pipeline Safety Bill Into Law: On June 22, 2016, President Obama signed into law reauthorizing the DOT’s PHMSA. The Protecting Our Infrastructure of Pipelines and Enhancing Safety Act of 2016 (SAFE PIPES Act; S. 2276) reauthorizes PHMSA for five years and expands its authority to issue emergency orders in the wake of hazardous materials releases or other events. The law also requires PHMSA to publish regular updates on regulations under development, upgrade standards for natural gas storage facilities, and undertake a review of pipeline integrity.

House Passes Legislation Undercutting Chevron and Auer Doctrines Over White House Opposition: The House of Representatives on July 12, 2016, passed H.R. 4768, the Separation of Powers Restoration Act of 2016 (SOPRA). The bill would amend the APA to overturn the so-called Chevron and Auer doctrines of judicial deference to agency interpretations of statutory and regulatory provisions. The Chevron doctrine, named for the case in which it was originally conceived, Chevron U.S.A., Inc. v. Natural Resources Defense Council, 467 U.S. 837 (1984), is the centerpiece of the Judicial Branch’s modern jurisprudence concerning the propriety of judicial deference to federal agencies’ statutory interpretations. Under this doctrine, a court reviewing an agency’s interpretation of a statute it administers must first determine, using traditional canons of statutory construction, whether the statute speaks clearly to the question the agency has addressed. If so, the court must follow Congress’s expressed intent. If, however, the statute does not reflect a clear congressional intent — i.e., it is “silent or ambiguous” on the question at hand — the court is to defer to the agency’s interpretation, provided that it is within the “permissible” range of available statutory interpretations. The Chevron doctrine displaced the Supreme Court’s prior rubric for whether and how to defer to administrative agencies; the foremost precedent reflecting this principle was Skidmore v. Swift & Co., 323 U.S. 124, 140 (1944). The Auer doctrine finds its roots in the Supreme Court’s decision in Bowles v. Seminole Rock & Sand Co., 325 U.S. 410 (1945). In that case, the Court was called upon to interpret a wartime price control regulation issued by the Administrator of the Office of Price Administration (OPA). The Court deferred to the OPA’s deference in the case. In 1997, post-Chevron, the Court directly addressed and re-affirmed the holding of Seminole Rock in Auer v. Robbins, 519 U.S. 452 (1997). Auer involved the interpretation of a Fair Labor Standards Act regulation promulgated by the Department of Labor. Citing Seminole Rock, the Court deferred to the Secretary of Labor’s interpretation. According to supporters of SOPRA, the Chevron and Auer doctrines have created a complex and evolving framework for review of agencies’ statutory interpretations. They further contend that this has broadly increased the power of federal administrative agencies, purportedly by ceding them authority to determine the metes and bounds of their authority under the myriad of federal statutes containing ambiguous provisions. Accordingly, they believe it is appropriate for Congress to overturn Chevron and Auer statutorily, rather than wait for the Court to address their numerous deficiencies. SOPRA accomplishes these goals by amending the APA to insert a de novo review term to render it as explicit as possible that courts, not agencies, must decide all questions of law. The bill then applies that clarified standard explicitly to all questions of law concerning the interpretation of constitutional, statutory, and regulatory provisions. By applying the de novo term to the interpretation of statutory provisions, the bill overturns Chevron. By applying the term to the interpretation of regulatory provisions, the bill overturns Auer. The White House “strongly opposes” the bill “because it would unnecessarily overrule decades of Supreme Court precedent, it is not in the public interest, and it would add needless complexity and delay to judicial review of regulatory actions.” In a Statement of Administration Policy, the White House vowed that “f the President were presented with H.R. 4768, his senior advisors would recommend he veto the bill.”

Senate Passes Bill Seeking To Reinvigorate Brownfields Remediation Program: On June 27, 2016, the Senate by unanimous consent passed legislation that seeks to reinvigorate the Brownfields remediation program under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). The Brownfields Utilization, Investment, and Local Development Act (BUILDs Act; S. 1479) would amend the brownfields provisions of CERCLA by increasing the dollar limit for cleanup grants, authorize EPA to make multi-purpose grants, and expand grant eligibility for certain publicly owned sites and non-profit organizations. The bill would also allow grant recipients to use a portion of grant funds for administrative costs, provide technical assistance grants to certain parties and authorize up to $2 million per FY in targeted funding grants to states. The BUILDs Act also authorizes the brownfields program at current funding levels ($250 million annually) through FY 2018.

House Subcommittee Holds Hearing On CERCLA Implementation: On July 13, 2016, the House Energy and Commerce Subcommittee on Environment and the Economy held a hearing examining certain aspects of oversight of implementation of CERCLA. While no legislation seeking to reform CERCLA presently is pending in Congress, Subcommittee Chair John Shimkus (R-IL) has stated that the recent passage of TSCA reform legislation could serve as a model for CERCLA implementation reforms. Shimkus also has stated that CERCLA and brownfields reauthorization are his next focus now that TSCA reform legislation is law. Testifying before the subcommittee were Representatives Lacy Clay (D-MO) and Ann Wagner (R-MO); Mathy Stanislaus, Assistant Administrator for the Office of Land and Emergency Management, EPA; Amy Brittain, Environmental Programs Manager, Site Remediation Section, Land Protection Division, Oklahoma Department of Environmental Quality (on behalf of theAssociation of State and Territorial Solid Waste Management Officials); Steve Nadeau, Partner, Honigman Miller Schwartz and Cohn LLP; Marianne Horinko, President, The Horinko Group; and Robert Spiegel, Executive Director, Edison Wetlands Association. A webcast of the hearing, panel member statements, and witness testimonies are available online.

Bipartisan House Bill Would Limit Electronic Waste Exports: On June 24, 2016, Representatives Paul Cook (R-CA) and Gene Green (D-TX) introduced the Secure E-waste Export and Recycling Act (SEERA; H.R. 5579). The bill seeks to stop the flow of electronic waste (e-waste) to China and other countries that regularly counterfeit electronics. The bill will ensure that such waste does not become the source of counterfeit goods that may reenter military and civilian electronics in the United States. SEERA addresses an issue first identified in a Senate Armed Services Committee study that found 1,800 cases of counterfeit parts in military technology. The Senate study concluded that “there is no way to predict how well they [counterfeit chips] will perform, how long they will last, and the full impact of failure.” Defense experts have also raised concerns that malware can be placed on counterfeits to help hackers and cyber-terrorists launch attacks. SEERA would stop the flow of e-waste from the United States by requiring domestic recycling of all untested, nonworking electronics.

Senate Passes GMO Bill That Includes A National Bioengineered Food Disclosure Standard And Federal Preemption And Exclusion Information: On July 7, 2016, the Senate passed a bill, An Act to Reauthorize and Amend the National Sea Grant College Program Act, and for Other Purposes (S. 764), through agreement to the House’s amendment to S. 764, with further amendment. The Senate’s amendment inserted two new subtitles that will amend the Agricultural Marketing Act of 1946: Subtitle E: National Bioengineered Food Disclosure Standard, and Subtitle F: Labeling of Certain Food. The national bioengineered food disclosure standard includes a definition for “bioengineering”: “a food (A) that contains genetic material that has been modified through in vitro recombinant [DNA] techniques; and (B) for which the modification could not otherwise be obtained through conventional breeding or found in nature,” as well as specifics on how the new standard will be established through requirements and procedures. The new requirements and procedures include the following:

  • Prohibition of a food derived from an animal to be considered a bioengineered food solely because the animal consumed feed produced from, containing, or consisting of a bioengineered substance;
  • Determination of the amounts of a bioengineered substance that may be present in food for the food to be a bioengineered food;
  • Establishment of a process for requesting and granting a determination by the Secretary regarding other factors and conditions under which a food is considered a bioengineered food;
  • Requirement that the form of a food disclosure under this section be a text, symbol, or electronic or digital link, with the disclosure option to be selected by the food manufacturer;
  • Provision of alternative reasonable disclosure options for food contained in small or very small packages; and
  • Requirements and procedures specific to small food manufacturers.

Subtitle F includes a section on federal preemption which states that any state regulations on “labeling of whether a food (including food served in a restaurant or similar establishment) or seed [in interstate commerce] is genetically engineered … or was developed or produced using genetic engineering,” and also a section on exclusion from federal preemption — that nothing in the subtitle, or in Subtitle E “shall be construed to preempt any remedy created by a State or Federal statutory or common law right.” On July 14, 2016, the House agreed to the Senate amendment, and passed it by a 306 to 117 vote. The bill is now on its way to the President’s desk. White House spokeswoman Katie Hill has stated that she anticipates that President Obama “would sign it in its current form.”

House Passes Battery Research Legislation: On July 11, 2016, the House passed the Electricity Storage Innovation Act (H.R. 5640). The bill authorizes $150 million a year to establish within the Department of Energy (DOE) an Electricity Storage Basic Research Initiative. DOE’s research under the bill would focus on increasing the efficiency of battery storage and advanced battery technology. The legislation directs DOE to research multivalent ion batteries, organic electrolytes, and mesoscale electrochemistry.

Senate Bill Would Require OSHA To Take Public Comment On Revised Retail PSM Enforcement Policy: Senator Deb Fischer (R-NE) on July 14, 2016, introduced a bill (S. 3253) that would require the Occupational Safety and Health Administration (OSHA) to take public comment on its revised enforcement policy towards retail establishments potentially subject to the Process Safety Management (PSM) standard. The PSM exempts “retail facilities.” See 29 C.F.R. § 1910.119(a)(2)(i). On July 22, 2015, however, OSHA issued a memorandum entitled “Process Safety Management of Highly Hazardous Chemicals and Application of the Retail Exemption (29 CFR 1910.119(a)(2)(i))” (Memorandum). In that Memorandum, OSHA interpreted the term “retail,” as used in the PSM standard, to apply to facilities “engaged in retail trade as defined by the current and any future updates to sectors 44 and 45” of the North American Industry Classification System Manual. This narrowed the exemption; OSHA’s previous interpretation of “retail” applied to facilities that obtained more than half of their income from direct sales to end users. OSHA also deferred enforcement of the new interpretation until July 22, 2016. More specifically, through September 30, 2016, OSHA will not cite employers for violations of the PSM standard at facilities that it would not have cited applying the interpretation of the term “retail” that was in place prior to July 22, 2015.

President Obama Signs FOIA Reform Bill: On June 30, 2016, President Obama signed the Freedom of Information Improvement Act of 2016 (S. 337). The law is intended to ensure disclosure and make it more difficult for federal agencies to withhold information under the Freedom of Information Act (FOIA). Key provisions of the bill include: require federal agencies to make information that is disclosable under such Act available to the public in an electronic, publicly accessible format; make available to the public copies of all releasable records under FOIA that have been requested three or more times or that inform the public of the operations and activities of the government; require agencies to provide the name, phone number, and e-mail address of an agency employee who can provide current information about the status of a FOIA request; require the Office of Management and Budget to ensure the operation of a consolidated online request portal that allows a member of the public to submit a FOIA request for records from a single website; require agencies, at a minimum, to provide an e-mail address at which FOIA requests are accepted and to publish such e-mail address on the agency website; establish a presumption of openness in administering FOIA by prohibiting an agency from withholding information otherwise disclosable under FOIA unless the agency reasonably foresees that disclosure would cause identifiable harm to an interest protected by a FOIA exemption or if the disclosure is prohibited by law; require agencies to identify the statute that exempts a record from disclosure; exempt from disclosure under FOIA records or information that would adversely affect intelligence sources and methods that are protected by a FOIA exemption; prohibit agencies from denying requests from Congress for information based upon a FOIA exemption; limit the FOIA exemption for agency communications to 25 years after the creation of records and information and require agency disclosure of opinions that are controlling interpretations of law, final reports or memoranda solicited and used to make a final policy decision, and guidance documents used to respond to the public; and require mandatory awards of attorney fees and litigation costs to prevailing parties in FOIA proceedings. Other provisions apply.

House Bill Would Reauthorize And Boost Funding For Brownfields Program: Representative Frank Pallone (D-NJ), ranking member of the House Energy and Commerce Committee, on July 14, 2016, introduced a bill seeking to reauthorize and boost funding for EPA’s Brownfields program. Paul Tonko (D-NY) co-sponsored the legislation. The Brownfields Authorization Increase Act (H.R. 5782) would provide $350 million in 2017 to boost funding to clean up and redevelop Brownfield sites across the country. The bill increases overall EPA funding for Brownfields grants, beginning with $350 million in 2017 and increasing by $50 million annually to a total of $600 million in 2022 and beyond. The bill also expands the scope of organizations eligible for Brownfields grants. The Brownfields program was created in 2002 by legislation authored in the House by Pallone and the late Republican Ohio Representative Paul Gillmor. The program assists communities with the cleanup of former industrial properties where redevelopment is complicated by the presence of environmental contamination. At that time, there were an estimated 450,000 Brownfields properties in the U.S. According to EPA, more than 59,000 areas have been revitalized under the program. The program’s authorization expired in 2016 and appropriations for it have declined steadily.


NAS Issues Report On Gene Drives: On June 8, 2016, the National Academy of Sciences (NAS) released a report titled Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values. Gene drives, broadly defined, are systems of biased inheritance in which the ability of a genetic element to pass from a parent to its offspring through sexual reproduction is enhanced. The promise of gene drives to solve various public health problems has hastened technological development in this area. According to the NAS report, there is “insufficient evidence available at this time to support the release of gene-drive modified organisms into the environment, the potential benefits of gene drives for basic and applied research are significant and justify proceeding with laboratory research and highly-controlled field trials.” The report is available online.

Chemical Safety Board To Hold July 27 Business Meeting: The U.S. Chemical Safety Board (CSB) will hold a public business meeting on July 27, 2016. The CSB plans to provide an update on its Strategic Plan for FY 2016-2020, the status of Office of the Inspector General audits, open investigations, and the CSB’s action plan. The CSB also intends to discuss financial and organizational updates. The meeting will be held at the CSB’s offices located at 1750 Pennsylvania Avenue, NW, Suite 910, Washington, DC, 20006 from 1:00 p.m. to 3:00 p.m. (EDT) and is open to the public. CSB will provide a conference call line for those who cannot attend in person. Use the following dial-in number to join the conference: 1-888-466-9863, passcode 7176 237#. An opportunity for public comments from audience members and phone participants will be provided.

EPA Rule Increases Limits On Civil Penalties For Enforcement Actions: On July 1, 2016, EPA’s Office of Enforcement and Compliance Assurance (OECA) promulgated the Civil Monetary Penalty Inflation Adjustment Rule, which increases the amount of civil penalties EPA may seek during enforcement actions for violations of environmental statutes it administers. 81 Fed. Reg. 43091. This adjustment for inflation is mandated by the Federal Civil Penalties Inflation Adjustment Act, and adjusts statutory minimum and maximum penalties applicable to statutory civil penalties assessed on or after August 1, 2016, for violations that occurred after November 2, 2015. EPA lists the adjusted penalty levels as compared to current enacted levels in Table 2 in the Federal Register notice for the rule. The rule does not alter EPA’s civil penalty policies, which guide OECA personnel to consider several factors when assessing penalties, including the violator’s good faith, compliance history, potential economic benefits gained by noncompliance, and ability to pay. The range of penalties that OECA could assess has increased significantly across the board, with several penalty limits increasing by two-fold or more. Impacted statutes include, but are not limited to, FIFRA, TSCA, CWA, CAA, RCRA, and CERCLA. More information on penalty adjustments for specific statutory violations is available in the Federal Register notice.

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