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November 17, 2017

Monthly Update for November 2017

Bergeson & Campbell, P.C.


EPA Extends Comment Period For Draft Guidance For Pesticide Registrants On Notifications, Non-notifications, And Minor Formulation Amendments: On October 5, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice of extension of the comment period for the draft guidance Pesticide Registration Notice (PR Notice) 2017-XX: Notifications, Non-notifications and Minor Formulation Amendment issued on September 6, 2017. 82 Fed. Reg. 46491. Comments now must be received by EPA on or before December 5, 2017. The notice states that it will “allow stakeholders additional time to submit comments on the proposed guidance.” Eleven comments were filed in the docket, most of which expressed significant concern with changes EPA is proposing, in addition to requesting an extension to the previous deadline which was set to end on October 6, 2017. EPA states that PR Notice 2017-XX will update and clarify “the scope of changes accepted by notification, non-notification and minor formulation amendments for all pesticide products, and supersedes both PR Notices 95-2 and 98-10 in their entirety.” A full summary of the changes in the draft guidance is available in our blog item “EPA Releases Draft Guidance for Pesticide Registrants on Notifications, Non-notifications, and Minor Formulation Amendments.” More information is available in our blog.

EPA Reaches Agreement On Dicamba: On October 13, 2017, EPA announced that it had reached an agreement with Monsanto, BASF, and DuPont on measures “to further minimize the potential for drift to damage neighboring crops from the use of dicamba formulations used to control weeds in genetically modified cotton and soybeans,” and “new requirements for the use of dicamba ‘over the top’ (application to growing plants) will allow farmers to make informed choices for seed purchases for the 2018 growing season.” EPA states that in a series of discussions, it “worked cooperatively with states, land-grant universities, and the pesticide manufacturers to examine the underlying causes of recent crop damage in the farm belt and southeast,” “sought extensive input from States and [U.S. Department of Agriculture (USDA)] cooperative extension agents from across the country, as well as the pesticide manufacturers, on the underlying causes of damage,” and “reviewed all available information carefully and developed tangible regulatory changes for the 2018 growing season.” The label changes that certain registrants of dicamba products have agreed to impose additional requirements for “over the top” use of these products next year. More information on EPA’s regulatory action on dicamba is available on EPA’s website. More information is available online.

Non-governmental Organizations (NGO) And Farmworkers File Motion For Expedited Briefing And Hearing In Chlorpyrifos Litigation: On October 13, 2017, Petitioners League of United Latin American Citizens (LULAC), et al. filed a motion to expedite briefing and hearing in League of United Latin American Citizens v. Pruitt, Case No. 17-71636 (9th Cir. June 5, 2017). In their motion, Petitioners request that the court “expedite proceedings because of the harm being caused by EPA Administrator Pruitt leaving chlorpyrifos tolerances in effect when he did not and cannot determine that chlorpyrifos is safe under the Food Quality Protection Act.” More information is available in our blog online.

EPA Proposes Reporting Requirements For Mercury Inventory: On October 26, 2017, EPA proposed reporting requirements for the Toxic Substances Control Act (TSCA) mercury inventory. 82 Fed. Reg. 49564. Under TSCA Section 8(b)(10)(B), the mercury inventory, which includes mercury “supply, use, and trade” in the United States, is required to be published every three years. Information on the 2017 mercury inventory report is available in our blog item “EPA Releases Inventory Report of Mercury Supply, Use, and Trade in the U.S.” Through this proposed rule, EPA states that it is delivering timely on the TSCA Section 8(b)(10)(D) mandate to promulgate a rule within two years of the enactment of new TSCA (by June 22, 2018) that will require “any person who manufactures [including import] mercury or mercury-added products or otherwise intentionally uses mercury in a manufacturing process” to make periodic reports to EPA to assist in the preparation of the mercury inventory. TSCA Section 8(b)(10)(C) further directs to “identify any manufacturing processes or products that intentionally add mercury; and … recommend actions, including proposed revisions of Federal law or regulations, to achieve further reductions in mercury use.” The proposed rule, however, states that “[a]t this time, EPA is not making such identifications or recommendations.” Comments on the proposed rule are due by December 26, 2017. More information is available in our blog.


EPA Extends Comment Period On Proposal To Repeal Clean Power Plan: On October 16, 2017, EPA proposed to repeal the Carbon Pollution Emission Guidelines for Existing Stationary Sources: Electric Utility Generating Units, commonly referred to as the Clean Power Plan (CPP), as promulgated on October 23, 2015. 82 Fed. Reg. 48035. The comment period on that proposal was scheduled to close on December 15, 2017. On November 8, 2017, however, EPA proposed to extend the comment period to January 16, 2018. 82 Fed. Reg. 51787. EPA also announced that it will hold a hearing on the proposed CPP rule on November 28 and 29, 2017.

EPA Issues Direct Final Rule On Formaldehyde Emission Standards For Composite Wood Products: On October 25, 2017, EPA issued a direct final action on a revision to the formaldehyde standards for composite wood products final rule published on December 12, 2016. 82 Fed. Reg. 49287. The revision updates multiple voluntary consensus standards that have been updated, superseded, or withdrawn since publication of the notice of proposed rulemaking on June 10, 2013, and amends an existing regulatory provision regarding the correlation of quality control test methods. The final rule is effective December 11, 2017, without further notice, unless EPA received relevant adverse comment by November 9, 2017. If EPA received adverse comments, the Agency will withdraw the rule informing the public that the rule will not take effect.

EPA Denies Petition Seeking To Expand The Ozone Transport Region: EPA on November 3, 2017, denied a petition submitted by several states seeking to expand the Ozone Transport Region (OTR) under the Clean Air Act (CAA). 82 Fed. Reg. 51238. On December 9, 2013, the states of Connecticut, Delaware, Maryland, Massachusetts, New Hampshire, New York, Pennsylvania, Rhode Island, and Vermont filed a petition with EPA requesting that EPA expand the OTR by adding the states of Illinois, Indiana, Kentucky, Michigan, North Carolina, Ohio, Tennessee, West Virginia, and the areas of Virginia not already in the OTR to address the interstate transport of air pollution with respect to the 2008 ozone National Ambient Air Quality Standards (NAAQS). In its denial, EPA stated that it believes that other CAA provisions “provide a better pathway for states and the EPA to develop a tailored remedy that is most effective for addressing any remaining air quality problems for the 2008 ozone NAAQS identified by the petitioners.” The final action was effective on November 4, 2017.

EPA Issues Notice Of Data Availability Regarding CAA Standards For Oil And Natural Gas Wells: On November 8, 2017, EPA issued a Notice of Data Availability (NODA) regarding its proposed rule to modify CAA standards for the oil and natural gas sector. 82 Fed. Reg. 51788. On June 16, 2017, EPA proposed to stay for two years certain requirements promulgated in the final rule titled “Oil and Natural Gas Sector: Emission Standards for New, Reconstructed, and Modified Sources.” 81 Fed. Reg. 35824; June 3, 2016. The November 8, 2017, NODA provides additional information on several topics raised by stakeholders commenting on the proposed stay, and EPA solicits comment on the information. The main topic areas are the legal authority to issue a stay and the technological, resource, and economic challenges with implementing the fugitive emissions requirements, well site pneumatic pump standards, and the requirements for certification of closed vent systems by a professional engineer. This notice also provides an updated cost savings and forgone benefits analysis for the two-year stay. The comment period on the NODA closes December 8, 2017.

EPA Withdraws EPCRA Rule Updating NAICS Codes For TRI Reporting: EPA on November 14, 2017, issued a direct final rule withdrawing its proposal to update the list of North American Industry Classification System (NAICS) codes subject to reporting under the Emergency Planning and Community Right-to-Know Act’s (EPCRA) Toxics Release Inventory (TRI) reporting. 82 Fed. Reg. 52674. On August 17, 2017, EPA issued a direct final rule and a proposed rule to update the list of NAICS codes subject to TRI reporting under EPCRA Section 313. 82 Fed. Reg. 39038 and 39101, respectively. Since the direct final rule and proposed rule’s publication, EPA received a public comment supporting the overall update, but noting that the direct final rule inadvertently omitted one of the covered NAICS codes. As a result of this omission, EPA is withdrawing the direct final rule published in the Federal Register on August 17, 2017, and will instead proceed with a final rule. The withdrawal was effective on November 14, 2017.


FDA Announces Guidance To Help Domestic And Foreign Facilities Register As Food Facilities Under FFDCA: On October 20, 2017, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance for industry #235 entitled “Current Good Manufacturing Practice Requirements for Food for Animals.” 82 Fed. Reg. 48822. The guidance, which FDA states is intended for domestic and foreign facilities that are required to register as food facilities under the Federal Food, Drug, and Cosmetic Act (FFDCA) because they manufacture, process, pack, or hold animal food for consumption in the U.S., contains information to help these facilities determine whether they need to comply with the current good manufacturing practice (CGMP) requirements for animal food established in the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals final rule (80 Fed. Reg. 56170 (Sept. 17, 2015)) as promulgated under the Food Safety Modernization Act (FSMA). This guidance also provides additional information and recommendations for compliance with the CGMP requirements for animal food, as well as compliance with related requirements such as training and recordkeeping.

FDA Announces Draft Guidance For Industry Intended To Provide Clarity On Application Of “Solely Engaged” Exemptions: On October 20, 2017, FDA announced the availability of a draft guidance for industry entitled “Application of the “Solely Engaged” Exemptions in Parts 117 and 507; Draft Guidance for Industry.” 82 Fed. Reg. 48828. The draft guidance is intended to help establishments and facilities subject to certain FDA regulations determine whether they are “solely engaged” in certain activities; establishments and facilities “solely engaged” in certain activities are exempt from some or all requirements of the regulations that FDA has established as part of its implementation of FSMA. 21 C.F.R. Part 117, specifically Subparts A, B, and F, includes requirements for establishments that manufacture, process, pack, or hold human food to follow CGMPs; and Subparts A, C, D, E, F, and G include requirements for domestic and foreign facilities that are required to register under FFDCA to conduct a hazard analysis and implement risk-based preventive controls for human food. 21 C.F.R. Part 507, specifically Subparts A, B, and F, relates to domestic and foreign facilities that are required to register, and include animal food CGMP requirements; and Subparts A, C, D, E and F include requirements to conduct a hazard analysis and implement risk-based preventive controls for animal food (the animal food preventive controls requirements). The guidance states that the exemptions in Parts 117 and 507 refer to the primary Subparts that contain CGMP and preventive controls requirements: Subpart B (CGMP), Subparts C and G (human preventive controls), and Subparts C and E (animal food preventive controls). Comments are due by April 18, 2018.

FDA Launches New Web Page And Timeline Listing Key FSMA Compliance Dates: On October 23, 2017, FDA announced the launch of its new web page that lists compliance dates for the FSMA final rules and its creation of a graphic timeline that lists key FSMA compliance dates by year. The FSMA final rules are: Preventive Controls for Human Food; Preventive Controls for Animal Food; Produce Safety; Foreign Supplier Verification; Sanitary Transportation; and Intentional Adulteration.

FDA, USDA, And EPA To Hold Public Sessions On Agricultural Biotechnology: On October 25, 2017, EPA’s Office of Pesticide Programs (OPP) announced that FDA, in coordination with USDA’s Animal and Plant Health Inspection Service (APHIS) and OPP, will be holding two public meetings to discuss FDA’s Agricultural Biotechnology Education and Outreach Initiative. The meeting were convened in Charlotte, North Carolina, on November 7, 2017, and in San Francisco, California, on November 14, 2017. EPA states that this initiative, which Congress appropriated three million dollars to fund, “calls for FDA to work with EPA and USDA to provide education and outreach to the public on agricultural biotechnology and food and animal feed ingredients derived from biotechnology, and the purpose of the meetings is “to provide the public an opportunity to share information, experiences, and suggestions to help inform the development of this education and outreach initiative.” FDA issued a notice on these public meetings in the Federal Register on October 13, 2017. 82 Fed. Reg. 47750. More information on the initiative is available on FDA’s website. More information is available in our blog.

FDA Issues Final Guidance On Deciding When To Submit An FFDCA 510(k) For A Change To An Existing Device: On October 25, 2017, FDA issued a notice of availability in the Federal Register announcing that the final guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device” is available. 82 Fed. Reg. 49375. FDA states that this guidance, which supercedes the previous guidance of the same name issued in 1997, will “clarify when a change in a legally marketed medical device would require that a manufacturer submit a premarket notification (510(k)) to FDA.” FFDCA Section 510(k) requires device manufacturers who must register to notify FDA of their intent to market a medical device at least 90 days in advance, which FDA states allows it to determine whether the device is equivalent to a device already placed into one of the three classification categories. The final guidance provides ten guiding principles that should be followed when deciding whether to submit a new 510(k) for a change to an existing device. The guiding principles include the following topics: changes made with intent to affect significantly safety or effectiveness of a device; initial risk-based assessment; unintended consequences of changes; use of risk management; the role of testing (i.e., verification and validation activities) in evaluating whether a change could significantly affect safety and effectiveness; evaluating simultaneous changes to determine whether submission of a new 510(k) is required; appropriate comparative device and cumulative effect of changes; documentation requirement; 510(k) submissions for modified devices; and substantial equivalence determinations.

FDA Recognizes Eight European Drug Regulatory Authorities As Capable Of Conducting Inspections Of Manufacturing Facilities That Meet FDA Requirements: On October 31, 2017, FDA issued a press release stating that as part of the Mutual Recognition Agreement between the U.S. and the European Union (EU), it recently completed eight capability assessments and now has determined that the drug regulatory authorities of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom (UK) to be capable of conducting inspections of manufacturing facilities that meet FDA requirements. FDA states that this achievement “marks an important milestone to successful implementation and operationalization of the amended Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement (MRA) that enables U.S. and EU regulators to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities.”

FDA Proposes To Revoke Use Of Health Claims On Relationship Between Soy Protein And Coronary Heart Disease: On October 31, 2017, FDA issued a proposed rule in the Federal Register proposing to revoke its regulation authorizing the use of health claims on the relationship between soy protein and coronary heart disease on the label or in the labeling of foods. 82 Fed. Reg. 50324. FDA states that it is taking this action based on its “review of the totality of publicly available scientific evidence currently available and our tentative conclusion that such evidence does not support our previous determination that there is significant scientific agreement (SSA) among qualified experts for a health claim regarding the relationship between soy protein and reduced risk of coronary heart disease.” Comments are due by January 16, 2018.

FDA Releases Draft Guidance: On November 6, 2017, FDA issued a notice of availability in the Federal Register of draft guidance for industry entitled “Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food.” 82 Fed. Reg. 51345. FDA states the guidance is intended for persons who participate in certain “co-manufacturing” agreements in the production of human or animal food — FDA defines “co-manufacturing” as a “contractual arrangement whereby one party (the brand owner) arranges for a second party (the co-manufacturer) to manufacture/process human or animal food on behalf of the first party.” The guidance states that “[t]o provide time for contracts to be revised to allow co-manufacturers to review all necessary documentation from the brand owner, FDA is announcing that, under certain circumstances and on a temporary basis, [it does] not intend to take enforcement action against a receiving facility that is a co-manufacturer, and that is not in compliance with certain supply-chain program requirements for food manufactured for the brand owner.” Further, FDA states that it does “not intend to take enforcement action regarding the affected provisions until November 6, 2019.”

FDA Issues Pesticide Residue Monitoring 2015 Report: On November 6, 2017, FDA issued its Pesticide Residue Monitoring Report and Data for Fiscal Year (FY) 2015. FDA states the report found that 98 percent of domestic and 90 percent of imported foods tested in FY 2015 were compliant with federal pesticide residue limits. Specifically, in FY 2015 (October 1, 2014, through September 30, 2015), “the levels of pesticide chemical residues in or on food generally remained well below established federal tolerances, or EPA limits,” and “no pesticide chemical residues were found in 49.8% of the domestic and 56.8% of the imported human food samples analyzed.” Further, FDA “found pesticide chemical residues in violation of federal tolerances (residue levels above the tolerance or residues for which no tolerance has been established) in less than 2% (15 out of 835) of domestic samples and less than 10% (444 out of 4737) of import samples.” More information is available in the report and in FDA’s Constituent Update.

FDA Releases Draft Menu Labeling Guidance: On November 9, 2017, FDAissued a notice of availability in the Federal Register of draft guidance for industry entitled “Menu Labeling: Supplemental Guidance for Industry.” 82 Fed. Reg. 52036. FDA states this draft guidance, which reflects input from stakeholders, including the public and industry in response to an interim final rule issued May 4, 2017 (82 Fed. Reg. 20825), includes expanded and new interpretations of policy and many graphical depictions to convey its thinking on various topics and to provide examples of options for implementation and it identifies places where FDA intends to be more flexible in its approach. Further, it addresses calorie disclosure signage for self-service foods, including buffets and grab-and-go foods; reasonable basis, and the criteria for considering the natural variation of foods; various methods for providing calorie disclosure information, including those for pizza; compliance and enforcement; and criteria for distinguishing between menus and other information presented to the consumer. This guidance document addresses concerns raised by stakeholders regarding the implementation of nutrition labeling required for foods sold in covered establishments, including expanded and new interpretations of policy. It also clarifies that there are additional options for complying with the labeling requirements and identifies places where FDA intends to be more flexible in its approach. Comments on the draft guidance are due by January 8, 2018.


Germany Holds Expert Dialogue On Nanotechnologies In The Automotive Sector: On September 26-27, 2017, the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety (BMUB) held an Expert Dialogue regarding the opportunities and risks of the application of nanotechnologies in the automotive sector. The Expert Dialogue provided an overview of current and future applications of nanomaterials in automobiles. A number of the presentations are available online, in German.

Presentations And Report Posted For Conference On Standardization For Nanotechnologies And Nanomaterials: In October 2017, the presentations and report for the June 20, 2017, Second European Conference on “Standardization for Nanotechnologies and Nanomaterials: Reliable data for an effective management of nanomaterials” were posted. Round tables were held on nanosafety; nanoparticle aerosol measurements; quality/relevance of data in nanomaterial databases and registries; identification of nanomaterials; nanomaterial exposure and risk assessment; and the impact of research projects on standardization. According to the Conference report, an additional conference within the M/461 framework will be held by the end of 2018.

EUTI Publishes Policy Brief On EUON: The European Trade Union Institute (ETUI) published a policy brief entitled “EU Observatory for Nanomaterials: a constructive view on future regulation.” The policy brief provides information about the EU Observatory for Nanomaterials (EUON), how it is being developed, its limitations, and “why it is not an ideal option.” ETUI’s recommendations include creating a framework to trace where nanomaterials are being produced and how they are used, and establishing worker exposure registries at the company level. The policy brief “urges policy-makers to make use of foresight and ethics to address fast-moving technological convergence and the new frontiers of science and technology.”

UK Parliamentary Office Publishes Note On Risk Assessment Of Nanomaterials: On October 5, 2017, the UK’s Parliamentary Office of Science and Technology (POST) published a POSTnote entitled “Risk Assessment of Nanomaterials.” According to POST, key points include:

  • Current regulatory frameworks applicable to nanomaterials within the UK are mainly set at the EU level; and
  • Post-Brexit, the UK will need to establish regulatory frameworks for nanomaterials.

OECD Publishes Summary Of Dossier On Silver Nanoparticles: The Organization for Economic Cooperation and Development (OECD) published a report entitled Silver Nanoparticles: Summary of the Dossier. The Summary includes information on physical and chemical properties; general information on exposure; hazards to the environment; and toxicological information.

BfR Publishes Q&A Regarding Study On Fate And Effects Of Tattoo Pigments In Human Skin: On October 12, 2017, the German Federal Institute for Risk Assessment (BfR) published questions and answers (Q&A) regarding a study on whether nanometric pigments from tattoo inks can permanently accumulate in lymph nodes. The study, “Synchrotron-based ν-XRF mapping and μ-FTIR microscopy enable to look into the fate and effects of tattoo pigments in human skin,” was published in September 2017.

EPA Publishes SNUR For MWCNTs (Generic): EPA published on October 19, 2017, a direct final rule promulgating significant new use rules (SNUR) for 29 chemical substances that were the subject of premanufacture notices (PMN). 82 Fed. Reg. 48637. The direct final rule includes a SNUR for multi-walled carbon nanotubes (MWCNT) (generic) (PMN Numbers P-15-487, P-15-488, P-15-489, P-15-490, and P-15-491). The SNUR requires:

  1. Use of personal protective equipment to prevent dermal exposure and a National Institute for Occupational Safety and Health-certified respirator with N-100, P-100, or R-100 cartridges with an assigned protection factor of at least 50 (where there is a potential for inhalation exposure);
  2. Use of the PMN substances only for the uses specified in the consent order;
  3. No use in application methods that generate a dust, mist, or aerosol unless such application method occurs in an enclosed process; and
  4. No use of the PMN substances resulting in releases to surface waters and disposal of the PMN substances only by landfill or incineration.

A significant new use is any use involving an application method that generates a dust, mist, or aerosol. The SNUR requirements do not apply when the PMN substances have been incorporated into a polymer matrix that has been reacted (cured) or embedded in a permanent solid polymer form that is not intended to undergo further processing except mechanical processing.

NIA Holds Webinar On Safe By Design For Nanomaterials: On October 24, 2017, the Nanotechnology Industries Association (NIA) held a webinar on Safe by Design for Nanomaterials. The webinar was open to all actors interested in nanomaterials and their safe management throughout their lifecycle, using the principles of Safe by Design from the earliest development stages. Links to the webinar presentations are available in our October 30, 2017, blog item, “NIA Holds Webinar on Safe by Design for Nanomaterials.”

ISO Publishes Standard On Use And Application Of Acellular In Vitro Tests And Methodologies To Assess Nanomaterial Biodurability: In October 2017, the International Organization for Standardization (ISO) published standard ISO/TR 19057:2017, “Nanotechnologies — Use and application of acellular in vitro tests and methodologies to assess nanomaterial biodurability.” The standard reviews the use and application of acellular in vitro tests and methodologies implemented in the assessment of the biodurability of nanomaterials and their ligands in simulated biological and environmental media. It is intended to focus more on acellular in vitro methodologies implemented to assess biodurability and, therefore, excludes the general review of relevant literature on in vitro cellular or animal biodurability tests.

OECD Report Examines How To Determine Concentrations Of Manufactured Nanomaterials In Workplace Air: OECD has posted an October 30, 2017, report entitled Strategies, Techniques and Sampling Protocols for Determining the Concentrations of Manufactured Nanomaterials in Air at the Workplace. The report includes the findings of research undertaken in non-industrial nanotechnology workplaces involving the measurement of nanomaterials emissions and exposures. It presents six case studies that demonstrate how measurement and assessment of nanomaterials can be undertaken and how results can be interpreted: grinding and extrusion of modified titanium dioxide; manufacture of clay-polyurethane nanocomposite material; grinding of titanium dioxide powder; jet milling of modified clay particles; decanting of single- and multi-walled carbon nanotubes; and synthesis of carbon nanotubes using chemical vapor deposition.

OECD Publishes Analysis Of Survey On Consumer And Environmental Exposures To Manufactured Nanomaterials: OECD published a November 7, 2017, report entitled Consumer and Environmental Exposure to Manufactured Nanomaterials — Information used to characterize exposures: Analysis of a Survey. The report provides a “light analysis” of the results of a Working Party on Manufactured Nanomaterials (WPMN) survey on consumer and environmental exposures to manufactured nanomaterials. The report recommends potential avenues for future work by OECD. According to the report, recommended next steps include obtaining feedback on the direction proposed for future OECD projects and identifying specific projects that can be undertaken by WPMN. Follow up on selected survey responses is also recommended to determine the feasibility and applicability of data for future activities.

NSF NSE Will Hold Grantees Conference On Progress In Nanotechnology: The National Science Foundation (NSF) Nanoscale Science and Engineering (NSE) grantees conference on progress in nanotechnology will be held December 12-13, 2017. The conference will highlight the research and education activities of ongoing NSE grant projects. It will include a combination of keynotes, panels, posters, program information sessions, discussions of research trends, and principal investigator meetings with NSF program directors. The conference will address the following themes:

ECHA Seeks Case Studies To Feature At SETAC Europe: The European Chemicals Agency (ECHA) will have six sessions at the Society of Environmental Toxicology and Chemistry (SETAC) Europe, which will be held May 13-17, 2018, in Rome, Italy. ECHA’s sessions will include one on recent developments in regulatory science and environmental risk assessment of nanomaterials. To support the session, ECHA welcomes abstracts on experience gained in environmental hazard and risk assessment of nanomaterials illustrated by case studies. The session will focus on how to produce adequate and reliable information suitable for regulatory purposes and on innovative approaches to communicate the risks and benefits of nanomaterials beyond the scientific community. Abstracts are due November 29, 2017.


BRAG Biobased Products News And Policy Report: Bergeson & Campbell, P.C. (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


Senator Menendez Calls For Investigation Of EPA’s Chemical Office In Wake Of New York Times Article: Prompted by a report by the New York Times alleging that the Trump Administration is revising the way the federal government evaluates the health and environmental risks of hazardous chemicals to prioritize the wishes of industry over health and safety, Senator Robert Menendez (D-MJ) called for an investigation into the “suppression of science, reversal of EPA chemical safety standards to please industry at [the] expense of public health.” In an October 23, 2017, letter to EPA’s Inspector General (IG), Senator Menendez requested that the IG “initiate an investigation into a recent New York Times report detailing political interference, suppression of science, and prioritization of industry recommendations over public health in EPA’s Office of Chemical Safety and Pollution Prevention, and throughout the agency at large.” The letter urges the IG to investigate reports of the suppression of science relating to the public health impacts of toxic and dangerous chemicals; the use of “administratively determined” hiring practices, and the extent to which these practices are used to circumvent EPA’s ethics or conflict of interest standards; and deference to industry requests, rather than scientific and technical analysis, in the context of the Agency’s rulemaking process.

Environmental Justice Bill Introduced: On October 24, 2017, Senator Cory Booker (D-NJ) introduced a bill seeking to strengthen protections for communities of color, low-income communities, and indigenous communities. The Environmental Justice Act of 2017 (S. 1996) would codify and expand the 1994 Executive Order (EO) on Environmental Justice (EO 12898). EO 12898 focused federal attention on environmental and human health impacts of federal actions on minority and low-income communities. The bill would also expand the EO by improving the public’s access to information from federal agencies charged with implementing the bill and creating more opportunities for the public to participate in the agencies’ decision-making process. The legislation also codifies the National Environmental Justice Advisory Council (NEJAC) and environmental justice grant programs. Under the bill, federal agencies must implement and update annually a strategy to address negative environmental and health impacts on communities of color, indigenous communities, and low-income communities. In addition, the bill codifies Council on Environmental Quality guidance to assist federal agencies with their National Environmental Policy Act (NEPA) procedures so that environmental justice concerns are effectively identified and addressed. The bill also codifies existing EPA guidance to enhance EPA’s consultations with Native American tribes in situations where tribal treaty rights may be affected by a proposed EPA action. In addition, the bill requires consideration of cumulative impacts and persistent violations in federal or state permitting decisions under the Clean Water Act (CWA) and the CAA. The bill clarifies that communities impacted by events like the Flint water crisis may bring statutory claims for damages and common law claims in addition to requesting injunctive relief. The bill also reinstates a private right of action for discriminatory practices under the Civil Rights Act, overruling the Supreme Court decision in Alexander v. Sandoval.

House Passes Bill Prohibiting Third Party Payments In Settlements: On October 24, 2017, the House passed a bill ending the federal government practice of entering into settlements where funds are paid to third party groups. The Stop Settlement Slush Funds Act of 2017 (H.R. 732) specifically prohibits government officials from entering into or enforcing a settlement agreement on behalf of the United States (resolving a civil action, a plea agreement, a deferred prosecution agreement, or a nonprosecution agreement) that provides for a payment or a loan to any person or entity other than the United States. The bill provides exceptions to allow payments or loans that: (1) remedy actual harm (including to the environment) caused by the party making the payment or loan, or (2) constitute a payment for services rendered in connection with the case or a payment that a court may order for restitution to victims in certain criminal cases or other persons in plea agreements. Federal agencies would be required to report annually for seven years to the Congressional Budget Office about the parties, funding sources, and distribution of funds for their settlement agreements permitted by the exceptions in this bill.

House Passes Legislation Abolishing “Sue And Settle” Litigation By EPA: On October 25, 2017seeking to put an end to EPA’s use of “sue and settle” tactics, the House passed the Sunshine for Regulations and Regulatory Decrees and Settlements Act of 2017 (H.R. 469). The bill limits the ability of defendant federal regulators and pro-regulatory plaintiffs “to abuse federal consent decrees and settlement agreements to require new regulations, reorder regulatory priorities, bind the discretion of future administrations, and limit the rights of regulated entities and State, local and Tribal co-regulators affected by actions taken under such decrees and settlements.” The bill accomplishes this by seeking to improve transparency, increase participation by affected regulated entities and co-regulators in the negotiation and consideration of decrees and settlements, strengthening public comment on and judicial review of proposed decrees and settlements, and assuring review by the Attorney General and agency heads of the types of proposed decrees and settlements that would most intrusively involve the Judiciary in the administration of agencies’ regulatory duties. This bill establishes public notice and comment procedures and motion to intervene standards for civil actions seeking to compel agency action and alleging that an agency is unlawfully withholding or unreasonably delaying an agency action, and for consent decrees or settlement agreements that require agency action, relating to a regulatory action that would affect the rights of: (1) private persons other than the person bringing the action; or (2) a state, local, or tribal government. The bill sets forth requirements for: agencies against which such an action is brought to publish online, within 15 days after receipt, the notice of intent to sue and the complaint; courts to consider motions to intervene and allow amicus participation; and any settlement proceedings to include intervening parties and to be conducted pursuant to the mediation or alternative dispute resolution program of the court or by a district judge. Agencies seeking to enter such a consent decree or settlement agreement must publish, and accept and respond to public comment on, the proposed agreement or decree for 60 days before filing it with the court. They must also make available to the court the administrative record and a summary of public comments and any public hearings. The Department of Justice, or an agency litigating a matter independently, must certify to the court its approval of such proposed: (1) consent decrees that include terms that convert into a nondiscretionary duty a discretionary authority of an agency to propose, promulgate, revise, or amend regulations, commit an agency to expend funds that have not been appropriated and budgeted or to seek a particular appropriation or budget authorization, divest an agency of discretion committed to it by statute or the Constitution, or otherwise afford any relief that the court could not enter under its own authority; or (2) settlement agreements that include terms that provide a remedy for a failure by the agency to comply with the terms of the agreement other than the revival of the civil action resolved by the agreement, interfere with the authority of an agency to revise, amend, or issue rules, or commit the agency to expend funds that have not been appropriated and budgeted or to exercise in a particular way discretion which was committed to the agency by statute or the Constitution. Courts: (1) shall not approve such consent decrees or settlement agreements unless they allow sufficient time and procedures to comply with the Administrative Procedure Act, rulemaking statutes, and EOs; and (2) shall grant de novo review if an agency files a motion to modify such a decree or agreement on the basis that its terms are no longer fully in the public interest due to changed facts and circumstances or the agency’s obligations to fulfill other duties. The House passed similar legislation in 2016 but it failed in the Senate. This bill also faces an uncertain future in the Senate.

Senate Approves EPA AA Nominations: On October 25, 2017, the Senate Environment and Public Works (EPW) Committee approved by recorded vote the nominations of William Wehrum, nominee to be Assistant Administrator (AA) for the Office of Air and Radiation (OAR) and Michael Dourson, nominee to be AA for the Office of Chemical Safety and Pollution Prevention at the EPA. By voice vote, the Committee also advanced the nominations of Matthew Leopold, nominee for General Counsel, and David Ross, nominee to be AA for the Office of Water at the EPA. The votes on Wehrum and Dourson were divided along party lines. Both nominees were controversial and received withering questions and comments during their confirmation hearings, and the original vote on them was postponed. Our blog describing the hearings is available online.

By a vote of 49-47, the Senate on November 9, 2017, narrowly confirmed Wehrum. Wehrum previously served as EPA’s acting AA for OAR from 2005 to 2007 and as EPA’s principal deputy AA and counsel to the AA for OAR.

Senate Bill Would Ban Asbestos: On November 2, 2017, Senators Jeff Merkley (D-OR), Cory Booker (D-NJ), Dianne Feinstein (D-CA), Dick Durbin (D-IL), Bernie Sanders (I-VT), Jon Tester (D-MT), Sheldon Whitehouse (D-RI), and Edward Markey (D-MA) introduced a bill to amend TSCA to require EPA to ban asbestos. The Alan Reinstein Ban Asbestos Now Act of 2017 (S. 2072), is named after Alan Reinstein, who passed away in 2006 at the age of 66 from mesothelioma, a disease caused by exposure to asbestos. Asbestos is still legal in the United States, even though it has been banned in most other developed countries. EPA included asbestos on its list of the first ten chemicals for risk reviews under the 2016 revised TSCA, but the safety assessment must be completed before EPA can consider any controls on asbestos, and EPA is not required to ban it. The bill specifically would amend TSCA to require EPA to identify and assess known uses of and exposures to all forms of asbestos. It also would require that, within 18 months of enactment, EPA must impose restrictions on the use of asbestos necessary to eliminate human or environmental exposure to all forms of asbestos. Also, within one year, EPA must disallow the manufacturing, processing, use, or distribution in commerce of asbestos.

House Bill Would Allow EPA To Waive RFG Requirements: On November 9, 2017, Representative James Sensenbrenner (R-WI) introduced the RFG Modernization Act (H.R. 4364). The bill would authorize EPA, at the request of a Governor of a state, to waive the reformulated gasoline (RFG) prohibitions and requirements under Section 211(k) of the CAA in covered jurisdictions due to excessively high gas prices. Currently, EPA’s temporary RFG waiver authority is tailored to address price spikes when there is a disruption in fuel supply, and does not specifically respond to the disparity in cost between RFG and conventional gasoline. Under the bill, Governors may seek a renewable six-week waiver from EPA for the sale of RFG in a portion of their state where its sale is currently mandated. In deciding whether to grant the waiver, EPA would be required to compare the price of RFG to the price of conventional gasoline, and evaluate other factors EPA deems appropriate.

House Bill Would Prohibit RCRA Citizen Suits Against Certain Agricultural Operations: A draft House bill seeks to undo a federal district court decision that allowed a citizen suit under the Resource Conservation and Recovery Act (RCRA) to proceed against agricultural operations that store and apply manure. The Farm Regulatory Certainty Act (no bill number assigned) would amend RCRA to specify that citizen suits may not be brought under RCRA against an agricultural operation if federal or state legal and enforcement actions are already underway. Introduced by Representative Dan Newhouse (R-WA), the bill seeks to remedy a situation caused by a decision in Community Association for Restoration of the Environment Inc., et al v. Cow Palace LLC, 2:13-cv-03016 (E.D. Wash.). In that decision, the federal district court for the Eastern District of Washington held that certain dairies had violated RCRA’s open dumping provision through their management of manure. The court ruled that the dairies had violated RCRA even though they had entered a consent order with EPA under the Safe Drinking Water Act to address potential issues associated with the manure management. The ruling allowed a RCRA citizen suit to proceed against the dairies. RCRA contains two different citizen suit provisions. Section 7002(a)(1)(A) provides for citizen suits to address alleged violations of RCRA requirements, including regulations, permits, and orders. Section 7002(a)(1)(B) provides for suits to address “imminent and substantial endangerment” to human health or the environment. The current citizen suit authority also specifies certain EPA or state actions that bar citizen suits from proceeding. For the imminent and substantial endangerment suits under Section 7002(a)(1)(B), a citizen suit is generally barred if, as to the alleged endangerment, EPA: is diligently prosecuting an action under RCRA Section 7003 or Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) Section 106; is engaging in a removal action under CERCLA Section 104; has incurred costs for remedial investigation under CERCLA Section 104 and is diligently proceeding with a remedial action; or has obtained a court order or issued an administrative order under CERCLA Section 106 or RCRA Section 7003 under which a responsible party is diligently conducting investigation, removal, or remedial activities. A citizen suit under Section 7002(a)(1)(B) also is generally barred if, as to the alleged endangerment, the state: is diligently prosecuting a citizen suit under RCRA Section 7002(a)(1)(B); is engaging in a removal action under CERCLA Section 104; or has incurred costs for remedial investigation under CERCLA Section 104 and is diligently proceeding with a remedial action. The Farm Regulatory Certainty Act would add to these statutory bars. It would bar any “imminent and substantial endangerment” citizen suits pertaining to (1) manure or crop residues returned to the soil as fertilizer by an agricultural operation, or (2) storage of manure or crop residue for such use, when they contributed to the activities which may present an endangerment, in two situations. Suits would be barred if either EPA or the state: is diligently prosecuting a civil or criminal court action against such agricultural operation; or is diligently conducting an administrative proceeding against, or has entered into a consent agreement with, such agricultural operation. Unlike the current statutory bars, EPA or state actions that would bar a citizen suit under this bill are not limited to RCRA or CERCLA actions. Thus, EPA and state actions under other statutory authorities could bar the types of citizen suits affected by this bill. Because states can bring RCRA citizen suits, the bill could also bar states from bringing action under Section 7002 where EPA is already acting. The bill does not bar citizen suits for regulatory violations arising from the covered activities. But the hazardous waste regulations under RCRA Subtitle C exclude animal and crop waste from the definition of “hazardous waste” when they are “returned to the soils as fertilizers.” Similarly, EPA’s solid waste regulations under RCRA Subtitle D explicitly “do not apply to agricultural wastes, including manures and crop residues, returned to the soil as fertilizers or soil conditioners.” Thus there are unlikely to be many citizen suits filed under Section 7002(a)(1)(A) alleging regulatory violations for the spreading of manure or crop residue for fertilizer at an agricultural operation. The House Energy and Commerce Environment Subcommittee held a November 9, 2017, hearing on the draft legislation. Committee member and witness testimonies and a webcast of the hearing are available online.


Department Of Commerce Report Identifies EPA Regulatory Programs Warranting Reform: On October 6, 2017, in a little noticed announcement, the Department of Commerce, issued a report entitled Streamlining Permitting and Reducing Regulatory Burdens for Domestic Manufacturing. The report identifies regulations warranting revision. The report was required under the January 24, 2017, EO on Streamlining Permitting and Reducing Regulatory Burdens for Domestic Manufacturing. 82 Fed. Reg. 8667. In response to the EO, the Commerce Department issued a Request for Information (RFI) asking industry stakeholders to identify the most burdensome regulations and permitting requirements they face. 82 Fed. Reg. 12786; March 7, 2017. The report states that commenters identified 375 “burdensome and costly regulations.” Of those, 302 (81 percent) are EPA regulatory programs, ranging from CWA wetlands permits, National Emission Standards for Hazardous Air Pollutants under the CAA, and hazardous waste listings under RCRA. The report makes three recommendations based on a review of the responses to the RFI:

  • Each federal agency’s Regulatory Reform Task Force should deliver to the President an action plan in response to all permitting and regulatory issues highlighted in the responses to the RFI.
  • There should be an annual, open form for regulators and industry stakeholders to evaluate progress in reducing regulatory burdens.
  • The administration should use existing authority to extend the use of streamlined permitting procedures in the Fixing America’s Surface Transportation Act of 2015 (FAST Act) to any project that will result in a significant, immediate economic benefit to the U.S.

EPA Administrator Ends “Sue And Settle” Litigation: On October 16, 2017, EPA Administrator Scott Pruitt issued a directive putting an end to EPA’s use of so-called “sue and settle” litigation. In the directive, Mr. Pruitt states that “EPA has previously sought to resolve lawsuits filed against it through consent decrees and settlements agreements that appeared to be the result of collusion with outside groups.” The directive states that this practice may have resulted in actions that created EPA priorities and rules outside the normal administrative process and that in reaching these settlements EPA may have excluded intervenors, interested stakeholders, and affected states from the settlement discussions. “The days of litigation, or ‘sue and settle’ are terminated,” Mr. Truitt stated in the directive, pledging that “EPA will not resolve litigation through backroom deals with any type of special interest group.” The directive lays out several steps EPA will take in future litigation. A memorandum to EPA staff, also issued on October 16, 2017, details the rationale behind ending the sue and settle practice. The memorandum characterizes the tactic as regulation through litigation that violates due process, the rule of law, and cooperative federalism.

President Trump Nominates FedEx Official To Head OSHA: President Trump on October 27, 2017, nominated Scott Mugno to be Assistant Secretary of Labor for the Occupational Safety and Health Administration (OSHA). Mr. Mugno is currently the Vice President for Safety, Sustainability and Vehicle Maintenance at FedEx Ground and also served as the Managing Director for FedEx Express Corporate Safety, Health and Fire Protection. Mungo’s responsibilities in both those positions included developing, promoting, and facilitating the safety and health program and culture. Mugno was twice awarded FedEx’s highest honor for his safety leadership at FedEx Express. Prior to FedEx, Mugno was a Division Counsel at Westinghouse Electric Corporation’s Waste Isolation Division and Deputy Staff Judge Advocate for the Eastern Region U.S. Army Military Traffic Management Command. Mungo also held other legal positions in the U.S. Army Judge Advocate General (JAG) Corps at the 24th Infantry Division at Fort Stewart, Georgia, and in small private–practice law firms before joining the U.S. Army JAG Corps.

CalEPA Issues Guidance Intended To Align With EPA’s Secondary Container Labeling For Pesticides: On Friday, November 3, 2017, the California Department of Pesticide Regulation (DPR) issued guidance (California Notice 2017-13) that DPR indicates is intended to align DPR policy with EPA guidance on secondary container labeling for pesticides. DPR’s guidance states that secondary containers are used by the pesticide industry as part of the process of applying pesticides and “cannot be sold or distributed.” The guidance further notes that secondary containers are “most commonly used in institutional settings for concentrated antimicrobials that are diluted prior to use or to hold pesticides filled from a larger container to be used and stored prior to application.” Registrants may elect to provide users with labels for secondary containers. DPR’s new guidance states: “Secondary container labels are not required to be submitted to U.S. EPA or DPR.” Under the new DPR policy, however, effective immediately, if a registrant submits a secondary container label to DPR, “it must bear the same signal word as the concentrate label or no signal word.” DPR states that it will accept a secondary container label with a lesser signal word, precautionary statements, and alternate directions for use for the diluted product only if acute toxicity data are submitted or are currently on file to support these lesser statements. DPR’s new guidance also incorporates EPA guidance on what a secondary label should contain. (EPA does not require secondary containers to be labeled, but notes that the applicator remains responsible for following the requirements on the pesticide product’s labeling, and complying with other relevant requirements in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and other statutes.) Although registrants are not required to submit secondary container labels to EPA for review, EPA recommends that the applicator identify the material in the secondary container in the event of a spill to ensure that adequate information regarding the pesticide can be obtained in case of a medical or environmental emergency. More information is available online.

EPA Releases Final Report On EPA Agency Actions That Potentially Burden Domestic Energy Resources: EPA on November 3, 2017, released its Final Report on Final Report on Review of Agency Actions that Potentially Burden the Safe, Efficient Development of Domestic Energy Resources. 82 Fed. Reg. 51160. On March 28, 2017, President Trump signed EO 13783, Promoting Energy Independence and Economic Growth. The EO establishes a national policy to promote the clean and safe development of domestic energy resources while avoiding unnecessary regulatory burdens. It directs federal agencies to “review all existing regulations, orders, guidance documents, policies, and any other similar agency actions that potentially burden the development or use of domestically produced energy resources.” The EO also orders EPA to review specific rules. The report is in direct response to the EO. It is available online.

USDA Withdraws Proposed Rule On Interstate Movement And Environmental Release Of Certain GE Organisms: On November 7, 2017, USDA’s APHIS withdrew its January 19, 2017, proposed rule on the importation, interstate movement, and environmental release of certain genetically engineered (GE) organisms to “update the regulations in response to advances in genetic engineering and understanding of the plant pest and noxious weed risk posed by [GE] organisms, thereby reducing burden for regulated entities whose organisms pose no plant pest or noxious weed risks” 82 Fed. Reg. 51582. Citing comments on the proposed rule critical of the proposed revisions, USDA stated it is committed to “explor[ing] a full range of policy alternatives” instead, and that it will “re-engage with stakeholders to determine the most effective, science-based approach for regulating the products of modern biotechnology while protecting plant health.” More specific comments from USDA and the reasons supporting its decision are set forth in the notice.

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