Regulatory Developments

Recent Federal Developments - July 2018

July 13, 2018

Available On-Demand - TSCA At 2: An Update On Implementation And Hot Topics: A recording of “TSCA at 2: An Update on Implementation and Hot Topics,” the third webinar in the 2018 Chemical Policy Summit Series, is now available. This webinar featured news and updates on Toxic Substances Control Act (TSCA) implementation from Nancy B. Beck, Ph.D., D.A.B.T.®, Deputy Assistant Administrator, U.S. Environmental Protection Agency (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP), plus case studies and insightful discussion from industry representatives Misty L. Bogle, Global Product Stewardship Manager, Vertellus Specialties Inc., and Michael Gould, EH&S Committee Chairman, RadTech North America, and Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®). Register online to view the webinar recording and download the slides.

TSCA/FIFRA/TRI

EPA Issues Final Rule Delaying Compliance Date For Human Subjects Policy By Six Months: On June 19, 2018, 16 federal agencies, including EPA, issued a final rule delaying until January 21, 2019, the general compliance date for 2017 issued revisions to the policy governing studies with human subjects that are sponsored or utilized for regulatory purposes by the federal government. 83 Fed. Reg. 28497. The revisions to the human testing policy were adopted on January 19, 2017, in a final rule that amended and expanded the “Common Rule” governing human testing originally promulgated in 1991. 82 Fed. Reg. 7149. The 2017 revisions to the human testing policy were originally scheduled to take effect on January 19, 2018, but the agencies published an interim final rule on January 22, 2018, that delayed the effective date for the new policy until July 19, 2018. Thereafter, on April 20, 2018, the same 16 agencies published a proposed rule (83 Fed. Reg. 17595) to delay the general compliance date for an additional six-month period, andto allow regulated entities to implement certain burden-reducing provisions during this interim period. More information is available in our blog “EPA Issues Final Rule Delaying Compliance Date for Human Subjects Policy by Six Months; Institutions May Utilize Three Burden-Reducing Provisions during the Delay.”

EPA Issues Final Guidance On Points To Consider When Preparing TSCA New Chemical Notifications: On June 20, 2018, EPA issued guidance intended “to improve transparency with the public and with companies seeking Agency review of their new chemical substances under TSCA.” EPA states that the guidance, entitled Points to Consider When Preparing TSCA New Chemical Notifications(Points to Consider Guidance), “promotes early engagement and communication, and enhances overall understanding of EPA’s technical review and analysis to better move chemicals through the evaluation process.” EPA incorporated comments from a December 2017 public meeting and feedback received on a November 2017 draft of the document in the final guidance. EPA published a Response to Comments Received on Points to Consider Posted for Comment November 2017. EPA states that it expects that use of the guidance will result in “more robust submissions.” EPA encourages companies to contact its new chemicals program to set up a pre-submission (or pre-notice) meeting before submitting their premanufacture notices (PMN). According to EPA, the pre-submission meeting is an opportunity to discuss the planned new chemical submission and to understand EPA’s approach to reviewing new chemicals for potential risks early in the process. More information is available in our blog.

EPA Discusses APEP For Products With Public Health Claims In The Marketplace: On June 21, 2018, during EPA’s Office of Pesticide Programs (OPP) webinar, EPA discussed the new draft risk-based strategy for ensuring the performance of public health antimicrobial products and announced the intended replacement of the former Antimicrobial Testing Program (ATP) with the new Antimicrobial Product Evaluation Program (APEP). Comments on the draft risk-based strategy may be submitted to EPA until July 16, 2018. More information is available in our blog.

EPA Issues Guidance On Creating Generic Names For Confidential Chemical Substance Identity Reporting Under TSCA: On June 21, 2018, EPA issued guidance intended to “assist companies in creating structurally descriptive chemical names for chemical substances whose specific chemical identities are claimed confidential, for purposes of protecting the specific chemical identities from disclosure while describing the chemical substances as specifically as practicable, and for listing substances on the TSCA Chemical Substance Inventory.” EPA states that the guidance, Guidance for Creating Generic Names for Confidential Chemical Substance Identity Reporting under the Toxic Substances Control Act, was developed in response to the requirement under new TSCA Section 14(c)(4) that EPA “develop guidance regarding -- (A) the determination of structurally descriptive generic names, in the case of claims for the protection from disclosure of specific chemical identity…” and the requirement under new TSCA Section 14(c)(1)(C) that submitters who assert a confidentiality claim for a specific chemical identity must include a structurally descriptive generic name developed consistent with EPA guidance. More information is available in our memorandum.

EPA Celebrates Anniversary Of Lautenberg Act By Releasing Final CBI Guidance, Animal Testing Strategy, And Final Mercury Reporting Rule: On June 22, 2018, EPA announced that it has met its statutory responsibilities under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) to release guidance and policy on confidential business information (CBI), a strategy to reduce animal testing, and a final mercury reporting rule. As noted in our June 29, 2016, memorandum, “TSCA Reform: EPA Publishes First Year Implementation Plan,” the Lautenberg Act included mandatory actions for EPA to complete by June 22, 2018, two years after former President Barack Obama signed the Act, which significantly amended TSCA. More information is available online.

EPA Releases Final Strategic Plan To Promote The Development And Implementation Of Alternative Test Methods Within The TSCA Program: On June 22, 2018, EPA released its Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program. Development of the Strategic Plan was required under Section 4(h)(2)(A) of the Lautenberg Act with a deadline of not later than two years after enactment. Release of the final Strategic Plan occurred on the second anniversary of enactment of amendments to TSCA. The goal of the strategy is to reduce the level of testing in vertebrates for chemicals regulated under TSCA. EPA describes alternative test methods and strategies as different descriptors that have a common goal. The former is based on reduction, refinement, and replacement of animal test methods (the 3Rs), while strategies incorporate more than just toxicity test methods to characterize hazard. The strategy as proposed relies on a range of applications and testing approaches to characterize human health and environmental endpoints. Collectively, alternative test methods and strategies combine to define a new term: new approach methodologies (NAM). The NAM designation is used as a broadly descriptive reference to any technology, methodology, approach, or combination thereof that can be used to provide information on chemical hazard and risk assessment that avoids the use of vertebrates. For the purposes of TSCA, EPA recognizes this new term (i.e., NAM) as encompassing any “alternative test methods and strategies to reduce, refine or replace vertebrate animals.” A much more detailed summary and analysis of this important issue is available in our memorandum.

EPA Holds Preparatory Meeting For Experts Selected To Serve As Letter Peer Reviewers: On June 25, 2018, EPA held a preparatory meeting for experts selected to serve as letter peer reviewers for EPA’s Exposure and Use Assessment and Human Health and Environmental Hazard Summary for five persistent, bioaccumulative, and toxic (PBT) chemicals. A list of those chemicals is available here. Although the meeting was scheduled for four hours, it adjourned after only two hours, as there were only a few questions from peer reviewers and only two outside stakeholders providing oral comments. More information, including highlights/takeaways from the meeting, is available in our blog “Highlights from EPA’s Preparatory Meeting for Experts Selected to Serve as Letter Peer Reviewers for Its Exposure and Use Assessment and Human Health and Environmental Hazard Summary for Five PBTs.”

EPA Proposes To Lower Dust-Lead Hazard Standards: Stating that addressing childhood lead exposure is one of its priorities, EPA on July 2, 2018, proposed to lower the dust-lead hazard standards (DLHS) for homes with dust-lead issues.  83 Fed. Reg. 30889.  Lead-based paint (LBP) was commonly used in housing until 1978.  Certain activities (remediation, modifications, lead abatement, etc.) in houses with LBP are subject to requirements set forth at 40 C.F.R. Part 745 and 24 C.F.R. Part 35.  The main component of these regulations is the DLHS.  EPA established dust-lead hazard DLHS of 40 micrograms per square foot (µg/ft2) for floors and 250 µg/ft2 for window sills in a January 5, 2001, final rule.  66 Fed. Reg. 1206.  In this proposal, however, EPA seeks to lower the DLHS for floor dust to 10 µg/ft2 and to lower the DLHS for window sill dust to 100 µg/ft2.  EPA is proposing this rule under TSCA  Sections 401, 402, 403, and 404. This proposed rule also is being issued in compliance with the December 27, 2017, decision of the U.S. Court of Appeals for the Ninth Circuit, and the subsequent March 26, 2018, order that directed EPA to issue a proposed rule within 90 days from the filed date of the order.  A Community Voice v. EPA, No. 16-72816 (Dec. 27, 2017).  In the proposal, EPA states that reducing childhood lead exposure is an EPA priority, and EPA is collaborating with other federal agencies to reduce lead exposures.  Former EPA Administrator Scott Pruitt hosted a meeting of principals from the 17 federal departments and agencies on the President’s Task Force on Environmental Health Risks and Safety Risks to Children in February 2018. At the meeting, the Task Force members committed to make addressing childhood lead exposure a priority and to develop a federal strategy to reduce childhood lead exposures.  This proposal “is one component of EPA’s prioritizing the important issue of childhood lead exposure.”  In the 2001 final rule, EPA examined the health effects of various dust-lead loadings, and analyzed those values against issues of practicality to determine the appropriate standards. At that time, the Centers for Disease Control and Prevention (CDC) identified a test result of 10 micrograms of lead per deciliter of blood (µg/dL) or higher in children as a “level of concern.”  Based on the available science at the time, EPA explained that health effects at blood lead levels (BLL) lower than 10 µg/dL were “less well substantiated.”  Further, EPA acknowledged that the standards were “based on the best science available to the Agency,” and if new data were to become available, EPA would consider changing the standards to reflect these data.  EPA states that new data have become available since the 2001 final rule that indicates that health risks exist at lower BLLs than previously recognized. The CDC now considers that no safe BLL in children has been identified.  CDC thus has abandoned the use of the term “level of concern” and is instead using the reference value to identify children who have been exposed to lead and who should undergo case management. In 2012, CDC established a blood lead reference level as a benchmark for case management (especially assessment of sources of lead in their environment and follow up BLL testing).  The reference level is based on the 97.5th percentile of the U.S. population distribution of BLLs in children ages 1-5 from the 2007-2008 and 2009-2010 National Health and Nutrition Examination Surveys.  Current best available science, which, as indicated above, has evolved considerably since 2001, informs EPA’s understanding of the relationship between exposures to dust-lead loadings, BLLs, and risk of adverse human health effects.  EPA claims that these new data and science are driving its lowering of the DLHS.  The comment period on the proposal closes on August 16, 2018.

RCRA/CERCLA/CWA/CAA

Presidential Reorganizational Plan Would Consolidate Cleanup Programs Into Superfund: The White House on June 21, 2018, issued a sweeping plan for reorganizing the federal government. Entitled Delivering Government Solutions in the 21st Century Reform Plan and Reorganization Recommendations, the plan would consolidate federal environmental cleanup programs into EPA’s Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund) program. The proposal specifically would consolidate portions of the Department of the Interior’s (DOI) Central Hazardous Materials Program and the U.S. Department of Agriculture’s (USDA) Hazardous Materials Management program into EPA’s Superfund program. The plan states that this consolidation would allow EPA to address environmental cleanup under CERCLA on federal land regardless of which of these agencies manages the land, while DOI and USDA would maintain their existing environmental compliance, bonding, and reclamation programs for non-CERCLA sites. The approach would primarily streamline the federal government’s response to abandoned mine sites in need of environmental assessment and cleanup. The agencies estimate that there are over 80,000 abandoned mine sites on federal lands, close to five percent of which could require a CERCLA-level cleanup. While DOI and USDA attempt to address those sites as they are identified, their environmental cleanup programs are not core to their missions, and therefore present a challenge for the agencies to address the wide range of environmental issues stemming from mining sites and other activities on federal lands. As such, certain sites requiring CERCLA-type cleanup may not be addressed in as timely a manner as they could be if included as part of a more holistic, national program. The opportunity, according to the plan, is that this approach would reduce inefficiencies, oversight costs, and indirect costs by consolidating the environmental assessment and cleanup activities under the agency with the most significant expertise in this area. This proposal would enable better use of resources and expertise, streamline the implementation of statutory and regulatory requirements, and facilitate a more comprehensive and consistent approach to addressing contaminated lands across the Nation, the plan states. Funding and full time employees (FTE) would shift from DOI (up to $10 million and eight FTEs) and USDA (up to $3.5 million and six FTEs) to EPA to cover the increase in the assessment and cleanup workload at EPA, while DOI and USDA would continue to maintain funding and FTEs for their existing compliance, bonding, and reclamation programs for modern mines. Although the end result would be a slightly larger Superfund program, it would continue to allocate resources based on risk. In addition, project managers would have control over the cleanup work and not have to direct the actions through another federal agency manager at federal sites. Noticeably absent from the plan is any broad change to or reorganization of EPA itself. Instead, the plan announces the launching of an examination of EPA field presence. EPA is to assess the best locations from which to provide key functions and services to customers. Some functions may be performed more effectively with enhanced proximity to customers, while others may be more efficient, but equally effective, if consolidated, the plan predicts. EPA also is to assess owned space vs. leasing space for field operations. EPA is also tasked with recalibrating resources devoted to oversight of state-delegated programs and EPA will recognize states as the primary implementers and enforcement authorities where states have authorized delegation of federal environmental programs. With input from the Environmental Council of the States (ECOS) and the states, EPA will streamline, reduce, and tailor its oversight activities to focus on national consistency and technical assistance to states.

EPA Extends Comment Period For Review Of SOX NAAQS: On June 21, 2018, EPA extended the comment period on its proposal to retain the current National Ambient Air Quality Standard (NAAQS) under the Clean Air Act (CAA) for sulfur oxides (SOX). 83 Fed. Reg. 28843. EPA is reviewing the SOX as required under the CAA. On June 8, 2018, EPA proposed to retain the current NAAQS. 83 Fed. Reg. 26752. The original comment period was slated to end on July 23, 2018. EPA is extending the comment period to August 9, 2018.

EPA Decides It Will Not Amend SPCC Program’s Scope To Include Hazardous Substances: On June 25, 2018, EPA issued a proposed action stating that it will not expand the scope of the Spill Prevention, Control, and Countermeasure (SPCC) regulations under the Clean Water Act (CWA) to address additional hazardous substances (HS). 83 Fed. Reg. 29499. The decision is somewhat of a reversal of an Obama era pledge to assess whether the scope of the SPCC program should be broadened. On July 21, 2015, the Environmental Justice Health Alliance for Chemical Policy Reform, People Concerned About Chemical Safety, and the Natural Resources Defense Council filed a lawsuit against EPA for failing to comply with an alleged duty to issue regulations to prevent and contain CWA HS spills from non-transportation-related onshore facilities, including aboveground storage tanks, under CWA Section 311(j)(1)(C). Environmental Justice Health Alliance for Chemical Policy Reform v. EPA, 15-cv-5705 (S.D.N.Y. July 21, 2015). On February 16, 2016, the United States District Court for the Southern District of New York entered a Consent Decree between EPA and the litigants establishing a schedule under which EPA is to sign “a notice of proposed rulemaking pertaining to the issuance of the Hazardous Substance Regulations” and take final action after notice and comment on the notice. Instead of proposing to add HS to the scope of the SPCC program, however, EPA is proposing no new regulatory requirements under CWA Section 311(j)(1)(C) at this time. EPA believes that the existing regulations are adequate to meet its obligations under that provision and that no new regulatory program is warranted. EPA defended its decision thus:

Based on the reported frequency and impacts of identified CWA HS discharges, and the Agency’s evaluation of the existing framework of EPA regulatory requirements relevant to preventing CWA HS discharges, EPA has determined that the existing framework of regulatory requirements serves to prevent CWA HS discharges. Additionally, EPA identified relevant requirements in other Federal regulatory programs and determined that they further serve to prevent CWA HS discharges, providing additional support for this proposed action.

EPA will take comments on this proposed no-decision until August 24, 2018.

EPA Issues Final Rule Extending Reporting Period Under Mercury And Air Toxics Standards: On July 2, 2018, EPA issued a final rule to extend the period during which certain electronic reports required by the Mercury and Air Toxics Standards (MATS) may be submitted as portable document format (PDF) files using the Emissions Collection and Monitoring Plan System (ECMPS) Client Tool. 83 Fed. Reg. 30879. The rule extends the end date of that period from June 30, 2018, to July 1, 2020. This extension is necessary because the electronic reporting system that owners or operators of affected MATS sources will be required to use when PDF filing is no longer allowed will not be available by June 30, 2018. This extension does not alter the responsibility of owners or operators of affected MATS sources to comply with the applicable MATS and report their compliance information to the appropriate authority. In addition, this extension ensures that the compliance information can be submitted in a timely manner and made available to the public.

EPA To Hold Public Hearing For The Renewable Fuel Standard Program: On July 3, 2018, EPA announced that it will hold on July 18, 2018, a public hearing on its proposed rule under the Renewable Fuel Standard (RFS) Program on the standards for 2019 and biomass-based diesel volume for 2020. 83 Fed. Reg. 31098. EPA published the proposed rule on July 10, 2018 (see Biobased Renewable Products section below). EPA has proposed amendments to the RFS regulations that would establish annual percentage standards for cellulosic biofuel, biomass-based diesel, advanced biofuel, and renewable fuels that would apply to all gasoline and diesel produced in the U.S. or imported in the year 2019. In addition, the proposal includes a biomass-based diesel applicable volume for 2020. The hearing will be held at the Ann Arbor Marriott Ypsilanti at Eagle Crest, 1275 S. Huron St., Ypsilanti, MI 48197 (phone number 734-487-2000).

EPA Extends Comment Period On Its Cost-And-Benefit Transparency ANPRM: On June 13, 2018, EPA issued an advance notice of proposed rulemaking (ANPRM) soliciting comments on how EPA can increase consistency and transparency in its cost and benefit evaluation of rulemakings. 83 Fed. Reg. 27524. On July 3, 2018, EPA extended the comment period on the ANPRM to August 13, 2018. 83 Fed. Reg. 31098.

EPA Clarifies “Waters Of The U.S.” Rescission With Supplemental Notice: On July 12, 2018, EPA and the U.S. Army Corps of Engineers (USACE) published in the Federal Register a Supplemental Notice of Proposed Rulemaking (SNPRM) providing additional information on its July 27, 2017, proposal to repeal the 2015 Rule Defining Waters of the United States (2015 WOTUS Rule). 83 Fed. Reg. 32227. EPA is supplementing the earlier notice to add clarity to the scope of that action and the policy and legal rationale for the rescission of the 2015 WOTUS Rule.

The SNPRM addresses the following key issues and proposed conclusions:

  • EPA and the Corps’ intention to permanently rescind the 2015 WOTUS Rule (emphasis added);
     
  • A related rule adding an applicability date to the 2015 WOTUS Rule does not change the agencies’ decision to proceed with its proposed repeal;
     
  • Regulatory certainty would be best served by repealing the 2015 WOTUS Rule and recodifying the scope of CWA jurisdiction currently in effect;
     
  • The 2015 WOTUS Rule exceeded the agencies’ authority under the CWA;
     
  • The 2015 WOTUS Rule appears to have expanded the meaning of tributaries and adjacent wetlands to include waters well beyond those regulated by the agencies under the preexisting regulations following the Rapanos and SWANCC U.S. Supreme Court decisions; and
     
  • The 2015 WOTUS Rule may have altered the balance of authorities between the federal and state governments, contrary to the agencies’ statements in promulgating the 2015 Rule and in contravention of CWA Section 101(b).
     

EPA and USACE are accepting public comments on the SNPRM through August 13, 2018. Given the amount of stakeholder interest in this overall WOTUS rulemaking, it is likely that many groups will request an extension of the current 30-day comment period.

In publishing the SNPRM, the agencies were likely seeking to shore up potential legal vulnerabilities in the proposed repeal that could be challenged; expect future litigation over the rescission once it is finalized. EPA’s Unified Regulatory Agenda indicates it anticipates issuing a final rescission in late 2018.

FDA

FDA Announces Draft Guidance On Mitigation Strategies To Protect Food Against Intentional Adulteration: On June 20, 2018, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance for industry entitled “Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry.” 83 Fed. Reg. 28651. The Federal Register notice states that this draft guidance document, when made final, will “help food facilities that manufacture, process, pack, or hold food, and that are required to register under the Federal Food, Drug, and Cosmetic Act [FFDCA] comply with the requirements of [its] regulation entitled ‘Mitigation Strategies to Protect Food Against Intentional Adulteration (IA),’” and to help them develop and implement a food defense plan (FDP) in accordance with the IA rule’s requirements. Specifically, the document provides guidance on:

  • Understanding the components of an FDP and the importance of each component;
     
  • Understanding how to conduct a vulnerability assessment to identify significant vulnerabilities and actionable process steps;
     
  • Understanding how to identify and implement mitigation strategies for the actionable process steps associated with a facility’s processes;
     
  • Understanding how to identify and apply the mitigation strategies management components (i.e., food defense monitoring, food defense corrective actions, and food defense verification);
     
  • Understanding the reanalysis requirements associated with the FDP;
     
  • Understanding the education, training, and/or experience required for individuals who perform certain activities; and
     
  • Understanding the recordkeeping requirements associated with the FDP and implementation of the FDP.
     

Comment on the draft guidance are due by December 17, 2018.

White House Announces Plan To Consolidate Federal Food Safety Under One Agency: On June 21, 2018, the White House released a reform plan and reorganization recommendations titled “Delivering Government Solutions in the 21st Century” that listed, as one of its mission alignment imperatives, the reorganization of the USDA’s Food Safety and Inspection Service and the food safety functions of the FDA into a single agency to be named the “Federal Food Safety Agency” within USDA that would “cover virtually all the foods Americans eat.” The plan states that the proposed consolidation would “merge approximately 5,000 [FTE] employees and $1.3 billion from FDA with about 9,200 FTEs and $1 billion in resources in USDA.” Further, following the food reorganization, FDA would be renamed to the “Federal Drug Administration” and would focus only on drugs, devices, biologics, tobacco, dietary supplements, and cosmetics.

FDA Announces Public Meeting On Comprehensive, Multi-Year Nutrition Innovation Strategy: On June 27, 2018, FDA announced it was hosting a public meeting entitled “FDA's Comprehensive, Multi-Year Nutrition Innovation Strategy” on July 26, 2018, from 8:30 a.m. to 5:30 p.m. (EDT) at the Hilton Washington DC/Rockville Hotel, 1750 Rockville Pike, Rockville, Maryland 20852. 83 Fed. Reg. 30180. The Federal Register notice states that the purpose of the public meeting is to “give interested persons an opportunity to discuss FDA's nutrition innovation strategy,” including:

  • A standard icon or symbol for the claim “healthy”;
     
  • A more efficient review strategy for evaluating qualified health claims;
     
  • Statements or claims that could facilitate innovation to promote healthful eating patterns;
     
  • Approaches for modernizing standards of identity;
     
  • Possible changes that could make ingredient information more consumer friendly; and
     
  • FDA’s educational campaign for consumers about the updated Nutrition Facts Label that consumers will be seeing in the marketplace.
     

Registration is available online. The advanced registration closing date is July 19, 2018. Comments must be submitted by August 27, 2018.

FDA Issues Guidance To Help Animal Drug Manufacturers Meet Antimicrobial Sales Data Reporting Requirements: On June 29, 2018, FDA released final Guidance for Industry #252 titled “Antimicrobial Animal Drug Sales and Distribution Reporting Guidance for Industry Small Entity Compliance Guide.” 83 Fed. Reg. 30534. The Federal Register notice states that this final guidance “follows publication of the May 2016 Antimicrobial Animal Drug Sales and Distribution final rule, which, among other things, revised the annual reporting requirements for drug sponsors of all antimicrobials sold or distributed for use in food-producing animals in order to obtain estimates of sales broken out by major food-producing species (i.e., cattle, swine, chickens, turkeys),” and is intended to help small businesses comply with reporting requirements for antimicrobial drug products sold or distributed for use in food-producing animals.

FDA Issues Draft Guidance Providing Recommendations On Human Drug And Biological Product Labeling: On July 9, 2018, FDA issued a draft guidance to provide recommendations for consideration when drafting the indications and usage section of human drug and biological product labeling titled “Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products -- Content and Format.” 83 Fed. Reg. 31759. The Federal Register notice states that draft guidance is intended to “assist applicants in writing the Indications and Usage section of labeling,” and the recommendations in the draft guidance are “intended to help ensure that the labeling is clear, concise, useful, and informative and, to the extent possible, consistent in content and format within and across drug and therapeutic classes.” Comments are due by September 7, 2018.

FDA Announces Cooperative Agreements In Support Of Efforts To Implement FSMA: On July 12, 2018, FDA announced that it has entered into new cooperative agreements with Hawaii, Kentucky, and Mississippi, as well as renewed agreements with 43 other states, in support of efforts to implement its Food Safety Modernization Act (FSMA) Produce Safety Rule. FDA states that under the cooperative agreements’ inspection component, it anticipates that “most inspections will be conducted by state partners. In addition, cooperative agreement funds are used for the state partners to conduct self-assessments to evaluate existing regulatory resources and food/produce safety programs and to determine infrastructure needs.” FDA will be providing $32.5 million in funding for the 46 states participating in the cooperative agreements.

NANOTECHNOLOGY

EU-Funded Researchers Testing Nano-Based Food Packaging: The European Commission (EC) announced on June 15, 2018, that researchers from the European Union (EU)-funded NANOPACK project found a solution for extending food shelf-life by using smart antimicrobial surfaces applied to active food packaging. According to the EC, the researchers are now running five pilot production runs of the new polymer composite, based on tiny nanotube formations, to test its technical, industrial, and commercial viability. The EC notes that the project is also considering legal, safety, and environmental aspects, as well as consumer and retailer acceptance of the new nanotech-inspired packaging.

EC Committee Publishes Final Opinion On Nano Styrene/Acrylates And Sodium Styrene/Acrylates Copolymers: On June 25, 2018, the EC’s Scientific Committee on Consumer Safety (SCCS) published its final opinion on styrene/acrylates copolymer (nano) and sodium styrene/acrylates copolymer (nano). In the final opinion, SCCS states that it cannot conclude on the safety of any of the three styrene/acrylate copolymer nano-entities submitted by the applicants. The EC requested that SCCS address any further scientific concerns with regard to the use of styrene/acrylates copolymer and sodium styrene/acrylates copolymer in nano form in cosmetic products. SCCS states: “For applications as evaluated in this Opinion, it is imperative that the safety assessment not only considers safety of the individual components (e.g. the encapsulating material and the encapsulated contents), but also the safety of all the components when put together in the form of a nano-sized entity.”

NanoMONITOR Available For Testing At Facilities: NanoMONITOR announced on June 25, 2018, that the NanoMONITOR Monitoring Station is available upon request to use in facilities to obtain robust data on the concentration of engineered nanomaterials. NanoMONITOR’s brochure states that access is provided on a transnational basis with no charge to the user. According to NanoMONITOR, by developing a real-time information and monitoring system, NanoMONITOR supports the risk assessment of nanomaterials under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. Interested users should complete the expression of interest form.

EFSA Publishes New Guidance On Nanotechnologies In Food And Feed: The European Food Safety Authority (EFSA) issued a July 4, 2018, press release announcing the availability of new guidance on how to assess the safety of nanoscience and nanotechnology applications. The guidance covers novel foods, food contact materials, food and feed additives, and pesticides, taking into account new developments that have taken place since publication of the previous guidance in 2011. The guidance specifically elaborates on the physicochemical characterization of nanomaterials in terms of how to establish whether a material is a nanomaterial, the key parameters that should be measured, the methods and techniques that can be used for characterization of nanomaterials, and their determination in complex matrices. The guidance also discusses nanospecific considerations relating to in vivo/in vitro toxicological studies, and outlines a tiered framework for toxicological testing. More information is available in our July 5, 2018, blog item.

OECD Report Presents Findings From Survey Aimed At Investigating Different Types Of Risk Assessment: The Organization for Economic Cooperation and Development (OECD) published a July 4, 2018, report entitled Investigating the Different Types of Risk Assessments of Manufactured Nanomaterials: Identifying Tools Available for Risk Management Measures and Uncertainties Driving Nano-Specific Data Needs. The report presents the findings from a survey conducted in 2016 that aimed at investigating the different types of risk assessment. A majority of survey participants identified the following recommendations:

  • There is further need for validated exposure/release scenarios and assessment for nanomaterials;
     
  • The utility of specific physical-chemical properties to predict environmental fate and hazard must be validated to agree to a set of required characterization parameters, which will likely be specific to the type of nanomaterial being assessed;
     
  • It is essential to improve the ability to use read-across/grouping/screening tests to assess nanomaterials; and
     
  • There needs to be continued development of validated test guidelines specific to nanomaterials.
     

NIOSH One-Pager Includes Accomplishments And Next Steps For Nanotechnology Research Center: On July 9, 2018, the National Institute for Occupational Safety and Health (NIOSH) published a one-page document on its Nanotechnology Research Center (NTRC), which conducts research to understand the potential effects on human health of exposure to engineered nanomaterials and develops methods to control or eliminate exposures. NTRC’s next steps include:

  • Publishing “Current Intelligence Bulletin: Health Effects from Occupational Exposure to Silver Nanomaterials”;
     
  • Evaluating biomarkers, cardiovascular toxicity, and pulmonary exposure to nanoclays and boron nitride nanotubes; and
     
  • Completing peer and stakeholder review of the draft “Current Intelligence Bulletin: Approaches to Developing Occupational Exposure Limits or Bands for Engineered Nanomaterials.”
     

NanoReg2 And Gracious Will Hold Scientific Workshop On Grouping Of Nanomaterials In September: The NanoSafety Cluster announced that its projects NanoReg2 and Gracious, which focus on grouping, have come together with the OECD Working Party for Manufactured Nanomaterials (WPMN) to host a two-day conference in Paris on September 12-13, 2018. The “Scientific workshop on Grouping of Nanomaterials” will immediately follow the September 11, 2018, WPMN meeting on physico-chemical parameters framework for the risk assessment of nanomaterials. The NanoSafety Cluster states that workshop outcomes will include recommendations on nanomaterials grouping that can support global regulations and standards development. Places are limited and potential participants are required to provide a short summary of their relevant expertise to allow the organizers to ensure representation from a diverse range of stakeholders.

Second Workshop On Quantifying Exposure To Engineered Nanomaterials From Manufactured Products Will Be Held In October: The “2nd Quantifying Exposure to Engineered Nanomaterials from Manufactured Products (QEEN II) Workshop” will be held October 9-10, 2018, in Washington, D.C. Sponsored by the Consumer Product Safety Commission (CPSC) and co-hosted by the National Nanotechnology Initiative (NNI), the Workshop will highlight new research on the tools and methods available to characterize and quantify effective population exposures, as well as the presence and release potential of nanomaterials. The Workshop is free and open to the public with registration on a first-come, first-served basis. Registration will be capped at 180 attendees. The 2018 U.S.-European Union (EU) “Bridging Nanotechnology EHS (NanoEHS) Research Efforts” joint workshop will also be held in Washington, D.C., on October 11-12, 2018.

BIOBASED/RENEWABLE PRODUCTS

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

Biofuel And Agricultural Groups Petition EPA Regarding RFS Obligations: On June 4, 2018, several biofuel and agricultural groups, including the Renewable Fuels Association, the Biotechnology Innovation Organization, the American Coalition for Ethanol (ACE), and the National Biodiesel Board, among others, petitioned EPA regarding EPA’s RFS obligations. The ACE announcement states that the petition asks EPA to “change its regulations to account for lost volumes of renewable fuel resulting from the unprecedented number of retroactive small refinery exemptions from [RFS] obligations recently granted by EPA.” The petition states that Section 211(o)(2)(a)(i) of the Clean Air Act (CAA) “requires EPA to ensure that the annual required volumes of renewable fuel are introduced into the nation’s transportation fuel supply,” and that EPA’s “suddenly reversing its prior policy and granting retroactive exemptions to so many small refineries without adjusting its Annual Standard Equations to account for the resulting lost volumes,” means that EPA is “failing to meet its statutory obligation to ‘ensure’ that transportation fuels in the United States contain the applicable volumes of renewable fuel.” The petition requests EPA to (1) convene a proceeding to reconsider the annual standard equations in 40 C.F.R. Section 80.1405(c); and (2) convene a proceeding to reconsider its final action entitled “Periodic Reviews for the Renewable Fuel Standard Program” (82 Fed. Reg. 58364 (Dec. 12, 2017)). More information is available at http://blog.braginfo.org/entry/biofuel-and-agricultural-groups-petition-epa-regarding-rfs-obligations.

EPA Proposes RFS Volume Requirements For 2020: EPA on July 10, 2018, issued proposed volume requirements under the RFS program for cellulosic biofuel, advanced biofuel, and total renewable fuel for calendar year 2019. 83 Fed. Reg. 32024. EPA also proposed biomass-based diesel volume standards for calendar year 2020. The proposed volume requirements are listed in the table below. The comment period on the proposed rule closes on August 17, 2018.

Proposed and Final Renewable Fuel Volume Requirements for 2018-2020
  2018 2019 2020
Cellulosic biofuel (million gallons) 288 381 N/A
Biomass-based diesel (billion gallons) 2.1 N/A* 2.43
Advanced biofuel (billion gallons) 4.29 4.88 N/A
Renewable fuel (billion gallons) 19.29 19.88 N/A
Implied conventional biofuel (billion gallons) 15 15 N/A
*The biomass-based diesel standard for 2019 was set at 2.1 billion gallons in 2018 and cannot be changed.
 
MISCELLANEOUS

ATSDR Announces Availability Of Draft Toxicological Profile For Perfluoroalkyls: On June 21, 2018, the Agency for Toxic Substances and Disease Registry (ATSDR) announced the availability of the Draft Toxicological Profile for Perfluoroalkyls for review and comment. 83 Fed. Reg. 28849. The draft represents ATSDR’s best efforts to provide important toxicological information on priority hazardous substances. The draft was much anticipated as it identifies draft intermediate oral exposures for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) that are more stringent than EPA risk estimates supporting the 2016 drinking water health advisories for lifetime chronic exposure to these substances. On July 13, 2018, ATSDR extended the comment period. 83 Fed. Reg. 32665. Comments are now due by August 20, 2018.

CEQ Issues ANPRM On Revising Implementation Of NEPA: On June 20, 2018, the Council on Environmental Quality (CEQ) issued an ANPRM announcing that it is considering updating its implementing regulations for the procedural provisions of the National Environmental Policy Act (NEPA). 83 Fed. Reg. 28591. CEQ is requesting comments on potential revisions to update and clarify CEQ NEPA regulations. Areas in which CEQ specifically seeks comment are the NEPA process and the scope of NEPA reviews. On July 11, 2018, CEQ extended the comment period on the ANPRM from July 20, 2018, to August 20, 2018. 83 Fed. Reg. 32071.

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

 
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