EPA Takes Next Step To Implement PFAS Legislation: On May 18, 2020, the U.S. Environmental Protection Agency (EPA) published a press release announcing that it will issue a final rule adding 172 per- and polyfluoroalkyl substances (PFAS) to the list of toxic chemicals subject to reporting under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) and Section 6607 of the Pollution Prevention Act (PPA). EPA is also setting a manufacture, processing, and otherwise use reporting threshold of 100 pounds for each PFAS being added to the list. EPA notes that it is taking these actions to comply with Section 7321 of the National Defense Authorization Act (NDAA) enacted on December 20, 2019. NDAA added 172 PFAS to the list of chemicals required to be reported to the Toxics Release Inventory (TRI) and established a 100-pound reporting threshold for these substances. The final rule officially incorporates these requirements into the Code of Federal Regulations (C.F.R.) for TRI. EPA states that as this action is being taken to conform the regulations to a Congressional legislative mandate, notice and comment rulemaking is unnecessary, and this rule is effective immediately.
EPA Announces Settlement Resolving TSCA Violations Involving PFAS: On May 20, 2020, EPA issued a press release announcing a final agreement with Swix Sport USA (Swix) resolving TSCA violations associated with the importation of noncompliant ski wax products containing PFAS. According to the press release, Swix agrees to pay a fine and develop a $1 million educational program to raise awareness in ski communities about PFAS chemicals in ski waxes. EPA states that Swix violated the TSCA Section 5 premanufacture notice (PMN) requirements and import certification requirements when it imported ski wax products containing six different PFAS chemicals on at least 83 occasions that were not included on the TSCA Inventory or otherwise exempt for commercial purposes. Once the chemicals were identified, Swix immediately ceased importation of the products containing the PFAS substances and quarantined products in its control in the United States. More information is available in our May 27, 2020, blog item.
EPA Publishes 2020 Annual Plan For Chemical Risk Evaluations Under TSCA: EPA recently published its 2020 Annual Plan for Chemical Risk Evaluations under TSCA (Annual Plan). TSCA Section 26(n) requires EPA to publish an annual plan at the beginning of each calendar year that identifies the chemical substances for which EPA expects to initiate or complete risk evaluations that year and the resources necessary for their completion, describes the status of each risk evaluation that has been initiated but not yet completed, and includes an updated schedule for completion of risk evaluations, if appropriate.
EPA Amends Small Manufacturer Definition: On May 28, 2020, EPA published in the Federal Register a final rule updating the definition of small manufacturers, including a new definition of what is considered a small government, used to determine reporting and recordkeeping requirements under TSCA. 85 Fed. Reg. 31986. According to EPA, the updated definitions will reduce reporting burdens on chemical manufacturers and small governments while maintaining the Agency’s ability to receive the information it needs to understand exposure to chemical substances manufactured in the United States. The final rule makes a technical correction to the small manufacturer reference at 40 C.F.R. Section 704.104 for hexafluoropropylene oxide, which only includes a rule-specific small processor definition and not a small manufacturer definition. The final rule also updates the current small manufacturer definition in the Preliminary Assessment Information Rule (PAIR) at 40 C.F.R. Section 712.25 to align it with the updated small manufacturer definition at 40 C.F.R. Section 704.3. EPA notes that the updated definitions will apply to the Chemical Data Reporting (CDR) Rule reporting period that began June 1, 2020, and will impact certain reporting and recordkeeping requirements for TSCA Section 8(a) rules. The final rule will be effective June 29, 2020.
EPA OIG Finds TSCA Consent Orders Need Better Coordination: On May 28, 2020, the EPA Office of Inspector General (OIG) issued a report entitled EPA Toxic Substances Control Act Consent Orders Need Better Coordination. OIG conducted the evaluation to determine what actions EPA took to verify compliance with the requirements of the 2009 TSCA PMN Consent Order with DuPont (responsibilities transferred to The Chemours Company in 2015) to prevent the release of GenX chemicals in the Cape Fear River in North Carolina. OIG found insufficient communication and coordination between the two EPA offices responsible for developing and enforcing the Consent Order requirements designed to reduce risks in the manufacture of GenX chemicals. OIG recommends that EPA establish and implement processes: for the Office of Enforcement and Compliance Assurance (OECA) to review and approve the terms and conditions of TSCA Section 5(e) Consent Orders that it is responsible for verifying during compliance monitoring and enforcement activities; and to provide final TSCA Section 5(e) Consent Orders to regions and verify that the regions have the final Consent Orders. OIG states that EPA “did not provide an acceptable corrective action for Recommendation 1, and we consider this recommendation unresolved.” For Recommendation 2, EPA provided an alternative course of action that OIG finds acceptable. OIG considers Recommendation 2 resolved with corrective action pending.
EPA Extends Comment And Reporting Period On Preliminary Lists Identifying Manufacturers Subject To Fee Obligations For EPA-Initiated Risk Evaluations: On May 28, 2020, EPA published a Federal Register notice extending the comment and reporting period on the preliminary lists of manufacturers (including importers) subject to fees associated with EPA-initiated risk evaluations under TSCA. 85 Fed. Reg. 32036. The new due date is June 15, 2020. EPA states that it is extending the comment period in response to stakeholder feedback and to allow companies additional time to report, or self-identify, as to whether they are a manufacturer subject to fees for the next 20 TSCA risk evaluations. EPA intends to issue final scope documents for the next 20 risk evaluations in summer 2020 and will publish the final list of fee payers no later than concurrently with the final scope documents.
EPA Releases Updated 2016 CDR Rule Data: On May 29, 2020, EPA released updated data collected during the 2016 CDR period. EPA notes that the updated 2016 CDR data now include information that was previously classified as confidential business information (CBI), such as aggregate production volumes and site-specific production volumes. EPA published an initial release of the 2016 CDR data in May 2017. The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amendments to TSCA were signed into law during the 2016 CDR submission period and changed CDR CBI reporting requirements. EPA states that as a result, it conducted “a thorough substantiation and verification process with companies that submitted 2016 CDR data.” According to EPA, this process allowed it to determine which claims met the new legal standard and ensure that valid CBI claims remained protected.
EPA Releases Biannual Update To Public TSCA Inventory: On June 1, 2020, EPA announced the availability of the latest TSCA Inventory. EPA notes that this biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. EPA plans the next regular update of the Inventory for early 2021. According to EPA, the Inventory contains 86,405 chemicals, of which 41,587 are active in U.S. commerce. Other updates to the TSCA Inventory include updates to commercial activity data and updated regulatory flags, such as Consent Orders and significant new use rules (SNUR).
OMB Begins Review Of Final SNUR On LCPFAC And PFAS Chemical Substances: On June 3, 2020, EPA submitted to the Office of Management and Budget (OMB) a final SNUR on long-chain perfluoroalkyl carboxylate (LCPFAC) and PFAS chemical substances. On March 3, 2020, EPA published a proposed supplemental SNUR for LCPFAC chemical substances that would make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of surface coatings on articles. 85 Fed. Reg. 12479. As noted in our February 28, 2020, memorandum, “Proposed Supplemental SNUR Would Remove Exemption for LCPFAC Chemical Substances Used as Surface Coatings on Articles,” one of the goals of the proposed supplemental SNUR is to establish the ground rules for EPA’s consideration of the article exemption in future SNUR actions. The final SNUR that is under OMB review is not publicly available, so it remains to be seen whether EPA has successfully established policies and procedures that both align with statutory requirements and also are workable, effective, predictable, transparent, and justified scientifically.
Ninth Circuit Vacates EPA’s Renewal Of Conditional Registrations For Lower Volatility Dicamba Formulations: On June 3, 2020, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an opinion in National Family Farm Coalition v. EPA, No. 19-70115, vacating EPA’s 2018 decisions to extend the conditional registrations for three reduced volatility dicamba herbicides, Bayer’s XtendiMax, Corteva’s FeXapan, and BASF’s Engenia. The manufacturers of these dicamba products designed them to facilitate control of glyphosate resistant weeds in strains of soybeans and cotton that have been genetically modified to be dicamba tolerant. Although the manufacturers intended these dicamba products to be less volatile and less susceptible to drift into adjacent non-target areas than previous formulations of dicamba, there were nonetheless many complaints that the products cause damage to non-tolerant crops and other vulnerable vegetation. The Petitioners that challenged EPA’s decision to extend the conditional registrations for these reformulated dicamba products include a group representing small farmers who claim that the new dicamba products have damaged their crops (National Family Farm Coalition) and several non-governmental organizations (NGO) that routinely oppose new pesticide registrations (the Center for Food Safety, the Center for Biological Diversity, and Pesticide Action Network North America). More information on the court’s opinion and our commentary are available in our blog.
Court Strikes Down Exemption For Importers In Final TSCA Mercury Inventory Rule: On June 5, 2020, the U.S. Court of Appeals for the Second Circuit issued its decision in a case challenging three exemptions from EPA’s final mercury inventory rule. Natural Resources Defense Council (NRDC) v. EPA, No. 18-2121. NRDC and Vermont challenged the rule, arguing that EPA unlawfully exempted too many manufacturers and importers to protect human health and the environment effectively. The court found that the exemption for importers of products containing mercury-added components is an unlawful interpretation of TSCA because it lacks a reasoned explanation. The court found that the exemption for manufacturers of products with mercury-added components and the exemption for high-volume manufacturers are lawful in light of Congress’s directive to “not require reporting which is unnecessary or duplicative.”
Bench Trial In Challenge To EPA’s Denial Of Fluoride Petition Will Resume On June 15 And Is Available Online: The U.S. District Court for the Northern District of California began hearing oral arguments on June 8, 2020, in a case seeking a rulemaking under TSCA Section 6 to prohibit the addition of fluoridation chemicals to drinking water supplies. Food & Water Watch, Inc. v. EPA, Case No. 3:17-cv-02162-EMC. The plaintiffs filed suit following EPA’s denial of a TSCA Section 21 petition requesting it to exercise its Section 6 authority to prohibit the purposeful addition of fluoridation chemicals to U.S. water supplies. The trial resumed on Monday, June 15, 2020. Readers interested in watching the trial remotely can find scheduling and Zoom information here. More information is available in our June 12, 2020, blog item.
EPA Begins Public Comment Period For Manufacturer-Requested Risk Evaluation For D4: EPA announced on June 12, 2020, that it is opening a public comment period for a manufacturer-requested risk evaluation of octamethylcyclotetra-siloxane (D4), a chemical used to make other silicone chemicals and as an ingredient in some personal care products. EPA will publish a notice in the Federal Register announcing the public comment period and beginning a 45-day comment period. EPA “welcomes all public comments on this request, particularly on the following”:
- Any information not included in the manufacturer request that the commenters believe EPA would need to conduct a risk evaluation;
- Additional conditions of use the Agency is proposing to include in the risk evaluation; and
- Information on conditions of use not included in the manufacturer request or in the additional conditions of use EPA is proposing to include in the risk evaluation.
EPA has opened Docket ID EPA-HQ-OPPT-2018-0443 for the request.
EPA Announces Third Temporary Modification To Pesticide Registration Notice 98-10 To Address Supply Chain Issues For Food-Contact Surface Sanitizer Products In Response To COVID-19: On May 15, 2020, EPA announced that it is issuing its third temporary modification to Pesticide Registration (PR) Notice 98-10 to include food-contact surface sanitizer products containing the active ingredient (AI) isopropyl alcohol. This new temporary amendment permits all the registration modifications outlined in the March and April modifications, while also expanding the criteria for the types of products that qualify for the provisions of this amendment.
EPA states that this temporary, time-limited amendment to PR Notice 98-10, dated May 11, 2020, will extend some of the supply chain flexibilities to products used in the food manufacture and preparation industries. Specifically, this temporary amendment expands these flexibilities to manufacturers of food-contact surface sanitizer products containing isopropyl alcohol and adds isopropyl alcohol to the list of AIs commodity chemicals allowed to be changed by notification in order to use any similar source to produce List N registered disinfectant products. According to EPA, these isopropyl alcohol sanitizer products are not to be applied directly to food. Instead, they are used to sanitize equipment and surfaces used in food manufacturing and food preparation. EPA intends for these flexibilities to increase the availability of products for use against the SARS-CoV-2. This third temporary modification to PR Notice 98-10, according to EPA, is in response to feedback from the food manufacture and preparation industries that are experiencing challenges acquiring sanitizers for use in production facilities processing low-moisture products like cereal, flour, and industrial baked goods. Additional information on submission information for registrants is available at Temporary Amendment to PR Notice 98-10.
OSHA Adopts Revised Enforcement Policies For Coronavirus: On May 19, 2020, the Occupational Safety and Health Administration (OSHA) announced that it adopted revised policies for enforcing its requirements with respect to coronavirus as economies reopen in states throughout the country. OSHA has issued two revised enforcement policies to ensure employers are taking action to protect their employees. First, OSHA is increasing in-person inspections at all types of workplaces. OSHA states that the new enforcement guidance reflects changing circumstances in which many non-critical businesses have begun to reopen in areas of lower community spread. The risk of transmission is lower in specific categories of workplaces, and personal protective equipment (PPE) potentially needed for inspections is more widely available. Second, OSHA is revising its previous enforcement policy for recording cases of coronavirus. Under OSHA's recordkeeping requirements, coronavirus is a recordable illness, and employers are responsible for recording cases of the coronavirus if the case:
- Is confirmed as a coronavirus illness;
- Is work-related as defined by 29 C.F.R. Section 1904.5; and
- Involves one or more of the general recording criteria in 29 C.F.R. Section 1904.7, such as medical treatment beyond first aid or days away from work.
Under the new policy, OSHA will enforce the recordkeeping requirements of 29 C.F.R. Part 1904 for employee coronavirus illnesses for all employers. OSHA acknowledges that given the nature of the disease and community spread, in many instances it remains difficult to determine whether a coronavirus illness is work-related, especially when an employee has experienced potential exposure both in and out of the workplace. OSHA states that its guidance emphasizes that employers must make reasonable efforts, based on the evidence available to the employer, to ascertain whether a particular case of coronavirus is work-related.
SAB Discusses COVID-19 Review Panel’s Draft Report: On May 20, 2020, the Science Advisory Board (SAB) convened the Chartered SAB meeting to review and discuss the draft report prepared by the SAB COVID-19 Review Panel. The draft report, SAB Technical Review of EPA’s Identification of Research Needs to Address the Environmental and Human Health Impacts of COVID-19, was funded by the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act. This research was conducted to assist EPA in its understanding of the environmental and human health impacts from COVID-19 and to identify EPA research already underway, as well as new EPA research that has been proposed. The research included an evaluation of the efficacy of available disinfectants in killing SARS-CoV-2, the virus that causes COVID-19, on different types of surfaces that may be frequently touched by multiple people, such as in subway cars, door handles, and railings. Areas of particular interest include the efficacy of disinfection methods in controlling the virus on porous materials and soft surfaces, and the efficacy of products that claim to offer residual or long-term control of the virus. EPA issued detailed charge questions for consideration by the SAB on April 21, 2020, and the SAB hosted a public teleconference and audio webcast of the presentation by EPA and the review by SAB on April 30, 2020. Additional information on the Chartered SAB meeting is available here.
Carper Releases Staff Report On “EPA’s Pandemic Of Pollution”: On May 20, 2020, Senator Tom Carper (D-DE), Ranking Member of the Senate Environment and Public Works Committee, issued a press release announcing the release of a staff report summarizing the actions taken by EPA “to roll back air pollution protections during the COVID-19 pandemic and the potential effects of those rollbacks on public health in light of emerging research that reports a link between exposure to air pollution and adverse outcomes from COVID-19.” The report describes:
- The connection between coronavirus outcomes and air pollution;
- The connection between climate change, air pollution, and pandemics; and
- EPA rules that will increase air pollution proposed or issued in final since March 1, 2020.
According to the press release, “[t]he report provides recommendations that EPA should act on immediately to improve human health and the environment during this time.”
Executive Order Addresses Regulatory Relief Intended To Support Economic Recovery: On May 22, 2020, Executive Order (EO) 13924, “Regulatory Relief To Support Economic Recovery,” was published in the Federal Register. 85 Fed. Reg. 31353. The EO states that agencies should address the economic emergency caused by COVID-19 “by rescinding, modifying, waiving, or providing exemptions from regulations and other requirements that may inhibit economic recovery, consistent with applicable law and with protection of the public health and safety, with national and homeland security, and with budgetary priorities and operational feasibility.” The EO directs heads of all agencies to use any emergency authorities that were previously invoked in response to the COVID-19 outbreak or that are otherwise available to them to support the economic response to the COVID-19 outbreak. The heads of all agencies are also encouraged to promote economic recovery through non-regulatory actions. The OMB Director, in consultation with the Assistant to the President for Domestic Policy and the Assistant to the President for Economic Policy, shall monitor compliance with the EO and may also issue memoranda providing guidance for implementing the EO.
OSHA Issues Alert On Social Distancing Intended To Keep Employees Safe At Work During The Coronavirus Pandemic: On May 28, 2020, OSHA issued an alert listing steps employers can follow to implement social distancing in the workplace and to help protect workers from exposure to the coronavirus. OSHA lists the following safety measures that employers can implement:
- Isolate any worker who begins to exhibit symptoms until they can either go home or leave to seek medical care;
- Establish flexible worksites (e.g., telecommuting) and flexible work hours (e.g., staggered shifts), if feasible;
- Stagger breaks and rearrange seating in common break areas to maintain physical distance between workers;
- In workplaces where customers are present, mark six-foot distances with floor tape in areas where lines form, use drive-through windows or curbside pickup, and limit the number of customers allowed at one time;
- Move or reposition workstations to create more distance and install plexiglass partitions; and
- Encourage workers to bring any safety and health concerns to the employer’s attention.
EPA Announces The Issuance Of An Advisory On Disinfectants Making False And Misleading Claims Against COVID-19: On June 1, 2020, EPA’s OECA announced that it issued a compliance advisory on products claiming to kill SARS-CoV-2, the novel coronavirus that causes COVID-19. EPA states that the advisory was issued because it has received tips and complaints concerning potentially false or misleading claims, including efficacy claims, associated with pesticides and devices. EPA says it is actively reviewing these claims and is working to identify others. EPA states that it intends to pursue enforcement for those products making false and misleading claims regarding SARS-CoV-2. EPA has made available a web page where tips can be reported. More information on the advisory is available in our blog.
OSHA And CDC Issue Guidance To Help Agriculture Workers During The Coronavirus Pandemic: On June 2, 2020, OSHA and the Centers for Disease Control and Prevention (CDC) announced the availability of guidance that includes recommended actions intended to protect agriculture workers from exposure to the coronavirus. The guidance recommends that owners and operators:
- Screen agricultural workers for coronavirus symptoms, manage workers who have symptoms upon arrival at work or who become sick during the day, and address return to work after worker exposure;
- Use touch-free clocks and automatic doors, install plastic barriers when distances of six feet between individuals are not possible, and rearrange chairs and tables in break areas;
- Implement cleaning, disinfection, and sanitation protocols;
- Train workers in a language they understand on the signs and symptoms of coronavirus, proper infection control and social distancing practices, and what to do if they or a coworker experience symptoms;
- Encourage workers to use cloth face coverings in certain circumstances (e.g., when utilizing shared methods of transportation); and
- Provide and train workers on proper use of PPE through videos or in-person visual demonstrations.
The guidance also explains what employers should do to prevent transmission of the virus among workers who share housing and transportation to and from the agricultural worksite.
OSHA Issues Alert Intended To Keep Stockroom And Loading Dock Workers Safe During Coronavirus Pandemic: OSHA announced on June 2, 2020, that it issued an alert listing safety tips employers can follow to protect stockroom and loading dock workers in the retail industry from exposure to the coronavirus. Safety measures employers can implement include:
- Stock displays (e.g., shelves and freezers) during slow periods or shifts during which stores are closed to minimize contact with the public;
- If stocking occurs while stores are open, use barriers or markers to separate shelf stockers physically from customers;
- Maintain at least six feet between co-workers and customers, where possible;
- Limit customer capacity in stores;
- Coordinate with vendors and delivery companies to minimize the need for stockroom and loading dock worker contact with delivery drivers;
- Allow workers to wear masks over their nose and mouth to prevent spread of the virus; and
- Encourage workers to report any safety and health concerns.
The new alert is available for download in English and Spanish.
Senate Finance Committee Holds Hearing On FDA’s Foreign Drug Manufacturing Inspection Process: On June 2, 2020, the Senate Committee on Finance hosted a full Committee hearing entitled “COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process.” Witnesses represented the U.S. Food and Drug Administration (FDA), the U.S. Government Accountability Office (GAO), and private sector companies. The hearing sought to examine the accountability of FDA’s vetting process, especially in regard to drugs necessitated by the COVID-19 pandemic. Lawmakers and witnesses in the public and private sector discussed FDA’s current policy and future measures to increase onshoring and prevent the influx of drugs from unsafe supply chains. For more information, please read the full memorandum.
EO Intends To Accelerate Economic Recovery From COVID-19 Pandemic By Expediting Infrastructure Investments And Other Activities: On June 4, 2020, President Donald J. Trump (R) signed an EO on “Accelerating the Nation’s Economic Recovery from the COVID-19 Emergency by Expediting Infrastructure Investments and Other Activities.” The EO states that “[u]nnecessary regulatory delays will deny our citizens opportunities for jobs and economic security, keeping millions of Americans out of work and hindering our economic recovery from the national emergency.” Under the EO, agencies “should take all reasonable measures to speed infrastructure investments and to speed other actions in addition to such investments that will strengthen the economy and return Americans to work, while providing appropriate protection for public health and safety, natural resources, and the environment, as required by law.” The EO directs agencies to provide a summary report within 30 days that identifies planned or potential actions to facilitate economic recovery that may be subject to emergency treatment as alternative arrangements pursuant to the National Environmental Policy Act (NEPA) regulations and agencies’ own NEPA procedures; may be subject to statutory exemptions from NEPA; may be subject to the categorical exclusions that agencies have included in their NEPA procedures pursuant to the NEPA regulations; may be covered by already completed NEPA analyses that obviate the need for new analyses; or may otherwise use concise and focused NEPA environmental analyses. Within 30 days, agencies must provide a summary report identifying planned or potential actions intended to facilitate economic recovery that may be subject to the regulation on consultations in emergencies promulgated by the Secretary of the Interior and the Secretary of Commerce pursuant to the Endangered Species Act (ESA).
EPA Prepares For 2020 Hurricane Season Amid COVID-19: EPA issued a press release on June 9, 2020, regarding its preparedness and response efforts for the upcoming hurricane season amid COVID-19. EPA states that it will follow the Federal Emergency Management Agency’s (FEMA) “COVID-19 Pandemic Operational Guidance for the 2020 Hurricane Season” and any relevant EPA guidance. EPA notes that it performs pre-landfall assessments of Superfund sites and major industrial facilities to identify potential impacts and countermeasures. According to EPA, it recently issued alerts to remind facility operators of certain requirements that call for preventing, minimizing, and reporting chemical releases due to hazardous weather. Additionally, EPA supports responses before, during, and after a hurricane by conducting air monitoring, ensuring the continued operation of drinking water and wastewater systems, and managing debris and impacted infrastructure.
House Subcommittee Holds Hearing On COVID-19’s Disproportionate Impact On Environmental Justice Communities: On June 9, 2020, the House Energy and Commerce Subcommittee on Environment and Climate Change held a hearing on “Pollution and Pandemics: COVID-19’s Disproportionate Impact on Environmental Justice Communities.” The hearing examined the relationship between disproportionate exposures to environmental pollution and disproportionate effects of the COVID-19 pandemic. Witnesses included Mustafa Santiago Ali, Vice President, Environmental Justice, Climate, and Community Revitalization, National Advocacy Center at the National Wildlife Federation; Jacqueline Patterson, Senior Director, Environmental and Climate Justice Program, National Association for the Advancement of Colored People (NAACP); and Shay Hawkins, President, Opportunity Funds Association.
OSHA Issues FAQs About Face Coverings, Surgical Masks, And Respirators In The Workplace: OSHA announced on June 10, 2020, the publication of a series of frequently asked questions (FAQ) regarding the use of masks in the workplace. OSHA states that the new guidance outlines the differences between cloth face coverings, surgical masks, and respirators. It further reminds employers not to use surgical masks or cloth face coverings when respirators are needed. In addition, the guidance notes the need for social distancing measures, even when workers are wearing cloth face coverings, and recommends following CDC’s guidance on washing face coverings.
House Subcommittee Will Hold Hearing On COVID-19’s Impact On The Energy Sector: On June 16, 2020, the House Energy and Commerce Subcommittee on Energy will hold a hearing on “Reviving Our Economy: COVID-19’s Impact on the Energy Sector.” According to the House Energy and Commerce Committee’s June 9, 2020, press release, the energy industry -- particularly clean energy -- has been one of the hardest-hit sectors. The Subcommittee will hear from experts on exactly what is needed to assist laid off workers and ensure that the United States “stay[s] on the path toward a healthy and prosperous clean energy future.”
EPA Requests Nominations For 2020 Clean Air Excellence Awards Program: On May 19, 2020, EPA published a Federal Register notice requesting nominations for the Clean Air Excellence Awards. 85 Fed. Reg. 29943. EPA established the awards program to recognize outstanding and innovative efforts that support progress in achieving clean air. The awards program is open to both public and private entities. Entries are limited to efforts related to air quality in the United States. There are five general award categories: (1) clean air technology; (2) community action; (3) education/outreach; (4) state/tribal/local air quality policy innovations; and (5) transportation efficiency innovations. There are also two special awards categories: (1) Thomas W. Zosel Outstanding Individual Achievement Award; and (2) Gregg Cooke Visionary Program Award. All submission entries must be postmarked by July 31, 2020.
EPA Requests Comment On Whether Its Approval Of A CWA Section 404 Program Is Non-Discretionary For Purposes Of ESA Section 7 Consultation: On May 21, 2020, EPA published a Federal Register notice requesting comment on whether it should reconsider its current position that consultation under ESA Section 7 is not required when EPA approves a state or tribe’s request to assume the Clean Water Act (CWA) Section 404 dredged and fill permit program under the CWA. 85 Fed. Reg. 30953. EPA will consider comments as it reviews this position. If EPA changes its current position, then it would take the position that its decision as to whether to approve or disapprove a state’s or tribe’s request to assume the CWA Section 404 permit program involves an exercise of discretion warranting consultation under ESA Section 7. Consultation under ESA Section 7 would consequently apply to state and tribal requests to assume the CWA Section 404 program and potentially subsequent program revisions, and EPA would consult on its actions with the U.S. Fish and Wildlife Service (FWS) and the National Marine Fisheries Service (NMFS) under ESA as appropriate. Comments are due July 6, 2020.
EPA Releases Modernized State Hazardous Waste Dashboard: On May 21, 2020, EPA announced the release of a modernized State Hazardous Waste Dashboard available to the public via the Enforcement and Compliance History Online (ECHO) web page. The State Hazardous Waste Dashboard provides summary trends of EPA and state enforcement and compliance activity, such as how many inspections were performed, how many violations were identified, and how many enforcement actions were taken. EPA states that it allows the public to see trends and allows EPA and states to review data quality and to see how states are doing with program implementation. The new platform provides a dynamic interface that allows users to customize their view to examine best the data and trends in which they are interested. The different sections of the chart (facilities, inspections, enforcement) will now update together, so selections made in any section are reflected in other sections, making it easier to see meaningful patterns and trends in the data.
EPA Requests Comment On Draft Ambient Water Quality Criteria Recommendations For Lakes And Reservoirs Of The Conterminous United States: On May 22, 2020, EPA published a Federal Register notice announcing the release of the Draft Ambient Water Quality Criteria Recommendations for Lakes and Reservoirs of the Conterminous United States: Information Supporting the Development of Numeric Nutrient Criteria for a 60-day comment period for scientific input. 85 Fed. Reg. 31184. According to EPA, these draft national criteria recommendations are models for total nitrogen and total phosphorus concentrations in lakes and reservoirs to protect three different designated uses -- aquatic life, recreation, and drinking water source protection -- from the adverse effects of nutrient pollution. EPA based the draft criteria recommendations on stressor-response models, which link nutrient pollution stressors (nitrogen, phosphorus) to responses associated with protection of designated uses. When final, the criteria recommendations will replace EPA’s previously recommended ambient nutrient criteria for lakes and reservoirs. Following closure of the 60-day public comment period, EPA will consider comments, revise the draft document, as appropriate, and then publish a final document that will provide recommendations for states and authorized tribes to establish water quality standards under the CWA. Comments are due July 21, 2020.
EPA Releases Policy Assessment For The Ozone National Ambient Air Quality Standards: On May 22, 2020, EPA published a Federal Register notice announcing that it would soon publish the document, Policy Assessment for the Review of the Ozone National Ambient Air Quality Standards. 85 Fed. Reg. 31182. EPA prepared the document as part of the current review of the national ambient air quality standards (NAAQS) for photochemical oxidants, including ozone (O3). EPA states that the policy assessment serves to “bridge the gap” between the currently available scientific and technical information and the judgments required of the Administrator in determining whether to retain or revise the existing O3 NAAQS. The primary and secondary O3 NAAQS are set to protect the public health and the public welfare from O3 and other photochemical oxidants in ambient air.
EPA Announces Final Amendments To Miscellaneous Organic Chemical Manufacturing National Emission Standards For Hazardous Air Pollutants: On June 1, 2020, EPA published a press release announcing final amendments to the Miscellaneous Organic Chemical Manufacturing National Emission Standards for Hazardous Air Pollutants (NESHAP), known as MON, to reduce hazardous air pollutants, including ethylene oxide. According to EPA, the final MON amendments are expected to reduce emissions of hazardous air pollutants from the source category by 107 tons per year, which includes reductions in ethylene oxide emission of approximately 0.76 tons per year. This final action addresses EPA’s obligation under the Clean Air Act (CAA) to conduct the residual risk and technology (RTR) review for the miscellaneous organic chemical manufacturing source category. EPA states that it evaluated the risks posed by air toxics from this source category and determined cancer risks for this source category to be unacceptable. To reduce risks to an acceptable level, the final rule includes additional requirements for process vents, storage tanks, and equipment in ethylene oxide service. In addition to reducing ethylene oxide emissions, the MON amendments include updates to requirements for flares controlling ethylene oxide emissions, or emissions from processes that produce olefins and polyolefins, heat exchange systems, and equipment leaks. According to EPA, once these requirements are implemented, it “has determined that risks will be acceptable and will provide an ample margin of safety to protect public health.”
EPA Issues Final Rule Intended To Help Ensure U.S. Energy Security And Limit Misuse Of The CWA: EPA issued a press release on June 1, 2020, announcing a final rule intended to “help accelerate and promote the construction of important energy infrastructure across the United States, while ensuring the nation’s waterways are protected.” According to the press release, the final rule increases the transparency and efficiency of the CWA Section 401 certification process to promote the timely review of infrastructure projects while continuing to ensure that Americans have clean water for drinking and recreation. EO 13868, “Promoting Energy Infrastructure and Economic Growth,” directed EPA to review Section 401 and EPA’s related regulations and guidance to determine whether EPA’s policies should be updated or clarified. In this final rule, EPA conducted the first comprehensive analysis of the text, structure, and legislative history of Section 401. The final rule:
- Specifies statutory and regulatory timelines for review and action on a Section 401 certification -- requiring final action to be taken within one year of receiving a certification request;
- Clarifies the scope of Section 401, including clarifying that 401 certification is triggered based on the potential for a project to result in a discharge from a point source into a water of the United States. When states look at issues other than the impact on water quality, they go beyond the scope of the CWA;
- Explains EPA’s roles under Section 401;
- Reaffirms EPA’s statutory responsibility to provide technical assistance to any party involved in a Section 401 water quality certification process; and
- Promotes early engagement and coordination among project proponents, certifying authorities and federal licensing and permitting agencies.
United States And Canada Release 2019 State Of The Great Lakes Report: On June 3, 2020, EPA announced the release of the 2019 State of the Great Lakes Report, which provides an overview of the status and trends of the Great Lakes ecosystem. EPA and Environment and Climate Change Canada (ECCC) developed the report in accordance with the Great Lakes Water Quality Agreement. EPA and ECCC made the assessment based on indicators of ecosystem health, such as drinking water, fish consumption, and beach closures. Overall, according to EPA, Great Lakes water quality is assessed as “fair and unchanging.” While progress to restore and protect the Great Lakes has occurred, including the reduction of toxic chemicals, challenges cited in the report include invasive species and excess nutrients that contribute to toxic and nuisance algae.
EPA Announces $6.9 Million In Supplemental Funding For Additional Clean Up And Reuse Of Brownfield Sites: EPA Administrator Andrew Wheeler announced on June 10, 2020, that EPA is providing $6.9 million in supplemental funding for 25 current successful Brownfields Revolving Loan Fund (Revolving Loan) grantees. The Revolving Loan supplemental funds are being provided to communities that have demonstrated success in using their Revolving Loan program to clean up and redevelop brownfield sites. According to EPA, the funds will be used to continue their progress in reusing vacant and abandoned properties and turning them into community assets such as housing, recreation and open space, health facilities, social services, and commerce opportunities.
EPA Proposes “Honest Accounting Standard” Intended To Improve Future CAA Rules: On June 11, 2020, EPA published in the Federal Register a proposed rule intended to improve the rulemaking process under the CAA by establishing requirements to ensure that consistent, high-quality analyses of benefits and costs are provided to the public for significant rules. 85 Fed. Reg. 35612. According to EPA’s June 4, 2020, press release, the final rule “will codify best practices for benefit-cost analysis in rulemaking, and provide clarity for states, local communities and industry regarding EPA’s rulemaking considerations.” The fact sheet states that the proposed regulation consists of three main requirements:
- EPA will prepare a benefit-cost analysis (BCA) for all future significant proposed and final regulations under the CAA. EPA anticipates significant regulations will include those with the largest annual impact on the economy; those that would disproportionately affect an industry, group, or area; or those that are novel or relevant for other policy reasons;
- The BCA should be developed in accordance with best practices from the economic, engineering, physical, and biological sciences. The proposed rule outlines required elements of BCAs, following established protocols for conducting best cost analyses published by OMB and further elaborated in EPA’s “Guidelines for Preparing Economic Analyses.” These include addressing all key elements of a BCA and -- to the extent permitted by law -- making underlying data available to the public; and
- EPA must increase transparency in the presentation of the benefits resulting from significant CAA regulations. In addition to a clear reporting of the overall results of the BCA, EPA proposes to require a summary presentation of the overall BCA results in the rule, including total costs, benefits, and net benefits. EPA also proposes to require a separate reporting of the public health and welfare benefits that are specific to the objective of the CAA provision under which the rule is promulgated.
Comments are due July 27, 2020.
EPA Requests Nominations For NDWAC Candidates: EPA published a Federal Register notice on June 12, 2020, inviting nominations from a diverse range of qualified candidates to be considered to fill vacancies on the National Drinking Water Advisory Council (NDWAC). 85 Fed. Reg. 35930. The 15-member NDWAC was established by the Safe Drinking Water Act (SDWA) to provide independent advice, consultation, and recommendations to the EPA Administrator on matters relating to the activities, functions, policies, and regulations required by the SDWA. This announcement solicits nominations to fill five vacancies with three-year appointments from December 2020 through December 2023. EPA states that it may also consider nominations received through this solicitation in 2021 and in the event of unplanned vacancies on the NDWAC. To enable EPA to maintain the representation required by statute, it is seeking nominees who are from appropriate state and local agencies concerned with water hygiene and public water supply; representatives of private organizations or groups demonstrating an active interest in the field of water hygiene and public water supply, including nominees associated with small, rural public water systems; and from the general public. Nominations are due July 13, 2020.
FDA Guidance For Pesticide Residues Information Collection: FDA on May 13, 2020, announced an opportunity for public comment on the information collection provisions in the guidance document titled “Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations.” 85 Fed. Reg. 28639. FDA estimates that the annual reporting burden is three hours and that the annual recordkeeping burden is 16 hours. FDA is accepting comments until July 13, 2020.
Environmental Assessment For Spent Bleaching Clay Food Additive Petition: FDA, on May 14, 2020, placed a revised environmental assessment in the docket for public review and comment for a food additive petition (FAP) filed by the Canadian Oilseed Processors Association for spent bleaching clay on December 20, 2016. 85 Fed. Reg. 28898. Approval of the FAP would provide for the safe use of spent bleaching clay as a flow agent in canola meal for all livestock and poultry species, and would provide for the safe use of silicon dioxide and diatomaceous earth as components of spent bleaching clay. FDA is accepting comments until June 15, 2020.
Comment Period Extended For Intentional Adulteration Guidance: On May 28, 2020, FDA announced that the comment period for the supplemental draft guidance document titled “Mitigation Strategies to Protect Food Against Intentional Adulteration; Draft Guidance for Industry” will be extended to August 14, 2020. 85 Fed. Reg. 32040. The draft guidance is intended to help food facilities comply with the requirements of the Food Safety Modernization Act (FSMA) “Mitigation Strategies to Protect Food Against Intentional Adulteration” regulation.
FAP For Silicon Dioxide In Animal Feed Approved: FDA, on June 2, 2020, amended 21 C.F.R. Section 573.940 to provide for the safe use of silicon dioxide as an anticaking agent, grinding aid, antifoaming agent, or carrier in animal feed components (ingredients, intermediate premixes, premixes, supplements, or concentrates). 85 Fed. Reg. 33538. The amendment is in response a food additive petition submitted by Evonik Corp. in 2019. This rule was effective June 2, 2020. Submit either electronic or written objections and requests for a hearing on the final rule by July 2, 2020.
Study Analyzes Existing Research On Dermal Absorption Of Nanomaterials Used In Consumer Products And At Workplaces: On May 20, 2020, The European Union (EU) Observatory for Nanomaterials (EUON) announced that a recent study has analyzed existing research on whether nanomaterials used in consumer products and at workplaces are absorbed through the skin. According to EUON, the study found that the lack of standardized, validated methods and the use of varying testing protocols make it difficult to compare results and evaluate whether nanomaterials can penetrate the skin. More information is available in our May 22, 2020, blog item.
EU NanoSafety Cluster Publishes Final Report Of (nano) TiO2 Safety Communication Task Force: On May 26, 2020, the EU NanoSafety Cluster announced the publication of the final report of the (nano) TiO2 safety communication Task Force. The goal of the task force was to provide scientific input to the ongoing classification of titanium dioxide (TiO2). The final paper concludes that an open discussion would serve to document formally where scientific consensus and differences exist and could form the basis for the design of future safety assessments and decisions.
National Academies Holds Briefing Webinar On Quadrennial Review Of NNI: As reported in our April 8, 2020, blog item, the National Academies of Sciences, Engineering, and Medicine (National Academies) published a prepublication copy of A Quadrennial Review of the National Nanotechnology Initiative: Nanoscience, Applications, and Commercialization. On June 9, 2020, the National Academies held a report briefing webinar featuring its report, A Quadrennial Review of the National Nanotechnology Initiative. During the webinar, members of the ad hoc committee discussed how U.S. nanotechnology programs compare to those in other nations, whether coordination under the U.S. National Nanotechnology Initiative (NNI) should continue, and how to improve the NNI’s research and development strategy to enhance further U.S. economic prosperity and security.
France Intends To Improve The Identification And Assessment Of Manufactured Nanomaterials In Food: On June 9, 2020, the French National Agency for Food, Environmental, and Occupational Health Safety (ANSES) issued a press release, in French, proposing an inventory of manufactured nanomaterials in food. ANSES used data published in the scientific literature to identify 37 substances used as food additives or ingredients for which it considers that the presence of nanoparticles is proven or suspected. ANSES used food databases to identify nearly 900 food products that incorporate at least one additive or ingredient that meets the classification “substances for which the presence of manufactured nanomaterials is proven.” Based on its research, ANSES created an inventory of the use of nanomaterials in food. According to the press release, its next step will be to study the health risks that these substances could present for consumers. ANSES expects the first results by early 2021.
NNI Will Hold Webinar On Advances In Self-Powered Wearable Sensors: NNI will hold a webinar on June 24, 2020, on “Advances in self-powered wearable sensors: A biofuel-powered electronic skin.” Dr. Wei Gao, California Institute of Technology, will discuss the development of “a flexible and fully perspiration-powered integrated electronic skin (e-skin).” In addition to being a wearable biosensor, the e-skin is also able to monitor muscle contractions. NNI states that the vital signs and molecular information collected using the platform could be used to design and optimize next-generation prosthetics. The webinar will also address the challenges and barriers to energy harvesting and improved efficiency in wearable sensors, and the role of nanotechnology in lowering these barriers. Registration is now open.
NanoHarmony Project Will Hold Introductory Webinar In July: The Nanotechnology Industries Association (NIA) will hold a webinar on July 7, 2020, on “Introducing the NanoHarmony project.” NanoHarmony brings together 14 expert partners from ten European countries and will work alongside the Organization for Economic Cooperation and Development (OECD) and European Chemicals Agency (ECHA) to support the development of test guidelines and guidance documents for eight endpoints where nanomaterial-adapted test methods have been identified as an industrial priority. NanoHarmony will coordinate the collection and use of available data and information to support the development of test methods and to organize a sustainable network for the needed exchange, as well as for future regulatory development needs.
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 summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to http://www.braginfo.org.
EPA Will Not Meet June 22, 2020, Deadline For Issuing Final Risk Evaluations: On May 20, 2020, the Senate Environment and Public Works Committee held an oversight hearing on EPA. EPA Administrator Andrew Wheeler was the only witness. During the hearing, Senator Jeff Merkley (D-OR) questioned Wheeler about the risk evaluations being done under TSCA, particularly the risk evaluation of asbestos. Wheeler acknowledged that EPA probably will not meet the June 22, 2020, deadline for issuing final risk evaluations for the first ten chemicals. Regarding the asbestos risk evaluation, EPA will do a separate supplemental risk evaluation on the legacy uses since EPA can likely complete the final risk evaluation of asbestos this summer. Merkley asked Wheeler whether he would commit to examining all significant pathways of exposure to asbestos, including air, waste, and drinking water. Wheeler responded that when a chemical under the TSCA review process is already being regulated under a different program, EPA decided early on that in setting out the parameters for the TSCA risk evaluations, it would not double regulate to focus its time on the areas of the chemicals that are unregulated at this point.
Republicans Introduce Legislation In House Intended To Reduce Foreign Critical Mineral Dependency: On May 28, 2020, Representatives Rob Bishop (R-UT), Ranking Member of the House Committee on Natural Resources, Frank Lucas (R-OK), Ranking Member of the House Committee on Space, Science, and Technology, and Kevin McCarthy (R-CA), Ranking Republican and House Republican Leader, joined bill leads Representatives Michael Waltz (R-FL) and Paul Gosar (R-AZ) in introducing the American Critical Mineral Exploration and Innovation Act of 2020. The May 28, 2020, press release issued by Republicans on the House Committee on Natural Resources states that the legislation aims to reduce America’s dependence on foreign sources of critical minerals by supporting responsible domestic mineral development. According to the press release, 14 of the 35 critical minerals identified by the U.S. Geological Survey (USGS) are currently imported to the United States at a rate of 100 percent.
House Committee On Transportation And Infrastructure Releases INVEST In America Act: On June 3, 2020, the House Committee on Transportation and Infrastructure released the text of the Investing in a New Vision for the Environment and Surface Transportation in America (INVEST in America) Act, a key component of the Moving Forward Framework that House Democrats released earlier this year. The INVEST in America Act authorizes nearly $500 billion over five years to address some of the country’s most urgent infrastructure needs, including:
- The backlog of roads, bridges, and transit systems in need of repair and replacement;
- Building resilient infrastructure that will withstand the impacts of climate change and extreme weather;
- Designing streets that are safer for all road users, including pedestrians and cyclists;
- Putting the United States on a path toward zero emissions from the transportation sector by prioritizing carbon pollution reduction, investing in public transit and the national rail network, building out fueling infrastructure for low- and zero-emission vehicles, and deploying technology and innovative materials;
- Increasing funding for public transit options in urban, suburban, and rural areas to integrate technology and increase routes and reliability with tools such as bus-only lanes and priority signaling;
- Making transformational investments in Amtrak to create a robust, reliable rail system and to address long-neglected maintenance needs in the Northeast Corridor and throughout the country while also enhancing rail worker and passenger safety and helping communities address grade crossing issues; and
- Improving access to federal funding to help communities around the country undertake transformative projects that are smarter, safer, and made to last.
The Committee will consider the legislation at a Committee markup scheduled for June 17, 2020. The current surface transportation authorization expires September 30, 2020.
Great American Outdoors Act Introduced In The House, Senate Advances Its Bill: On June 4, 2020, Representatives Xochitl Torres Small (D-NM), Joe Cunningham (D-SC), Mike Simpson (R-ID), Steve Stivers (R-OH), Brian Fitzpatrick (R-PA), TJ Cox (D-CA), Lee Zeldin (R-NY), Mikie Sherrill (D-NJ), John Katko (R-NY), Kendra Horn (D-OK), Jared Golden (D-ME), and Jeff Fortenberry (R-NE) introduced the Great American Outdoors Act, a bipartisan bill that would fully and permanently fund the Land and Water Conservation Fund (LWCF), which provides funds that allow communities to purchase land and turn it into public resources. The legislation would allocate $12 billion towards the deferred maintenance backlog and $900 million for LWCF to invest in public parks, playgrounds, and access to public lands. The legislation is a companion to the Great American Outdoors Act (S. 3422) introduced in the Senate in March 2020. On June 10, 2020, the Senate voted 79 to 18 to move forward on its bill. The Senate is expected to vote on final passage during the week of June 15, 2020.
Bipartisan Growing Climate Solutions Act Introduced In The Senate: On June 4, 2020, Senators Sheldon Whitehouse (D-RI), Mike Braun (R-IN), Debbie Stabenow (D-MI), and Lindsey Graham (R-SC) introduced the Growing Climate Solutions Act, “which will break down barriers for farmers and foresters interested in participating in carbon markets so they can be rewarded for climate-smart practices.” According to Whitehouse’s June 4, 2020, press release, the bill has the support of the American Farm Bureau Federation, National Corn Growers Association, Environmental Defense Fund, McDonald’s, Microsoft, and over 40 farm groups, environmental organizations, and Fortune 500 companies [click here for the full list]. The bill establishes a Greenhouse Gas Technical Assistance Provider and Third-Party Verifier Certification Program through which the U.S. Department of Agriculture (USDA) will be able to provide transparency, legitimacy, and informal endorsement of third-party verifiers and technical service providers that help private landowners generate carbon credits through a variety of agriculture and forestry related practices. As part of the program, USDA will administer a new website, which will serve as a “one stop shop” of information and resources for producers and foresters who are interested in participating in carbon markets. The bill instructs USDA to produce a report to Congress to advise about the further development of this policy area, including: barriers to market entry, challenges raised by farmers and forest landowners, market performance, and suggestions on where USDA can make a positive contribution to the further adoption of voluntary carbon sequestration practices in agriculture and forestry.
Senate Committee Will Hold Hearing On Challenges Facing Recycling In The United States: On June 17, 2020, the Senate Committee on Environment and Public Works will hold an oversight hearing on “Responding to the Challenges Facing Recycling in the United States.”
EPA OIG Report States Further Efforts Needed To Uphold Scientific Integrity Policy At EPA: On May 20, 2020, the EPA OIG released a report entitled Further Efforts Needed to Uphold Scientific Integrity Policy at EPA. OIG conducted an Agency-wide survey to determine whether EPA’s Scientific Integrity Policy is being implemented as intended to ensure scientific integrity throughout EPA. OIG states that the survey revealed some concerns with specific aspects of scientific integrity at EPA, including dissatisfaction with EPA’s culture of scientific integrity (59 percent; 1,425 of 2,402) and the release of scientific information to the public (57 percent; 1,049 of 1,842). OIG recommends that EPA’s deputy administrator lead an effort to examine the causes associated with the scientific integrity concerns identified in the survey and communicate the results to EPA employees, including planned actions to address the causes. OIG also made 11 recommendations to the EPA science advisor, including developing procedures for addressing and resolving allegations of scientific integrity violations, communicating the outcomes of reports of scientific integrity violations, and improving the release of scientific information to the public. OIG states that EPA agreed with its recommendations and provided acceptable corrective actions. According to OIG, EPA has completed two recommendations, and the others are resolved with corrective actions pending.
EPA Releases Proposed Rule Intended To Improve The Transparency Of Guidance: On May 22, 2020, EPA published in the Federal Register its “first ever” proposed rule intended to improve the transparency of guidance. 85 Fed. Reg. 31104. According to EPA, the new rule will significantly increase the transparency of its practices around guidance and will improve its process for managing guidance documents. When final, the rule will:
- Establish the first formal petition process for the public to request that EPA modify or withdraw a guidance document;
- Ensure that EPA’s guidance documents are developed with appropriate review and are accessible and transparent to the public; and
- Provide for public participation in the development of significant guidance documents.
Comments are due June 22, 2020. For more information, please read the full memorandum.
Final SECURE Rule Will Update And Modernize USDA’s Biotechnology Regulations: On May 18, 2020, USDA’s Animal and Plant Health Inspection Service (APHIS) issued the much-anticipated final Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule. 85 Fed. Reg. 29790. The rule is intended to update and modernize USDA’s biotechnology regulations under the Plant Protection Act. The final rule amends the regulations regarding the movement (importation, interstate movement, and environmental release) of certain genetically engineered (GE) organisms in response to advances in genetic engineering and APHIS’s understanding of the plant pest risk posed by GE organisms, thereby reducing the regulatory burden for developers of organisms that are unlikely to pose plant pest risks. For more information, please read the full memorandum.
EPA Begins Public Comment Period On Systematic Review Protocol For Methylmercury IRIS Assessment: EPA published a Federal Register notice on May 28, 2020, beginning a 45-day public comment period on the Systematic Review Protocol for the Methylmercury Integrated Risk Information System (IRIS) Assessment. 85 Fed. Reg. 32037. This document communicates the rationale for conducting the assessment of methylmercury, describes screening criteria to identify relevant literature, outlines the approach for evaluating study quality, and describes the dose-response methods. EPA seeks public comment on components of the Systematic Review Protocol, including the described strategies for literature searches, criteria for study inclusion or exclusion, considerations for evaluating study methods, information management for extracting data, approaches for synthesis within and across lines of evidence, and methods for derivation of toxicity values. Comments are due July 13, 2020.
Chartered SAB And SAB Chemical Assessment Advisory Committee Will Meet June 23-24: EPA published a Federal Register notice on May 28, 2020, announcing a public meeting of the Chartered SAB and the SAB Chemical Assessment Advisory Committee. 85 Fed. Reg. 32035. The Chartered SAB and the SAB Chemical Assessment Advisory Committee will meet June 23-24, 2020, to conduct consultations with EPA on activities to re-examine and consolidate EPA's Human Toxicity Assessment Guidelines and new approach methods and reducing the use of laboratory animals for chronic and carcinogenicity testing. In addition, the Chartered SAB will conduct quality reviews of two draft SAB reports: Science Advisory Board Report on its Technical Review of EPA's Computable General Equilibrium Model, and Science Advisory Board Review of the All Ages Lead Model External Review Draft 2.0.
ATSDR Proposes Substances To Be Evaluated: On May 28, 2020, the Agency for Toxic Substances Disease Registry (ATSDR) requested public comment on nominations of substances ATSDR should evaluate for Toxicological Profile development. 85 Fed. Reg. 32039. ATSDR will consider nominations from the Substance Priority List and for non-Comprehensive Environmental Response, Compensation, and Liability Act substances that may have public heat implications. Comments are due by June 29, 2020.
State Department Updates Regulations For Implementation Of NEPA: On May 29, 2020, the State Department published a final rule in the Federal Register that updates its regulations for implementation of NEPA to reflect EO 13867 that revised the process for the development and issuance of Presidential permits for certain facilities and land transportation crossings at the international boundaries of the United States. 85 Fed. Reg. 32294. The final rule also provides several nonsubstantive administrative updates. The final rule will be effective July 13, 2020. Comments are due June 29, 2020.
OSHA Will Conduct Virtual Meeting To Prepare For 39th Session Of The UN Subcommittee Of Experts On GHS: On June 1, 2020, OSHA published a Federal Register notice advising interested persons that it will conduct a virtual public meeting in advance of certain international meetings. 85 Fed. Reg. 33200. The first meeting will be held in advance of the 39th session of the United Nations (UN) Subcommittee of Experts on the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) to be held as a virtual symposium in early July 2020, in Geneva, Switzerland. OSHA, along with the U.S. Interagency GHS Coordinating Group, plans to consider the comments and information gathered at this public meeting when developing the U.S. government positions for the UN Subcommittee meeting. The virtual public meeting will take place approximately two weeks preceding the international meeting. OSHA will post specific information for each meeting when available on the OSHA website.
NIH Names Rick Woychik Director Of NIEHS And NTP: On June 11, 2020, the National Institutes of Health (NIH) announced that Richard P. Woychik, Ph.D., has been appointed Director of NIH’s National Institute of Environmental Health Sciences (NIEHS), Research Triangle Park, North Carolina. Dr. Woychik served as NIEHS Acting Director since October 2019 and officially began his new role as the NIEHS Director on June 7, 2020. NIEHS conducts and supports environmental health sciences in alignment with real-world public health needs and translates scientific findings into knowledge that can inform real-life individual and public health outcomes. As NIEHS Director, Woychik also inherits the additional responsibility as Director of the National Toxicology Program (NTP). NTP is a federal, inter-agency program that reports directly to the U.S. Department of Health and Human Services. Three federal agencies comprise NTP, including NIEHS (part of NIH), the National Center for Toxicological Research (part of FDA), and the National Institute for Occupational Safety and Health (part of CDC). Woychik initially joined NIEHS in 2010 as Deputy Director. Prior to NIEHS, Woychik served nearly ten years as the President and Chief Executive Officer of The Jackson Laboratory, Bar Harbor, Maine, where he oversaw seven major building projects in Maine and California, enhanced the organization’s focus on basic mechanistic research in model organisms with a focus on translation to human health and disease, established the Genetics Resource Science division, and oversaw a major realignment of the nonprofit business unit to improve substantially efficiency and outreach to the global biomedical community. Dr. Woychik earned his Ph.D. in molecular biology in 1984 from Case Western Reserve University in Cleveland. He moved into the field of molecular genetics during his postdoctoral training in Philip Leder’s laboratory in the Department of Genetics at Harvard Medical School, Boston.