Category: Administrative & Regulatory

EPA Announces Additional Action to Assure Availability of Disinfectant Products for Use Against the Novel Coronavirus

On March 31, 2020, the U.S. Environmental Protection Agency (EPA) announced it is taking further action to help ease the production and availability of EPA-registered disinfectants by temporarily allowing manufacturers of certain already-registered EPA disinfectant products to obtain certain active ingredients from any source without prior approval from EPA.  This only applies to products on EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (List N).  EPA announced on March 26, 2020, similar action on certain inert ingredients.

EPA typically requires disinfectant manufacturers to first apply for and receive EPA approval prior to making a change in the source of the active ingredient.  Under this temporary amendment, however, manufacturers can source certain active ingredients from alternate suppliers by informing EPA.  Once EPA has been notified, the registrant can immediately distribute or sell a product modified according to this temporary amendment, provided that the resulting formulation is chemically similar to the current formulation (i.e., the purity of resulting product from the alternate source falls within the certified limits of the currently registered formulation for which they are making the source change).  EPA states that by allowing manufacturers to obtain certain active ingredients from any source it will help alleviate reports of supply chain disruptions by pesticide registrants who manufacture disinfectant products on List N.

The eligible active ingredients are:

  • Citric Acid, Chemical Abstracts Service Registry Number (CASRN) 77-92-9;
  • Ethanol, CASRN 64-17-5;
  • Glycolic Acid, CASRN 79-14-1;
  • Hydrochloric Acid, CASRN 7647-01-0;
  • Hypochlorous Acid, CASRN 7790-92-3;
  • Hydrogen Peroxide, CASRN 7722-84-1;
  • L-Lactic Acid, CASRN 79-33-4; and
  • Sodium Hypochlorite, CASRN 7681-52-9.

EPA will assess the continued need for and scope of this temporary amendment on a regular basis and will update it if EPA determines modifications are necessary.  EPA will notify the public at least seven days prior to terminating this temporary amendment at www.epa.gov/pesticides.

After the termination date of the temporary amendment, registrants will not be able to release for shipment new registered product unless that product is produced using a source of active ingredient identified in the product’s approved Confidential Statement of Formula (CSF) or otherwise would have complied with relevant requirements in the absence of this temporary amendment.

EPA states in its temporary amendment to Pesticide Registration (PR) Notice 98-10, the following procedures to submit a notification for currently registered disinfectant products listed on EPA’s List N:

  • A cover letter with a subject line that clearly indicates that this is a “notification per TEMPORARY AMENDMENT TO PR NOTICE 98-10 (Insert date or other citation) for EPA Registration No. XXXXXX and [insert product name]”;
  • The active ingredient; and
  • The following statement:

[Name of Registrant] is notifying EPA of its intent to use one or more alternate, unregistered sources of active ingredient listed in the TEMPORARY AMENDMENT TO PESTICIDE REGISTRATION (PR) NOTICE 98-10 (Insert date or other citation) in the formulation of EPA Registration No. [xxx-xx].  Each source is chemically identical to (i.e., within the certified limits of) the active ingredients in the Confidential Statements of Formula previously accepted by EPA [insert CSF date(s)]. This self-certification is consistent with the provisions of PR Notice 98-10 and no other changes have been made to the Confidential Statement of Formula or labeling of this product.  Further, I confirm that the ingredients statement of this label remains truthful.  I understand that it is a violation of 18 U.S.C. Section 1001 to willfully make any false statement to EPA.  I further understand that if this self-certification is not consistent with the terms of PR Notice 98-10 and 40 C.F.R. 152.46, this product may be in violation of FIFRA and I may be subject to enforcement actions and penalties under section 12 and 14 of FIFRA.

Applications must be submitted via the CDX portal.  At this time, EPA is not accepting paper applications.  Once an application is submitted, EPA requests that an email is sent to disinfectantslist@epa.gov with the CDX tracking number (CDX _ 2020 _ XXXXXXX).  A registrant may distribute or sell a product modified according to this temporary amendment to PR Notice 98-10 once EPA receives the notification.

©2020 Bergeson & Campbell, P.C.

For more on COVID-19 hygiene and other concerns, see the National Law Review Coronavirus News page.

TTB and FDA Relax Restrictions on the Production of Hand Sanitizers by Alcohol Manufacturers

With the increasing pace of the spread of the Coronavirus (COVID-19) and the related emergent need to increase the available supply for hand sanitizer products across the United States, the Alcohol and Tobacco Tax and Trade Bureau (TTB), followed by the Federal Drug Administration (FDA), have relaxed requirements for certain alcohol producers to produce these products without first amending their existing permits or obtaining prior formula approval.

On March 18, 2020, TTB came forward advising industry members that it has found it necessary and desirable to waive provisions of the internal revenue law to provide certain exemptions and authorizations for distilled spirits permittees to produce ethanol-based hand sanitizers to address the demand for such products during this time of national emergency. More specifically, TTB’s guidance provides:

  1. The exemptions are in effect through June 30, 2020.

  2. Alcohol fuel plants (AFPs) and beverage distilled spirits plants (DSPs) are exempted from the need to obtain additional permits or bonds to manufacture hand sanitizer or to supply ethanol to other TTB-authorized permit holders.

  3. All TTB-permitted DSPs are authorized to manufacture hand sanitizer without prior formula approval if the formula is consistent with the World Health Organization (WHO) guidance.

  4. Industrial alcohol user permittees may also use denatured ethanol to manufacture hand sanitizer consistent with the WHO guidance, and these permit holders are further exempted from the need to request approval to increase the quantities of ethanol they may procure.

  5. Hand sanitizers made with denatured alcohol are not subject to federal excise tax, but federal excise taxes will apply to hand sanitizer made with undenatured alcohol.

On March 20, 2020, the FDA—which also has jurisdiction over the production of hand sanitizing products—issued revised guidance that specifies that the FDA does not intend to take action against firms that prepare alcohol-based hand sanitizers for consumer use and for use as healthcare personnel hand rubs for the duration of the public health emergency declared by the Secretary of Health and Human Services on January 31, 2020. More importantly, to be compliant with FDA’s guidance, the alcohol at issued must be denatured (not undenatured) and the packaging must be consistent with FDA’s Labeling for Ethyl Alcohol Formulation Consumer Use found at Appendix A to the guidance.

Finally, for those alcohol manufacturers (or others) that are not currently licensed DSPs or related permit holders, TTB is also expediting its processing and approval of these applications (in some instances within days) to allow for greater production and access to these vital products in our time of national need.

© 2020 McDermott Will & Emery

National Labor Relations Board Tightens Standard for Joint Employer Status

A business is a joint employer of another employer’s employees only if the two employers share or codetermine the employees’ essential terms and conditions of employment, according to a recently unveiled and long-awaited final rule from the National Labor Relations Board (NLRB). This means that a business must exercise “substantial direct and immediate control” over such issues as wages, benefits, hours of work, hiring, discharge, discipline, supervision and work direction. The rule, which takes effect on April 27, 2020, tightens the legal test the NLRB uses to determine whether workers are jointly employed by affiliate businesses, including franchisors and franchisees.

Specifically, the new rule substantially tightens the standard for joint employer status articulated by the NLRB in its 2015 Browning-Ferris decision. In that decision, the NLRB departed from a half-century’s worth of precedent in determining that it could consider employers who exercised indirect control over the terms and conditions of another employer’s employees, or who reserved the right to exercise such control, as joint employers. The new rule expressly rejects this standard, making clear that neither “indirect” control nor a reservation of right to control terms and conditions of employment is sufficient, on its own, to establish joint employer status. The new rule returns the NLRB to its pre-Browning-Ferris jurisprudence, which required actual and direct control. The new rule also notes that “sporadic, isolated, or de minimus” direct control will not be enough to warrant a finding of joint employment.

The issue of joint employer status is significant for businesses because workers and the unions that represent them can collectively bargain with joint employers and hold them jointly liable for unfair labor practices, which are violations of federal labor law. The Browning-Ferris decision, with its broader test for joint employer status, engulfed more contractors and franchisors into costly and time-consuming labor disputes and contract negotiations. By rejecting the Browning-Ferris standard, the NLRB’s new narrower test brings certainty to this area of law by ensuring that labor disputes and contract bargaining only involve those contractors and/or franchisors that exercise direct control over the employees of another employer. NLRB Chairman Jon Ring made this very point when he explained that “employers will now have certainty in structuring their business relationships, [and] employees will have a better understanding of their employment circumstances.”

This new rule is particularly important to franchisors and comes on the heels of the Department of Labor’s (DOL) new joint-employer rule, which also affected franchisors. Since the Browning-Ferris decision, there has been uncertainty about how much “control” is too much. This new NLRB rule provides welcomed clarity for franchisors, and will allow franchisors to provide more operational support and guidance to franchisees, which should result in franchisees having the opportunity to run their small businesses in a manner that will make a difference in their communities. Franchisors can protect their brands through appropriate brand standards and require franchisees to meet those standards without the heightened risk of being deemed a joint employer of their franchisees’ employees.

However, franchisors must be mindful of various state joint employer regulations, which may be broader in scope than the new rule, as well as plaintiffs’ lawyers asserting claims based on control theories. Franchisors should continue to review their business models and business practices (training, technology and field support) to ensure they are not involved in the exercise of control over a franchisee’s employees. Franchisors also should appropriately address these issues in their franchise agreements and operations manuals.

In sum, the NLRB’s new joint employer test is a win for employers, returning the NLRB’s joint-employer status jurisprudence to the narrower direct and actual control standard. Under this new test, contractors and franchisors who do not want to become joint employers should be careful to avoid exercising direct control over another employer’s employees’ terms and conditions of employment, including wages and benefits. The new rule’s clarity allows businesses to know where they stand as a potential joint employer and to prepare accordingly.

© 2020 Faegre Drinker Biddle & Reath LLP. All Rights Reserved.

For more on NLRB decisions, see the National Law Review Labor & Employment law section.

New NLRB Rule Defining Joint-Employer Status to Take Effect

The National Labor Relations Board has announced the issuance of its final rule governing joint-employer status. The new rule, which was first proposed in September 2018 and has been the subject of extensive public comment, will become effective April 27, 2020.

The critical elements for finding a joint-employer relationship under the new rule is the possession and the exercise of substantial direct and immediate control over the terms and conditions of employment of those employed by another employer.  The essence of the new rule is described in the Board’s February 25, 2020 press release:

To be a joint employer under the final rule, a business must possess and exercise substantial direct and immediate control over one or more essential terms and conditions of employment of another employer’s employees. The final rule defines key terms, including what are considered “essential terms and conditions of employment,” and what does, and what does not, constitute “direct and immediate control” as to each of these essential employment terms. The final rule also defines what constitutes “substantial” direct and immediate control and makes clear that control exercised on a sporadic, isolated, or de minimis basis is not “substantial.”

Evidence of indirect and/or contractually reserved control over essential employment terms may be a consideration for finding joint-employer status under the final rule, but it cannot give rise to such status without substantial direct and immediate control. Importantly, the final rule also makes clear that the routine elements of an arm’s-length contract cannot turn a contractor into a joint employer.

The new rule marks a return to a standard similar to that which the Board followed from 1984 until 2015.  In 2015, in Browning-Ferris Industries, the Board adopted a much more liberal test under which a finding that the putative joint employer possessed indirect influence and the ability (including through a reserved contractual right) to influence terms and conditions, regardless of whether the putative joint employer actually exercised such influence or control, could result in it being held to be a joint-employer of a second employer’s employee.

As a practical matter, the standard under the Board’s new rule should make it much more difficult to establish that a company is a joint-employer of a supplier, contractor, franchisee, or other company’s employees. The new rule will mean that a party claiming joint-employer status to exist will need to demonstrate with evidence that the putative joint-employer doesn’t just have a theoretical right to influence the other employer’s employees’ terms and conditions of employment, but that it has actually exercised that right in a substantial, direct and immediate manner.

This new rule is likely to make it much more difficult for unions to successfully claim that franchisors are joint-employers with their franchisees, and that companies are joint-employers of personnel employed by their contractors and contract suppliers of labor, such as leasing and temporary agencies.

©2020 Epstein Becker & Green, P.C. All rights reserved.

For more on the Joint-Employer Rule see the National Law Review Labor & Employment Law section.

EPA Registers New Uses for Existing Products to Help Reduce the Spread of Candida auris

On February 12, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of 11 products that have been approved for use to disinfect surfaces against the emerging multidrug-resistant fungus Candida auris (C. auris).  C. auris can cause severe infections and spreads easily among hospitalized patients and nursing home residents.  The 11 products are approved for use against C. auris to disinfect surfaces in hospitals, nursing homes, and other healthcare facilities, to help reduce patient infections.  There were no antimicrobial pesticide products registered specifically for use against C. auris prior these new use registrations.

EPA worked in collaboration with the Centers for Disease Control and Prevention (CDC) and other federal partners to ensure that the products would be effective against C. auris.  Previously, on October 16, 2019, EPA had granted public health exemptions under the provisions of section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) as amended, to the CDC, for uses of antimicrobial products, on hard, nonporous surfaces in healthcare settings for disinfection from C. auris.

The 11 products that are now registered for use against C. auris are:

  •  Avert Sporicidal Disinfectant Cleaner (EPA Reg. No. 70627-72);
  •  Blondie (EPA Reg. No. 67619-24);
  •  Dagwood (EPA Reg. No. 67619-25);
  •  Micro-Kill Bleach Germicidal Bleach Wipes (EPA Reg. No. 37549-1);
  •  Oxivir 1 (EPA Reg. No. 70627-74);
  •  Oxivir 1 Wipes (EPA Reg. No. 70627-77);
  •  Oxivir Wipes (EPA Reg. No. 70627-60);
  •  Oxycide™ Daily Disinfectant Cleaner (EPA Reg. No. 1677-237);
  •  Virasept (EPA Reg. No. 1677-226);
  • Wonder Woman Formula B Germicidal Wipes (EPA Reg. No. 9480-12); and
  •  Wonder Woman Formula B Spray (EPA Reg. No. 9480-10).

Because there are few products with C. auris claims at this time, CDC and EPA have identified additional products that are effective against C. auris. Although these products do not yet have formal EPA-registered claims for C. auris, testing at CDC has confirmed they are effective against C. auris.  The label on the product will not include instructions for C. auris.  CDC guidance states to “follow the instructions provided for C. albicans, if included, or else follow those for fungicidal activity.” These products include:

  •  Oxivir TB Spray (EPA Reg. No. 70627-56); and
  •  PDI Super Sani-Cloth (EPA Reg. No. 9480-4).

The CDC Guidance further states that, if none of the above-listed products are available, or any of the EPA-registered products that are newly approved for the specific claims against C. auris, CDC recommends use of an EPA-registered hospital-grade disinfectant effective against Clostridioides difficile spores, because CDC believes these products have been used effectively against C. auris (List K).

Additional information on C. auris is available on EPA’s website and CDC’s website.

©2020 Bergeson & Campbell, P.C.

For more on EPA disinfectant registrations, see the National Law Review Environmental, Energy & Resources section.

Congress Tackles PFAS on Multiple Fronts

With the enactment of the PFAS Act of 2019 and related provisions in December, opposing forces in Congress came together to force regulatory action on several different aspects of per- and poly-fluorinated substances (PFAS). Issues on which agreement was not reached are now before the Senate in House-passed legislation. While the PFAS debate continues in Congress, federal agencies are now tasked with multiple obligations related to PFAS. Companies that handle PFAS will have added PFAS reporting obligations under both the Toxics Release Inventory and the Toxic Substances Control Act.

The PFAS Act of 2019 is title LXXIII of the massive National Defense Authorization Act for Fiscal Year 2020 (NDAA), Public Law 116-92 (Dec. 20, 2019). This alert summarizes its six subtitles, as well as other PFAS provisions in the NDAA related to the Department of Defense (DOD). It then provides a preview of future legislative developments.

PFAS Act of 2019 Provisions

Subtitle A – Drinking Water Monitoring

EPA must include certain PFAS and classes of PFAS in the fifth Unregulated Contaminants Monitoring Rule (UCMR 5), expected later this year. EPA’s PFAS Action Plan (Feb. 2019) had called for EPA to take this action, but Subtitle A requires it to do so. EPA had included six PFAS in UCMR 3.

The PFAS to be included are all PFAS and classes of PFAS for which EPA has a validated test method for drinking water and that are not subject to a national primary drinking water standard under the Safe Drinking Water Act (SDWA). EPA has a validated test method for 18 PFAS, which it adopted in 2009 and expanded in 2018, EPA Method 537.1. The PFAS Action Plan had predicted additional test methods in 2019, but this did not occur.

The SDWA limits the number of unregulated contaminants that may be included in each UCMR to 30, but the NDAA excludes the listed PFAS from that limit.

Subtitle A also provides grant eligibility through the Drinking Water State Revolving Funds to address PFAS.

Subtitle B – Toxics Release Inventory

EPA’s PFAS Action Plan had set as a long-term action exploring data availability for listing some PFAS as toxic chemicals for purposes of the Toxics Release Inventory (TRI) under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA). EPA had begun that lengthy process with an advance notice of proposed rulemaking, published on December 4, 2019.

The NDAA disrupted this process later that month. By its terms, Subtitle B automatically added multiple PFAS to the TRI list as of January 1, 2020, and others will be automatically added as certain milestones are reached. EPA posted a list of 160 PFAS that were added as of January 1, 2020. The reporting threshold for all of the chemicals is set at 100 pounds unless revised by EPA within the next 5 years. Reporting on these 160 PFAS will be due by July 1, 2021.

Future automatic additions to the TRI list (as of January 1 of the following year) are mandated whenever:

  • EPA finalizes a toxicity value for a PFAS. (EPA has a provisional peer-reviewed toxicity value for PFBS, adopted in 2014.) Toxicity values are used in risk assessments under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA).
  • EPA finalizes a significant new use rule (SNUR) under the Toxic Substances Control Act (TSCA) for a PFAS or class of PFAS.
  • EPA adds a PFAS or class of PFAS to an existing SNUR.
  • EPA designates a PFAS or class of PFAS as active on the TSCA Inventory.

In addition, over the next two years, EPA must determine whether certain listed PFAS meet any of the listing criteria in section 313. If so, EPA must add them to the TRI list within two years of making that determination.

These additions to the TRI list are subject to the provision that, if any PFAS chemical identity is claimed confidential, the PFAS is not added to the list until EPA reviews a substantiation of that claim. If EPA upholds the claim, that PFAS must be added to the list in a manner that does not disclose its identity (such as through a generic name).

Subtitle C – USGS Performance Standard and Sampling

Subtitle C directs the United States Geological Survey (USGS) to coordinate with EPA to develop an appropriate testing methodology for PFAS that is “as sensitive as is feasible and practicable,” with the ability to detect as many “highly fluorinated compounds” as possible. Highly fluorinated compounds are defined to mean PFAS with at least one fully fluorinated carbon atom. USGS must also develop quality assurance and quality control measures to ensure accurate sampling and testing, as well as a training program.

In addition, USGS must carry out nationwide sampling for PFAS. The nationwide sampling program must start with drinking water near locations with known or suspected sources of PFAS. Later stages of sampling will be based on an evaluation by USGS in consultation with the states and EPA to determine where sampling should occur, with an emphasis on direct human exposure through drinking water. The results of the sampling must be sent to EPA and, upon request, the states. In addition, USGS must prepare a report and submit it to certain committees and members of Congress.

EPA’s PFAS Action Plan called for EPA to collaborate with USGS, the Army Corps of Engineers, and universities to lead the science of PFAS.

Subtitle D – Emerging Contaminants

Subtitle D encourages research into “emerging contaminants,” defined broadly to include any physical, chemical, biological, or radiological substance or matter in water for which there is no national primary drinking water standard and that may have an adverse impact on the health of individuals. It mandates several actions to improve the level of technical understanding as well as support for states.

First, EPA, in collaboration with states and other stakeholders, must establish a strategic plan for improving existing federal efforts to identify, monitor, and assist in the development of treatment systems for emerging contaminants and to assist states in responding to human health risks posed by such contaminants.

Second, Subtitle D requires the establishment of a Working Group within 180 days of enactment to coordinate federal activities identifying and analyzing public health effects of emerging contaminants in drinking water. The Working Group will be comprised of representatives from several federal entities, including EPA, the National Institutes of Health, the Centers for Disease Control and Prevention, the Agency for Toxic Substances and Disease Registry, USGS, and others in the discretion of EPA.

Third, it requires the Director of the Office of Science and Technology Policy to establish the National Emerging Contaminant Research Initiative within 180 days of enactment. The goal will be improving the identification, analysis, monitoring, and treatment methods for emerging contaminants, including identifying priority emerging contaminants for research emphasis. Within one year after establishing the research initiative, involved agencies must issue solicitations for grant proposals for research projects consistent with that strategy.

Finally, Subtitle D requires EPA to study the actions it can take to increase technical assistance and support to states with respect to drinking water in emerging contaminants and issue a report to Congress within 18 months. Based on the findings in that report, EPA must develop a program to provide technical assistance to states within three years of enactment. When evaluating applications submitted by states seeking assistance, EPA must give priority to states with affected areas, primarily in financially distressed communities. Emergency assistance may be provided without application. EPA must also establish and maintain a database of available resources developed to assist states with testing for emerging contaminants and make it available to states and stakeholder groups with a scientific or material interest, such as drinking water utilities. The database must be searchable and available through the EPA website.

Subtitle E – TSCA Provisions

Subtitle E requires EPA to take two actions regarding TSCA – finalize amendments to two SNURs for certain PFAS substances by June 22, 2020, and issue a final rule by January 1, 2023, requiring manufacturers of PFAS to report detailed information about their PFAS.

The two PFAS SNURs and the effect of Subtitle E on EPA’s timetable for finalizing them are discussed in another Beveridge & Diamond alert, available here.

Subtitle E also amends TSCA § 8(a) so as to direct EPA to issue a final rule that would require each person who has manufactured a PFAS in any year since 2011 to submit a report that includes, for each year since 2011, detailed information on that PFAS. EPA must issue the rule by January 1, 2023.

The information that a PFAS manufacturer must provide includes, for each such PFAS:

  • Its common or trade name, chemical identity, and molecular structure.
  • Its categories or proposed categories of use.
  • The total amount manufactured or processed, reasonable estimates of the total amount to be manufactured or processed, the amount manufactured or processed for each of its categories of use, and reasonable estimates of the amount to be manufactured or processed for each of its categories of use or proposed categories of use.
  • A description of the byproducts resulting from its manufacture, processing, use, or disposal.
  • All existing information concerning its environmental and health effects.
  • The number of individuals exposed to it, and reasonable estimates of the number who will be exposed to it in their places of employment and the duration of such exposure.
  • The manner or method of its disposal.

Subtitle F – Guidance on Disposal; Research

EPA must publish interim guidance on the destruction and disposal of PFAS within one year of enactment. The guidance must address aqueous film-forming foam (AFFF), soil and biosolids, textiles (other than consumer goods) treated with PFAS, spent water treatment equipment, landfill leachate containing PFAS, and waste streams from facilities manufacturing or using PFAS. EPA must publish revisions at least every three years.

EPA’s Office of Research and Development must examine the effects of PFAS on human health and the environment and make that information public It must also develop a process for prioritizing PFAS and classes of PFAS for additional research. A total of $15 million per year for each of the next five years is authorized for appropriation for this research.

DOD-Related PFAS Provisions of the NDAA

The National Defense Authorization Act includes several PFAS provisions in Title III, related to DOD operations and maintenance at military bases. AFFF containing PFAS, used for putting out fires, is the subject of several provisions. These include prohibiting the uncontrolled release of AFFF containing PFAS, with limited exceptions for emergency response as well as incineration requirements for the disposal of AFFF that must meet the Resource Conservation and Recovery Act (RCRA). The use of PFAS AFFF must be phased out by October 1, 2024, and the use of PFAS in packaging for meals ready-to-eat (MREs) must end by October 1, 2021. There are also provisions for information sharing with municipal drinking water utilities located adjacent to military installations.

Additional PFAS Legislation

During the conference to reconcile the House and Senate versions of the NDAA, the House managers pushed for additional PFAS provisions, but the two sides did not reach agreement on those provisions. On January 10, 2020, the House passed a revised H.R. 535, the PFAS Action Act of 2019, with the votes of 24 Republicans, and sent it to the Senate for its consideration. Senate passage is probably unlikely, particularly in light of the rejection by Senate conferees on the NDAA of some of these provisions.

As revised, H.R. 535 would require a number of regulatory actions on PFAS, including:

  • A requirement that EPA designate PFOA, PFOS, and their salts as hazardous substances under CERCLA § 102(a) within one year of enactment, and determine within five years of enactment whether to designate additional PFAS as hazardous substances.
  • An amendment to TSCA § 4 directing EPA to adopt a rule requiring comprehensive toxicity testing on all PFAS, with a proposed test rule due six months after enactment and a final rule due two years after enactment.
  • An amendment to TSCA § 5 eliminating exemptions for PFAS (such as those for R&D, impurities, and the low-volume exemption).
  • An amendment to TSCA § 5 providing that, for five years after enactment, all PFAS that are the subject of premanufacture notices or significant new use notices are deemed to present an unreasonable risk. EPA would be required to issue orders to prohibit all manufacture, processing, and distribution of those PFAS.
  • An amendment to SDWA § 1412(b) directing EPA to promulgate a national primary drinking water regulation for PFAS (including at last PFOA and PFOS) within two years of enactment. It would also require EPA to publish a health advisory for a PFAS not subject to a national primary drinking water regulation within one year of a finalized PFAS toxicity value or effective quality control and testing procedure for a PFAS, whichever is later.
  • A provision that EPA may not impose a financial penalty for violation of a PFAS national primary drinking water regulation until five years after its adoption.
  • An amendment to the SDWA requiring EPA to establish a program to award grants to affected community water systems.
  • A requirement that EPA adopt a final rule adding PFOA, PFOS, and their salts to the list of hazardous air pollutants under the Clean Air Act § 112(b) within six months of enactment, and to determine within five years of enactment whether to issue final rules adding other PFAS to that list.
  • An amendment of RCRA § 3004 to prohibit unsafe incineration of PFAS.
  • A requirement that EPA revise the Safer Choice Standard of the Safer Choice Program within one year of enactment to identify requirements for certain consumer products to meet to be labeled with a Safer Choice label, including a requirement that they not contain any PFAS.
  • A requirement that EPA issue guidance on minimizing the use of AFFF and related equipment containing PFAS within one year of enactment.
  • A requirement that EPA investigate methods and means to prevent contamination of surface waters by GenX.
  • A prohibition of introducing PFAS pollutants to a treatment works under the Federal Water Pollution Control Act (FWPCA) without first notifying the treatment works of the identity and quantity of each PFAS; whether the PFAS is susceptible to treatment by the treatment works; and whether the PFAS would interfere with the treatment works.
  • A requirement that EPA establish a website containing information on the testing of household well water within one year of enactment.
  • A requirement that EPA develop a risk-communication strategy to inform the public about potential hazards of PFAS.
  • A requirement that EPA publish a plan under FWPCA § 304(m) by September 30, 2021, that contains the results of a review of the introduction into treatment works or discharge of PFAS from categories of point sources (other than publicly owned treatment works). Based on that results of that review, EPA would be required to initiate as soon as practicable the process for adding certain PFAS to the list of toxic pollutants under FWPCA § 307(a), and within two years of publication of the plan to publish human health water quality criteria for other PFAS. EPA would also be required to adopt human health water quality criteria for PFOA, PFOS, and their salts within two years of enactment for each priority industry category, and to adopt a final rule within four years of enactment establishing effluent limitations and pretreatment standards for those PFAS for each priority industry category.

The White House announced on January 7, 2020, that it strongly opposes H.R. 535 and that President Trump’s senior advisors may recommend the bill be vetoed if passed by both Houses.

© 2020 Beveridge & Diamond PC

For more on PFAS regulation, see the Environmental, Energy & Resource section of the National Law Review.

The Promise and Peril of Autonomous Vehicles

The possibility of self-driving cars on our roads is prompting both excitement and anxiety. Advocates point to the possibility of increased safety, lower pollution, even less congestion. Critics aren’t sold on many of the supposed advantages.

So, what happens when driverless vehicles start hitting our roads? As with so many innovations, there are likely to be pluses and minuses.

Let’s consider safety. The United States Department of Transportation estimates that roughly 95% of road accidents are caused by human mistakes; driving too fast for conditions, not paying attention to the road, or illegal maneuvers such as driving through red lights. Given human tendencies to get distracted, one would expect that autonomous vehicles will be safer.

Autonomous vehicles are outfitted with sensors and cameras, which enable them to “see” their surroundings and react to traffic and pedestrians. Companies working on these vehicles have been testing these vehicles in simulated settings as well as on real roads. There is much to tout about their safety aspects: they’re not distracted like humans, they obey speed limits and traffic signs, they don’t drive fatigued.

But driving in traffic has turned out to be more challenging than expected, and a few well-publicized accidents – one involving a Tesla and one an Uber vehicle that killed a pedestrian – have prompted concerns the self-driving technology is not ready for prime time. In particular, that sensors and cameras may not be able to react in real-time to cope with humans who behave like, well, humans.

More choices or less?

“We’re moving to a future where people don’t own cars,” says Dr. Daniel Sperling, director of the Institute of Transportation Studies at the University of California, Davis. “You’ll have a subscription service, maybe, that emphasizes smaller vehicles, or you might want a cheaper service where it’s a van,” he adds.

Dr. Alain Kornhauser, director of the program in transportation at Princeton University, agrees to a point, saying privately owned cars are not likely to vanish completely — especially in rural areas, where getting a driverless taxi may be more challenging. Still, he says, the number of people who own cars — and the number of cars owned per family — will drop sharply.

In many cities with ridesharing services like Lyft or Uber, owning a vehicle has become less urgent. Autonomous vehicles could multiply ridesharing options.

But what if you’re in a rural area without these services? Should rural communities consider investing in self-driving vehicles as a form of public transport? What if you’re in a major city but can’t afford to either own an autonomous vehicle or even subscribe to the service?

There’s also the question of what happens to public transport as self-driving vehicles increase. Will we continue to support and improve the infrastructure for public transportation?

Public transport systems in the U.S. are not as robust as in some European nations. One of the main concerns for Seleta Reynolds, General Manager of Department of Transportation for Los Angeles, is managing access for people in different parts of Los Angeles because she understands how much that can impact one’s financial well-being.

“You can get to about 12 times as many jobs in an hour in a car as you can by transit in L.A.,” she said.

If autonomous vehicles end up reducing access, the financial and social impact could ripple across communities.

Then there is the question of what autonomous vehicles will do to people who drive for a living. According to the U.S. Bureau of Labor Statistics, more than 2.5 million people earn their living from driving – employed as tractor-trailer truck drivers, taxi and delivery drivers, and as bus drivers. If those jobs disappear, that could represent a potential loss of employment equal to what we saw during the Great Recession of 2008.

Many of the people driving vehicles for a living are classified as low-skilled workers. It will be difficult for such unemployed workers to quickly find new work, and the cost of re-training them could be high.

Autonomous vehicles have the potential to spur a massive and exciting paradigm shift. But there are darker clouds on the horizon too. The question is: will we be able to manage the changes wrought by self-driving vehicles in a positive way?

Copyright © 2020 Godfrey & Kahn S.C.

For more on autonomous vehicle developments, see the National Law Review Utilities & Transport Law section.

Navigable Waters Protection Rule Substantially Narrows the Scope of Waterbodies Subject to Regulation under the Clean Water Act

On January 23, 2020, the Environmental Protection Agency (“EPA”) and the U.S. Army Corps of Engineers (the “Corps”) (collectively the “Agencies”) released a final rule re-defining the term “waters of the United States” as applied under the Clean Water Act (“Final Rule”).

The Final Rule substantially narrows the scope of waterbodies subject to regulation under the Clean Water Act—notably removing interstate streams as a separate jurisdictional category; excluding ephemeral streams and water features; requiring rivers, streams and other natural channels to directly or indirectly contribute flow to a territorial sea or traditional navigable water; and excluding wetlands that are not adjacent to another non-wetland jurisdictional water. Further, the Agencies confirm that groundwater is not subject to regulation under the Clean Water Act and, consequently, that surface water features connected only via groundwater likewise are not jurisdictional. In support of this narrower scope, the Agencies explain that states and tribes retain the authority to regulate non-jurisdictional waters within their authority, provided those states and tribes deem such regulation appropriate.

The Final Rule replaces the definition of “waters of the United States” adopted under a 2015 Obama-era “WOTUS Rule” (the “2015 WOTUS Rule”), which was formally repealed by the Agencies on October 22, 2019.  As explained in previous Van Ness Feldman alerts, the 2015 WOTUS Rule expanded federal control over several types of waterbodies, particularly with respect to tributaries, adjacent waters, and wetlands. 2015 WOTUS Rule has been subject to numerous legal challenges. These challenges resulted in a patchwork regulatory regime where application of the 2015 WOTUS Rule was enjoined from implementation in 28 states, while the remaining 22 states were subject to the more expansive regulatory definition of the “waters of the United States.”

The Agencies have described the Final Rule as providing “consistency, predictability, and clarity,” as well as appropriately recognizing state and tribal regulatory authority.  The Final Rule pulls from three Supreme Court opinions in United States v. Riverside Bayview Homes (Riverside Bayview), Solid Waste Agency of Northern Cook County v. United States (SWANCC), and Rapanos v. United States (Rapanos) to adopt a unifying legal theory to define “waters of the United States” based on sufficient surface water connections with downstream traditional navigable waters and territorial seas.  In adopting a unifying interpretive approach, the Agencies explicitly eliminate the case-specific application of their previous interpretation of Justice Kennedy’s significant nexus test in what was called their “Rapanos Guidance.”

Under the Final Rule, the overall categories of jurisdictional and excluded waters, in many ways, are similar to the existing regulatory scheme.  As a practical matter, however, the Final Rule substantially narrows the scope of waterbodies subject to regulation under the Clean Water Act.  The Agencies classify jurisdictional and excluded waters as follows:

The Agencies will primarily rely on states and tribes to regulate non-jurisdictional waters within their authority, provided those states and tribes deem such regulation appropriate.

Among the Final Rule’s most significant changes from the 2015 WOTUS Rule’s definition of federally regulated waters of the United States are the exclusions of ephemeral streams and wetlands that are not adjacent to another non-wetland jurisdictional water.  Another notable element is the Agencies’ confirmation that groundwater is not subject to regulation under the Clean Water Act and, consequently, that surface water features connected only via groundwater likewise are not jurisdictional.

The Final Rule also provides definitions for key terms and offers guidance on their intended application of the regulated and non-regulated categories of waters.  Key issues addressed by the Agencies include:

  • “Tributary” is defined as a river, stream, or similar naturally occurring surface water channel that contributes surface water flow to a territorial sea or traditional navigable water in a typical year directly or through another jurisdictional water.  A tributary must be perennial or intermittent in a typical year.  The Agencies also explain that a tributary does not lose its jurisdictional status if it contributes surface water flow to a downstream jurisdictional water in a typical year through a channelized non-jurisdictional surface water feature, through a subterranean river, culvert, dam, tunnel or similar artificial feature, or through a debris pile, boulder field or similar natural features.  Tributaries include ditches that relocate a tributary, were constructed in a tributary, or are constructed in an adjacent wetland and have surface flow to the downstream jurisdictional water.
  • Certain delineation determinations will require the presence of the necessary jurisdictional features in a “typical year,” i.e., defined as “when precipitation and other climatic variables are within the normal periodic range (e.g. seasonally, annually) for the geographic area of the applicable aquatic resource based on a rolling thirty-year period.”
  • Ditches are not included as a separate category of jurisdictional waters, but instead are included in the definition of tributary.  Ditches that are constructed in, or that relocate, a tributary or that are constructed in adjacent wetlands are included as a tributary and are jurisdictional if the flow in the ditch is perennial or intermittent during a typical year and that flow reaches a traditional navigable water or territorial sea.  The Preamble notes that the majority of ditches used to drain surface and shallow subsurface water from croplands are expected to be non-jurisdictional.
  • Lakes, ponds and other impoundments do not lose their jurisdictional status if they contribute surface water flow to a downstream jurisdictional water through a culvert, dike, pipe, spillway, tunnel or other artificial feature or through a natural feature such as a debris pile or boulder field.  However, lakes, ponds and impoundments that are connected downstream to jurisdictional waters only by diffuse stormwater runoff or directional sheet flow over upland areas are not jurisdictional.  An ecological connection between a lake, pond or impoundment is insufficient to establish federal jurisdiction.
  • An impoundment must have a surface water connection to a downstream jurisdictional water in order to be regulated.  The downstream surface water connection does not need to be natural but may be through any manner of artificial features (tunnels, culverts, spillways, etc.).  However, lakes, ponds and impoundments that lose water only through evaporation, underground seepage or consumptive use are no longer considered jurisdictional waters.
  • Adjacent wetland are defined as wetlands that either:   (i) abut a territorial sea, traditional navigable water, or regulated lake, pond, or impoundment; (ii) are inundated by flooding from one of these jurisdictional waters; (iii) are physically separated from one of these waters by a natural berm, bank, dune or similar natural feature; or (iv) are physically separated from one of these waters by an artificial dike, barrier or other structure, including a road, that allows for a direct hydrologic surface connection with the regulated water in a typical year (such as through a culvert, flood or tide gate, pump or similar feature).  Application of these categories still requires further context to the relevant connections.  For example, the Agencies explain that a subsurface connection through porous soils is insufficient to establish jurisdiction over a wetland separated by an artificial structure, such as a dike.  Likewise, if the surface flow between the wetland and the abutting jurisdictional water across, or through, a dike or other artificial barrier only occurs after a 100-year storm event, this would not be sufficient to establish jurisdiction because the surface water connection would not occur once during a typical year.  Finally, the Final Rule eliminates the prior definition of “adjacent”—which had included the terms “bordering, contiguous, or neighboring.”  The elimination of the prior “adjacent” definition further limits the regulatory reach over wetlands under the Final Rule.

For each category of regulated waters, the Preamble in the Final Rule provides guidance on how the Final Rule will be implemented.  Issues of implementation also are addressed in an “Implementation Statement” that was concurrently issued by the Agencies.

Lawsuits challenging this Final Rule are expected, likely resulting in continuing uncertainty, and, potentially, a further state-by-state patchwork of regulation, until these cases ultimately are addressed by the Supreme Court.  For now, however, project and resource developers should carefully consider how the Final Rule may affect their permitting obligations for proposed development and work in or near waterbodies and wetlands.

© 2020 Van Ness Feldman LLP

For more on WOTUS & the Clean Water Act, see the National Law Review Environmental, Energy & Resources page.

NEPA Overhaul? CEQ Proposes Significant Changes to Federal Environmental Review

The Council on Environmental Quality (CEQ), a division of the Executive Office of the President, today published in the Federal Register a Notice of Proposed Rulemaking that would make significant changes to its regulations implementing the National Environmental Policy Act (NEPA).

CEQ’s efforts spring from a 2017 Executive Order that directed it to “enhance and modernize the Federal environmental review and authorization process” by, among other initiatives, ensuring “that agencies apply NEPA in a manner that reduces unnecessary burdens and delays as much as possible, including by using CEQ’s authority to interpret NEPA to simplify and accelerate the NEPA review process.”  Today’s publication, the first comprehensive update of the CEQ NEPA regulations since their promulgation in 1978, proposes noteworthy reductions in the scope of and timeline for federal environmental review.

Key proposed changes include:

  • Limiting the scope of the NEPA review.  CEQ proposes to exclude from NEPA review non-federal projects with minimal federal funding or minimal federal involvement such that the agency cannot control the outcome on the project, reasoning that “[i]n such circumstances, there is no practical reason for an agency to conduct a NEPA analysis because the agency could not influence the outcome of its action to address the effects of the project.”  The impact of this change on privately-funded (i.e., non-federal) projects is unclear, however, because major federal actions subject to NEPA review under the proposed rule include “actions approved by permit or other regulatory decision as well as Federal and federally assisted activities.”
  • Eliminating cumulative impact analyses.  CEQ proposes to change how to address cumulative impacts, such that analysis of cumulative effects is not required under NEPA, finding that “categorizing and determining the geographic and temporal scope of such effects has been difficult and can divert agencies from focusing their time and resources on the most significant effects,” and “can lead to encyclopedic documents that include information that is irrelevant or inconsequential to the decision-making process.”
  • Requesting comments on GHGs.  The effect that elimination of cumulative impact analyses will have on NEPA review of the greenhouse gas (GHG) impacts of a proposed project is unclear.  Just last summer, in its proposed draft guidance on how NEPA analyses should address GHG emissions, “Draft National Environmental Policy Act Guidance on Consideration of Greenhouse Gas Emissions,” CEQ stated that “the potential effects of GHG emissions are inherently a global cumulative effect.” CEQ has invited comment on this issue, noting that if it finalizes its proposed rulemaking, it would review the draft GHG guidance for potential revisions consistent with the regulations.
  • Establishing time limits of two years for completion of Environmental Impact Statements (EISs) and one year for completion of Environmental Assessments.  Currently, the average time for federal agencies to complete an EIS is four and a half years.  A two-year presumptive time limit, measured from the date of the issuance of the notice of intent to the date a record of decision is signed, would bring the majority of EISs within the timeline achieved by only a quarter of EISs prepared over the last decade, according to the CEQ’s report on EIS Timelines.

Because the rulemaking proposes sweeping changes to NEPA, these changes likely will be challenged in court.  Nevertheless, the changes are indicative of a federal push to reduce the scope and time of environmental review, particularly related to highway and energy infrastructure projects.  In an op-ed piece, CEQ Chairwoman Mary B. Neumayr stated that the proposed changes “would modernize, simplify, and accelerate the NEPA process in order to promote public involvement, increase transparency, and enhance the participation of states, tribes, and localities. These changes would also reduce unnecessary burdens and delays and would make important clarifications to improve the decision-making process.”

Public comments are due March 10, 2020.  CEQ will host two public hearings on the proposed rule: in Denver, CO, on February 11, 2020 and in Washington, DC, on February 25, 2020.

©2020 Pierce Atwood LLP. All rights reserved.

More from The Council on Environmental Quality in the National Law Review Environmental, Energy & Resources legal articles’ section.

Pennsylvania Liquor Control Board Tackles Wine Slushie Sales by Restaurant Licensees

Ever since beer distributors in Pennsylvania were permitted to sell growlers for off-premises consumption, which is loosely interpreted as a closed container by the Pa.L.C.B., there has been an influx of beer distributors installing slushie machines and selling malt beverage slushies. Now, are wine slushies fair game?

In a recent Legal Advisory Opinion from the Pa.L.C.B., a question was presented as to whether Pennsylvania restaurant licensees that hold an additional Wine Expanded Permit (“WEP”) can sell wine to go in a container with a sealed lid.

Specifically, the question related to whether a WEP permits the sale of wine slushies to go in a sealed container.

As a bit of background, a WEP can be obtained by any restaurant licensee in Pennsylvania and permits the sale of wine, or wine-based drinks, for off-premises consumption. The sales of wine cannot exceed 3,000 milliliters in a single transaction (typically 4 bottles of wine), similar to the 192-fluid ounce (two six-packs) limitation for off-premises beer sales by a restaurant licensee. The sale of wine and beer can occur during the same transaction so long as the respective volume limitations are met for each product. Interestingly, the statute authorizing the issuance of the WEP to restaurant licensees does not have any limitations on the sale of wine to go, other than that the sale prices must not be less than what the licensee paid for the product from the Pa.L.C.B.

Now that we have covered the law related to a WEP, what was the Pa.L.C.B.’s response to the question in the Legal Advisory Opinion?

The Pa.L.C.B. stated that, because there are no other limitations for a WEP other than selling 3,000 milliliters or less in a single transaction, a WEP holder can sell wine slushies to go in any container, and are not limited to sales of wine in the container it was purchased by the WEP holder. This would permit wine, or any other wine-based drinks without any other alcohol mixed in, to be poured in a cup with or without a lid and sold for off-premises consumption as long as the volume does not surpass 3,000 milliliters in a single transaction.

It is important to note, however, that your local municipality may have open container rules that the licensee or its consumers must follow. With the proliferation of malt beverage slushie sales at beer distributors, I have to imagine this is something the municipalities have dealt with and are aware of. As far as Pennsylvania state law, this legal opinion clearly permits WEP holders to serve wine or wine cocktails (without liquor) in “to go” containers.

Additionally, the Pennsylvania Liquor Code generally prohibits the fortification or adulteration of any liquor, which includes wine.

The Pa.L.C.B. will permit the mixing or infusing of liquor or wine, but such mixtures or infusions, which are mixed in large volumes, must be discarded at the end of the business day. The Pa.L.C.B. has issued numerous advisory opinions stating that adding ice or water to create malt beverage slushies in the slushie machine would be adulterating the original product, but it appears this Legal Advisory Opinion permits WEP holders to serve wine-based drinks for off-premises consumption. In fact, there have been previous opinions that Distributor licensees were not permitted to mix because they are not permitted to have on-premises sales, which restaurant licensees are permitted to do. Therefore, if a WEP holder must add ice or water to the slushie machine to freeze the wine to make wine slushies, it must be discarded daily at the end of the business day (11 p.m. for WEP sales). To the extent that the slushie, or wine cocktail, is a single-serve preparation, those products can be sold in any container for off-premises consumption to the extent permitted by local ordinance.

Finally, because slushie machines have been determined to be “dispensing systems” (like a malt beverage draft system) they must be cleaned in conformance with the Pennsylvania Liquor Code, which requires weekly cleaning depending on the system you are operating.

©2020 Norris McLaughlin P.A., All Rights Reserved

For more liquor licensing updates, see the National Law Review Biotech, Food & Drug law page.