Proposed TSCA Fee Rule Changes

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On December 18, 2020, EPA signed a proposed rule revision for TSCA fees to defray costs for activities under TSCA sections 4, 5, and 6.  This revision proposes updates to the 2018 fees rule and requires EPA to review the fees every three years with ability to adjust the fees.  This adds three new fee categories of a Bona Fide Intent to Manufacture or Import Notice, a Notice of Commencement of Manufacture or Import, and an additional fee associated with test orders.

The Bona Fide Intent to Manufacture or Import Notice covers EPA costs of reviewing bona fide notices.  The 2018 Fee Rule did not have any fees associated with reviewing the notices.  The cost is proposed as 500 dollars, and 90 dollars for small businesses.

The Notice of Commencement (NOC) of Manufacture or Import requires those who submit premanufacture notices to provide notice to the EPA within 30 days of when the chemical substance is first manufactured or imported.  Unlike the new Bona Fide Fee proposal, the NOC fees already existed under the 2018 Fee Rule, but fell under other categories, such as premanufacture notices.  The new proposal will have NOC fees as their own category and are proposed as 500 dollars, and 90 dollars for small businesses.

The new proposed fee associated with test orders applies to recipients who fail to follow terms or conditions of an original order.  Under the 2018 Fee Rule, the recipient had the option to redo the testing and submit new data without paying additional costs from the original test order.  The proposed fee with require payment for the original test order and any resubmitted data.  The new fee for resubmitted data is proposed to be equal to the cost of reviewing the initial data.

EPA is also proposing exemptions to some fee triggering activities:

  • an exemption for research and development activities on fees for EPA-initiated risk evaluations,
  • an exemption for entities manufacturing less than 2,500 lbs. of a chemical subject to an EPA-initiated risk evaluation fee;
  • an exemption for manufacturers of chemical substances produced as a non-isolated intermediate on fees for EPA-initiated risk evaluations;
  • and exemptions for manufacturers of a chemical substance subject to an EPA-initiated risk evaluation if the chemical substance is imported in an article, produced as a byproduct, or produced or imported as an impurity

Two other notable proposed changes are:

  • EPA proposes a volume-based fee allocation for EPA-initiated risk evaluation fees in any situation that does not involve a consortium.
  • EPA proposes export-only manufacturers to pay fees for EPA-initiated risk evaluations.

PFAS in the NDAA

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The 2021 National Defense Authorization Act (NDAA) addresses PFAS in several ways.  Sections 330 and 334 incentivize developers to create and promote additional alternative firefighting foam to replace the PFAS-containing aqueous film-forming foam.

Section 332 establishes an interagency body on PFAS research and development.  The interagency group will have representatives from at least 19 different agencies. The Director of the Office of Science and Technology Policy will Co-Chairs the group with a representative from another member agency, which will change on a biannual rotating basis. Goals of the organization will be:

  • Removal of PFAS from the environment,
  • Safe destruction or degradation of PFAS,
  • Development of safer and environmentally friendly alternatives to PFAS,
  • Understanding sources of environmental PFAS contamination and exposure, and
  • Understanding the toxicity of PFAS to humans and animals.

Section 333 states that the “Department of Defense may not procure any covered item that contains perfluorooctane sulfonate (PFOS) or perfluorooctanoic acid (PFOA).”  ”Covered items” is limited to nonstick cookware and utensils, and fabrics that have been treated with stain-resistant coatings.  This section does not take effect until April 1, 2023.

Section 335 requires providing notification to agricultural operations located in areas exposed to department of defense PFAS use.  Any agricultural operation within 1 mile of a military or National Guard facility where PFAS has been detected in the ground water, drinking water, or well water must be notified.  Notification must occur within 60 days of the enactment of the NDAA. Notification of any updated testing results must occur within 15 days after validated test results are received.

The NDAA was passed by Congress on December 11, 2020.

BPA and Proposition 65

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On October 19, 2020, a California appeals court ruled in favor of the Office of Environmental Health Hazard Assessment (OEHHA) listing bisphenol A (BPA) as a chemical known to cause cancer or reproductive harm under Proposition 65.  The American Chemistry Council (ACC) had attempted to prevent BPA from being added to the Proposition 65 list. ACC alleged OEHHA abused its discretion by refusing to consider the 2009 determination of a committee working for OEHHA, the Developmental and Reproductive Toxicant Identification Committee (DRTIC).  DRTIC’s 2009 panel voted unanimously that BPA should not be added to the Prop 65 list because it “did not meet the criteria for listing pursuant to the state’s qualified experts listing mechanism.”  The criteria for a chemical being listed under Proposition 65 for developmental or reproductive effects include sufficient evidence in humans, limited evidence in humans supported by sufficient animal data, sufficient evidence in animals that would extrapolate to humans, and statistical considerations with biological plausibility.  However, DRTIC’s 2015 panel, comprised of different members, reversed that recommendation.

Key points from the suit are below.

  • The court rejected the need for clear evidence of a chemical causing cancer or reproductive harm being a requirement.
  • The court made some notable statements:
    • Proposition 65 is not limited to chemicals known to cause cancer in humans.
    • OEHHA need not consider DRTIC’s recommendations.

The ruling raises alarms for many manufacturers.  BPA is found in many different products, such as polycarbonate plastic found in bottles, tableware, and food containers.  According to the California Attorney General, 80 private enforcement actions were commenced in 2020 alleging violations of Proposition 65 for products containing BPA.  For example, Five Below Inc. and 1616 Holdings Inc. received notices of violation in relation to their cell phone cases and Air Pod cases.  The notice of violation claims the cases can cause female reproductive toxicity due to BPA dermal exposure from handling the cases and the possibility of ingesting BPA if placed in contact with the user’s mouth.  The notice also states that plaintiffs “seek[] constructive resolution of this matter without engaging in costly and protracted litigation.”

FIFRA Enforcement Against Electrolux

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An October 6, 2020 Consent Agreement and Final Order (CAFO) between EPA and Electrolux Home Products, Inc. resulted in Electrolux agreeing to pay nearly $7 million.  EPA settled FIFRA violations in relation to the import and distribution of Electrolux dehumidifiers and air conditioners containing a filter manufactured with nanosilver.  Although the products made pesticidal claims, they were not registered with EPA – pesticide products imported into the United States for distribution or sale must be first registered with EPA, unless the product is exempt from FIFRA (e.g., under the treated articles exemption).  Marketing materials for the dehumidifiers and air conditioners included the following pesticidal claims “Antimicrobial Filter Cleans air by removing harmful bacteria” and “Our removable, washable filter reduces bacteria, room odors and other airborne particles for a healthier, more comfortable environment.”  The CAFO notes that “at no time relevant to the allegations herein was the nanosilver that was used to manufacture the filters that were contained in the [dehumidifiers and air conditioners] registered with the EPA”, in violation of Section 12(a)(1)(A) of FIFRA, 7 U.S.C. § 136j(a)(1)(A). 7 U.S.C. § 136l(a)(1).

Key Points of the Agreement are as follows:

  • Electrolux failed to file a Notice of Arrival of Pesticides and Devices for these imports on 141 occasions.
  • Electrolux imported unregistered pesticide products on 573 occasions.
  • EPA issued a Stop Sale, Use or Removal Order.
  • Electrolux offered to rework all dehumidifiers and air conditioners that contained a filter manufactured with nanosilver.
  • The Civil Penalty to settle the action is $6,991,400.
  • The Civil Penalty includes a 20% reduction in the amount for Electrolux’s good faith efforts to bring their products into compliance with FIFRA.

EPA Petition on Chemours PFAS

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On October 14, 2020, EPA received a petition to require health and environmental testing under Section 21 of the Toxic Substances Control Act (TSCA) on certain PFAS manufactured by Chemours in Fayetteville, North Carolina.  The petitioners consist of the Center for Environmental Health, the Cape Fear River Watch, Clean Cape Fear, Democracy Green, Toxic Free NC, and the NC Black Alliance.  The petition requests testing on 54 PFAS which Chemours produces.  The petition states that the 54 PFAS meet the criteria for testing in section 4(a) of TSCA.  It states that,

Based on the known hazards of these analogues, untested PFAS with potential for exposure would meet the criteria for testing in section 4(a)(1)(A) of TSCA because they “may present an unreasonable risk of injury” and have “insufficient information and experience” to determine their effects on health or the environment.

The PFAS produced by Chemours includes both commercial products and byproducts from their manufacturing process.  Some of the testing differs based on whether the compound is Tier 1 (detection in human sera, food or drinking water) or Tier 2 (significant potential for human exposure based on detection in environmental media and other evidence).  The petition also states that Gen X chemicals have been detected in drinking water and private wells in the vicinity of the Chemours plant.  A major point of concern for the petitioners involves the North Carolina consent order, which is the result of a lawsuit against Chemours from the North Carolina Department of Environmental Quality addressing PFAS contamination in the Cape Fear River basin from the Chemours’ facility.  The petition states current testing of Gen X chemicals by Chemours has been inadequate to fully evaluate the risks and additional carcinogenicity studies are needed.

The petition proposes testing with animal studies:

  • 28-day repeated dose rodent toxicology studies to determine impact on health,
  • Multigeneration or extended one-generation and 2-year rodent carcinogenicity studies for Tier 1 substances,
  • Testing on both mice and rats using oral routes of administration,
  • Inhalation testing used for volatile chemicals, and
  • Toxicokinetic studies to characterize relationship between serum concentrations and dermal to evaluate biological half-life and potential for bioaccumulation.

The petition also proposes the following human studies:

  • A human health study for the Cape Fear watershed to determine the relationship between exposure in the Cape Fear watershed and health outcomes.
  • Testing to determine human half-lives of the listed chemicals through longitudinal biomonitoring and exposure estimation in workers.

The European Commission’s Chemicals Strategy for Sustainability

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On October 14, 2020 the European Commission communicated the Chemicals Strategy for Sustainability Towards a Toxic-Free Environment to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions.  This ambitious Strategy is intended to “chart a new long-term vision for the EU’s chemical policy … [that] strives for a toxic-free environment, where chemicals are produced and used in a way that maximises their contribution to society including achieving the green and digital transition, while avoiding harm to the planet and to current and future generations.”  If fully implemented, the Strategy would amend REACH, the CLP (the Regulation on the Classification, Labelling and Packaging of hazardous substances), and other legislation addressing the safety of toys, cosmetics, biocides, plant protection products, food, carcinogens in the workplace as well as legislation on environmental protection.

The Strategy focuses on the following topics:

  • Safe and Sustainable-by-Design
  • Non-Toxic Material Cycles
  • Innovating Industrial Production
  • Protection Against Most Harmful Chemicals
  • Endocrine Disruptors
  • Chemical Pollution in [the] Natural Environment
  • PFAS
  • Coordinate and Simplify Actions across EU Chemical Legislation
  • Zero Tolerance for Non-Compliance
  • Information Requirements

The Strategy will implement a new hierarchy for chemical management with a three-level approach.  The use of safe and sustainable chemicals for both humans and the environment will be highlighted and is the first level.  Minimizing and controlling hazardous substances is the second level.  Eliminating and remediating substances of concern is the third and final level.  The Strategy will implement their new hierarchy through a series of methods mentioned below.

To facilitate Safe and Sustainable-by-Design, the Commission will:

  • Develop EU safe and sustainable-by-design criteria for chemicals;
  • Ensure the development, commercialization, deployment and uptake of safe and sustainable-by-design substances; and
  • Establish Key Performance Indicators to measure the industrial transition towards the production of safe and sustainable chemicals.

To address non-toxic material cycles, the Commission will:

  • Minimize the presence of substances of concern in products;
  • Ensure that authorizations and derogations from restrictions for recycled materials under REACH are exceptional and justified;
  • Support investments in sustainable innovations that can decontaminate waste streams, increase safe recycling and reduce the export of waste, in particular plastics and textiles; and
  • Develop methodologies for chemical risk assessment that take into account the whole life cycle of substances, materials and products.

To implement Innovating Industrial Production, the Commission will support:

  • Research and development in advanced materials; and
  • Research, development and deployment of low-carbon and low environmental impact chemical and material production processes.

To extend protection against most harmful chemicals, the Commission will:

  • Extend the generic approach to risk management to ensure that consumer products do not contain chemicals that cause cancers, gene mutations, affect the reproductive or the endocrine system, or are persistent and bioaccumulative;
  • Define criteria for essential uses to ensure that the most harmful chemicals are only allowed if their use is necessary for health, safety or is critical for the functioning of society and if there are no alternatives that are acceptable from the standpoint of environment and health; and
  • Extend to professional users under REACH the level of protection granted to consumers.

To address endocrine disruptors, the Commission will:

  • Propose to establish legally binding hazard identification of endocrine disruptors;
  • Ensure that endocrine disruptors are banned in consumer products;
  • Strengthen workers’ protection by introducing endocrine disruptors as a category of substances of very high concern under REACH; and
  • Ensure that sufficient and appropriate information is made available to authorities to allow the identification of endocrine disruptors.

To address chemical pollution in the natural environment, the Commission will:

  • Propose new hazard classes and criteria in the CLP Regulation to fully address environmental toxicity, persistency, mobility and bioaccumulation;
  • Introduce endocrine disruptors, persistent, mobile and toxic and very persistent and very mobile substances as categories of substances of very high concern; and
  • Ensure that the information made available to authorities on substances allows comprehensive environmental risk assessments.

To address PFAS, the Commission will:

  • Ban all PFAS in fire-fighting foams as well as in other uses;
  • Establish an EU-wide approach to identify and develop innovative methodologies for remediating PFAS contamination in the environment and in products; and
  • Provide research and innovation funding for safe innovations to substitute PFAS.

To coordinate and simplify actions across EU chemical legislation, the Commission will:

  • Use a ‘Public Activities Coordination Tool’ to provide an up-to-date overview of all planned and ongoing initiatives on chemicals by authorities across legislation;
  • Establish an expert working group to discuss initiatives on hazard/risk assessment on chemicals across chemical legislation; and
  • Reform the REACH authorization and restriction processes.

To effect zero tolerance for non-compliance, the Commission will:

  • Strengthen the principles of ‘no data, no market’ and the ‘polluter-pays’ under REACH;
  • Carry out audits in Member States to ensure compliance and enforcement of chemicals legislation;
  • Target known areas of high risk of non-compliance, in particular online sales, imported articles, classification and labelling and restrictions; and
  • Extend the scope of action of the European Anti-Fraud Office for coordination and investigation, to tackle the circulation of illicit chemical products in the EU.

To extend information requirements, the Commission will:

  • Extend the duty of registration under REACH to certain polymers of concern;
  • Assess how to best introduce information requirements under REACH on the overall environmental footprint of chemicals;
  • Amend REACH information requirements to enable an effective identification of substances with critical hazard properties; and
  • Amend REACH information requirements to enable identification of all carcinogenic substances manufactured or imported in the EU.

PFAS in California’s Water Supply

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Testing of California’s public water supply wells reveals that 60 percent of them contain the “forever” chemicals, perfluoroalkyl and polyfluoroalkyl substances (PFASs). The concentrations of these substances were higher at airports than landfills and public supply wells.  One million parts per trillion were detected at airports, while landfills had 10,000 parts per trillion and public wells had 100 parts per trillion. EPA has established a health advisory level at 70 parts per trillion for the combined amounts of PFOA and PFOS.

The health advisories from EPA offer guidance for states and the federal government to meet standards that will avoid adverse health effects.  Studies of individuals exposed to PFASs show increases in hormonal issues, organ damage, and cancer. Nationally, the Safe Drinking Water Act (SDWA) regulates maximum contaminant levels (MCLs) allowed in drinking water for over 90 chemicals.  However, PFASs currently remain on EPA’s unregulated and non-enforceable list for SDWA MCLs.  EPA’s PFAS Action Plan shows that the Agency is still in the information gathering phase to determine the prevalence and full effects of the PFASs with regulation in the future.

Individual states have been putting their own regulation forward for PFASs.  For example, in September 2020 California Governor Gavin Newsom signed Senate Bill No. 1044, which governs the tracking and recall of firefighting foam containing PFASs.

Recent Green Marketing Litigation

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Dr. Pepper recently won litigation over whether it had made deceptive marketing claims by labeling products made with “all-natural” ingredients.  The Northern District Court of California dismissed the case finding that no reasonable consumers would not expect the product to be completely free of any trace pesticides.

The litigation was brought by Hawyuan Yu who claimed that he purchased Mott’s Natural Applesauce and Natural Apple Juice from a Costco on multiple occasions believing that they were insecticide free because of the “all-natural ingredients” label.  However, the products contained the synthetic insecticide acetamiprid.  Acetamiprid is a chloropyridinyl neonicotinoids insecticide.  Note.  Acetamiprid is not on the list of synthetic substances allowed for use in “organic” crop production (7 CFR §205.601).

Yu argued that Natural Applesauce and Natural Apple Juice should not contain any amount of acetamiprid in the products because the “natural” label leads reasonable consumers to believe that there would not be any levels of pesticides in the products.  He sued for unfair and deceptive acts and practices under the California Legal Remedies Act, violation of California’s False Advertising Law, violation of California’s Unfair Competition Law, breach of express warranty, and unjust enrichment.  The court disagreed.  It applied the reasonable consumer test and held that reasonable consumers would not expect the product to be completely free of any trace pesticides, following case law including the recent 9th Circuit decision in Becerra v. Dr. Pepper/Seven Up, Inc.

It is important to note that food labeled as organic is backed by federal regulations and independently verified, while “natural” is not presently a regulated term — FDA regulatory proceedings to define the term “natural” in regard to food is still ongoing.

Executive Order on Pandemic Regulatory Relief and Revised OSHA Guidance

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In the past several days, OSHA has revised portions of the pandemic guidance issued previously, and the President has issued an Executive Order on regulatory relief to support the economic recovery. Key aspects of these recent actions are summarized below.

Executive Order on Regulatory Relief

The President’s Order includes the following primary provisions:

  1. Agencies should address this economic emergency by rescinding, modifying, waiving, or providing exemptions from regulations and other requirements that may inhibit economic recovery, consistent with applicable law.
  2. The heads of all agencies are directed to use, to the fullest extent possible and consistent with applicable law, any emergency authorities available to them.
  3. The heads of all agencies must identify regulatory standards that may inhibit economic recovery and consider taking appropriate action, including by issuing proposed rules as necessary, to temporarily or permanently rescind, modify, waive, or exempt entities from those requirements for the purpose of promoting job creation and economic growth.
  4. The heads of all agencies shall accelerate procedures by which a regulated entity may receive a pre-enforcement ruling with respect to whether proposed conduct in response to the pandemic is consistent with statutes and regulations administered by the agency.
  5. In formulating policies of enforcement discretion, good faith attempts to comply with applicable guidance should be considered a rationale for declining enforcement. Non-adherence to guidance may not by itself form the basis for an enforcement action by a Federal agency.

Revised OSHA Guidance for Identifying Work-Related Coronavirus Cases

OSHA has revised its enforcement guidance for recording cases of coronavirus as a workplace-related illness on OSHA Form 300.  Under OSHA’s recordkeeping requirements, employers are responsible for recording cases of COVID-19, if:

  1. The case is a confirmed case of COVID-19, as defined by the Centers for Disease Control and Prevention (CDC);
  2. The case is work-related as defined by 29 CFR § 1904.5; and
  3. The case involves one or more of the general recording criteria set forth in 29 CFR § 1904.7

Employers must make a reasonable inquiry to determine if a case is work related and recordable.  A reasonable inquiry does not require the employer to contact medical personal or obtain medical records.  An employer can rely on statements made by an employee.  An employer must ask the employee how he or she believes she contracted COVID-19; inquire about any out-of-work activities while respecting employee privacy; and review employees work environment while considering any other employees that may have contracted COVID-19.

An employer must consider any reasonably available information, even if obtained at a later time, after the employee’s infection.  OSHA also notes the following as indicators of work-related cases of COVID-19:

  • Several cases among employees who typically work closely together;
  • Employee contracts COVID-19 after lengthy, close exposure with a customer or another employee with a confirmed case of COVID-19, with no other explanation; or
  • The employee’s job duties include frequent, close exposure to the general public in location with ongoing community transmission;

OSHA also notes that a case is not likely to be work-related where an employee’s case is the only case in the vicinity and the job duties do not include contact with the public.   An employee’s close and frequent association with someone outside of work who contracts COVID-19 also indicates the employee’s case is not work related.

If after making a good-faith effort to determine if the case is work-related and the employer still cannot make a determination, the employer does not need to record the case as a work-related illness.

A work-related case should be coded as a respiratory illness on OSHA Form 300.  An employees’ identity need not be provided, if the employee requests confidentiality.

Revised OSHA Enforcement Plan

In response to workplaces reopening, OSHA has revised its Interim Enforcement Response Plan for COVID-19.  OSHA will increase workplace inspections and enforcement in geographic areas experiencing either sustained elevated community transmission or a resurgence in community transmission.  Particular attention for on-site inspections will be given to high-risk workplaces, including workplaces with high numbers of complaints or known COVID-19 cases.  The policy includes inspection, citation and rapid response procedures.

Applicability of OSHA standards varies by workplace.  OSHA identifies the following as standards that may apply:

  • 29 CFR Part 1904, Recording and Reporting Occupational Injuries and Illness.
  • 29 CFR § 1910.132, General Requirements – Personal Protective Equipment.
  • 29 CFR § 1910.133, Eye and Face protection.
  • 29 CFR § 1910.134, Respiratory Protection.
  • 29 CFR § 1910.141, Sanitation.
  • 29 CFR § 1910.145, Specification for Accident Prevention Signs and Tags.
  • 29 CFR § 1910.1020, Access to Employee Exposure and Medical Records.
  • Section 5(a)(1), General Duty Clause of the Occupational Safety and Health (OSH) Act of 1970.

Verdant Law includes experienced attorneys who have been following these developments closely and stand ready to assist clients with regulatory or enforcement issues, whether with OSHA or other agencies.

OSHA/EPA Guidance for COVID-19 Activities

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In the past few weeks, OSHA has taken the following actions related to short-term COVID-19 risk in the workplace, advising industry with respect to evaluating exposure, use of PPE, reporting and compliance with OSHA standards and guidance, among other matters. Most of these items can be accessed at OSHA’s COVID-19 website. In addition, EPA and CDC have issued updated guidance for cleaning and disinfecting workplaces and businesses.

  1. Fact sheet on worker exposure. OSHA has published a fact sheet, available online, describing positions from high to low risk of exposure to assist employers in classifying risk and identifying exposed workers.
  2. Interim complaint plan. OSHA has published an interim plan advising Area Offices processing coronavirus-related complaints, referrals, and severe illness reports.  OSHA’s goal is to respond rapidly to implement appropriate corrective measures.
  3. Worker rights. OSHA has published a webpage on worker rights to a safe workplace, noting that employees have a right to speak about exposure and health-related concerns and/or file a complaint with OSHA with protection from retaliation.
  4. Respirator flexibility. OSHA has issued enforcement guidance, available online, assuring employers flexibility in enforcement of the Respiratory Protection standard and other health-related standards, where employers extend or reuse N-95 masks, due to shortage.  Employers may consider use of alternative classes of NIOSH-approved respirators that provide equal or greater protection compared to an N-95 mask.
  5. Illness reporting. Employers should be aware that employee cases of COVID-19 are “reportable events” for Form 300 reporting, for compliance with 29 CFR Part 1904.  Additional explanation is provided on OSHA’s COVID-19 webpage.
  6. Planning guidance. OSHA has developed COVID-19 planning guidance based on traditional infection prevention and industrial hygiene practices, as well as relevant engineering, administrative, and work practice controls and personal protective equipment (PPE).  The guidance is available on OSHA’s COVID-19 webpage and encourages flexible H.R. policies with liberal leave for illness.
  7. Good faith compliance efforts. Noting that current developments may limit worker training opportunities, OSHA has issued interim guidance to inspectors to consider an employer’s good faith compliance efforts during the pandemic.  Inspectors are directed to consider whether the employer: (1) explored all options to comply with applicable standards (e.g., use of virtual training or remote communication strategies); (2) implemented interim alternative protections, such as engineering or administrative controls; and (3) rescheduled required activity as soon as possible. Employers unable to comply with OSHA requirements due to mandated closure should demonstrate a good faith attempt to meet applicable requirements as soon as possible following the re-opening of the workplace.

Verdant Law includes experienced OSHA attorneys who have been following these developments closely and stand ready to assist clients with OSHA issues, whether related to the pandemic or other matters.