The European Commission’s Chemicals Strategy for Sustainability

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

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

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

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

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.

Green Isn’t Just a Color: Navigating the Green Marketing Legal Landscape

Phil Moffat and Irene Hantman presented on the green marketing legal landscape at the Product Stewardship Conference on September 10, 2019. 

The presentation opened with an overview of green marketing, noting that the number of environmental marketing claims is on the rise, with an attendant increase in the number of claims that are false and/or deceptive. 

Ms. Hantman reviewed the “seven sins” of greenwashing:

  • Hidden Trade-Off
    • No Proof
    • Vagueness
    • Irrelevance
    • The Lesser of Two Evils
    • Fibbing
    • Worshiping False Labels

Ms. Hantman then reported on litigation over green marketing claims.  She noted that green marketing claims have been litigated in federal and state courts, in administrative proceedings before the FTC, and in private forums, and that companies face litigation from federal agencies, state agencies, and from private parties.  First Ms. Hantman discussed the 2017 case ECM Biofilms v. FTC.  That case began when the FTC filed an administrative complaint, ECM then appealed the agency’s findings – that ECM violated the prohibition in section 5 of the FTC Act on the use of deceptive advertising —  all the way to the 6th Circuit Court of Appeals, where the court upheld FTC’s finding. 

Ms. Hantman also reported that Volkswagen paid $570 million for deceptive marketing in a settlement with the Attorneys General for 41 states, Washington, DC, and Puerto Rico.  That settlement was part of the litigation over Volkswagen’s use of defeat devises in “green” diesel cars.

Ms. Hantman then shared information on other FTC enforcement against green marketing claims including, the 2018 settlements against Benjamin Moore, ICP Construction, YOLO Colorhouse, and Imperial Paints for misleading claims that their products were free of emissions and volatile organic compounds (VOCs).  She also reported on FTC’s enforcement against Engineered Plastic Systems in 2014.  That case involved business to business marketing.  Under the final FTC consent order, the company must have credible evidence including scientific proof, to support any environmental benefit claims it makes.

Ms. Hantman also provided information regarding recommendations made by the National Advertising Division (NAD), Better Business Bureau in green marketing cases brought before the NAD by competitors.  She described the Olivet case in which Van Ness Plastic Molding Company challenged Olivet’s claim that its containers are made of recycled materials.  She also described cases involving sustainability and energy savings claims.

Mr. Moffat then provided information on sources of regulation of green marketing claims.  He discussed the role of the NAD in investigating competitor challenges and consumer complaints.  He reported that all states and the District of Columbia have consumer protection statutes.  Mr. Moffat also described private causes of action that consumers and competitors might pursue.

Mr. Moffat then presented information on the FTC Act and the FTC’s Green Guides.  He noted that, section 5 of the FTC Act, 15 U.S.C. § 45, authorizes the FTC to take legal action against “unfair or deceptive” practices in commerce, however the statute doesn’t give FTC the authority to set environmental standards (e.g., testing protocols).  He also explained that the FTC published the Green Guides to help advertisers avoid making deceptive claims under Section 5, stressing that the Green Guides are non-binding administrative interpretations.  The presentation explained that because the Green Guides are non-binding administrative interpretations, they don’t preempt federal, state, or local law; compliance will not necessarily preclude FTC enforcement of Section 5; and that compliance with voluntary standards won’t guarantee Section 5 compliance.

Mr. Moffat explained that the Green Guides apply to claims about the environmental attributes of a product, package, or service in connection with the marketing, offering for sale, or sale of such item or service to individuals, businesses, or other entities; and that Section 5 applies to environmental claims in any marketing medium, whether asserted directly or by implication. He then reported on principles established by the Guides that focus on avoiding deception: “a representation, omission, or practice is deceptive if it is likely to mislead consumers acting reasonably under the circumstances and is material to consumers’ decisions.”  

The presentation also discussed the need to substantiate claims.  Marketers must identify all express and implied claims that the advertisement reasonably conveys, and ensure that all reasonable interpretations of their claims are truthful, not misleading, and supported by a reasonable basis.  For environmental marketing claims, a “reasonable basis” often requires “competent and reliable scientific evidence.”

Mr. Moffat provided examples of the specific topics covered by the Green Guides including:

  • General environmental benefit claims,
  • Certifications and seals of approval,
  • Degradable,
  • Free-of,
  • Non-toxic, and
  • Recycled content.

The presentation then discussed general environmental benefits claims.  Mr. Moffat noted that marketers should not make unqualified general environmental benefit claims as it is difficult, if not impossible, to substantiate all express and implied claims.

Mr. Moffat also reported on issues raised by seals of approval and certifications.  He explained that third-party certifications and seals of approval are appealing, but stressed that companies must exercise due diligence because third-party certifications and seals are not a safe haven from enforcement or lawsuits.

Mr. Moffat wrapped up the presentation with examples of when free-of and non-toxic claims can be deceptive.

Click here for a copy of the presentation.

CAA Permitting and NAAQS Review

On April 9, Verdant attorney Kurt Blase addressed the American Coatings Association Powder Coatings Committee on Powder and PM: Permitting and NAAQS Review. The presentation examined the effect of powder coating lines on facility particulate matter (PM) emissions, and the potential effects of EPA’s current review of the PM national ambient air quality standards (NAAQS) on permitting of powder operations.

It was reported that the addition of powder lines at a facility is likely to increase PM permitting requirements, and that permit conditions are likely to be more stringent for facilities located in airsheds that include other significant PM sources. EPA’s progress to date in the PM NAAQS review was then discussed, including the possibility that the review could result in more stringent standards for PM2.5, PM10 or both. If that were to occur, permitting requirements for powder lines may become more stringent as well. EPA is on a schedule to complete the PM NAAQS review by late 2020.

Green Marketing, the FTC’s “Green Guides,” and “Zero VOC”

Phil Moffat presented on Green Marketing, the FTC’s “Green Guides,” and “Zero VOC” at the American Coatings Association’s Conference Making Sustainability Ideas Happen: Coatings For the Future on April 10, 2019.

The presentation opened with an overview of green marketing, noting that the number of environmental marketing claims is on the rise, with an attendant increase in the number of claims that are false and/or deceptive, and that DIY building and construction products are being “greened” more quickly than rest of home and consumer products marketplace. 

The Green Guides

Mr. Moffat then discussed the FTC Act and the FTC’s Green Guides.  He noted that, section 5 of the FTC Act, 15 U.S.C. § 45, authorizes the FTC to take legal action against “unfair or deceptive” practices in commerce, however the statute doesn’t give FTC the authority to set environmental standards (e.g., testing protocols).  He also explained that the FTC published the Green Guides to help advertisers avoid making deceptive claims under Section 5, stressing that the Green Guides are non-binding administrative interpretations.  The presentation noted that because the Green Guides are non-binding administrative interpretations, they don’t preempt federal, state, or local law; compliance will not necessarily preclude FTC enforcement of Section 5; and that compliance with voluntary standards won’t guarantee Section 5 compliance.

Mr. Moffat explained that the Green Guides apply to claims about the environmental attributes of a product, package, or service in connection with the marketing, offering for sale, or sale of such item or service to individuals, businesses, or other entities; and that Section 5 applies to environmental claims in any marketing medium, whether asserted directly or by implication. He then reported on principles established by the Guides that focus on avoiding deception: “a representation, omission, or practice is deceptive if it is likely to mislead consumers acting reasonably under the circumstances and is material to consumers’ decisions.”  

The presentation also discussed the need to substantiate claims.  Marketers must identify all express and implied claims that the advertisement reasonably conveys, and ensure that all reasonable interpretations of their claims are truthful, not misleading, and supported by a reasonable basis.  For environmental marketing claims, a “reasonable basis” often requires “competent and reliable scientific evidence.”

The presentation then reviewed a type of claim popular with the building products industry – certifications and seals of approval.  Certifications and seals of approval are often “endorsements” covered by the FTC’s Endorsement Guides, 16 CFR Part 255.  The presentation noted that third-party certifications and seals of approval are appealing, but stressed that companies must exercise due diligence because third-party certifications and seals are not a safe haven from enforcement or lawsuits.

FTC and “Zero VOC”

Mr. Moffat then reported on FTC Enforcement re Zero VOC Claims pre 2017 – 2018 and post 2017-2018 and noted differences between the two.  

In 2017 – 2018 the FTC took enforcement actions against four companies for Zero VOC Claims.  The companies were making variety of claims, such as:

  • Zero emissions,
  • Zero VOC
  • No odor, and
  • Pregnancy/baby safe,
  • Asthma and allergy approved.

The consent agreements that FTC entered into with these companies defined “trace” level of emissions as follows:

  • Intentional Addition: A VOC has not been intentionally added to the product;
  • Material Harm: Emission of the product does not cause material harm that consumers typically associated with emission, including harm to the environment or human health; and
  • Background: Emission of the product does not result in more than harmless concentrations of any compound higher than would be found under normal conditions in the typical residential home without interior architectural coating.

Emission means any compound that is emitted or produced during application, curing, or exposure of a covered product.

Following the 2017-1018 enforcement actions, the FTC’s position is that:

  • Consumers understand “Zero VOC” primarily as an emissions claim;
  • “Emission” is broadly defined to include VOC, as well as other substances emitted and produced (e.g., SVOC, exempts);
  • Zero VOC claims means a prohibition on exceedance of background concentrations during application and drying; and
  • Defines background as “normal” conditions in the “typical” unpainted house.

The presentation noted that the FTC has rescinded the 2013 Enforcement Policy and that the industry should now follow the 2018 Consent Orders and accompanying guidance letters.  The guidance letters suggest that compliance for a Zero VOC claim can be achieved if a company can substantiate that:

  • Its product has trace levels of emissions six hours or less after application and afterwards, and
  • That the paint contains no substance that could cause material harm to the average adult under normal anticipated use.

Mr. Moffat closed the program by stressing that claiming Zero-VOC carries risk.  He observed that companies considering such claims should first ensure the return is worth the legal, commercial, and reputational risks, and then develop an approach to manage those risks, including their approach to substantiation, disclosures, etc.

EPA Draft Guidance helps Distinguish When Biostimulants are Pesticides under FIFRA

On March 27, 2019, EPA published Draft Guidance for Plant Regulator Label Claims, Including Plant Biostimulants.  The guidance is intended to help companies that produce products that the Agency considers to make claims that are considered plant growth regulator (PGR) claims. This is because making PGR claims subjects the products to regulation under FIFRA as pesticides.  According to EPA, “plant biostimulants” (PBS) are a relatively new category of products containing naturally-occurring substances and microbes that are used to stimulate plant growth, enhance resistance to plant pests, and reduce abiotic stress.

A product makes a PGR claim if, through physiological action, it claims to:

  • Accelerate or retards the rate of plant growth;
  • Accelerate or retards the rate of plant maturation; or
  • Otherwise alter the behavior of plants or the produce thereof.

The draft guidance does not provide a definition for “plant biostimulant,” nor does any EPA regulation. The Guidance does provide the following “description” of PBS: 

“Generally speaking, a ‘plant biostimulant’ is a naturally-occurring substance or microbe that is used either by itself or in combination with other naturally-occurring substances or microbes for the purpose of stimulating natural processes in plants or in the soil in order to, among other things, improve nutrient and/or water use efficiency by plants, help plants tolerate abiotic stress, or improve the physical, chemical, and/or biological characteristics of the soil as a medium for plant growth.”

The Agency is asking for comments on whether EPA should develop a definition for plant biostimulants, noting that the development of a definition would require rulemaking.

At the heart of the issue is whether a PBS product, as understood by EPA, physiologically influences the growth and development of plants in such a way as to be considered plant regulators by the Agency, and thereby triggering regulation under FIFRA as a pesticide. FIFRA section 2(u) includes plant regulators in its definition of a pesticide.  

Based on the plant regulator definition contained in FIFRA section 2(v), EPA believes that many PBS products and substances may be excluded or exempt from regulation under FIFRA depending upon their intended uses as plant nutrients (e.g., fertilizers), plant inoculants, soil amendments, and vitamin-hormone products.  

A key consideration in determining whether or not a product is a pesticide is what claims are being made on product labels. The draft guidance is intended to provide assistance for identifying product label claims that are considered to be plant regulator claims by the Agency, thereby subjecting the products to regulation under FIFRA as pesticides. The guidance provides examples of product label claims generally considered “non-pesticidal:”

  • Plant nutrition-based claims (i.e., necessary for normal growth of plants and in a form readily useable by plants);
  • Plant inoculant-based claims (i.e., enhance availability/update of plant nutrients through root system); and
  • Soil amendment-based claims (i.e., intended for the purpose of improving soil characteristics favorable for plant growth).

The guidance also provides examples of generic product label claims generally considered by the Agency to be “non-pesticidal.”  In addition, examples of label claims that are considered by the Agency to be PGR claims that trigger regulation under FIFRA as a pesticide are included.  A list of PGR active ingredients contained in EPA-Registered Products is included as well.

The Federal Register notice announcing the guidance notes that as guidance the document is not binding on the Agency or any outside parties, and that the Agency may depart from it where circumstances warrant and without prior notice.

Irene Hantman to Moderate ABA SEER Program — Controversies in Food Contact

The November Safer Chemicals, Healthy Families Food Contact Report Card pointed a spotlight on food contact substances, leaving consumers to wonder whether they should be concerned about the presence of PFAS and other toxic substances in their food packaging.  A panel of experts in food contact issues will discuss this issue.  The program will also provide background on FDA jurisdiction and key concepts such as TTC (Threshold of Toxicological Concern).  Join key stakeholders in this discussion.

This program is presented by thePesticides, Chemical Regulation, and Right-to-Know Committee, ABA Section of Environment, Energy, and Resources; Food, Cosmetics, and Nutrceuticals Committee, ABA Science and Technology Law Section; Food Safety Specialty Section, Society of Toxicology

Date/Time:
Thursday April 25, 2019, 11:30 – 1:00

Panelists:
Paul Honigfort,  Director, Division of Food Contact Notifications, Center for Food Safety and Applied Nutrition
Mitch Cheeseman, Steptoe
Tom Neltner, Environmental Defense Fund
Kevin Kenny, Decernis

Moderator:
Irene Hantman, Verdant Law

Location:
Verdant Law, 10 G Street NE, Washington, DC
(Remote participation is also available.)

To register for the program contact Andrew Sitko at admin@verdantlaw.com