Antimicrobial Inert Ingredient QR Code/Website Link

EPA is now allowing companies to include a QR code or website link on their product labels to provide information on inert ingredients.  As of this publication date, this option is only available for antimicrobial pesticide products.  Providing this additional information is strictly voluntary for companies, with exception on a case-by-case basis for where it has been required.  Although voluntary, providing this information is encouraged for showing transparency.

EPA states that if a company chooses to disclose their inert ingredients, they should include all of them.  Any partial lists could mislead the consumer into believing it was a complete list.  The Agency also recommends listing ingredients in descending order of weight.

Pesticide producers should note that including a QR code or website link results in the information being subject to FIFRA and EPA review in order to ensure there is no violation of FIFRA’s provisions against misbranding (FIFRA sections 2(q) and 12(a)(1)(E)).  The companies including this information need to verify the its accuracy.  Companies must also submit an application to EPA for voluntary inert ingredient disclosure.  The application identifies the proposed changes on the product label detailing the QR code or website link, and includes a self-certification statement.  The self-certification statement includes acknowledgement that any false statements could lead to enforcement actions.   EPA’s announcement also mentions that once the Agency gains experience handling this type of labeling, they may allow inert ingredient disclosure applications to be included with other actions.

Amazon Creates New Restricted Substances List

In December 2020, Amazon announced they will avoid the intentional addition of chemicals in certain products in their U.S. and EU market.  These restrictions concern Amazon’s food contact packaging.  The chemicals targeted have carcinogenic, mutagenic, reproductive, and other toxicant properties.  Amazon also focused on chemicals that are persistent and bioaccumulative.  The chemicals on the restricted substances list include all PFAS, phthalates, and BPA.   This announcement comes shortly after a 2020 court case closed in December, in which the plaintiff alleged Amazon had PFAS in their disposable plates.

Amazon has updated their chemicals and restricted substances page on the website to reflect the announcement.  The company already seeks to avoid a number of chemicals in their Amazon brands of Private Brand Baby, Household Cleaning, Personal Care, and Beauty products, including formaldehyde, nonylphenols, parabens, and phthalates.

Chlorpyrifos Registration Status

Farmworker Justice is pressuring EPA to ban the use of the pesticide chlorpyrifos.  The organization is collecting signatures on a petition supporting the ban.  The petition notes that chlorpyrifos can cause dizziness, vomiting, convulsions, numbness in the limbs, loss of intellectual functioning, respiratory paralysis, and death.  Farmworker Justice plans to send the petition to EPA and key members of Congress.

According to EPA, chlorpyrifos has been in use since 1965 and is registered with various limitations, such as “restricting entry into treated fields for 24 hours up to five days.”  Use of the pesticide has been at issue for a number of years.  In 1996, EPA recognized the need to contain chlorpyrifos exposure after the Food Quality Protection Act created more stringent safety standards.  In 2000, EPA reached an agreement with registrants of chlorpyrifos to eliminate, phase out, and modify certain uses.  In 2002, EPA created buffer zones for using chlorpyrifos and increased the personal protective equipment requirement for application.  In 2011, EPA complete a comprehensive preliminary human health risk assessment for all chlorpyrifos uses and revised the assessment in 2014.  In 2012, EPA further restricted aerial application and created “no-spray” zones.  The U.S. Ninth Circuit Court of Appeals ordered EPA to ban chlorpyrifos within 60 days in August 2018, but the Department of Justice requested a rehearing, which was granted on February 6, 2019, effectively vacating the earlier ruling.

Until February 3, 2021, EPA is accepting public comment on a proposed interim decision on chlorpyrifos that was released in December 2020.  EPA’s proposed interim decision recognizes the need for precautions in the use of chlorpyrifos.  The proposed interim decision asserts that all pesticides registered by EPA follow FIFRA mandates that ensure that proper use, as directed by the product label, will not cause unreasonable risks to health.

Amicus Brief on EPA and Sulfoxaflor

On December 7, 2020, the attorneys general for 11 states filed an amicus brief with the Ninth Circuit Court of Appeals opposing EPA’s remand motion concerning the pesticide sulfoxaflor.  EPA’s motion asked the court to allow revision of its registration for sulfoxaflor without vacating it.  EPA initially registered sulfoxaflor for use in 2013 with limitations on its use due to its toxicity to bees and the potential risk to birds.  In 2019, EPA registered new uses for sulfoxaflor, including application to alfalfa, corn, cacao, grains, pineapple, strawberries.  At issue in the litigation are the following:

  • Approval of sulfoxaflor uses without consideration of its effects on endangered species after 2015 Ninth Circuit Court ruling to vacate the registration.
  • Need for consideration of sulfoxaflor’s effects on endangered species in its registration.
  • Need for consultation with expert agencies.
  • Whether the Endangered Species Act (ESA)-protected species are endangered in violation of EPA’s FIFRA mandate that its pesticide use approvals not result in “unreasonable adverse effects on the environment.”

Granting EPA’s motion would allow sulfoxaflor use for at least seven years.

The amicus brief states EPA’s motion for remand without vacatur is unwarranted because EPA has demonstrated ongoing and systematic failure to consult under the ESA.  The attorneys general noted that Congress ordered EPA to report on its ESA consultation progress in 2014 and 2018.  The brief stressed that the backlog of pesticide chemicals for review is already quite long, and that EPA has admitted that the evaluation of sulfoxaflor on remand would not begin until June 2025, at the earliest.  Concern that without proper foundational review by EPA, the burden of ensuring pesticide safety passes down to the states was emphasized by the brief.  Finally, the brief argues that “proceeding to the merits would most efficiently resolve the issues in this case.”

Proposed TSCA Fee Rule Changes

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

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

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

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

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

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.