Better Business Bureau Challenge Results in Clarifying Disclosure in Antimicrobial Toilet Seat Advertising

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Business Bureau (BBB) National Programs develops self-regulatory industry programs and resolves disputes on issues including advertising and privacy.  According to BBB National Programs, National Advertising Division (NAD) case decisions “represent the single largest body of advertising law in the country.”

A recent NAD case concerned antimicrobial claims made by Ginsey Industries, Inc. (“Ginsey”) on its Clorox-branded toilet seats.  Bemis Manufacturing Company challenged elements of these claims (though not the product’s antimicrobial efficacy).  During the challenge, Ginsey voluntarily committed to add a disclosure acknowledging that the product does not protect uses against bacteria and remove an “antimicrobial checkmark image inside the Clorox chevron logo.”

NAD additionally recommended that Ginsey modify its website to display the disclosure statement more conspicuously and work with retailers to do the same with their websites.  In response, the company stated that while it disagrees that “further modifications to its online product listings are necessary to protect consumers,” it would comply with NAD’s decision.

FDA Issues Draft Guidance for MoCRA Facility Registration and Product Listing

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The U.S. Food and Drug Administration (FDA) has released draft guidance, Draft Guidance for Industry: Registration and Listing of Product Facilities and Products, on the new regulatory requirements established in the Modernization of Cosmetics Regulation Act (MoCRA).  Among other provisions, MoCRA added section 607 to the Federal Food, Drug, and Cosmetics Act (FFDCA), requiring cosmetic product facility registration and cosmetic product listing.  The draft document details key registration and product listing requirements, including who must submit, what information is required, when registration and listings must be submitted, and how the FDA intends to accept registration and listing information.

All persons who own or operate a facility engaged in the manufacture or processing of a cosmetic product for distribution in the U.S. must register their facility.  Under MoCRA, a cosmetic product “means a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.”  FFDCA section 607(a)(1) provides two exceptions regarding who must register.  The first exception is for small businesses that have average gross annual sales of less than $1 million in the previous three years, unless they manufacture or process cosmetics that regularly come in contact with the mucus membrane of the eye, are injected, are intended for internal use, or are intended to alter appearance for more than 24 hours (and are not meant to be removed by the customer).  The second exemption is for facilities subject to the drugs and devices requirements under chapter V of the FFDCA, unless they also manufacture cosmetics that are not subject to the drug and device requirements.  The same exemptions apply for submission of product listing information.

Facility registration requirements are outlined in sections 607(a) and (b) of the FFDCA.  The requirements for facility registration include all brand names under which the cosmetic products manufactured or processed in the facility are sold and the product categories for each cosmetic product manufactured or processed in the facility.  Registrations must be submitted by December 29, 2023, for facilities that were manufacturing or processing cosmetic products on December 29, 2022.  Facilities that began manufacturing or processing after December 29, 2022, must register within 60 days of first engaging in that activity or by February 27, 2024, whichever date is later.  Registrations must be updated within 60 days of any changes to the registration information and must be renewed biennially.

Product listing requirements are outlined in FFDCA section 607(c) and include the facility registration number for each facility where the cosmetic product is manufactured or processed, its applicable cosmetic category or categories, and a list of product ingredients (including fragrances, flavors, or colors).  Listings must be submitted by December 29, 2023, for products that were marketed on December 29, 2022.  Products that were first marketed after December 29, 2022, must be listed within 120 days of marketing the product, or within 120 days of December 29, 2023, whichever date is later.  Any updates to the listing must be made annually.

Importantly, FDA clarified that any prior registrations through the Agency’s voluntary cosmetics registration programs will not be transferred to the new system; submitters will have to re-submit this information.

According to FDA, an electronic submission portal should be open for submissions beginning in October 2023, although a paper submission form is also available.

EPA Faces Lawsuit for Classifying Water Filtration System as a Pesticide Product

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The U.S. District Court for the Northern District of Texas will be tasked with determining whether EPA’s Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) enforcement actions against Berkey, a water filters brand, were arbitrary and capricious in the case Shepherd v. Regan.  The case concerns seven Stop Sale, Use and Removal Orders (SSUROs) issued by EPA against third-party distributors and manufacturers of Berkey water filtration products due to their alleged use of silver as an unregistered antimicrobial pesticide.

The complaint does not deny the presence of silver in Berkey products.  However, the plaintiffs say that they are unaware of any instances where a Berkey-authorized entity claimed that the silver in their products was “used for any purpose other than to protect the filter itself.”  This is significant because articles treated with a FIFRA-registered pesticide for the purpose of protecting the article are exempt from FIFRA under the treated articles exemption at 40 CFR 152.25.

The plaintiffs argue that the orders were the result of an unlawful reinterpretation of a 2007 notice, which clarified EPA’s position that equipment that uses electrodes to emit ions for pesticidal purposes is a “pesticide,” rather than a “device,” under FIFRA.  The complaint alleges that EPA reinterpreted this notice without opportunity for public comment to “now apply to the presence of inert silver in water filters.”

In its response, EPA argues that the plaintiffs—which do not represent Berkey itself—lack standing.  The Agency also characterizes the 2007 notice referenced in the complaint as a “straw man” with no bearing on the case.  EPA does not believe there is any ambiguity regarding the distinction between “pesticides” and “devices,” arguing that EPA has excluded water filters containing pesticidal substances from its interpretation of “devices” since 1975.

EPA focuses on claims made by the SSURO recipients, which allegedly advertised that Berkey filters removed viruses and pathogenic bacteria.  The Agency has long held that such public health claims make a product ineligible for the treated article exemption, EPA says.  Combined with knowledge of the presence of silver in the products, and no pesticide registration, EPA argues that it had “reason to believe” (the requirement for issuance of an SSURO) that the substances were sold in violation of FIFRA.

DuPont De Nemours Inc. Sues EPA Regarding GenX Test Order

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Earlier this year, the US Court of Appeal for the Third Circuit ordered EPA to provide documentation regarding the Agency’s decision to order DuPont De Nemours Inc. to provide information on GenX chemicals through two section 4 test orders under the Toxic Substances Control Act (TSCA). DuPont brought this case to challenge the testing requirements imposed on the company, asserting that EPA had incorrectly identified the company as a manufacturer of the chemicals identified in the test orders:  hexafluoropropylene oxide (also known as trifluoro(trifluoromethyl)oxirane) and 6:2 Fluorotelomer sulfonamide betaine, two GenX chemicals. The test orders required testing on the inhalation effects toxicity of the chemicals in order to enable EPA to further understand protentional risks posed to human health and the environment. In addition to the cost of the toxicity studies, the manufacturers subject to the orders were assessed a fee of $11,650 to be split evenly amongst them.

After receiving the order to provide documentation, EPA requested several time extensions, but eventually stipulated to an agreement dismissing the case. The motion filed in May 2023 released DuPont from the test orders on 6:2 fluorotelomer sulfonamide betaine and hexafluoropropylene oxide. The Court then dismissed the case.

Audit Finds EPA’s New Chemicals Program Lacks Sufficient Guidance

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On August 2, 2023, EPA’s Office of Inspector General (“OIG”) released a report on its audit of EPA’s New Chemicals Program. The audit identified recordkeeping and quality assurance issues with the program as administered by EPA’s New Chemicals Division (“NCD”). The audit, which began in October 2021, was conducted in response to several internal complaints submitted to OIG.

The New Chemicals Program reviews whether new chemicals or significant new uses of existing chemicals pose an “unreasonable risk” to human health or the environment under the Toxic Substances Control Act (“TSCA”). According to the report, NCD did not have finalized, up-to-date guidance for recordkeeping or for many of the steps in the new chemicals review process, contrary to EPA protocol.  OIG stated that these issues resulted from insufficient staff resources, which prevented NCD from both conducting the chemical reviews within statutory time frames and finalizing guidance for the activities composing the review process. The report also found frequent technical issues with NCD’s TSCA Confidential Business Information systems.

Some of the complaints to OIG alleged that staff were pressured to focus on deadlines rather than chemicals’ potential risks during the new chemical review process. However, OIG found no evidence of this; for example, the report notes that NCD employees were not evaluated on the speed at which they reviewed chemicals.

OIG made the following four recommendations to EPA’s Office of Pollution Prevention and Toxics (“OCSPP”) based on its findings:

  1. Develop a plan to regularly review NCD’s guidance documents,
  2. Develop a plan to periodically assess the effectiveness of NCD’s recordkeeping system,
  3. Develop a plan to identify the root causes of the technical issues, and
  4. Conduct periodic reviews of NCD’s workload.

OCSPP’s response, which was included in the report, agreed with each of OIG’s recommendations and proposed corrective actions in line with the recommendations.

This audit was not the first to find issues with EPA’s implementation of TSCA provisions. A 2019 GAO report identified similar issues, such as insufficient guidance and resources, with the new chemicals review process. In 2020, OIG found that EPA had missed deadlines on existing chemical risk evaluations and that EPA’s ability to meet future deadlines was at risk. EPA has since proposed a fee adjustment designed to increase TSCA fee collections. Most recently, in February 2023, GAO determined that EPA had missed most TSCA deadlines for reviewing new and existing chemicals.  In general, EPA agreed in part or in full when recommendations were made in these reports and corrective actions have been completed or are pending.

FDA Reaffirms Softening Chemicals are Okay for Food Packaging

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FDA recently denied a citizen petition requesting that the Agency prohibit the use of eight ortho-phthalates and revoke prior sanctioned uses for five additional ortho-phthalates in food packaging. Ortho-phthalates are used to soften plastics. They can be found in plastic film wrap on foods, cap gaskets used on the metal lids of glass jars, beverage caps, and other packaging.

The original petition was submitted by Earthjustice in 2016. FDA responded in May 2022, denying the petition; Earthjustice submitted a petition for reconsideration in June of that same year. Earthjustice stated that it filed the petition for reconsideration because FDA needed to consider the “mounting scientific evidence that phthalates in food cause serious harm,” evidence that has been developed since the petition was originally submitted.  According to Earthjustice, there is now significant scientific evidence that links phthalates to fibroid tumors in women and preterm births.

The petition for reconsideration alleged that FDA ignored the scientific information presented within the original petition, did not take new information into consideration when denying the petition, and failed to take action on the use of phthalates. In its response to the petition for reconsideration, FDA maintained that it did, in fact, assess the scientific information presented in the original petition, which it did not find persuasive enough to change its position on phthalate regulation at this time.

Further, under 21 CFR § 10.33, FDA is only required to grant a petition for reconsideration if all the following criteria apply:

(1) The petition demonstrates that relevant information or views contained in the administrative record were not previously or not adequately considered.

(2) The petitioner’s position is not frivolous and is being pursued in good faith.

(3) The petitioner has demonstrated sound public policy grounds supporting reconsideration.

(4) Reconsideration is not outweighed by public health or other public interests.

The Agency holds that no information was presented in the petition that has not already been presented and is, therefore, in the administrative record. Because all of the above requirements must be met for reconsideration without the presentation of new relevant information in the petition, FDA has no further obligation at this time.

PFAS Action Filed Against The Children’s Place

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In July, a proposed class action lawsuit was filed against the children’s clothing store The Children’s Place, Inc. The complaint states that the company knowingly sells clothing containing per- and polyfluoroalkyl substances (PFAS) despite knowing that these substances are harmful to children’s health. Specifically, the complaint alleges violations of Illinois’ Consumer Fraud and Deceptive Business Practices Act, fraudulent concealment, breach of implied warranty, and unjust enrichment. The allegations are based on the company’s knowledge of the presence of PFAS in their school uniform products and their failure to disclose this fact in its labeling and advertising, knowing parents would not purchase or pay premium prices for the PFAS-containing products.

The Children’s Place products at issue in the case are school uniforms that meet the requirements of Chicago public and private schools. Plaintiff purchased a number of these items for her child. school uniform.  The complaint states that none of the labeling for these items identified the presence of PFAS in the products, and therefore, Plaintiff concluded that PFAS were not present in any of the school uniform items she purchased. However, according to the complaint, independent third-party testing determined many of these school uniform items contained PFAS. Plaintiff additionally claims that the presence of PFAS in these items runs counter to the testing protocols reported in the Children’s Place’s Annual Environment, Social, and Governance Report.  According to the report, the testing protocols help the company avoid unwanted chemical substances in its finished products and provide consumers with confidence that the products they purchase are safe.

The complaint cites to recent studies and reports on the presence of PFAS in children’s school uniforms, stating, “The presence of PFAS in school uniforms is particularly concerning, as uniforms are worn directly on the skin for upwards of eight hours per day, five days per week, by children, who are uniquely vulnerable to harmful chemicals. Due to children’s lower body weight and sensitive development, exposure to PFAS at a young age for prolonged periods of time may result in a greater lifetime threat of adverse health outcomes.” Plaintiff claims that because of the potential harm, she would not have purchased these products for her child had she been aware of the presence of PFAS.

EPA Seeks Input on Expansion of the Safer Choice and Design for the Environment Programs

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EPA recently solicited public comment on its proposed expansion of the Agency’s Safer Choice and Design for the Environment programs. The expansion would include certification of additional product categories; the programs are currently limited to cleaners and disinfectants. Participation in the programs by manufacturers is voluntary. The programs help consumers and businesses acquire products that meet strict criteria for effects on human health and the environment; products certified by the programs do not present a risk of harm to human health or the environment.

The proposed expansion comes as a result of increasing consumer interest in the chemicals used in products and consumers’ desire to make informed purchasing decisions. During the comment period, the Agency seeks input on which new product categories it should add to these programs and how adding these products will benefit the health of humans and the environment. All products in any category that is added will be subject to the human health and environmental toxicology criteria detailed in the Safer Choice Standard. No product containing intentionally added PFAS can be approved for either program.

Minnesota Passes Legislation Requiring Reporting on Intentionally Added PFAS

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This June, Minnesota became the latest state to pass legislation that will require manufacturers to report intentionally added PFAS in consumer products. It also bans intentionally added PFAS in certain product categories. The legislation will require manufacturers with intentionally added PFAS in consumer products to report the following information to the Minnesota Pollution Control Agency (“MPCA”):

  • A brief description of the product, including a universal product code (UPC), stock-keeping unit (SKU), or other numeric code assigned to the product.
  • The purpose for which PFAS are used in the product, including in any product components.
  • The amount of each PFAS, identified by its Chemical Abstracts Service Registry Number (CASRN), in the product, reported as an exact quantity determined using commercially available analytical methods or as falling within a range approved for reporting purposes by MPCA.
  • The name and address of the manufacturer and the name, address, and phone number of a contact person for the manufacturer.
  • Any additional information requested by the commissioner as necessary.

Manufacturers will need to submit this information to MPCA on or before January 1, 2026. Furthermore, manufacturers must then receive approval from the Agency before they can sell, offer for sale, or distribute products at issue for sale within the state.

If MPCA does not receive this information and believes a product contains intentionally added PFAS, the Agency can mandate the manufacturer of the product to conduct testing for PFAS. If product testing reveals there are no intentionally added PFAS in the product, the manufacturer must submit a certificate of compliance to MPCA attesting to this fact and including the supporting testing results and any other relevant information. If testing confirms there are intentionally added PFAS in the product, the manufacturer must provide testing results and additional information outlined in the legislation to the Agency.

The legislation bans intentionally added PFAS in a number of products. Such products include:

  • Carpets and rugs
  • Fabric treatments
  • Textile furnishings
  • Upholstered furniture
  • Cleaning products
  • Cookware
  • Cosmetics
  • Dental floss
  • Menstrual products
  • Children’s products
  • Ski wax

The bans on these products will have staggered effective dates between January 1, 2025, and January 1, 2032. The legislation does caveat that MPCA will permit the sale of products with intentionally added PFAS only in instances where the commissioner has determined there is a currently unavoidable use. Product categories that fall under a currently unavoidable use are not detailed in the legislation, but it does specifically state that none of the above product categories are eligible for a currently unavoidable use exemption.

Environment Canada Issues Mandatory Information Request for 850 Chemical Substances

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On June 24, 2023, the Science and Risk Assessment Directorate of Environment Canada published a notice in the Canada Gazette, the Canadian equivalent of the United States Federal Register, that enumerated a mandatory information request for 850 chemical substances for the purpose of assessing whether these substances are toxic or are capable of becoming toxic, or for the purpose of assessing whether to control or the manner in which to control the listed substances under the  Chemicals Management Plan — 2023. The notice details the information that manufacturers, importers, and users of the identified substances will be required to submit.

These 850 substances at issue are divided into four categories:

  • Part 1: Substances for which reporting is required if manufacture, import, or use is 100 kg or more;
  • Part 2: Substances for which reporting is required if manufacture, import, or use is 1,000 kg or more;
  • Part 3: Substances for which reporting is required if import and use for a specific application(s) is 100 kg or more; and
  • Part 4: Substances for which reporting is required if manufacture, import, and use “with additional use activity” is 100 kg or more.

In the notice, Environment Canada grouped reporting requirements by threshold, concentration, and intended use. Reporting is required for substances present at a concentration greater than or equal to 0.1 percent in a mixture or product. In addition, reporting is required for substances present in certain manufactured items (defined as items that are formed into a specific physical shape or design during manufacture and have, for their final use, a function or functions dependent in whole or in part on its shape or design) including products:

  • Intended to be used by or for children under the age of 14 years;
  • Intended to come into contact with the mucosa of an individual other than eyes;
  • Intended to release the substance during conditions of use such that the substance may be inhaled or come into dermal contact with an individual;
  • Present in cookware or cooking or serving utensils;
  • Present in food packaging material;
  • Present in clothing or footwear;
  • Present in bedding, sleeping bags, or towels;
  • Present in some furniture, mattresses, cushions, or pillows; and
  • Present in some flooring materials.

Reporting is not required for substances covered by other regulations, including substances that is or is contained in:

  • A pest control product registered under the Pest Control Products Act
  • A fertilizer or supplement registered under the Fertilizer Act
  • A feed registered under the Feeds Act

Additionally, there are exemptions for tetrachloroethylene used in specific situations, such as solvent degreasing and used in dry cleaning. Substances solely in transit through Canada will also be exempt.

Information required includes the concentration, or range of concentrations, of the substance by in goods, where applicable; substance functions; information on commercial and consumer, including use by children; and the title(s) of any unpublished data or studies related to the substance that has not already been provided to the Government of Canada.

Responses are due by January 17, 2024, and must be submitted using the online reporting system available through Environment and Climate Change Canada’s Single Window.