New Study Finds Multiple Toxic Chemicals in Consumer Products

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This May, the American Chemical Society published a new study evaluating the presence of toxic chemicals in consumer products.  The study found use of at least one chemical known to the state of California to cause cancer, reproductive issues, and/or developmental issues in over one hundred types of consumer products.

The study’s authors used data from the California Air Resources Board’s (CARB) Consumer Product Regulatory Program, which collects data on volatile organic compounds (VOCs) in California consumer products.  They then cross-referenced this data against the list of harmful chemicals regulated under California’s Safe Drinking Water and Toxic Enforcement Act, commonly known as Proposition 65 or Prop 65, to determine the hazards posed by each product category.  It should be emphasized that the study provides only a partial picture of the use of hazardous chemicals in consumer products; only about 200 of the 865 Prop 65-listed substances are VOCs.

More than 100 product categories contained at least one VOC chemical listed under Prop 65 (a “listed chemical”).  Consumers were exposed to the greatest number of listed chemicals in categories that included personal care products, cleaners, and household products; for workers, adhesives had the greatest number of listed chemicals.  The study also determined that more than 5,000 tons of listed chemicals were released from California consumer products in 2020.

In general, the product categories with the most listed chemicals were also the categories in which exposures to especially hazardous listed chemicals were highest.  After comparing the product categories with the highest numbers especially hazardous chemicals with the categories with the highest potential exposures, the researchers assembled a list of 30 product categories and 11 especially hazardous chemicals—including formaldehyde and methylene chloride—that they believed should be prioritized for regulation.

In addition, the study noted that certain occupations put workers at particular risk of exposure to listed chemicals.  For example, janitors could be exposed to five prioritized product categories, including cleaners, detergents, and degreasers.  Construction workers, nail/hair salon employees, and automobile maintenance/repair workers were also described as particularly at-risk.

Because CARB only makes data available by product category, the study did not identify particular brands or products in their analysis.

Vinyl Institute Seeks Judicial Review of EPA Test Order

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Congress granted EPA new test order authority through the 2016 Lautenberg Amendments to the Toxic Substances Control Act (TSCA).  In May 2022, EPA received its first legal challenge to this new authority from the Vinyl Institute.  The Vinyl Institute is a coalition of seven companies which manufacture a solvent, 1,1,2-trichloroethane, that EPA listed as a priority chemical in December 2019 and that is currently undergoing risk evaluation.  The Vinyl Institute is seeking judicial review of a test order for 1,1,2-trichloroethane, for an avian reproduction test.  Specifically, the petition to the DC Circuit Court argues that EPA has not adequately explained the need for the data.  1,1,2-trichloroethane is used as a solvent and an intermediate in the production of 1,1-dichloroethane.  During the risk prioritization process, the Agency determined that it had insufficient data on the substance to understand if it has the potential to harm wildlife and issued the test order.

The Vinyl Institute stated in their petition that the Test Rule is arbitrary, capricious, and an abuse of discretion.  It alleges that EPA failed to:

  • Adequately explain why the avian reproduction test is necessary,
  • Consider all available information and data for the substance,
  • Cite reliable and representative information and data in support of the Test Order,
  • Adequately justify the need for the test without first requiring screening level testing, and
  • Consider the relative costs of the Test protocols, along with availability of facilities and personnel to perform the testing.

As of this date, the parties have filed motions regarding whether additional submission may be made to the record.

EPA Proposes to Stop Authorized Use of Certain PFAS in Pesticide Products

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EPA is proposing to remove 12 PFAS substances from the current list of inert ingredients approved for use in pesticide products. Under EPA’s 2021 PFAS Strategic Roadmap the Agency is reviewing substances approved as inert ingredients in pesticides and potentially taking action to limit their use. Inert ingredients in pesticides serve to increase effectiveness and product performance including improving the ease of pesticide application and extending shelf life.

The 12 chemical substances proposed for removal are no longer in any registered pesticide product, but EPA believes it is important to remove these chemicals.  This means that a review of available information for these chemicals would be required for their future use in pesticide products. In discussing the proposal Michal Freedhoff, EPA’s Assistant Administrator for the Office of Chemical Safety and Pollution Prevention stated, “ensuring that these 12 chemicals can no longer be used in pesticides is an important step to protect workers, the public, and our planet from unnecessary PFAS exposure.”

CoverGirl Cosmetics and Coty Inc PFAS Suit

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CoverGirl Cosmetics and Coty Inc. are facing a class action lawsuit for marketing their TruBlend Pressed Powder as sustainable and safe while allegedly it contained PFAS.  The complaint was filed in the U.S. District Court for the Southern District of California.  According to the complaint, independent lab testing found that the product contained increased fluorine levels, an indicator of the presence of PFAS.   The complaint also notes that defendants misrepresent the product in their marketing materials which state that they hold themselves to the highest quality standards when it comes to safety and efficacy of their products.  Plaintiffs argued that these acts violate the California Unfair Competition Law and the California False Advertising Law, and constitute fraud and negligent misrepresentation.

The plaintiff asserts that the presence of PFAS is a concern because PFAS exposure through inhalation, ingestion, and skin contact can result in PFAS entering the body. The makeup in question is applied directly to the face and is prolonged skin contact.  Plaintiff contends that PFAS are present at a greater concentration than recommended by the current EPA health advisory limit for safe consumption.

FDA Rejects Phthalate Petition

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On May 19, 2022, the US Food and Drug Administration (FDA) announced that it has denied two petitions to ban phthalates in food packaging.  In conjunction with denying the petitions, the FDA accepted a petition requesting that the Agency stops authorizing 23 phthalates for use in food containers as they are no longer used by industry.

In addition to being in food containers, phthalates are used as additives in cosmetics, detergents, and shower curtains.  Industry often uses them to soften plastics.  Although allowed in many products, the 2008 Consumer Product Safety Improvement Act bans a concentration of more than 0.1 percent of di-(2-ethylhexyl) phthalate (DEHP); dibutyl phthalate (DBP); or benzyl butyl phthalate (BBP) in all children’s toy and childcare articles.  Being exposed to concentrated amounts of phthalates can cause reproductive and developmental issues.

Multiple groups, including the Environmental Defense Fund and Earthjustice, have petitioned the FDA in the last decade to block the authorization of phthalates in food packaging, but the petitions have always failed, with the FDA citing a lack of information to justify blocking authorization of phthalates.

FDA’s acceptance of the petition to stop authorizing certain phthalates was due to the industry no longer using those substances. As the industry has abandoned use of those phthalates, the FDA found it appropriate to stop their authorization.  Currently, there are eight phthalates that the FDA still authorizes.  Shortly after the FDA’s announcement, they issued a request for information regarding current uses, levels, dietary exposure, and safety data for those phthalates.

Chlorpyrifos Food Tolerance Revoked  

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Earlier this year, EPA denied all objections to and hearing requests for a rule that terminates the use of the chlorpyrifos pesticide on food crops. As a result of the new rule, producers may no longer apply any chlorpyrifos to food or feed products, although there is an exemption for farmers to use the pesticide on certain exported food products.

Following its registration in 1965, farmers have used chlorpyrifos as an insecticide on food crops such as soybeans, corn, fruit and nut trees, and vegetables. It has also been used for agricultural purposes such as cattle ear tags, poultry houses, turkey, swine, and dairy barns.

There is significant potential for the pesticide to cause neurological effects, particularly in pregnant women and children. Children who are exposed to chlorpyrifos may experience lifelong intellectual disabilities and lowered IQ levels. Farmworkers who use the pesticide or work in fields where the pesticide has been used are also at increased risk of adverse health effects from exposure with including effects on the nervous system such as headaches, blurred vision, muscle weakness, and seizures. The chemical has been the focus of environmental advocacy groups because of its toxicity to wildlife, particularly birds, fish, aquatic vertebrates, and bees. For example, these groups argue that the chemical impacts the health and existence of nearly 1,400 animals and plants protected under the Endangered Species Act.

In 2000, the EPA banned chlorpyrifos for residential indoor use but continued allowing the use of these chemicals on food products. In 2014 and 2016, the EPA published data confirming that all toddlers were being exposed to chlorpyrifos at levels 140 times greater than the Agency had determined was safe.  However, the Agency did not take actions to limit chlorpyrifos pesticide use at that time. In 2017, the EPA again failed to take action to ban chlorpyrifos. The Agency decision argued that additional scientific evidence was needed. Meanwhile, beginning in 2019, some states banned or restricted the use of chlorpyrifos, including California, Maryland, New York, and Hawaii. In recent years, many toxic torts lawsuits have been filed against chlorpyrifos manufacturers and distributors. Many of these cases are still ongoing.

The EPA’s current final rule banning chlorpyrifos in food was issued in response to the Ninth Circuit Court of Appeals’ order directing the EPA to issue a final rule after the Natural Resources Defense Council and the Pesticide Action Network North America filed a petition with the Court. These organizations had previously petitioned the Agency for a ban, which was denied under the Trump administration in 2017 and again in 2019, leading to its Ninth Circuit challenge. EPA administrator Michael S. Regan addressed the delay in EPA’s action against the chemical, stating, “[t]oday EPA is taking an overdue step to protect public health. Ending the use of chlorpyrifos on food will help to ensure children, farmworkers, and all people are protected from the potentially dangerous consequences of this pesticide.”

Flame Retardant Rule Do-Over Sought By EPA Granted in Federal Case

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On June 23, 2022, the Ninth Circuit Court of Appeals granted EPA a request for voluntary remand on a risk management rule for decabromodiphenyl ether (decaBDE).  This allows EPA to reconsider the rule at issue and make changes they deem necessary.  DecaBDE is a flame retardant added to the plastics used in many products on the market, such as televisions, computers, and upholstered articles. The January 2021 risk management rule prohibits manufacturing or importing decaBDE for all products after February 28, 2022, 60 days after the publication of the final rule.  The rule gives the hospital curtain industry 18 months to come into compliance, and 3 years for new aerospace vehicles. Replacement parts for motor and aerospace vehicles were granted an exclusion from the prohibition of manufacturing, processing, and distribution of decaBDE.

Petitioners opposing EPA in this matter are a coalition consisting of the Alaska Community Action on Toxics, Yurok Tribe, the Consumer Federation of America, Learning Disabilities Association of America, and the Center for Environmental Transformation.  the coalition, argues that EPA has had more than a year to review unidentified provisions of the final rule.  The coalition also asserts that EPA’s Final Rule is inadequate because it lacks 1) risk management measure to reduce exposure of decaBDE generally, 2) an exclusion for unrestricted recycling of plastics containing decaBDE, and 3) restrictions on releases of the chemical to the air, water, or land.

In 2021, the Ninth Circuit Court of Appeals had also granted EPA’s request to revisit two other chemical risk evaluations, including the one for hexabromocyclododecane (HBCD which is also a flame retardant).  Along with granting EPA’s request to reconsider the rule, the Ninth Circuit denied the petitioners request to impose deadlines on the reconsideration and potential amendment of the rule.

Biological Opinion Proposes Malathion Mitigation Measures

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The U.S. Fish and Wildlife Service’s (FWS) nationwide final biological opinion (BiOp) for Malathion has prompted EPA to take steps to protect a number of endangered species that were identified as being threatened by the insecticide.  Malathion is an organophosphate insecticide use on a wide variety of food and non-food crops to kill insects systemically and on contact.  It is also used as a mosquito adulticide.  The BiOp was prompted after EPA released a biological evaluation on malathion in January 2017EPA’s evaluation found the insecticide was likely to affect both aquatic and terrestrial animals by inhibiting and enzyme necessary for synapse and neuromuscular function, leading to sublethal effects and mortality.

FWS collaborated with EPA and the malathion technical registrants to create the BiOp.  The BiOp also includes information provided by stakeholders, non-governmental organization, and members of the public who commented on EPA’s initial evaluation.  The BiOp states that malathion is likely to jeopardize 78 different species and destroy or adversely affect 23 habitats.  FWS proposed mitigation measures that would reduce the application rates, create no spray zones, and apply label changes for the pesticide users to follow.  One proposed mitigation measure for reducing the application rates would restrict application when rain is predicted and when certain types of crops are in bloom. The purpose of these mitigation measures is to minimize the likelihood of exposure to different species and reduce the affects to their development and habitats.

The BiOp states specific measures and mandatory label instructions will be available through EPA’s Bulletins Live! Two website, which provides information on endangered species, along with other relevant information.  Registrants were asked to submit amended labels to EPA by June 29, 2022.

State of Washington Regulates PFAS In Lieu of Cosmetics Ban

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A proposal in Washington state has stalled in the state House, after passing their Senate, that would have banned cosmetics that contain phthalates, formaldehyde, and PFAS.   The proposal, Senate Bill 5703, states that legislature finds certain chemicals in cosmetic products to be linked with various negative health effects, such as cancer, birth defects, and damage to the reproductive system. It further states that if enacted, it would have prohibited the sale and distribution of any cosmetics containing these and an additional 31 different substances such as ortho-phthalates, phenolic compounds, parabens, and lead compounds beginning January 1, 2025.

Although Senate Bill 5703 did not progress, the governor did sign into law House Bill 1694, which allows the state department of ecology to recognize and regulate consumer products containing PFAS.  The bill gives the ecology depart the authority to restrict PFAS product to any limit.   The state’s department of ecology is directed to determine an initial set of regulatory actions regarding PFAS consumer products by June 1, 2024 and must adopt rules to implement the initial set of determinations of regulatory actions by December 1, 2025.  Washington has also created a $266,00 fund for identifying and testing cosmetics for the purpose of determining which cosmetics present harmful effects.

Washington is not the first state to ban hazardous substances from cosmetics.  In 2020, California passed a ban on cosmetics containing harmful substances, identifying some PFAS chemicals.  Maryland took the same course of action in 2021.  In addition, several other states, such as New Hampshire, Minnesota, Michigan, and Maine have begun drafting legislature to restrict PFAS in cosmetics.

EPA Takes Steps to Regulate PFAS in Commerce

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On March 16, 2022, EPA announced that the Agency would be taking two steps to further regulate PFAS in commerce. First, EPA notified manufactures of high-density polyethylene (HDPE) that they are obligated to comply with existing TSCA requirements to prevent unintentional PFAS contamination. Second, EPA stated that the Agency will remove two types of PFAS from the Safer Chemical Ingredients List (SCIL).

EPA provided notice that manufacturers, importers, processors, distributors, users, and other entities who engage in the disposal of HDPE containers and other plastics containing fluorinated polyolefins must adhere to the significant new use notice requirement under TSCA. This notice was provided via an open letter to the HDPE industry that was initially posted on March 16, 2022, and then reissued with minor revisions on March 24, 2022.  Here, EPA reminded the HDPE industry that the process of fluorination can lead to the unintentional manufacture of PFAS (e.g., byproducts).  Furthermore, EPA stated that the manufacture of certain PFAS, including long-chain perfluoroalkyl carboxylates, via fluorination of polyolefins is considered a significant new use under TSCA because the byproducts exemption provided at 40 CFR § 721.45(e) does not apply. Specifically, this exemption does not apply because these PFAS are not “used only by public or private organizations that (1) burn it as a fuel, (2) dispose of it as a waste, including in a landfill or for enriching soil, or (3) extract component chemical substances from it for commercial purposes.” Therefore, a significant new use notification (SNUN) must be submitted to EPA at least 90 days before initiating such use so that the Agency can review the potential risks of this new use before industry can place the product into the stream of commerce.

The two PFAS that EPA will be removing from the SCIL, CASRN 449177-94-0 and 452080-67-0, were initially placed on the list in 2012.  In October of 2021, EPA began revisiting its previous PFAS endorsements pursuant the PFAS Strategic Roadmap. These two chemicals were subsequently removed from the list based on “a growing understanding of the toxicological profiles for certain PFAS, and incomplete information on the potential health and environmental effects of these substances.” Henceforth, these products that contain these PFAS will not be eligible Safer Choice certification. In addition, existing products containing these substances, that have received the Safer Choice certification, must be reformulated to maintain said certification.