EPA Evaluation of PFAS Leaching in Fluorinated Containers

On September 8, 2022, EPA announced findings of the Agency’s evaluation of PFAS leaching in fluorinated containers.  Specifically, the evaluation assessed the extent to which PFAS that are present in the packaging leach into the contents of the containers.  The study tested the leaching potential of PFAS over a 20-week test period into water, methanol and similar solutions that were packaged in different brands of HDPE fluorinated containers.  EPA undertook this evaluation after learning of PFAS contamination in some mosquitocide products, and after conducting a study of other pesticides stored in fluorinated high-density polyethylene containers.   In both cases the Agency found varying levels of PFAS in the contents of the containers.

The announcement reported that EPA has determined that any liquid products packaged in HDPE containers that have been treated with fluorination technology could be contaminated with PFAS, including water-based products.  The Agency also reported that the amount of PFAS that leach into the products could increase over time.   EPA noted that the Agency does not know if all fluorinated containers will leach PFAS because the Agency’s analysis did not test all the different fluorination technologies.

The announcement included a reminder that pesticide registrants must notify the Agency if they discover PFAS in any of their products.  Under FIFRA §6(a)(2) and 40 CFR §159.179, “additional factual information on unreasonable adverse effects, including metabolites, degradates and impurities (such as PFAS)” must be reported to EPA within 30 days after the registrant “first possesses or knows of the information.”  Note that the Agency considers any level of PFAS to be potentially toxicologically significant and therefore reportable.

The announcement also noted that in many cases, the manufacture of PFAS from the fluorination of polyolefins is subject to the Agency’s significant new use rule  for long-chain perfluoroalkyl carboxylates (LCPFACs) under the Toxic Substances Control Act (TSCA).  Companies must notify EPA at least 90 days before starting manufacturing or processing of these chemical substances for this significant new use.  TSCA requires significant new use notification in these situations to allow EPA review any associated risks and impose any needed protections.

Implementing Statutory Addition of Certain PFAS Substances to the Toxics Release Inventory Reporting

In July 2022, EPA released a final rule adding five PFAS to the list of chemicals required to be reported to the Toxics Release Inventory (TRI) under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA). TRI tracks the management of certain toxic chemicals that may pose a threat to human health or the environment and provides this information to the public. Pursuant to the National Defense Authorization Act (NDAA), EPA is required to automatically add PFAS to the TRI whenever it takes one of the following actions:

  • EPA finalizes a toxicity value for a PFAS or class of PFAS;
  • EPA determines that a PFAS or a class of PFAS is covered by a TSCA Significant New Use Rule (SNUR);
  • EPA adds PFAS or a class of PFAS to an existing SNUR; or
  • EPA finds that a PFAS or class of PFAS is active in commerce (under TSCA Section 8).

Under this rule, facilities in specific industry sectors that manufacture, process, distribute, or use any of the five PFAS added to the TRI, must submit a TRI report if they exceed the PFAS reporting threshold of 100 pounds. Four of the substances are added to the list effective January 1, 2022, and the remaining substance is effective January 1, 2021, meaning TRI reporting due in 2023 must account for these substances.

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

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

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

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.

PFAS From Certain Plastic Can Violate Chemicals Law, EPA Says

Earlier this year, EPA released a letter to manufacturers, processors, distributors, users, and those that dispose of fluorinated high-density polyethylene (HDPE), informing them of possible violations of the Toxic Substances Control Act (TSCA).  EPA determined through recent testing that certain PFAS have unintentionally formed during or following the process of fluorinating polyolefins. Manufacturers and processors of fluorinated polyolefins modify polymers with fluorine to create high-performance barriers.  These barriers are then used in the storage and transport of various products to keep the product inside the container without notable permeation.  During some methods of fluorination, such as in the presence of oxygen, PFAS can occur as a byproduct.

EPA first noticed the unintentional formation of PFAS in containers used in storing and transporting pesticides, and it is researching whether this problem occurs in other HDPE products. This effort to restrict human health and environmental exposure to PFAS is one of many steps the Agency has outlined in its PFAS Strategic Roadmap.

EPA’s letter reminds the HDPE industry that certain long-chain PFAS are subject to a TSCA Significant New Use Rule (SNUR) (See 40 CFR § 721.10536). Generally, chemical substances created during the manufacturing process that does not have a separate commercial purpose are considered byproducts and are exempt from SNUR requirements under 40 CFR § 721.45(e). But certain long-chain PFAS byproducts produced during the manufacture of fluorinated polyolefins do not meet the requirements of the byproducts exemption and therefore require a SNUR. These rules require the manufacturer to notify EPA at least 90 days before commencing the manufacture (including import) or processing of these chemicals for significant new use.

The Agency encourages the industry to review the relevant regulations at 40 CFR § 721. Any questions on the topic can be directed to the Existing Chemicals Risk Management Division in the Office of Pollution Prevention and Toxics at TSCA_PFAS@epa.gov.

Chlorpyrifos Food Tolerance Revoked  

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

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

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

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.