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.

EPA Implements Collaborative Research Program to Support PMN Reviews

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On February 24, EPA announced a new effort “to modernize the process and bring innovative science to the review of new chemicals.”  In addition, the effort is expected to “increase the transparency of the human health and ecological risk assessment process.”  The Office of Chemical Safety and Pollution Prevention (OCSPP) is collaborating on this effort with the Agency’s Office of Research and Development (ORD) and other federal entities including the National Toxicology Program at the National Institute of Environmental Health Sciences.

The draft Strengthening the Science and Process to Evaluate New Chemicals Under TSCA; TSCA New Chemicals Collaborative Research Program: Problem Statement, Vision and Action Plan was released for public comment on March 9.  Written comments will be accepted through April 26, 2022.  In addition, stakeholders may comment at a virtual public meeting on April 20 and 21, 2022.  Instructions for registering for the meeting are available here.

EPA explains that the Collaborative Research Program (CRP) “will refine existing approaches and develop and implement new approach methodologies (NAMs) to ensure the best available science is used in TSCA new chemical evaluations.”  Components of this effort include:

  • Updating the methodology for using data from analogous chemicals to determine potential risks from new chemicals where health effects data on the new substance are not available.
  • Updating and augmenting the models used for predicting a chemical’s physical-chemical properties and environmental fate/transport, hazard, exposure, and toxicokinetics.
  • Developing a decision support tool to integrate the information streams used in new chemical risk assessments into a final risk assessment.

The docket for this effort is EPA-HQ-OPPT-2022-0218.

 

IRIS Review of PFHxA and its Related Salts

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EPA’s Integrated Risk Information System (IRIS) program is developing assessments for five PFAS:  perfluorobutanoic acid [PFBA], perfluorohexanoic acid [PFHxA], perfluorohexane sulfonate [PFHxS], perfluorononanoic acid [PFNA], perfluorodecanoic acid [PFDA], and their associated salts.  On February 2, EPA released the draft IRIS assessment for PFHxA.

The IRIS assessment followed a systemic review protocol that outlines the related scoping and problem formulation efforts, including a summary of other federal and state assessments of PFHxA. The protocol also lays out the systematic review and dose-response methods used to conduct the review.

The review found that PFHxA exposure is likely to cause hepatic, developmental, and hematopoietic effects in humans.  In addition, the review reported that current evidence suggests that PFHxA exposure might cause endocrine effects in humans.

PFAS Found in L’Oréal Cosmetics

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A class action lawsuit has been filed in a New York federal court alleging that L’Oréal USA failed to disclose its Waterproof Mascara Products contain PFAS. Third-party testing revealed that PFAS are present in several of L’Oréal’s waterproof mascaras. PFAS are commonly found in cosmetics because of their durability, spreadability, and waterproof and oilproof properties While PFAS are largely unregulated in cosmetics at the federal level although the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) Office of Cosmetics and Colors has authority to do so under the Federal Food Drug and Cosmetic Act, consumer demand for PFAS-free products has led companies such as Sephora and Ulta Beauty to designate PFAS-free brands as “clean” beauty brands.

The Complaint states that since at least 2018, the company has misleadingly and fraudulently advertised its Waterproof Mascara Products. Plaintiffs allege that the mascaras were labeled as safe, effective, and high quality, utilizing phrases such as “ophthalmologist tested’ and “hypoallergenic,” yet packaging and ingredient lists failed to disclose the presence of PFAS.

According to the Complaint, L’Oréal, with exclusive knowledge of the formulas, ingredients, and suppliers, knew or should have known the waterproof mascara products contained or had a material risk of containing PFAS. Additionally, Plaintiffs assert that L’Oréal should have known that the presence or material risk of PFAS was a material consideration to consumers. The Complaint alleges that had consumers been aware of the presence of PFAS they would not have purchased the products or would not have purchased them at a premium price.

The case is Hicks v. L’Oreal USA Inc., S.D.N.Y., No. 1:22-cv-01989, 3/9/22.

Litigation Over the De Minimis Concentration and Alternate Threshold Exemptions in the PFAS TRI Reporting Rules

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On January 20, 2022, the National PFAS Contamination Coalition, Sierra Club, and Union of Concerned Scientists (collectively the “Coalition”) filed a complaint in the District Court for the District of Columbia challenging two final rules promulgated by EPA related to TRI PFAS Reporting.  Specifically, the Coalition asserts that two rules violate the National Defense Authorization Act for Fiscal Year 2020 (NDAA) by allowing two exemptions to the Act’s PFAS reporting mandate — the de minimis concentration and alternate threshold exemptions.  These rules are “Implementing Statutory Addition of Certain Per- and Polyfluoroalkyl Substances; Toxic Chemical Release Reporting” (85 Fed. Reg. 37,354) and the “Implementing Statutory Addition of Certain Per- and Polyfluoroalkyl Substances (PFAS) to the Toxics Release Inventory Beginning With Reporting Year 2021” (86 Fed. Reg. 29,698) (collectively the “TRI PFAS Rules”).

According to the Coalition, allowing the de minimis exemption means that PFAS otherwise subject to the rule “will not be reported to the TRI because they are used in mixtures in low concentrations —even where the total amount of the PFAS manufactured, processed, or otherwise used is well over the 100-pound threshold set by Congress.”  The compliant further explains that the alternate threshold exemption permits covered facilities that release and disposal of less than 500 pounds per year of a TRI-listed PFAS to submit “a bare-bones certification rather than the detailed toxic chemical release form, reducing the information disclosed to the public.”

Adopting these rules without allowing for notice and opportunity for comment, promulgation violated the notice and comment provisions of the Administrative Procedure Act, according to the Coalition.  The Coalition further asserts that the NDAA did not authorize EPA to allow an exemption for de minimis concentrations.  Nor, according to the Coalition, does the NDAA allow for alternate threshold exemptions.  The Coalition argues that “the TRI PFAS Rules are also arbitrary and capricious because they are premised on the idea that communities do not need to know about releases of small amounts of toxic chemicals, or even releases of large amounts where the chemical of concern is present in low concentrations, flouting evidence that exposure to even extremely low levels of PFAS is dangerous.”

The complaint argues that Plaintiffs’ members are deprived of critical information by the de minimis concentration and alternate threshold exemptions.   According to the Coalition, the exemptions deprive Plaintiffs of knowledge about the toxic air and water pollution that they and their families are exposed to, which impairs their ability to advocate for stronger protections from that pollution.  The absence of these data also impairs Plaintiff’s ability to “conduct the research and analysis needed to inform communities and guide policy development.”

As previously posted, EPA complied a roadmap outlining key actions and commitments on PFAS for 2024.  This roadmap states that EPA intends to propose a rulemaking in 2022 to remove the “de minimis eligibility” from supplier notification requirements for Chemicals of Special Concern for TRI reporting, and categorize PFAS as such.

Recent State Activity on PFAS Regulation

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Since January 2022, many states have passed and proposed dozens of laws regulating PFAS substances.  These legislative efforts address topics including setting drinking water standards for PFAS, banning PFAS in consumer products, banning or restricting the use of firefighting foams containing PFAS, and adding PFAS substances to toxic and hazardous substances lists.

Virginia and Washington will soon adopt regulations establishing maximum contaminant levels for drinking water.  Indiana and Rhode Island have also proposed doing so.  California is considering legislation that would establish a Central Basin Communities water fund that would, in-part, offset treatment costs of PFAS-contaminated public water systems.

Minnesota, California, and Rhode Island have proposed legislation that would ban the use of PFAS in consumer products.  Products that would be subject to these bans range from cosmetics and cookware to carpets and clothing.

Arkansas, California, Illinois, Maine, and Louisiana have passed laws banning or restricting the use of firefighting foams containing PFAS.  Rhode Island and Ohio have proposed legislation that would restrict the use of firefighting foams.

Minnesota has added PFAS substances to its list of Toxic and Hazardous Substances.  California has added PFAS to the list of substances subject to Prop 65.  A Rhode Island bill would include PFAS in the definition of “hazardous substances” for purposes of industrial property remediation.

Legislative efforts have also addressed notice requirements.  Maine enacted legislation that requires manufacturers to provide notification if any personal, residential, commercial, or industrial product contains PFAS.  A bill pending in the California General Assembly would create a publicly accessible registry of products containing PFAS.  The bill would also require manufacturers to register PFAS-containing products.  A Minnesota bill would require manufacturers of products for sale in the state that contain intentionally added PFAS to provide written notice of the PFAS, its amount, and its purpose.

Other legislative proposals would enact the following:

  • A prohibition on products containing PFAS from being classified as recyclable.
  • A requirement for state-owned solid waste disposal facilities to establish leachate treatment to reduce PFAS.
  • A requirement for screening for PFAS in sludge or sludge-derived compost that is applied to land.
  • A requirement to adopt groundwater quality standards for certain PFAS.
  • A prohibition on the sale of products labeled as “compostable” or “home compostable” if it has a total organic fluorine concentration greater than 100 parts per million (ppm).