EPA Proposes Adding Over 100 PFAS to TRI List

/in , ,

Significantly more PFAS substances would be subject to Toxic Release Inventory (TRI) reporting under a proposed rule published by EPA on October 8, 2024.  The proposed rule would add 16 individual PFAS and 15 PFAS categories to the TRI list, which currently contains 196 PFAS.

The proposed additions would be made due to their potential human health effects, environmental effects, or both.  According to EPA, the 15 proposed category additions encompass over 100 individual PFAS.

The added PFAS would be subject to a reporting threshold of 100 pounds.  The manufacture, processing, and otherwise use of substances within a PFAS category would cumulatively count towards that category’s 100-pound threshold.

EPA is also proposing to add the proposed PFAS to the list of chemicals of special concern, which would make them ineligible for the de minimis exemption.  Under the de minimis exemption, facilities can disregard small concentrations of TRI chemicals in mixtures and trade name products when making threshold determinations.

EPA previously designated existing PFAS on the TRI list as chemicals of special concern in October 2023.  In that rulemaking, EPA argued that the move would “result in a more complete picture of the releases and waste management quantities for PFAS.”

The FY 2020 National Defense Authorization Act (NDAA) instructed EPA to add certain PFAS to the TRI list with a 100-pound reporting threshold.  “Congress’ use of this low reporting threshold demonstrates a concern for even relatively small quantities of these PFAS,” EPA said.

EPA was required to evaluate some of the proposed PFAS additions for possible inclusion by section 7321 of the NDAA.  However, the NDAA did not specify what the threshold should be for those additions.  In the proposed rule, EPA defended its proposed 100-pound threshold, saying that it would “maintain consistency for all chemicals added to TRI pursuant to the NDAA.”

The NDAA also instructs EPA to add PFAS automatically when certain conditions are met.  In the proposed rule, EPA clarified its interpretation of those conditions, which include when EPA “finalizes a toxicity value” for a PFAS.

Finally, EPA is proposing that it add related PFAS (like an acid and its associated salts) under the NDAA as a category going forward. The proposed rule would also consolidate certain existing individual PFAS on the list into categories.

Comments on the proposed rule are due November 7, 2024.

EPA’s Draft Risk Evaluation of DINP Finds Minimal Risks, but Determines That the Phthalate Presents an Unreasonable Risk

/in , ,

On August 30, 2024, EPA released its draft risk evaluation for diisononyl phthalate (DINP).  The draft risk evaluation determined that most uses of DINP under the Toxic Substances Control Act (TSCA) “do not pose risk to the environment or the general population.”

The draft only identified three uses that “raise concerns” out of 47 evaluated conditions of use.  However, EPA preliminarily found that DINP presents an unreasonable risk of injury to human health due to the agency’s “single risk determination” approach to risk evaluations.

Two of these three uses were found to raise concerns for workers: industrial use of adhesives and sealants and industrial use of paints and coatings, specifically in scenarios in which unprotected workers used high-pressure sprayers.  According to the draft, these uses could create high concentrations of DINP in mist that an unprotected worker could inhale.

The other use—use of DINP in construction and building materials that cover large surface areas—was found to raise concerns for consumers.  This use could result in young children inhaling DINP-containing dust that settles “onto vinyl flooring, in-place wallpaper, and carpet backing and [is] resuspended into the indoor environment,” the draft says.

The draft risk evaluation identified developmental toxicity and liver damage as potential health effects of these types of exposures.  DINP also has the potential to cause “phthalate syndrome,” a collection of adverse effects on the developing male reproductive system, EPA said.

According to EPA, DINP is primarily used as a plasticizer to manufacture flexible polyvinyl chloride, better known as PVC.  Data from the Chemical Data Reporting rule indicates that hundreds of millions of pounds of DINP are manufactured annually.

EPA initiated the risk evaluation process after a 2019 request from ExxonMobil Chemical Company to review DINP and its chemical relative diisodecyl phthalate (DIDP).  EPA only found one concerning condition of use in DIDP’s draft risk evaluation, which was released this May.

DINP is a category of chemical substances which include 1,2-benzene-dicarboxylic acid, 1,2-diisononyl ester (CASRN 28553-12-0) and 1,2-benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich (CASRN 68515-48-0).

Amended TSCA requires EPA to issue a risk management rule to address any unreasonable risks found by the final evaluation.  Comments on the draft risk evaluation are due on November 4, 2024.

Third Circuit FIFRA Preemption Ruling Creates Circuit Split

/in , ,

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) expressly preempts a Pennsylvania law that allegedly requires Monsanto to include a cancer warning on its “Roundup” weedkillers, the Third Circuit ruled on August 15, 2024.  The decision in Schaffner v. Monsanto Corp. creates a split with the Ninth and Eleventh Circuits, which have found that similar state-level duty to warn laws were not preempted because the state-law labelling requirements were equivalent to a requirement under FIFRA.

Like the Ninth and Eleventh circuits, the Third Circuit applied a “parallel requirements” test outlined by the Supreme Court in Bates v. Dow Agriscience LLC to determine whether the state law diverged from FIFRA requirements.  Those circuits determined that the state laws were not preempted because they were equivalent to FIFRA’s statutory definition of “misbranding.”

But the Third Circuit ruled that those circuits erred when conducting the test by failing to take into account EPA regulations limiting the modification of precautionary statements on labels.  According to the court, these regulations would require Monsanto to seek EPA approval before adding a warning.

“If EPA regulations specifically identify the contents required to be included on a pesticide label, a state-law requirement is preempted unless it is equivalent to that specific regulatory requirement,” the court said.  “The state-law duty cannot survive preemption simply because its standard of liability is equivalent to the broad statutory definition of misbranding.”

The highly technical decision had to contend with the Supreme Court’s holding in Bates, which it acknowledged “plausibly indicates that [FIFRA] does not on its own preempt all state-law duties to include a warning omitted from” its label.  The Third Circuit concluded that there was no discrepancy because the Supreme Court had not considered how regulations would affect preemption under FIFRA section 136v(b), which addresses preemption.

Writing for the panel, Chief Judge Michael A. Chagares rejected arguments that the Third Circuit should be bound to the Ninth Circuit’s decision.  “The complex subject of preemption under FIFRA has not been comprehensively analyzed in prior caselaw, and the Supreme Court has yet to address FIFRA preemption in the specific circumstances presented by this case,” the decision states.

He also noted that the Supreme Court’s recent overruling of Chevron deference did not undermine EPA’s authority to promulgate FIFRA regulations, including those requiring agency preapproval of product labels, because FIFRA explicitly grants EPA authority “to prescribe regulations to carry out the [statute’s] provisions.”

The Supreme Court denied Monsanto’s petition for certiorari in the Ninth Circuit’s case, Hardeman v. Monsanto Co., in 2022.  A blog post on the Eleventh Circuit’s case, Carson v. Monsanto Co., can be found here.

EPA Issues Seldom-Used Emergency Order to Suspend Registrations of Pesticide DCPA

/in , , ,

For the first time in almost 40 years, EPA has issued an emergency order under section 6(c)(3) of the Federal Insecticide, Fungicide, and Rodenticide Act to suspend the registrations of all pesticide products containing the active ingredient dimethyl tetrachloroterephthalate (DCPA).

The emergency measure is based on DCPA’s thyroid effects in fetuses, which EPA deemed so severe that continued use of DCPA during the time period required to cancel its registrations would pose an imminent hazard.  According to EPA, thyroid hormone perturbations linked to DCPA “can lead to downstream health problems such as low birth weight, impaired brain development, decreased IQ, impaired motor skills, and decreased bone deposition.”

Occupational exposures to DCPA can be over twice as high (as a factor of body weight) as the level at which the thyroid effects were observed in mouse fetuses, and the herbicide’s residues present risks of concern even 30 days after application to crops, EPA said.  DCPA is also registered for non-agricultural uses, including on golf courses and athletic fields.

American Vanguard Corporation (AMVAC), the sole registrant of DCPA, voluntarily canceled all but two of its DCPA products and their use on turf.  It also voluntarily ceased sale and distribution of the only remaining end-use product until EPA approved product labels that would address DCPA’s risks.  However, EPA “determined that there is no combination of practicable mitigations under which DCPA use can continue without presenting an imminent hazard.”

DCPA is currently undergoing registration review, which occurs every 15 years.  EPA assessed DCPA’s health risks in 2023 after AMVAC submitted a study on its thyroid effects and other information requested by the agency.

The agency intends to issue a notice of intent to cancel DCPA registrations within 90 days of the order, which was published on August 7, 2024.

Also known by its trade name Dacthal, DCPA is used on a variety of crops for weed control.  According to EPA, the emergency order will have a negligible impact on produce prices but may impact growers of crops including bok choy, collards, kale, green onions, and leeks.

Update:

On August 28, 2024, EPA announced that it is initiating a voluntary cancellation of DCPA after AMVAC notified the agency of its intent to cancel the remaining pesticide products.  According to EPA, AMVAC also intends to cancel its international registrations.

Court Finds EPA’s Transparency in New Chemicals Disclosures Reviewable

/in , , ,

EPA’s alleged failure to disclose certain information submitted to its New Chemicals Program is subject to judicial review under the Toxic Substances Control Act (TSCA) and the Administrative Procedure Act (APA), the D.C. District Court ruled on August 20, 2024.

In Environmental Defense Fund v. Regan,  No. 1:20-cv-00762-LLA, five environmental organizations allege that EPA engages in a pattern or practice of violating TSCA’s disclosure requirements for premanufacture notices (PMNs) and applications for test marketing exemptions (TMEs).  The suit’s 10 counts include allegations that EPA failed to publish timely and complete notices of receipt of PMNs; failed to make health and safety studies, safety data sheets, and other information contained in PMN submissions available for examination; and failed to disclose information claimed as confidential business information when it facially did not qualify as confidential.

EPA moved for judgment on the pleadings, asserting that the plaintiffs are barred from seeking relief under TSCA for most of their claims.  While TSCA’s citizen suit provisions allow persons to compel the agency to perform nondiscretionary duties, EPA argued that the relevant statutory and regulatory provisions “do not impose a date-certain deadline” on EPA.  The agency also argued that judicial review under the APA would be inappropriate because the claims concern activities that are interlocutory in nature and too minor to meet the APA’s threshold for “agency action.”

The court denied EPA’s motion.  Even in instances where TSCA does not set an explicit deadline, the court said that it is sometimes apparent that activities must be taken in relation to other events.  Three of the plaintiffs’ 10 counts were found to fall in this category.  For example, TSCA directs EPA to provide immediate notice of TME applications for public input and requires EPA to make a determination on each application within 45 days.  Since “[n]otice must precede comment” and “comment must precede the EPA’s decision,” “[t]he only logical conclusion” is that notice is required prior to expiration of the 45-day period, the court held.

For the seven remaining allegations—which all concerned the availability of information submitted with a new chemical notification, and for which a deadline for agency disclosure to interested parties could not be ascertained from the statutory structure—the court was unconvinced by EPA’s argument that the APA could not offer relief.  The APA’s definition of agency action has been interpreted expansively by the courts, and the fact that the challenged activities are merely “interim steps” is not dispositive, the decision states.  Importantly, as part of this analysis, the court held that TSCA section 5(b) creates a “freestanding right to information” submitted as part of a new chemical notification.

Judge Loren L. AliKhan also granted the plaintiffs’ motion to compel the administrative record, rejecting EPA’s arguments that the claims should be understood as “failures to act” rather than actions—meaning that they would not have an administrative record.  However, she did not go so far as to agree with the plaintiffs on the merits.

According to EPA, since the case was filed in 2020, the agency has made “substantial and ongoing improvements to its practices for preparing and publishing public notices and public files as part of its ongoing commitment to improving the administration and transparency” of its New Chemicals Program.

In addition to the Environmental Defense Fund, the plaintiffs include the Center for Environmental Health, the Environmental Health Strategy Center, the Natural Resources Defense Council, and the Sierra Club.

EPA Updates Safer Choice and Design for the Environment Standard

/in , , ,

On August 8, 2024, EPA finalized updates to the Safer Choice and Design for the Environment Standard.  The revised standard implements sustainable packaging criteria and introduces a Safer Choice Cleaning Service Certification for cleaning service providers.

Created in 2009, the Safer Choice program allows products such as cleaners and detergents to carry a special label if they meet human and environmental health requirements.  Products must meet both holistic and component-level requirements to be approved for partnership with EPA, which is renewable and lasts three years.  Design for the Environment operates under the same standard and applies specifically to antimicrobial products.

Under the updated standard, primary packaging for certified products can no longer contain intentionally added PFAS.  The revisions also require packages to either be 1) designed to be reused or 2) recyclable and made of a certain percentage of recycled content.

The update also inaugurates a certification program for cleaning services that use certified products “to the maximum extent practicable.”  The agency says that it will consider exceptions on a case-by-case basis, including in situations where limited certified products are available for a certain product class.

Other changes include stricter requirements for pet care products and voluntary criteria aimed at reducing carbon-based energy consumption.  The new standard does not alter the master criteria for ingredients or any of the supplemental requirements for certain product classes.

The update is the first revision to the standard since 2015 and the fourth in its history.  New products must comply with the updated standard immediately.  Existing partnership products must comply within a year after they are notified of the updates.

 

EPA Proposes Risk Management Rule for 1-Bromopropane

/in , ,

On August 8, 2024, EPA published a proposed rule to restrict use of the solvent 1-bromopropane (1-BP) (CASRN 106-94-5).  The proposed rule is the result of the agency’s revised 2022 determination that 1-BP presents an unreasonable risk of injury to human health due to effects including neurotoxicity, developmental toxicity, and carcinogenicity.

According to EPA, 1-BP is used in a wide variety of applications, including “vapor degreasing, aerosol degreasing, adhesives and sealants, and in insulation.”  Data from the Chemical Data Reporting rule shows that annual production of the substance, also known as n-propyl bromide, increased from 15.4 to 25.8 million pounds between 2012 and 2015.  This increase was because 1-BP is “an alternative to ozone-depleting substances and chlorinated solvents,” according to a 2020 EPA risk evaluation.

Under the proposed rule, all consumer uses of 1-BP would be banned except for use in insulation.  EPA is also proposing to prohibit four industrial and commercial uses, including use in adhesives and sealants, dry cleaning solvents, and automotive care products.  EPA estimates that these banned uses represent about 3% of the current annual production of 1-BP.

Other industrial and commercial uses would be subject to a workplace chemical protection program (WCPP), which would implement an inhalation exposure concentration limit for 1-BP of 0.05 ppm as an eight-hour time weighted average.  Use of chemically resistant gloves would also be required for uses including manufacturing, processing, and disposal.

Notably, in an effort to protect fenceline communities, EPA is proposing to prohibit owners or operators from increasing releases of 1-BP to outdoor air to comply with WCPP requirements.

EPA is proposing staggered compliance dates for the prohibited uses, which would become effective in six months for manufacturers, nine months for processors, and in 12 months for distribution to retailers.  Non-federal entities subject to the WCPP would be required to conduct baseline airborne exposure testing within six months and ensure that the inhalation exposure limit is met within nine months.

1-BP was added to the Toxics Release Inventory list of reportable chemicals in 2015 and became the first addition to the list of hazardous air pollutants in 2022.  More on 1-BP’s addition to the list can be found in a previous blog post.

Comments on the proposed rule are due September 23, 2024.

EPA Releases Second Version of Interim Guidance on PFAS Destruction and Disposal

/in , ,

On April 8, 2024, EPA released the second version of its interim guidance on the destruction and disposal of PFAS and PFAS-containing materials.  The updated interim guidance builds on the initial guidance issued in 2020 by providing new recommendations for the management of PFAS-containing materials.

The updated interim guidance focuses on three categories of large-scale destruction and disposal technologies: underground injection, landfilling, and thermal treatment.  For each category, EPA identifies the technology with a lower potential for environmental release of PFAS when compared to other technologies within their category:

  • Permitted Class I non-hazardous industrial or hazardous waste injection wells (underground injection);
  • Permitted hazardous waste landfills (landfilling); and
  • Permitted hazardous waste combustors (thermal treatment).

However, each technology has drawbacks and is only suitable for certain types of PFAS-containing materials.  For example, EPA notes that new information suggest landfills may release more PFAS into the environment than previously understood, and that transportation logistics may limit the types and amounts of PFAS-containing fluids that can be inserted into Class I wells.

EPA emphasizes the limitations of available data and includes a list of prioritized research needs to inform future guidance.  High-priority research needs include information on releases from landfills and data on releases from thermal treatment units.  EPA describes a new analytical method, OTM-50, that it believes will better characterize the products of incomplete combustion.

In addition, the updated interim guidance presents a new evaluation framework designed to assess emerging technologies and determine their suitability for specific PFAS-containing materials. It also includes an updated list of tools to screen for potentially vulnerable populations living near likely PFAS destruction or disposal sites.

EPA was mandated to publish and triennially update the interim guidance by the FY 2020 National Defense Authorization Act.  More information on the updated interim guidance can be found in an EPA fact sheet.

Comments on the updated interim guidance are due October 15, 2024.

EPA Proposes to Designate Five Substances as High Priority

/in , ,

On July 25, 2024, EPA published a notice proposing to designate a new batch of existing chemicals as high priority substances under section 6 of the Toxic Substances Control Act (TSCA).  TSCA section 6 requires EPA to continually designate existing chemicals as “high-priority” based on factors including hazard and exposure potential.  Once a high priority designation is made, EPA is required to conduct a risk evaluation and regulate the chemical if it is found to present an unreasonable risk.

If the notice is finalized as proposed, EPA would immediately initiate risk evaluations for the following five substances:

  • Vinyl Chloride (CASRN 75-01-4)
  • Acetaldehyde (CASRN 75-07-0)
  • Acrylonitrile (CASRN 107-13-1)
  • Benzenamine (CASRN 62-53-3)
  • 4,4’-methylene bis(2-chloroaniline) (MBOCA) (CASRN 101-14-4)

According to an EPA press release, vinyl chloride is a known human carcinogen linked to liver, brain, and lung cancer in exposed workers.  In the release, EPA stated that vinyl chloride’s health hazards helped motivate the passage of TSCA in 1976.

The press release noted that the other four substances are probable human carcinogens and that some pose other types of hazards, such as respiratory and reproductive harms.  All five substances are used to make plastic; vinyl chloride is mostly used to make polyvinyl chloride, better known as PVC.

EPA announced that it was beginning the process of prioritizing these chemicals in December 2023.  In that announcement, EPA also stated that that it “expects to initiate prioritization on five chemicals every year, which will create a sustainable and effective pace for risk evaluations.”

Comments on the notice are due October 23, 2024.

Kansas City Grocers Ordered to Stop Selling Illegally-Imported Disinfectants

/in , , ,

On May 6, 2024, EPA Region 7 announced that 17 grocery stores in the Kansas City area had been ordered to stop the sale and use of certain Fabuloso-brand cleaners and other disinfectants because of potential health risks.  The orders, issued by the Kansas and Missouri Departments of Agriculture in partnership with EPA, require the stores to immediately remove the illegal products from their shelves.

According to EPA’s press release, the products contain glutaraldehyde, an active ingredient not approved for household disinfectant use in the U.S. due to its potential health risks. These risks include “throat and lung irritation, asthma and difficulty breathing, dermatitis, nasal irritation, sneezing, wheezing, burning eyes, and conjunctivitis.”

EPA says that the products were illegally imported.  The press release states that their labels are primarily in Spanish and that the affected grocers “serve Hispanic communities.”

It is important to note that not all Fabuloso products are unsafe.  There is also an EPA approved US version of Fabuloso which does not contain glutaraldehyde.  According to the press release, some stores subject to the orders sold both the illegal and the approved US versions of the disinfectants.