Update on Roundup Appeal to the U.S. Supreme Court

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Roundup has been the subject of countless lawsuits.  One critical case is Monsanto v. Hardeman, 21-241.  Bayer has petitioned the U.S. Supreme Court for relief.  Recent Court action suggests that the Supreme Court might hear the case.  In December the U.S. Supreme Court solicited the Biden administration’s opinion on whether to hear Bayer AG’s appeal of a $25 million award to Edwin Hardeman.  Hardeman asserts that decades of exposure to Roundup caused his non-Hodgkin’s lymphoma.

Bayer contends that the Ninth Circuit wrongly affirmed the district court’s decision.  The company argues that the Ninth Circuit wrongly decided that FIFRA did not preempt Hardeman’s state-law failure-to-warn claim, despite EPA’s conclusion that such a cancer warning would be false and therefore prohibited by FIFRA.  The company asserts that ruling contravenes the Supreme Court’s holding that any state labeling requirement not “genuinely equivalent” to a FIFRA labeling requirement is preempted. Bates v. Dow Agrosciences LLC, 544 U.S. 431, 454 (2005).

Bayer further argues that the Ninth Circuit wrongly affirmed the admission of expert opinions that glyphosate can cause non-Hodgkin’s lymphoma and caused Hardeman’s cancer specifically, even though those opinions rested on “little more than subjective intuitions” in conflict with Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 597 (1993), which requires trial courts to play “a gatekeeping role” to ensure that expert opinions are reliable, and with Federal Rule of Evidence 702, which requires expert opinions to be the product of “reliable principles and methods,” “reliably applied … to the facts of the case,” Fed. R. Evid. 702(c)-(d).

The following groups have filed amici briefs in the case: CropLife America, U.S. Chamber of Commerce, Atlantic Legal Foundation, Lawyers for Civil Justice, Product Liability Advisory Council, Inc., Retail Litigation Center, Inc., and Washington Legal Foundation. In response to the Supreme Court announcement, Bayer released a statement declaring that “[n]ow that the Supreme Court has requested input from the Solicitor General in this case, we will not entertain any further settlement discussions with plaintiff lawyers that are representing a substantial number of Roundup claims.”

It is expected that, before the current Court term ends in late June, the justices will probably say whether or not they will hear the case.

EPA Proposes Addition of 12 Chemicals to Toxic Chemical List

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EPA is proposing to add 12 chemicals to the list of toxic chemicals which are subject to the reporting requirements under the Emergency Planning and Community Right-to-Know Act (EPCRA), section 313.  Under EPCRA section 313(e)(1), any person may petition EPA to add chemicals to or delete chemicals from the list. EPA issued a statement of policy in the Federal Register of February 4, 1987 (52 FR 3479) (FRL-3101-6) providing guidance regarding the recommended content of and format for petitions.  Additionally, EPA believes one chemical should be classified as a persistent, bioaccumulative, and toxic (PBT) chemical.  The Toxics Use Reduction Institute filed a petition for EPA to consider 25 chemicals for inclusion the toxic chemicals list. EPA reduced the list to 12 because the other chemicals did not meet the statutory criteria listed below.

The chemicals substance identities and CASRNs are:

  • 1-Bromopropane; 106-94-5
  • Dibutyltin dichloride; 683-18-1
  • 1,3-Dichloro-2-propanol; 96-23-1
  • Formamide; 75-12-7
  • 1,2,5,6,9,10-Hexabromocyclododecane; 3194-55-6
  • 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta[g]-2-benzopyran (HHCB); 1222-05-5 (PBT chemical identified by EPA)
  • N-Hydroxyethylethylenediamine; 111-41-1
  • Methylhexahydrophthalic anhydride; 25550-51-0
  • Nitrilotriacetic acid trisodium salt; 5064-31-3
  • Nonylphenol; 25154-52-3
  • p-(1,1,3,3-Tetramethylbutyl)phenol; 140-66-9
  • 1,2,3-Trichlorobenzene; 87-61-6
  • Triglycidyl isocyanurate; 2451-62-9
  • Tris(2-chloroethyl) phosphate; 115-96-8
  • Tris(1,3-dichloro-2-propyl) phosphate; 13674-87-8
  • Tris(dimethylphenol) phosphate; 25155-23-1

EPCRA section 313 allows for the addition of chemicals if they meet one of three different requirements: acute human health effects criterion, chronic human health effects criterion, and environmental effects criterion.   Substances can be added to the section 313 list if:

  • The chemical can reasonably be anticipated to cause significant health issues in humans, existing beyond the facility site, as a result of continued releases.
  • The chemical can reasonable be anticipated to cause cancer, reproductive issues, neurological disorders, heritable genetic mutations, or other chronic health effects in humans.
  • The chemical can reasonably be anticipated to cause a significant adverse effect on the environment to due to its toxicity that it warrants reporting under this section in the judgment of the Administrator.

EPA believes these 12 chemicals in moderately low to low doses/concentrations each meet at least one of the criteria. EPA is proposing a 100-pound reporting threshold for HHCB because it has been shown to be bioaccumulative in aquatic species with bioconcentration factor values greater than 1,000.  The threshold for reporting non-PBT, toxic chemicals is 10,000 pounds of the chemical used at a facility per year.

White House Plan to Combat PFAS

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The White House announced a multi-agency plan to address the risks posed by PFAS.  The plan involves eight federal agencies including the Departments of Agriculture, Defense, Agriculture, Homeland Security, and Health and Human Services (HHS).   The White House explained that “To safeguard public health and protect the environment, the efforts being announced will help prevent PFAS from being released into the air, drinking systems, and food supply, and the actions will expand cleanup efforts to remediate the impacts of these harmful pollutants.”

A key element in this plan is EPA’s PFAS Roadmap, which addresses PFAS through a number of environmental statutes from TSCA to the Safe Drinking Water Act.

The White House Council on Environmental Quality (CEQ) Chair Brenda Mallory will lead the newly-formed Interagency Policy Committee on PFAS. The committee on PFAS will work to coordinate and help develop new policy strategies to support research, remediation, and removal of PFAS in communities across the country.

The White House Fact Sheet also identified efforts underway at the DOD, FDA, and other HHS agencies.

DOD is conducting PFAS cleanup assessments at the nearly 700 DOD installations and National Guard locations where PFAS were used or may have been released.  The Department expects to complete its initial assessments by the end of 2023.  In addition, DOD manages a large research and development program on PFAS detection, treatment, and destruction—with $70 million devoted to a PFAS-free replacement firefighting foam.

The FDA will expand its testing of the food supply to advance efforts to estimate dietary exposure to PFAS from food.  In addition, FDA will report on the process of phasing out sales of certain PFAS from food contact uses, following the 3-year phase out agreements reached with certain manufacturers in 2020.  Outreach efforts are also underway to ensure that companies are reminded of packaging requirements that are intended to reduce human exposure to PFAS.  The FDA will also monitor the presence of and potential exposure to PFAS in cosmetics.

HHS will review the research on human health and PFAS.  This includes a study by two HHS agencies, Centers for Disease Prevention and Control (CDC) and Agency for Toxic Substances and Disease Registry (ATSDR), in eight states that will provide information about the health effects of PFAS exposure.

EPA PFAS Strategic Roadmap

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EPA has compiled a roadmap outlining Key Actions to address the risks posed by PFAS.  The roadmap identifies key actions under TSCA and other statutes including the Clean Water Act, the Safe Drinking Water Act, and Superfund.

TSCA

The roadmap calls for EPA to “close the door” on abandoned PFAS; i.e., PFAS chemicals that are no longer produced.  Many of these substances have no restrictions under TSCA.  This leaves the door open for manufacturers to start producing the chemicals again.  The roadmap intends for EPA to designate all uses of these substances that are not current uses as Significant New Uses.  This will allow EPA to review and make determinations on the potential risks, and require safety measures, before allowing the manufacturing of those chemicals again.   The roadmap states that EPA plans to implement this action item during the summer of 2022.

There is an ongoing goal of completing toxicity assessments for two PFAS known as GenX chemicals.  EPA also has a goal to publish health advisories for GenX chemicals and PFBS in Spring 2022.

Other actions under TSCA include

  • Publish national PFAS testing strategy,
  • Review previous decisions on PFAS, and
  • Finalize new PFAS reporting under TSCA Section 8.

TRI

Another key action in the roadmap is for EPA to categorize PFAS on the Toxic Release Inventory (TRI) as “Chemicals of Special Concern” and to remove the de minimis eligibility from supplier notification requirements for all Chemicals of Special Concern.  Adding PFAS to TRI has a projected completion goal of 2022.

CWA

The roadmap calls for restricting PFAS discharges from industrial sources through a multi-faceted Effluent Limitations Guidelines (ELG) program.  EPA plans to undertake rulemaking to restrict PFAS discharges from organic chemicals, plastics and synthetic fibers, metal finishing, and electroplating operations.  A proposed rule for plastics and synthetic fibers is expected in Summer 2023, and a rule for metal finishing and electroplating is expected in Summer 2024.  Other industries EPA is considering issuing PFAS ELGs for include electrical and electronic components, textile mills, and landfills.

SDWA

EPA has goal to establish a national primary drinking water regulation for PFOA and PFOS.  EPA regulates drinking water for over 90 contaminants but that does not include any for PFAS.  EPA expects to issue a proposed regulation in Fall 2022.  The agency has a statutory deadline of March 2023 to complete this action.

Superfund

EPA is developing a Notice of Proposed Rulemaking to designate PFOA and PFOS as CERCLA hazardous substances.  This would require facilities to report on PFOA and PFOS releases that meet or exceed set reportable quantities.  The proposed rulemaking will be available for public comment in Spring 2022.   EPA is also asking for public comment on designating additional PFAS as hazardous substances under CERCLA.

CAA

The Clean Air Act requires EPA to regulate emissions of hazardous air pollutants, which do not currently include PFAS.  EPA plans to identify sources of PFAS air emissions, concentration levels, and cost-effective mitigation technologies.

EPA Extends Submission Deadline for Health and Safety Studies on 50 Chemicals

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EPA is allowing manufacturers and importers additional time to submit unpublished health and safety studies’ data for 50 chemicals.  The new deadline for 20 of the 50 chemicals is December 1, 2021, updated from September 27, 2021.  The new deadline for the remaining 30 chemicals is January 25, 2022.  The 20 chemicals in the first group fall into the category of high priority for risk evaluation – note that EPA explains that being classified as high priority does not necessarily mean that a chemical is high risk.  These chemicals are currently undergoing Risk Evaluation under TSCA.  The Health and Safety studies will help EPA prepare scoping documents that identify the hazards, exposures, conditions of use of the chemicals, and potential exposures to them.

The 30 chemicals in the second group are organohalogen flame retardants.  These chemicals are being evaluated by the Consumer Product Safety Commission, which is a member of TSCA’s Interagency Testing Committee.

Additional information on the reporting requirements for the 50 chemicals can be found here and additional information on initial addition of the chemicals to the list here.

Policy Changes for PFAS Entering the Market

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On April 27, 2021 EPA announced policy changes regarding new PFAS prior to the chemicals entering the market.  Previously, low volume exemptions were allowed for some new PFAS.  EPA will implement new rules for reviewing and managing the low volume exemption requests.  After receiving the request, EPA has 30 days to conduct the review and determine if the chemical in the request could cause serious human health effects or significant environmental effects.  If either of the effects are determined, or if the process would take more than 30 days, the request is denied.

EPA stated it is unlikely to grant any low volume exemptions for PFAS due to the chemicals’ history of damaging health effects and the complexity of the process resulting in longer than 30 days to complete a review.  Denying these lengthy process reviews of PFAS allows the EPA to devote more time on pre-manufacture notice review processes and mitigate potential risks of the chemicals.  EPA is also looking for way to work with companies which have been granted low volume exemptions for PFAS and have them voluntarily withdraw their low volume exemptions.

PBT Rules

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In January 2021, EPA published the final rules for five Persistent, Bioaccumulative, and Toxic (PBT) chemicals.  The public comment period for these rules is open until May 17, 2021.  The five PBT chemicals are:

  • Decabromodiphenyl ether (DecaBDE)
  • Phenol, isopropylated phosphate (3:1) (PIP (3:1))
  • 2,4,6-Tris(tert-butyl)phenol (2,4,6-TTBP)
  • Hexachlorobutadiene (HCBD)
  • Pentachlorothiophenol (PCTP)

DecaBDE is used as an additive flame retardant in plastic enclosures for TVs, computers, and other household appliances.  It is toxic to aquatic animals and terrestrial invertebrates, causing developmental, neurological, and immunological issues.  It also harms the liver and is a carcinogen.  EPA’s published rule for decaBDE prohibits the manufacture, important, process and distribution of decaBDE products with a few exceptions, such as wire and cable for the two-year period until the prohibition goes into effect.

PIP (3:1) is used as a plasticizer, flame retardant, anti-wear additive, and anti-compressibility additive.  It is toxic to aquatic plants and animals, potentially causing reproductive and developmental effects on the animals’ organs.  EPA’s published rule for PIP (3:1) prohibits processing and distribution of PIP (3:1) and products containing it with some exceptions, such as various automotive and aviation products.  EPA issued a temporary 180-day “No Action Assurance” on the prohibitions for processing and distributing PIP (3:1) articles, which gives EPA enforcement discretion to ensure important articles are no interrupted in the supply chain.

2,4,6-TTBP is used as a reactant in processing and is used in fuel, fuel-related additives, oils, and lubricants.  It is toxic to aquatic plants and animals, causing developmental issues and harm to the liver. EPA’s published rule is to effectively prevent the use of 2,4,6-TTBP as a fuel injector cleaner and fuel additive for small commercial operations by prohibiting distributions of the chemical in concentrations above 0.3% in any container with less than 35 gallons.  Additionally, EPA prohibits its use as an oil and lubricant additive in concentrations of 0.3% regardless of the container size.

HCBD is burned as waste fuel after being created as a byproduct in the manufacturing of chlorinated hydrocarbons, particularly perchloroethylene, trichloroethylene, and carbon tetrachloride.  It is toxic to aquatic animals, birds, causing renal, reproductive, and developmental effects.  It is also potentially a human carcinogen. EPA’s published rule prohibits manufacturing, processing, and distributing HCBD is all products except those that unintentionally create it as a byproduct in the production of chlorinated solvents.

PCTP is used to make rubber more pliable.  It is toxic to fish, plants, and birds, causing liver and reproductive effects.  EPA’s published rule prohibits the manufacturing, processing, and distribution of all PCTP products above 1% concentration by weight of the chemical.

Amazon Creates New Restricted Substances List

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In December 2020, Amazon announced they will avoid the intentional addition of chemicals in certain products in their U.S. and EU market.  These restrictions concern Amazon’s food contact packaging.  The chemicals targeted have carcinogenic, mutagenic, reproductive, and other toxicant properties.  Amazon also focused on chemicals that are persistent and bioaccumulative.  The chemicals on the restricted substances list include all PFAS, phthalates, and BPA.   This announcement comes shortly after a 2020 court case closed in December, in which the plaintiff alleged Amazon had PFAS in their disposable plates.

Amazon has updated their chemicals and restricted substances page on the website to reflect the announcement.  The company already seeks to avoid a number of chemicals in their Amazon brands of Private Brand Baby, Household Cleaning, Personal Care, and Beauty products, including formaldehyde, nonylphenols, parabens, and phthalates.

Chlorpyrifos Registration Status

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Farmworker Justice is pressuring EPA to ban the use of the pesticide chlorpyrifos.  The organization is collecting signatures on a petition supporting the ban.  The petition notes that chlorpyrifos can cause dizziness, vomiting, convulsions, numbness in the limbs, loss of intellectual functioning, respiratory paralysis, and death.  Farmworker Justice plans to send the petition to EPA and key members of Congress.

According to EPA, chlorpyrifos has been in use since 1965 and is registered with various limitations, such as “restricting entry into treated fields for 24 hours up to five days.”  Use of the pesticide has been at issue for a number of years.  In 1996, EPA recognized the need to contain chlorpyrifos exposure after the Food Quality Protection Act created more stringent safety standards.  In 2000, EPA reached an agreement with registrants of chlorpyrifos to eliminate, phase out, and modify certain uses.  In 2002, EPA created buffer zones for using chlorpyrifos and increased the personal protective equipment requirement for application.  In 2011, EPA complete a comprehensive preliminary human health risk assessment for all chlorpyrifos uses and revised the assessment in 2014.  In 2012, EPA further restricted aerial application and created “no-spray” zones.  The U.S. Ninth Circuit Court of Appeals ordered EPA to ban chlorpyrifos within 60 days in August 2018, but the Department of Justice requested a rehearing, which was granted on February 6, 2019, effectively vacating the earlier ruling.

Until February 3, 2021, EPA is accepting public comment on a proposed interim decision on chlorpyrifos that was released in December 2020.  EPA’s proposed interim decision recognizes the need for precautions in the use of chlorpyrifos.  The proposed interim decision asserts that all pesticides registered by EPA follow FIFRA mandates that ensure that proper use, as directed by the product label, will not cause unreasonable risks to health.

Amicus Brief on EPA and Sulfoxaflor

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On December 7, 2020, the attorneys general for 11 states filed an amicus brief with the Ninth Circuit Court of Appeals opposing EPA’s remand motion concerning the pesticide sulfoxaflor.  EPA’s motion asked the court to allow revision of its registration for sulfoxaflor without vacating it.  EPA initially registered sulfoxaflor for use in 2013 with limitations on its use due to its toxicity to bees and the potential risk to birds.  In 2019, EPA registered new uses for sulfoxaflor, including application to alfalfa, corn, cacao, grains, pineapple, strawberries.  At issue in the litigation are the following:

  • Approval of sulfoxaflor uses without consideration of its effects on endangered species after 2015 Ninth Circuit Court ruling to vacate the registration.
  • Need for consideration of sulfoxaflor’s effects on endangered species in its registration.
  • Need for consultation with expert agencies.
  • Whether the Endangered Species Act (ESA)-protected species are endangered in violation of EPA’s FIFRA mandate that its pesticide use approvals not result in “unreasonable adverse effects on the environment.”

Granting EPA’s motion would allow sulfoxaflor use for at least seven years.

The amicus brief states EPA’s motion for remand without vacatur is unwarranted because EPA has demonstrated ongoing and systematic failure to consult under the ESA.  The attorneys general noted that Congress ordered EPA to report on its ESA consultation progress in 2014 and 2018.  The brief stressed that the backlog of pesticide chemicals for review is already quite long, and that EPA has admitted that the evaluation of sulfoxaflor on remand would not begin until June 2025, at the earliest.  Concern that without proper foundational review by EPA, the burden of ensuring pesticide safety passes down to the states was emphasized by the brief.  Finally, the brief argues that “proceeding to the merits would most efficiently resolve the issues in this case.”