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.”

PFAS in the NDAA

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The 2021 National Defense Authorization Act (NDAA) addresses PFAS in several ways.  Sections 330 and 334 incentivize developers to create and promote additional alternative firefighting foam to replace the PFAS-containing aqueous film-forming foam.

Section 332 establishes an interagency body on PFAS research and development.  The interagency group will have representatives from at least 19 different agencies. The Director of the Office of Science and Technology Policy will Co-Chairs the group with a representative from another member agency, which will change on a biannual rotating basis. Goals of the organization will be:

  • Removal of PFAS from the environment,
  • Safe destruction or degradation of PFAS,
  • Development of safer and environmentally friendly alternatives to PFAS,
  • Understanding sources of environmental PFAS contamination and exposure, and
  • Understanding the toxicity of PFAS to humans and animals.

Section 333 states that the “Department of Defense may not procure any covered item that contains perfluorooctane sulfonate (PFOS) or perfluorooctanoic acid (PFOA).”  ”Covered items” is limited to nonstick cookware and utensils, and fabrics that have been treated with stain-resistant coatings.  This section does not take effect until April 1, 2023.

Section 335 requires providing notification to agricultural operations located in areas exposed to department of defense PFAS use.  Any agricultural operation within 1 mile of a military or National Guard facility where PFAS has been detected in the ground water, drinking water, or well water must be notified.  Notification must occur within 60 days of the enactment of the NDAA. Notification of any updated testing results must occur within 15 days after validated test results are received.

The NDAA was passed by Congress on December 11, 2020.

EPA Petition on Chemours PFAS

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On October 14, 2020, EPA received a petition to require health and environmental testing under Section 21 of the Toxic Substances Control Act (TSCA) on certain PFAS manufactured by Chemours in Fayetteville, North Carolina.  The petitioners consist of the Center for Environmental Health, the Cape Fear River Watch, Clean Cape Fear, Democracy Green, Toxic Free NC, and the NC Black Alliance.  The petition requests testing on 54 PFAS which Chemours produces.  The petition states that the 54 PFAS meet the criteria for testing in section 4(a) of TSCA.  It states that,

Based on the known hazards of these analogues, untested PFAS with potential for exposure would meet the criteria for testing in section 4(a)(1)(A) of TSCA because they “may present an unreasonable risk of injury” and have “insufficient information and experience” to determine their effects on health or the environment.

The PFAS produced by Chemours includes both commercial products and byproducts from their manufacturing process.  Some of the testing differs based on whether the compound is Tier 1 (detection in human sera, food or drinking water) or Tier 2 (significant potential for human exposure based on detection in environmental media and other evidence).  The petition also states that Gen X chemicals have been detected in drinking water and private wells in the vicinity of the Chemours plant.  A major point of concern for the petitioners involves the North Carolina consent order, which is the result of a lawsuit against Chemours from the North Carolina Department of Environmental Quality addressing PFAS contamination in the Cape Fear River basin from the Chemours’ facility.  The petition states current testing of Gen X chemicals by Chemours has been inadequate to fully evaluate the risks and additional carcinogenicity studies are needed.

The petition proposes testing with animal studies:

  • 28-day repeated dose rodent toxicology studies to determine impact on health,
  • Multigeneration or extended one-generation and 2-year rodent carcinogenicity studies for Tier 1 substances,
  • Testing on both mice and rats using oral routes of administration,
  • Inhalation testing used for volatile chemicals, and
  • Toxicokinetic studies to characterize relationship between serum concentrations and dermal to evaluate biological half-life and potential for bioaccumulation.

The petition also proposes the following human studies:

  • A human health study for the Cape Fear watershed to determine the relationship between exposure in the Cape Fear watershed and health outcomes.
  • Testing to determine human half-lives of the listed chemicals through longitudinal biomonitoring and exposure estimation in workers.

PFAS in California’s Water Supply

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Testing of California’s public water supply wells reveals that 60 percent of them contain the “forever” chemicals, perfluoroalkyl and polyfluoroalkyl substances (PFASs). The concentrations of these substances were higher at airports than landfills and public supply wells.  One million parts per trillion were detected at airports, while landfills had 10,000 parts per trillion and public wells had 100 parts per trillion. EPA has established a health advisory level at 70 parts per trillion for the combined amounts of PFOA and PFOS.

The health advisories from EPA offer guidance for states and the federal government to meet standards that will avoid adverse health effects.  Studies of individuals exposed to PFASs show increases in hormonal issues, organ damage, and cancer. Nationally, the Safe Drinking Water Act (SDWA) regulates maximum contaminant levels (MCLs) allowed in drinking water for over 90 chemicals.  However, PFASs currently remain on EPA’s unregulated and non-enforceable list for SDWA MCLs.  EPA’s PFAS Action Plan shows that the Agency is still in the information gathering phase to determine the prevalence and full effects of the PFASs with regulation in the future.

Individual states have been putting their own regulation forward for PFASs.  For example, in September 2020 California Governor Gavin Newsom signed Senate Bill No. 1044, which governs the tracking and recall of firefighting foam containing PFASs.

Walmart to phase out chemicals in cosmetics and household products.

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Walmart, the world’s largest retailer, announced on Thursday a new initiative to eliminate certain chemicals of concern in cosmetics and household products. The company will also expand ingredient disclosure and begin to label its own brand of cleaning products using U.S. Environmental Protection Agency (EPA) Design for Environment (DfE) guidelines.

Under its “Policy on Sustainable Chemistry in Consumables,” [PDF] Walmart will work with suppliers to phase out an initial list of ten “priority” substances. Walmart will not disclose the list of substances until it has further discussed the new policy with suppliers, said the company’s senior vice president for sustainability, Andrea Thomas. However, Thomas said the list was developed with input from suppliers, academics, nonprofits, and the EPA, and that the chemicals were chosen based on their use in products, potential impact, and the availability of viable alternatives. In order to ensure that any replacement chemicals comply with established “green chemistry” requirements, Walmart is requiring its suppliers to use a tool called GreenWERCS, which Walmart developed with the help of the Environmental Defense Fund (EDF) and other public health groups in 2009.

Beginning in 2014, Walmart will start monitoring progress of its new policy, and will also begin to identify some its private brand cleaning products for inclusion in the DfE labeling program. Beginning in 2015, the policy will require suppliers to provide public online ingredient disclosure for products in the categories covered. By 2018, any products still containing “priority” chemicals on Walmart’s list—which will be regularly reviewed to see if additional chemicals should be prioritized—will have to disclose these ingredients on package labels.

Consumer and environmental health advocates welcomed the initiative, which many said was the first chemical policy of this scope by a global retailer. Over the past several years, major Walmart suppliers like SC Johnson, Johnson and Johnson and Procter & Gamble have taken steps to phase out hazardous chemicals. However, as the world’s largest retailer, Walmart’s policy has the most significant potential to encourage large companies to use safer chemicals in their products.

Verdant Proudly Sponsors Prop.65 Clearinghouse's Green Chemistry Conference

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Green Chemistry:

Verdant is pleased to announce its sponsorship of the Prop.65 Clearinghouse Green Chemistry Annual Conference.  This year’s conference will be held on Tuesday, April 9, 2013, at the The City Club of San Francisco, 155 Sansome Street.

  • Verdant attorney, Philip Moffat, will present on “REACH 2013.”
  • Verdant attorney, Catherine Lin, will present on “Supply Chain Management.”

More information about the conference is available here and an agenda is available here.   A copy of Mr. Moffat’s presentation is available here [PDF].

CIEL Report Claims Regulation Stimulates Chemical Innovation

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Chemical Regulation/Innovation:

Earlier this month, the Center for International Environmental Law (CIEL) released its report, Driving Innovation: How stronger laws help bring safer chemicals to market.  In the report, CIEL offers research showing that stronger laws foster innovation by large and small companies alike.  Among other things,CIEL cites the number of patents for alternative chemicals filed every time there’s new chemical regulation. CIEL is located in Washington, D.C. and Geneva, Switzerland.  More information about CIEL is available here.

Forbes magazine recently published an article on this same topic, citing the CIEL report among other sources.  That article is available here.

What do others think of this conclusion?