EPA Releases Final Scope Documents Under New Policy

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On August 31, 2021, EPA released Toxic Substance Control Act (TSCA) final scope documents for diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP).  The final scope documents are the first to implement the Agency’s new policy for considering exposure to the chemicals from media that are regulated outside of TSCA including air and water, including drinking water.  In a press release on the path forward for risk evaluations, the Agency noted that the previous administration’s “…approach to exclude certain exposure pathways also resulted in a failure to consistently and comprehensively address potential exposures to potentially exposed or susceptible subpopulations, including fence-line communities (i.e., communities near industrial facilities).”  Both risk evaluations were requested by the manufacturer, ExxonMobil, through the American Chemistry Council’s High Phthalates Panel (ACC HPP).

The scope documents for these risk evaluations includes the following information: the conditions of use, potentially exposed or susceptible subpopulations (PESS), hazards, and exposures that EPA plans to consider, along with a description of the reasonably available information and science approaches EPA plans to use in the risk evaluations, a conceptual model, an analysis plan, and the plan for peer review of the draft risk evaluation for this category of chemical substances.

Some of these conditions of use were identified in the manufacturer request as circumstances on which EPA was requested to conduct a risk evaluation. EPA identified other conditions of use from information reported to EPA through Chemical Data Reporting (CDR), published literature, and consultation with stakeholders for both uses currently in production and uses whose production may have ceased

EPA plans to evaluate releases to the environment as well as human and environmental exposures resulting from the conditions of use of these substances that EPA plans to consider in the risk evaluation.  In addition to including occupational exposure, consumer and bystander exposure, and PESS, the scope of the risk evaluations will include general population exposures.  Specifically, EPA plans to evaluate general population exposure to the substances via the oral route from drinking water, surface water, groundwater, ambient air, soil, fish ingestion, and human breast milk; via the inhalation route from air and drinking water; and via the dermal route from contact with drinking water, surface water, groundwater and soil.

In addition to considering the data and information sources provided by the ACC HPP submissions, EPA conducted a comprehensive search to identify and screen multiple evidence streams (i.e., chemistry, fate, release and engineering, exposure, hazard) to inform the development of these scoping documents.

EPA Requires Reporting on Fifty Chemicals

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On June 29, 2021 EPA finalized a rule that requires manufacturers of 50 chemicals to report health and safety studies data to the EPA.  This rule was issued under the Toxic Substances Control Act (TSCA), section 8(d) and pertains to 20 chemicals EPA designated as high-priority for risk evaluation and 30 chemicals that are organohalogen flame retardants.  EPA is also requiring manufacturers to report unpublished studies for the chemicals relating to environmental effects, occupational, general population, and consumer exposure.

The TSCA Interagency Testing Committee added these 50 chemicals to their Priority Testing Lists in its 69th through 74th reports, which led to the issuing of this rule.  EPA’s goal with this rule is to determine if there is an unreasonable risk to health or environment under the chemical’s conditions of use.  Additionally, this information will be considered in situations, as applicable, in read across and category development for assessing new chemicals.  The final rule is effective July 29, 2021.

Confidential Status Change of TSCA Chemicals

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The confidential business information status of chemicals on the TSCA Inventory is scheduled for change, removing the confidential chemical identity status for 390 chemicals.  This will move the chemicals to the public portion of the TSCA Inventory.  During the 2012, 2016, and 2020 reporting periods, one or more manufacturers reported these chemicals as non-confidential, which is a result of at least one of these manufacturers not reporting a previous confidential chemical as confidential.

EPA recognizes that some manufacturers may have simply been in error for not reporting their chemicals as confidential.  However, EPA states that for each of the 390 chemicals, there is independent reporting based and EPA validated reasons to include the chemicals on the list.  EPA intends to move these chemicals from the confidential chemical identity status of the TSCA Inventory to the public portion sometime during the summer of 2021.

EPA also recognizes stakeholder interest in the status change for these chemicals and has given June 30, 2021 as a deadline for interest, questions, or concerns regarding the change.

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.

ITC Submits New Priority Testing List

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The TSCA Interagency Testing Committee (ITC) submitted a report to EPA on April 13, 2020 listing an additional 39 chemicals on the priority testing list.  Within the 39 chemicals, 15 are already designated as high-priority substances and 24 are organohalogen flame retardants.  The priority testing list currently has five other high-priority substances and six organohalogen flame retardants.  The high-priority substance list contains substances with the most demand for evaluation from a risk-based screening process.

ITC also recommended the 15 high-priority substances be added to TSCA section 8(d) Health and Safety Data Reporting rule in order for EPA to obtain unpublished health and safety studies.  The report states the high-priority substances may present an unreasonable risk for the health of people and/or the environment.  The risk evaluation process has already begun for each of these high-priority substances.

The 24 organohalogen flame retardants were added to the priority testing listing after the Consumer Product Safety Commission (CPSC) voted to ask the ITC to add the chemicals.  In addition, CPSC granted a petition to begin rulemaking for additive, nonpolymeric organohalogen flame retardants under the Federal Hazardous Substances Act

EPA is currently seeking public comments on the revisions to the priority testing list and any information relevant to the listing.  The comment period is open until May 28, 2021.

Manufacturer Request for Risk Evaluation of OTNE

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On November 20, 2020, EPA received a manufacturer request for risk evaluation for the chemical substances in the octahydro-tetramethyl-naphthalenyl-ethanone chemical category (OTNE).  These substances are used as fragrance ingredients.  The three manufacturers, International Flavors and Fragrances, Inc., Privi Organics USA Corporation, and DRT America, Inc., sent the request through the OTNE Consortium.

The risk evaluation request applies to four chemicals within OTNE.  The Toxic Substances Control Act (TSCA) considers two of the chemicals to be persistent, bioaccumulative and toxic (PBT) chemicals.  While completing the risk evaluation for the OTNE chemical, EPA is not allowed to consider costs or other non-risk factors (15 U.S.C. 2605(b)(4)(F)(iii)).  The request for evaluation also includes possible conditions of use for EPA to identify.

EPA has until no later than June 5, 2021 to either grant or deny the request to conduct the risk evaluation for the OTNE chemicals.  In order for EPA to grant the request, it must meet all of the requirements listed under 40 CFR 702.37(e)(6)(ii).  These conditions are that the request constitutes conditions of use that warrant inclusion in a risk evaluation, EPA has all the necessary information to conduct the risk evaluation, and all the remaining criteria of 40 CFR 702.37 are met, such as manufacturers paying fees to support the risk evaluations.

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.

EPA Changing Systematic Review Approach

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In February 2021, EPA announced the Agency’s commitment to strengthening science used in chemical risk evaluations.  EPA stated the Agency will continue to update its systematic review approach and its broader efforts to review the first 10 TSCA risk evaluations.  The first 10 TSCA risk evaluations were complete in January 2021.  Following the review of their 2018 systematic review approach by the National Academies of Science, Engineering, and Medicine (NAS), EPA stated they will never use that particular systematic review again.

NAS recommendations included:

  • Engaging in ongoing cross-sector efforts to develop and validate new tools and approaches.
  • Incorporating components of existing hazard assessments approaches.
  • Creating a handbook to assist with incomplete and hard to follow documentation.
  • Using standard descriptors for the strength of evidence.

EPA stressed that the NAS report was based on earlier EPA practices, and part of the reason for updating the systematic review approach is to ensure the review of the first 10 TSCA risk evaluations are done in accordance with Executive Orders and other directives from the Biden Administration.  The Agency’s goals from the review are that:

  • All Agency actions meet statutory obligations,
  • Be guided by the best available science,
  • Ensure the integrity of Federal decision-making, and
  • Protect human health and the environment.

EPA has begun the process of creating a TSCA systematic review protocol in collaboration with the Agency’s Office of Research and Development.  The new review protocol will incorporate approaches from the Integrated Risk Information System (IRIS) Program, as recommended by NAS.  EPA expects to publish and take comments on the new review protocol later this year.

EPA Issues Stop Sale, Use, or Removal Orders to Amazon

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In February 2021, EPA announced that the Agency issued a “stop sale” order to Amazon in relation to unregistered pesticides and disinfectants.  This is the third stop sale order Amazon has been issued by EPA and brings the list of products in the stop sale order from 30 to 70.  The first stop sale order for unregistered pesticide products was on August 12, 2015.  The second stop sale order for unregistered pesticide products was on January 29, 2016.  For the current stop sale order, a majority of the products at issue make antimicrobial, antibacterial, or antiviral claims.  A few examples include Antimicrobial Pure Copper Therapy Ring, Replaceable Wipes Made of Sterile Non-Woven Fabric, and Antibacterial Sanitizing Disinfecting Alcohol Wipes.  EPA states that consumers wishing to purchase products to kill the coronavirus SARS-CoV-2 (COVID-19) should refer to the Agency’s list of disinfectants, instead of purchasing unregistered pesticides, because unregistered pesticides have not been evaluated for safety and efficacy by EPA.

In its announcement, EPA reminded the public that unregistered pesticides pose health risks to consumers, children, pets, and others who are exposed to the products.  Additionally, EPA advised consumers to dispose of the unregistered pesticides and disinfectants in accordance with local, state, and federal laws.  The announcement noted that pesticides and disinfectants intended for sale in the U.S. must be evaluated by EPA and have approved labeling with an EPA registration number according the requirements of the Federal Insecticide Fungicide and Rodenticide Act.

Antimicrobial Inert Ingredient QR Code/Website Link

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EPA is now allowing companies to include a QR code or website link on their product labels to provide information on inert ingredients.  As of this publication date, this option is only available for antimicrobial pesticide products.  Providing this additional information is strictly voluntary for companies, with exception on a case-by-case basis for where it has been required.  Although voluntary, providing this information is encouraged for showing transparency.

EPA states that if a company chooses to disclose their inert ingredients, they should include all of them.  Any partial lists could mislead the consumer into believing it was a complete list.  The Agency also recommends listing ingredients in descending order of weight.

Pesticide producers should note that including a QR code or website link results in the information being subject to FIFRA and EPA review in order to ensure there is no violation of FIFRA’s provisions against misbranding (FIFRA sections 2(q) and 12(a)(1)(E)).  The companies including this information need to verify the its accuracy.  Companies must also submit an application to EPA for voluntary inert ingredient disclosure.  The application identifies the proposed changes on the product label detailing the QR code or website link, and includes a self-certification statement.  The self-certification statement includes acknowledgement that any false statements could lead to enforcement actions.   EPA’s announcement also mentions that once the Agency gains experience handling this type of labeling, they may allow inert ingredient disclosure applications to be included with other actions.