PCRRTK Friday Forum with Tala Henry and Jeff Dawson on PFAS

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Join the ABA/SEER’s Pesticide, Chemical Regulation, Right-to-Know Committee for a remote Friday Forum with EPA’s Tala Henry, Deputy Director, Office of Pollution Prevention & Toxics, and Jeff Dawson, Deputy Director, Health Effects Division, Office of Pesticide Programs for an overview of EPA’s PFAS Roadmap with emphasis on OCSPP key activities. The program will be held on Friday, December 17th 11-12 pm ET. There is no charge for participation. RSVP to ihantman@verdantlaw.com if you would like to attend.

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EPA is allowing manufacturers and importers additional time to submit unpublished health and safety studies’ data for 50 chemicals.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.

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.

False Claims Suit Against Danimer Scientific

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Danimer Scientific is facing a federal securities class action after an investor, Darryl Keith Rosencrants, filed a suit against the manufacturer in May, 2021.  The suit is a result of severe stock price drops after the publication of articles alleging the manufacturer made false claims on their products.  Danimer maintains that their claims are accurate.

Danimer sells polyhydroxyalkanoates (PHAs) under their brand name Nodax.  These PHAs are used in the creation of various plastic items, such as water bottles, straws, and food containers.  Danimer claims on their website that their Nodax products are 100 percent renewable and biodegradable in marine, freshwater, and soil environments.  They further state that the biodegradability due to certain microorganisms means the Nodax products have the possibility to biodegrade in landfills.

The plaintiff alleges Danimer overstated and exaggerated claims on the biodegradability of Nodax in oceans and landfills.  The plaintiff further claims that these statements led to an inflated value of the company and resulted in the severe drop in stock price once publication reported on the issue.  An article published in the Wall Street Journal on March 20, 2021 states Danimer made misleading claims and cites at least one expert calling Nodax’s biodegradability “not accurate” and “greenwashing”.  When stock trading opened again, Danimer’s value dropped 12.87 percent.

Spruce Point Capital Management, an investment firm, published a report critical of Danimer on several issues, including degradability, on April 22, 2021.  Throughout the trading day, the stock dropped 8.04 percent.  From March 20, 2021 to April 22, 2021, the total drop in value was 54 percent.  The Plaintiff and other Class members are claiming losses and damages due to the precipitous decline of Danimer’s market value securities.

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.

Rite Aid Chemical Policy Update

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The pharmacy chain Rite Aid expanded its chemical management policy on March 3, 2021 to add transparency, include additional chemicals on their restricted substance list, and update their screening method.  Transparency for the new policy requires suppliers to be more specific in listing their ingredients, such as replacing ‘fragrance’ with the ingredients that make up the fragrance.  These generic terms will be replaced with the substances in those components.  Additionally, Rite Aid is encouraging their suppliers to disclose nonfunctional constituents such as by-products and contaminants.  This additional level of detail on the packaging of products sold at Rite Aid stores will become mandatory by December 2023.

Rite Aid initially had eight chemicals on its restricted substance list (triclosan, propyl paraben, formaldehyde, dibutyl phthalate, toluene, diethyl phthalate, butyl paraben, and nonylphenol ethoxylates).  The new policy has added 61 chemicals.  These chemicals include heavy metals, PFAS, Bisphenols, and solvents.

Along with updating their chemical management policy, Rite Aid has transitioned away from survey-based assessments for identifying chemicals on the restricted substance list.  Rite Aid began the transition process to WERCSmart in September 2018 and has now finish the transition.  Rite Aid suppliers are required to report the substances in their products to WERCSmart.  WERCSmart then analyzes the substances to see if they meet the retailer’s policy.  The chemical management policy does not address CBI issues, although WERCSmart may protect confidential data.

OSHA Proposes Revisions to Hazard Communication Standard

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On February 15, 2021, OSHA posted a notice of proposed rulemaking to make changes to the Hazard Communication Standard.  The proposed changes include updates the criteria for classification on health and physical hazard, updating labels, new labeling provisions for small containers, technical amendments for the contents of safety data sheets, and revisions to definitions of certain terms.

The revised criteria for classification of certain health and physical hazards now includes any hazards associated with a change in the chemical’s physical form or from a reaction with other chemicals. The revised provisions for updating labels now includes the date the chemical is released for shipment.  Labels for bulk shipments can be on the immediate container or with the shipping papers, bills of lading or other electronic means that makes it immediately available to workers “in printed form on the receiving end of shipment”.

The proposed changes also state that chemical manufacturers or importers need to update the label for each individual container with each shipment, but do not need to relabel chemicals that have been released for shipment and are awaiting future distribution. For the new labeling provisions for small containers, additional options are available in situations where it is not feasible to use the full label information.  This includes putting the full label information on an outer package, a statement on the outer package that the smaller container needs to remain in the outer package when not in use, and at least has the product identifier on containers less than or equal to 3 ml.

OSHA is taking public comments on all of the proposed changes and the use of electronic template files to create safety data sheets and labels.  The comment period is open until May 19, 2021.