Court Finds EPA’s Transparency in New Chemicals Disclosures Reviewable

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.

California to Require Substantiation of Carbon Neutral Claims

Under a new California law enacted on October 7, 2023, companies selling carbon offsets or making carbon-neutral claims must now provide evidence to substantiate these measures and claims.

The law requires that businesses marketing carbon offsets disclose specific information on their websites.  This includes details on how emissions reductions were estimated, data and calculation methods to verify these estimates, whether there is third-party oversight, and the accountability measures in place if the project is not completed or proves to be less effective than advertised.  Companies that buy offsets will be required to provide an overview of each offset, including the business that sold the offset, on their websites.

In addition, the measure requires companies that claim to be carbon neutral or claim that they have made significant emissions reductions to support their claims with all available evidence.  Companies must also disclose whether there is third-party oversight of their claims or supporting data.

The law, which is reportedly the first of its kind in the US, authorizes fines of up to $500,000 per violation.  In a press release, the law’s author characterized the legislation as providing necessary transparency amid concerns about corporate greenwashing and the effectiveness of many carbon offsets.

EPA Releases PFAS Analytic Tools

On January 5, EPA released its PFAS Analytic Tools database, a collection of PFAS information the Agency has brought together from internal Agency databases, other federal agencies, and state and tribal agencies. The data will be particularly useful to the Agency when it reviews submissions on  PFAS releases from the Toxics Release Inventory (“TRI”) reporting.  In addition, EPA expects that the database will benefit state, local, and tribal governments in navigating the PFAS-related requirements they are subject to.  The Agency also expects that the database will help communities gain a better understanding of local PFAS releases.

The database has 11 tabs that include:

  • An integrated map,
  • Drinking water contamination, production,
  • Wastewater and/or stormwater discharge monitoring,
  • Superfund sites,
  • Industry sectors in which PFASs were manufactured or used as raw materials, and
  • toxic releases.

In its press release on the database and on the database interface itself, the Agency identifies several data gaps. For example, the drinking water Unregulated Contaminant Monitoring Rule (“UCMR”) data was collected only between 2012 and 2015. EPA notes that state agencies and public water systems may have better data on PFAS levels in drinking water. Additionally, only a few states have set PFAS effluent limits for National Pollutant Discharge Elimination System (“NPDES”) permit holders, causing significant gaps in discharge monitoring. (The Agency has initiated rulemaking to increase monitoring effluent for PFAS.

Each tab identifies relevant data gaps and limitations.

The Agency is taking steps to fill these data gaps, including:

  • Initiating rulemaking to increase monitoring effluent for PFAS;
  • Publishing the fifth Unregulated Contaminant Monitoring Rule, which will significantly increase the number of drinking water samples collected by regulated entities (EPA predicts the number of samples collected will be in the millions);
  • EPA’s proposal to designate PFAS as hazardous substances under CERCLA; and
  • EPA’s recent proposal to change PFAS reporting requirements in the TRI data collection.

EPA recently held a webinar introducing the database and demonstrating its use.  A recording of the webinar is available here. A copy of the Agency’s presentation is available here.

EPA Updates New Chemical Review Program Webpage to Increase Transparency

In December 2022, EPA announced updates to its New Chemicals Review Program website to include additional information and metrics on the Agency’s review of new chemicals and significant new uses.  In the announcement, the Agency stressed its commitment to increasing efficiency, effectiveness, and transparency through the chemical review process. To progress in this goal, the website will now include:

  • A more detailed breakdown of new chemical submissions, including a month-by-month count of new chemical submissions, completed risk assessments, and completed risk management actions for all notices and exemptions.
  • Greater details and explanations on each step of the review process. This includes “the extent to which the submitter has provided additional information during the review period – subsequent to the original submission – and the level of effort needed to potentially rework some or all of the risk assessment as a result” and applicability of new approaches developed by the Agency to standardize reviews for certain new chemicals.
  • A status tracker for new chemical exemptions (e.g., Low Volume Exemptions (LVEs) and Test Market Exemptions (TMEs)).

According to EPA, the new website will be updated monthly.

California Department of Toxic Substances Hosted Engagement Sessions on Sustainable Chemistry Definition

The California Department of Toxic Substances Control (CDTSC) hosted two engagement sessions encouraging stakeholders to share their perspectives on an actionable definition of sustainable chemistry that was provided by the Expert Committee on Sustainable Chemistry (ECOSChem). ECOSChem is a 20-person group including representatives from academia, government, industry, and non-governmental organizations.  The group has been tasked with establishing “an ambitious, actionable definition and criteria for sustainable chemistry that can enable effective government policy, inform business and investor decision making, enhance chemistry education, and spur the adoption across all supply chains of chemicals that are safer and more sustainable.”

In its draft, ECOSChem defined sustainable chemistry as “the practice and application of chemistry that eliminates negative impacts to humans and ecosystems, as well as benefits current and future generations.” The definition was drafted with five criteria in mind (1) health and safety through hazard elimination, (2) climate and ecosystem impacts, (3) circularity, (4) equity and justice, and (5) transparency. In addition to the definition, , ECOSChem provided the following indicators of what sustainable chemistry will look like:

A sustainable chemical, material, process, or product will…

  • Eliminate all associated hazards and hazardous emissions to all people and ecosystems across its existence.
  • Not result in releases, including releases of byproducts or breakdown products, that negatively persist or bioaccumulate.
  • Eliminate impacts on climate and biodiversity by utilizing earth-abundant, non-toxic chemical building blocks that minimize habitat and resource degradation, greenhouse gas emissions, carbon footprints, and energy consumption, including for transportation and distribution.
  • Be designed to have [a] lifetime appropriate for its use and enable safe reuse and non-toxic recycling.
  • Prioritize resource and energy conservation and reclamation, reduce consumption of finite resources, and waste prevention, minimization, and elimination.
  • Be designed such that all associated negative social impacts are eliminated.
  • Be made or implemented to prioritize the remediation of harms for communities and societies that have been disproportionately impacted by traditional chemistries, chemicals, and chemical processes, and/or support the needs of workers, marginalized groups (e.g., immigrant communities, and communities of color), and vulnerable groups (e.g., pregnant women and children).
  • Be made or implemented in a way that does not create new problems or shift harm to other communities or societies.
  • Have had its health, safety, and environmental data disclosed in an accessible format to individuals, workers, communities, policymakers, and the public.
  • Use independent, third-party systems to verify sustainability, health, safety, and other claims. The sources for verification should be openly accessible.

ECOSChem members will use the feedback received at the meeting to revise the definition to ensure that the language is clear and actionable.

 

 

 

 

EPA Implements Collaborative Research Program to Support PMN Reviews

On February 24, EPA announced a new effort “to modernize the process and bring innovative science to the review of new chemicals.”  In addition, the effort is expected to “increase the transparency of the human health and ecological risk assessment process.”  The Office of Chemical Safety and Pollution Prevention (OCSPP) is collaborating on this effort with the Agency’s Office of Research and Development (ORD) and other federal entities including the National Toxicology Program at the National Institute of Environmental Health Sciences.

The draft Strengthening the Science and Process to Evaluate New Chemicals Under TSCA; TSCA New Chemicals Collaborative Research Program: Problem Statement, Vision and Action Plan was released for public comment on March 9.  Written comments will be accepted through April 26, 2022.  In addition, stakeholders may comment at a virtual public meeting on April 20 and 21, 2022.  Instructions for registering for the meeting are available here.

EPA explains that the Collaborative Research Program (CRP) “will refine existing approaches and develop and implement new approach methodologies (NAMs) to ensure the best available science is used in TSCA new chemical evaluations.”  Components of this effort include:

  • Updating the methodology for using data from analogous chemicals to determine potential risks from new chemicals where health effects data on the new substance are not available.
  • Updating and augmenting the models used for predicting a chemical’s physical-chemical properties and environmental fate/transport, hazard, exposure, and toxicokinetics.
  • Developing a decision support tool to integrate the information streams used in new chemical risk assessments into a final risk assessment.

The docket for this effort is EPA-HQ-OPPT-2022-0218.

 

Rite Aid Chemical Policy Update

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.

EPA's ChemView database updated with new chemical SNURs and consent orders.

Yesterday, EPA announced updates to ChemView, its public online tool for accessing information about chemicals regulated under the Toxic Substances Control Act (TSCA). The updates include enhanced data functions as well as updated, more comprehensive information.

The improved data functions include:

  • Improving the display and content for the Chemical Data Reporting information;
  • Adding a new link that displays the pollution prevention information generated as part of the Toxics Release Inventory program; and
  • Launching an administrative tool that will save EPA resources by streamlining the loading of future information.

ChemView’s databases were updated with the following new information:

  • 244 consent orders;
  • An additional 1,205 Significant New Use Rules (SNURs) for new and existing chemicals;
  • 16 additional chemicals with test rule data, and
  • Updates to the Safer Chemicals Ingredient List (part of the agency’s Design for Environment program).

In EPA’s press release, Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Jim Jones explained that the agency was acting since Congress’ attempts to reform TSCA have so far been unsuccessful: “In the absence of TSCA reform, EPA is moving ahead to improve access to chemical health and safety information, and increase the dialogue to help the public choose safer ingredients used in everyday products.”

With the updates, ChemView now covers 10,000 chemicals and includes for the first time consent orders and new chemical SNURs. ChemView was first launched in 2013 to improve the availability of information on existing chemicals by displaying “key health and safety information and uses data in a format that allows quick understanding.”

U.S. chemical industry opposes fracking disclosure rules.

Trade groups representing the U.S. chemical industry are urging EPA not to adopt rules requiring the disclosure of hydraulic fracturing chemicals and mixtures. The Society of Chemical Manufacturers and Affiliates (SOCMA) and the American Chemistry Council (ACC) both filed comments in September responding to EPA’s May 19, 2014 Advance Notice of Proposed Rulemaking. That notice announced that the agency was “initiating a public participation process to seek comment on the information that should be reported or disclosed for hydraulic fracturing chemical substances and mixtures and the mechanism for obtaining this information.” EPA’s filing was made in response to a section 21 citizen petition under the Toxic Substances Control Act (TSCA) and suggested that the contemplated reporting mechanism could be authorized under TSCA §§ 8(a) or 8(d), voluntary, or a combination of both, and “could include best management practices, third-party certification and collection, and incentives for disclosure.”

Both groups argue that mandating disclosure of hydraulic fracturing chemicals and mixtures could reveal trade secrets. In its comments, the ACC wrote that EPA should first finalize its ongoing hydraulic fracturing study, and that voluntary programs “have worked well in the past” and state level regulation is more appropriate than federal. SOCMA proposed “the use of structurally descriptive generic names if a specific name would potentially reveal a trade secret” along with better information collection via EPA’s enhanced Chemical Data Reporting (CDR) in combination with the industry’s voluntary chemical registry, FracFocus.

TSCA reform still faces obstacles in Senate.

Congress’ efforts to pass legislation modernizing the Toxic Substances Control Act (TSCA) have flown under the radar in recent months, but this weekend, the Associated Press provided an update on the difficult path for TSCA reform in the Senate. The AP reports that during the summer, Senate Environment and Public Works Committee Chair Barbara Boxer (D-CA) rejected the revised version of the Chemical Safety Improvement Act (CSIA) presented to her by Sens. Tom Udall (D-NM) and David Vitter (R-LA). Sens. Boxer and Udall both agreed that the new draft’s state preemption provisions remained too broad and must be narrowed.

This latest draft has not been released publicly, although Sen. Udall said it makes “big progress” with regard to TSCA’s safety standard and stressed that it “is a huge improvement compared to the law as it stands now, and as it has stood since 1976.” In contrast, Sen. Boxer said the new draft does not make needed improvements to TSCA. Sen. Boxer pointed to the legislation’s long timelines for reviewing chemicals of concern, saying the bill “could leave nearly a thousand chemicals of greatest concern unaddressed.”

Sen. Boxer also told the AP she would propose a provision to specifically address toxic chemicals that could endanger drinking water, like the chemical MCHM that contaminated drinking water in a massive spill in West Virginia last January.

The AP article quotes NGO representatives from Safer Chemicals, Healthy Families and the Environmental Defense Fund as optimistic that TSCA reform will eventually pass. The American Chemistry Council, which backs the CSIA, has set passing TSCA reform as its top legislative priority, and spent almost $6 million in lobbying during the first half of the year.