EPA Releases Chemical Data Reporting National Review

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EPA has released its first-ever Chemical Data Reporting (CDR) National Review (“Review”), which provides a comprehensive analysis of data submitted to the Agency during the 2020 CDR reporting cycle. The report presents information about chemicals that were manufactured and imported into the US from 2016 through 2019. In its press release on the Review, the Agency stated that the document will assist stakeholders in evaluating and understanding information about the types, quantities, and uses of chemicals produced domestically or imported into the U.S.

Manufacturers and importers of chemical substances listed on the Toxic Substances Control Act (“TSCA”) Inventory are required to report data to the EPA every four years if they manufacture or import substances at or above specific thresholds unless the chemical has been exempted from the reporting requirement. Typically reporting is required when an entity manufactures or imports 25,000 pounds or more of a chemical during any year in the reporting period at any single site. Companies must report how chemicals are processed or used (industrial processing and use data), and whether they are used in commercial or consumer products (commercial and/or consumer use data) in addition to manufacturing and import volumes.

According to EPA, the CDR database is the most comprehensive source of basic screening-level, exposure-related information on chemicals that is available to the Agency. EPA uses the database to screen and prioritize chemicals for further review.

The Review summarizes data from the most recent CDR reporting cycle data (2020), covering activities from 2016 to 2019, and provides trend data for reporting over the past decade. During this reporting period, more than 7.2 trillion pounds of chemicals were manufactured or imported at 5,238 sites.

The Review provides interactive trend analysis, including an interactive map of CDR sites and characteristics of the communities in which these sites are located.  It also includes maps displaying CDR reporting sites by state, and figures with production volumes. In addition, the Review contains informational charts and figures to increase understanding of a variety of CDR data elements, such as analyses of chemical use information. Environmental justice tools from EPA’s EJScreen, the Agency’s environmental justice mapping tool, are also contained in the document.

The Review’s key findings include:

  • Of the more than 8,000 chemicals reported for the 2020 CDR reporting cycle, about 54% were manufactured domestically, and 46% were imported. This is a 10% increase in imported chemicals from the 2016 CDR.
  • Two industry sectors manufactured and imported the bulk of the volume reported to the 2020 CDR: petroleum and coal products manufacturing (64%) and chemical manufacturing (14%). Although it produced less volume than the petroleum and coal products sector, the chemical manufacturing sector produced the majority of chemicals (84%) reported to the 2020 CDR and represented nearly half (43%) of all sites.
  • 180 PFAS were reported by 57 sites for a total production volume of about 678 million pounds.
  • Of the 37 Chemicals undergoing Risk Evaluation, 33 chemicals were reported to the 2020 CDR; that is, they were manufactured or imported at above threshold volumes (2,500 lbs.) in at least one year during the reporting cycle. Thirty-four Risk Evaluation chemicals were reported in both the 2012 and 2016 reporting cycles.
  • Total production volume for the 33 TSCA Risk Evaluation chemicals was about 38 billion pounds. The volume was reported across 254 sites.
  • The number of sites that manufactured and/or imported TSCA Risk Evaluation Chemicals has increased by 40% over the past 10 years, while the manufactured and imported volumes have generally remained consistent.

Community Sues EPA Over Terms for Production of Petrochemical Fuel

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Cherokee Concerned Citizens, on behalf of the Cherokee Forest neighborhood  a fenceline community in Pascagoula, Mississippi, has filed a petition in the U.S. Court of Appeals for the District of Columbia Circuit for review of a TSCA section 5(e) consent order. The consent order covers 18 chemicals that were the subject of premanufacture notifications submitted by Chevron in 2021. In its press release announcing the litigation, Earthjustice asserted that the production of these chemicals would result in air pollution that would pose a 1 in 4 cancer risk (25 % of the residents living nearby could develop cancer over their lifetime), 250,000 times greater than what the Agency typically considers unreasonable.

TSCA requires EPA to regulate the manufacturing, processing, and distribution of substances that present an unreasonable risk of injury to health or the environment without consideration of costs or other non-risk factors. The Statute states that the Administrator shall issue consent orders and significant new use rules “to the extent necessary to protect against such risk.”

EPA identified skin and eye irritation; acute toxicity; systemic toxicity (neurotoxicity, body weight effects, and liver, kidney, blood, spleen, and other organ effects); reproductive and developmental toxicity; oral and inhalation portal of entry effects; genetic toxicity; and carcinogenicity as hazards of these New Chemical Substances. These hazards were identified based on the substance’s estimated physical/chemical properties by comparing them to compositionally analogous mixtures for which there is information on human health hazard, using available human hazard information on representative constituents of these New Chemical Substances, and other structural information. As is often the case with PMNs, there were no experimentally derived hazard data for these New Chemical Substances.  For a number of the substances, risks were identified for the general population (infants) for systemic and/or oral portal-of-entry effects via drinking water. Risks to adults for this exposure route were also identified. In addition, risks were identified for the general population for systemic and/or inhalation portal-of-entry effects via fugitive air inhalation for some of the substances at issue.

The consent order imposes worker protection and limitations on the distribution of the new chemical substances. It does not restrict air emissions or wastewater discharges of the substances. The Chevron facility called out by Earthjustice is permitted under the Clean Air and the Clean Water Acts.

EPA Releases Proposed Approach for Considering Cumulative Risks Under TSCA

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EPA recently released two documents regarding cumulative risk assessments under TSCA section 6, Draft Proposed Principles of Cumulative Risk Assessment Under the Toxic Substances Control Act, and Draft Proposed Approach for Cumulative Risk Assessment of High-priority Phthalates and Manufacturer-Requested Phthalate under the Toxic Substances Control Act. The first document details a set of principles for evaluating the cumulative risk of substances under TSCA; the second document presents a proposed approach for applying those principles to the evaluation of the cumulative risk posed by certain phthalate chemicals which are currently undergoing TSCA section 6 risk evaluation.

In the  Draft Proposed Principles of Cumulative Risk Assessment Under TSCA, EPA explained that it plans to alter its approach to individual substance evaluations under TSCA section 6 by taking a cumulative assessment approach when appropriate. Previously, the Agency looked at the risks posed by a single substance under its specific conditions of use. The Agency now intends to implement a new approach to evaluating human health effects, which it believes is more appropriate when considering human exposure to these substances. People are often exposed to many chemical substances with similar effects at the same time, and looking at the combined exposure health risk will paint a more complete picture. The Agency believes that this approach will allow for more effective mitigation of identified unreasonable risks and provide particularly useful information for communities that face higher than normal levels of chemical pollution.

Phthalates will be subjected to a cumulative risk assessment because the group of substances has similar effects on human health and has generally been found concurrently in the human body. The phthalates to be assessed as a group include DEHP, BBP, DBP, DIBP, DCHP, DINP, and DIDP. The chemical group is often used in industrial and consumer products to make plastics more flexible and durable. The draft proposal requests comment and peer review on its assessment that six phthalate substances are toxicologically similar, and the U.S. population is frequently co-exposed to these substances, making a cumulative risk assessment the most appropriate course of review action under TSCA.

The Agency is accepting comments on these documents through April 28, 2023.

Verdant Law Presents on Chemical Regulatory Framework and Implications for Product Design

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This month Verdant Law founder Phil Moffat traveled to Orlando, Florida, to present at the International Consumer Product Health and Safety Organization (ICPHSO) 2023 Annual Meeting and Training Symposium. Mr. Moffat’s presentation discussed the implications of chemical regulation for product design.

The presentation outlined recent trends in the chemical regulatory landscape, including EPA’s PFAS reporting rule, state regulations banning PFAS in children’s toys, flame retardants, and other products, and state PFAS labeling and reporting rules. The presentation discussed the risk of regrettable substitutions from both human health and environmental perspectives, as well as from a product efficiency perspective. (An example of decreased product efficiency could be removing PFAS used to waterproof a product may decrease the product’s efficiency if the replacement doesn’t repel water as well.) It also addressed risks associated with introducing multiple versions of the same product into commerce. In addition, Mr. Moffat covered risks of regulatory noncompliance, including penalties, seizures, recall, and market backlash, as well as risks of legal liability. The presentation recognized that the regulatory framework could be incredibly difficult for companies to navigate.

If you would like to view the presentation, it can be found here. For questions or assistance with regulatory compliance for consumer and industrial products, please contact Verdant Law.

EPA Updates New Chemical Review Program Webpage to Increase Transparency

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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.

EPA Releases White Paper on Modernizing the Process and Bringing Innovative Science to Evaluating New Chemicals Under TSCA

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EPA recently released a white paper, The New Chemicals Collaborative Research Program: Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA. The document was produced as a summary report to the Board of Scientific Counselors as an integrative research plan under the 2023-2026 Chemical Safety for Sustainability (CSS) Strategic Research Action Plan. This plan seeks to address concerns by both industry and environmental organizations, including the significant lag in EPA’s review of new chemicals, lack of transparency in the process, and insufficient consideration of potential hazards. In addition, the plan would allow EPA’s staff to use new scientific methods to analyze chemical impacts on humans and the environment.

Under TSCA, chemical manufacturers have not been required to provide chemical hazard data in their PMN applications. Under the proposed new processes, data on toxicity, exposure, chemical use, and other databases, in conjunction with computer-based analysis methods, would make chemical reviews easier for the Agency. The plan will focus on five key research areas:

(1) Updates and refinements to chemical analog and category approach.

(2) Development and expansion of databases containing TSCA chemical information.

(3) Development and refinement of predictive models for physiochemical properties, environmental fate/transport, hazard, exposure, and toxicokinetics.

(4) Integration and application of in vitro New Approach Methodologies (NAMs).

(5) Development of a TSCA new chemicals decision support tool that utilizes curated data.

Using these NAMs, the Agency hopes to fill information gaps and address the challenges of its current framework.

Petition to Remove Polyvinyl from EPA’s Safer Choice and Safer Chemical Ingredients List

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On November 15, 2022, BlueLand and Plastic Pollution Coalition filed a petition with EPA on behalf of itself and numerous non-profit organizations fighting plastic pollution and climate change, requesting that EPA require health and environmental testing and regulation of polyvinyl alcohol under TSCA, and that the substance be removed from EPA’s Safer Choice and Safer Chemical Ingredients lists. TSCA section 21 permits any person to petition EPA to initiate a proceeding for the issuance, amendment, or repeal of a rule or order under TSCA section 4 (rules or order requiring chemical testing), section 5(d) or (f) (orders affecting new chemical substances) section 6 (rules imposing regulatory controls on chemicals), and section 8 (rules requiring information).

Polyvinyl alcohol, also referred to as PVA or PVOH, is commonly used in consumer-packaged goods, including laundry and dishwasher detergent pods and sheets. PVA is a petroleum-based polymer that serves as the thin layer of plastic film on these pods. The film dissolves in the water during a washing machine or dishwasher cycle. However, the PVA itself does not; tiny pieces of plastic debris called microplastics are contained in the wastewater.

Microplastics are suspected of contributing to plastic pollution in oceans and waterways. A recent study detailed in Degradation of Polyvinyl Alcohol in US Wastewater Treatment Plants and Subsequent Nationwide Emission Estimate stated that approximately 75 % of PVA from these pods persists through conventional wastewater treatment, ultimately ending up in waterways and ecosystems. Additionally, microplastics have been found in human food and water sources, the human bloodstream, and human breast milk.

The petition argues that under TSCA (15 U.S.C 2603), EPA has the authority to and should require extensive health and environmental safety testing of PVA once it is released into ecosystems and waterways. The petition also requests that PVA be removed from EPA’s Safer Chemicals Ingredient List developed by EPA’s Safer Choice Program; the list arranges chemicals by functional-use class to help manufacturers find safer chemical alternatives than traditional chemicals that meet the criteria of the Safer Choice Program. The petition argues that based on PVA’s bioaccumulative and persistence qualities, when applied to the Safer Choice Program’s guidance on polymers, PVA does not meet the requirements to be listed.

EPA Releases Supplemental Proposed Rulemaking to Modify TSCA Fees Rule

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On November 16, 2022, EPA published a supplemental notice of proposed rulemaking (SNPRM) (87 FR 68647) addressing fees for the administration of TSCA. The SNPRM modifies and supplements the Agency’s proposed TSCA fees rule issued on January 11, 2021. The 2021 proposed rule was released pursuant to TSCA section 26(b)(4)(F), which requires EPA to review and, if necessary, adjust fees every three years. EPA determined this SNPRM was necessary based on comments on the proposed rule, adjustments to EPA’s cost estimates, and additional experience in implementing the 2018 Fee Rule. Modifications include:

  • Increasing fee amounts and the estimates of EPA’s costs for TSCA administration.
  • Expansion of the fee requirements to companies required to submit information for test orders.
  • Narrowing the proposed exemptions for the test rule fee activities to only: (1) importers of articles containing a chemical substance; (2) producers of a chemical substance as a byproduct; (3) manufacturers (including importers) of a chemical substance as an impurity; (4) producers of a chemical as a non-isolated intermediate; (5) manufacturers (including importers) of small quantities of a chemical substance solely for research and development and; (6) manufacturers (including importers) of chemical substances with production volume less than 1,100 lbs of a chemical subject to a TSCA section 4 test rule.
  • Adjustments to the self-identification and reporting requirements of EPA-initiated risk evaluation and test rule fees to reduce the burden of calculating and reporting production volumes to comply with the 2021 proposed recordkeeping requirements. EPA is considering using ranking methodologies and reporting production volume ranges instead of averages.
  • The proposal of a partial refund of fees for PMNs withdrawn any time after the first 10 business days during the assessment period for the chemical.
  • Adjustment of the fee payment obligations to require payment by processors subject to test orders and enforceable consent agreements.
  • Extending the time frame for test orders and test rule payments.

The proposed fee increases are as follows:

Fee Category 2018 Fee Rule Current Fees* 2022 Supplemental Proposed Rule
Test order $9,800 $11,650 $25,000
Test rule $29,500 $35,080 $50,000
Enforceable consent agreement $22,800 $27,110 $50,000
PMN and consolidated PMN, SNUN, MCAN, and consolidated MCAN $16,000 $19,020 $45,000
LoRex, LVE, TME, Tier II exemption, TERA, Film Articles $4,700 $5,590 $13,200
EPA-initiated risk evaluation $1,350,000 Two payments totaling $2,560,000 Two payments totaling $5,081,000
Manufacturer-requested risk evaluation on a chemical included in the TSCA Work Plan Initial payment of $1.25M with final invoice to recover 50% of actual costs Two payments of $945,000, with final invoice to recover 50% of actual costs Two payments of $1,497,000, with final invoice to recover 50% of actual costs
Manufacturer-requested risk evaluation on a chemical not included in the TSCA Work Plan Initial payment of $2.5M, with final invoice to recover 100% of actual costs Two payments of $1.89M, with final invoice to recover 100% of actual costs Two payments of $2,993,000, with final invoice to recover 100% of actual costs

*The current fees reflect an adjustment for inflation required by TSCA and went into effect on January 1, 2022.

EPA states that increased fees will ensure recovery of 25% of implementation costs, consistent with the direction of the Fiscal Year 2022 appropriations bill. The Agency also states that the fee increases will strengthen its ability to successfully implement TSCA in a manner that is both protective and sustainable.  Furthermore, EPA asserts that the fee increases will improve on-time performance and quality significantly.

EPA officials have repeatedly argued that the 2016 Lautenberg Amendments tasked the Agency with many new responsibilities but did not increase the TSCA budget accordingly. According to the Agency, while there was a fee increase in 2018, EPA was only able to collect about half of the 25% target fees since the 2018 rule’s finalization. Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff commented, “[f]or the last six years, we’ve lacked the needed resources to build a sustainable chemical safety program that’s grounded in science, protects communities from dangerous chemicals, and supports innovation; with today’s action, we’re continuing to adjust TSCA fees to account for the full costs of running the program the way that Congress intended.”

EPA will hold a webinar on December 6, 2022, from 1:00 PM to 2:30 PM to provide stakeholders with an overview of the SNPRM and accept public comments. Registration closes on December 1, 2022; you can register for the webinar here.

Verdant Law’s Irene Hantman Gives Presentation to Chemical Society of Washington on Chemical Commercialization

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Verdant Law is pleased to announce that Irene Hantman gave a presentation, Chemical Commercialization: What to Know about EPA Regulations, before the Chemical Society of Washington. The presentation provided a comprehensive overview of chemical commercialization under the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The overview of TSCA detailed the definitions of chemical substances and substances in commerce, background on the TSCA Inventory and the premanufacture notification (PMN) process, and the EPA platforms for reporting and submitting data related to PMNs and active Inventory substances. The overview of FIFRA outlined the definition of pesticides under the law, the pesticide registration process, data requirements, review timelines and fees, and potential tolerance limitations EPA may set on chemicals with food uses. For questions about this presentation, contact Irene Hantman.

EPA Evaluation of PFAS Leaching in Fluorinated Containers

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On September 8, 2022, EPA announced findings of the Agency’s evaluation of PFAS leaching in fluorinated containers.  Specifically, the evaluation assessed the extent to which PFAS that are present in the packaging leach into the contents of the containers.  The study tested the leaching potential of PFAS over a 20-week test period into water, methanol and similar solutions that were packaged in different brands of HDPE fluorinated containers.  EPA undertook this evaluation after learning of PFAS contamination in some mosquitocide products, and after conducting a study of other pesticides stored in fluorinated high-density polyethylene containers.   In both cases the Agency found varying levels of PFAS in the contents of the containers.

The announcement reported that EPA has determined that any liquid products packaged in HDPE containers that have been treated with fluorination technology could be contaminated with PFAS, including water-based products.  The Agency also reported that the amount of PFAS that leach into the products could increase over time.   EPA noted that the Agency does not know if all fluorinated containers will leach PFAS because the Agency’s analysis did not test all the different fluorination technologies.

The announcement included a reminder that pesticide registrants must notify the Agency if they discover PFAS in any of their products.  Under FIFRA §6(a)(2) and 40 CFR §159.179, “additional factual information on unreasonable adverse effects, including metabolites, degradates and impurities (such as PFAS)” must be reported to EPA within 30 days after the registrant “first possesses or knows of the information.”  Note that the Agency considers any level of PFAS to be potentially toxicologically significant and therefore reportable.

The announcement also noted that in many cases, the manufacture of PFAS from the fluorination of polyolefins is subject to the Agency’s significant new use rule  for long-chain perfluoroalkyl carboxylates (LCPFACs) under the Toxic Substances Control Act (TSCA).  Companies must notify EPA at least 90 days before starting manufacturing or processing of these chemical substances for this significant new use.  TSCA requires significant new use notification in these situations to allow EPA review any associated risks and impose any needed protections.