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

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

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

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

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

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

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

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.

Implementing Statutory Addition of Certain PFAS Substances to the Toxics Release Inventory Reporting

In July 2022, EPA released a final rule adding five PFAS to the list of chemicals required to be reported to the Toxics Release Inventory (TRI) under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA). TRI tracks the management of certain toxic chemicals that may pose a threat to human health or the environment and provides this information to the public. Pursuant to the National Defense Authorization Act (NDAA), EPA is required to automatically add PFAS to the TRI whenever it takes one of the following actions:

  • EPA finalizes a toxicity value for a PFAS or class of PFAS;
  • EPA determines that a PFAS or a class of PFAS is covered by a TSCA Significant New Use Rule (SNUR);
  • EPA adds PFAS or a class of PFAS to an existing SNUR; or
  • EPA finds that a PFAS or class of PFAS is active in commerce (under TSCA Section 8).

Under this rule, facilities in specific industry sectors that manufacture, process, distribute, or use any of the five PFAS added to the TRI, must submit a TRI report if they exceed the PFAS reporting threshold of 100 pounds. Four of the substances are added to the list effective January 1, 2022, and the remaining substance is effective January 1, 2021, meaning TRI reporting due in 2023 must account for these substances.

EPA Issues First Test Order for PFAS in Commercial Firefighting Foam

EPA recently issued a test order under TSCA section 4 to select companies requiring that they develop and submit certain information on 6:2 fluorotelomer sulfonamide betaine, a PFAS. The order is part of the Agency’s National PFAS Testing Strategy which will evaluate a large number of PFAS for potential human and ecological effects as “most PFAS lack data for robustly characterizing their potential toxicity.

The test order was issued to Chemours Company, DuPont De Nemours Inc., National Foam Inc., and Johnson Controls Inc.  6:2 fluorotelomer sulfonamide betaine is used to make commercial firefighting foam and certain floor finishes.  The test order explains that EPA found insufficient data on 6:2 fluorotelomer sulfonamide betaine to determine or predict the effects on human health specifically by the inhalation route.  The order applies a tiered testing strategy.  EPA has ordered the companies to generate of data on certain physical-chemical properties (e.g., density, particle size, hydrolysis as a function of pH).  The Agency will use those data to determine whether further testing (e.g., inhalation toxicokinetic study, acute inhalation study) is needed.  Under TSCA section 4(a)(4), EPA is required to employ a tiered screening and testing process under which the results of screening-level tests or assessments of available information inform the decision as to whether additional tests are necessary.

EPA intends to issue additional test orders to other PFAS manufacturers in the coming months. A detailed overview of the activities involved in issuing a TSCA Section 4 order can be found here.

PFAS From Certain Plastic Can Violate Chemicals Law, EPA Says

Earlier this year, EPA released a letter to manufacturers, processors, distributors, users, and those that dispose of fluorinated high-density polyethylene (HDPE), informing them of possible violations of the Toxic Substances Control Act (TSCA).  EPA determined through recent testing that certain PFAS have unintentionally formed during or following the process of fluorinating polyolefins. Manufacturers and processors of fluorinated polyolefins modify polymers with fluorine to create high-performance barriers.  These barriers are then used in the storage and transport of various products to keep the product inside the container without notable permeation.  During some methods of fluorination, such as in the presence of oxygen, PFAS can occur as a byproduct.

EPA first noticed the unintentional formation of PFAS in containers used in storing and transporting pesticides, and it is researching whether this problem occurs in other HDPE products. This effort to restrict human health and environmental exposure to PFAS is one of many steps the Agency has outlined in its PFAS Strategic Roadmap.

EPA’s letter reminds the HDPE industry that certain long-chain PFAS are subject to a TSCA Significant New Use Rule (SNUR) (See 40 CFR § 721.10536). Generally, chemical substances created during the manufacturing process that does not have a separate commercial purpose are considered byproducts and are exempt from SNUR requirements under 40 CFR § 721.45(e). But certain long-chain PFAS byproducts produced during the manufacture of fluorinated polyolefins do not meet the requirements of the byproducts exemption and therefore require a SNUR. These rules require the manufacturer to notify EPA at least 90 days before commencing the manufacture (including import) or processing of these chemicals for significant new use.

The Agency encourages the industry to review the relevant regulations at 40 CFR § 721. Any questions on the topic can be directed to the Existing Chemicals Risk Management Division in the Office of Pollution Prevention and Toxics at TSCA_PFAS@epa.gov.